PURPOSE

University of Utah Institutional Review Board (IRB) standard operating procedures (SOPs) provide a framework for the ethical and scientifically sound conduct of human research. This SOP outlines the University of Utah IRB practice for creating, publishing, and routine review of its policies, procedures, and guidance documents. Supported by institutional policies and written procedures, the IRB SOPs ensure that the rights and welfare of human research subjects are overseen and protected uniformly, regardless of personnel changes.

SCOPE

This SOP applies to the University of Utah Institutional Review Board and staff.

POLICY

The University of Utah Institutional Review Board functions independently. Federal regulations governing human subjects research, and the University of Utah Administration, through the Vice President for Research, grant the IRB this authority as part of the Human Research Protection Program.

The IRB maintains an active Federal Wide Assurance (FWA) and agrees to apply 45 CFR 46 whenever the University of Utah is engaged in human subjects research conducted or supported by any U.S. federal department or agency that has adopted the U.S. Federal Policy for the Protection of Human Subjects (also known as the Common Rule) of the department or agency conducting or supporting the research determines that the research shall be conducted under a separate assurance.

Research that is not federally funded, supported or otherwise subject to federal oversight, and that is outside of the FWA is subject to commensurate protections by the University of Utah IRB except where otherwise described in University of Utah IRB policy (see IRB SOP 105: Non-Federally Funded Research).

The IRB adheres to 21 CFR 50 and 56 for clinical investigations regulated by the Food and Drug Administration (FDA). The IRB applies the principles of the International Conference on Harmonization’s Good Clinical Practices (ICH-GCP) to clinical investigations, as adopted by the FDA and insofar as the standards and requirements are consistent with 21 CFR.

The University of Utah IRB applies the standards of the HIPAA Privacy Rule (45 CFR Part 160 and Subparts A and E of Part 164) to research that involves the use of protected health information.

PROCEDURES

1. Review, Approval, and Revision of IRB SOPs
   1. If the creation of a new SOP is necessary, the SOP will be sent to the full IRB Executive Committee for review and approval.
   2. Each SOP that has been approved and published on the IRB website will be reviewed no less than three years from the date of approval as described in this policy. The review date is determined as three years from the last date of approval. The IRB Director may extend the review date as deemed necessary.
   3. For the review of an approved SOP, an IRB Administrator initially reviews the SOP for consistency with state or federal guidelines, current practices or institutional polices. If minor clarifications and changes are necessary, the IRB Administrator provides the revised SOP to a designated member(s) of the IRB Executive Committee for approval. If the IRB Administrator determines that significant changes to a policy must be made, the revised SOP may be sent to the full IRB Executive Committee for approval.
   4. Review and approval of the SOP is documented by an IRB Administrator who records the date approved, and the IRB Executive Committee member(s) responsible for approval. The approval date is the effective date.
2. SOP Dissemination
   1. Any new or revised SOP is disseminated to IRB members and IRB staff by an IRB Administrator. Record of dissemination and any applicable training is documented by the IRB Administrator.
   2. Approved SOPs are posted on the IRB website by an IRB Administrator or designee.
3. Creating and Using IRB Forms
   Forms are used to ensure that policies are integrated into the daily research and review operations and enable the IRB to manage review, tracking, and notification functions consistently. Forms are not subject to the same standards of control cited in sections 1 and 2. Forms include checklists, applications, and automated notifications sent by the University of Utah Electronic Research Integrity and Compliance Administration system (ERICA).
   1. Forms are created and revised by IRB administrators or designee under the direction of the IRB Director.
   2. As applicable, forms are implemented in the ERICA online system by the ERICA programmer(s).

PURPOSE

Training of Institutional Review Board (IRB) staff and IRB members is critical to fulfilling its mandate to protect the rights and welfare of research subjects consistently throughout the University of Utah research community. The training and education of those who conduct research is equally important to ensure that human subjects are being adequately protected. Therefore, training and continuing education is valued and required for IRB staff, IRB members, and for those conducting human subject research at the University of Utah.

SCOPE

This SOP applies University of Utah IRB staff and IRB members. The SOP also applies to those who conduct human subject research at the University of Utah and its affiliates, namely investigators and key study personnel.

DEFINITIONS

1. Affiliated institutions (i.e., affiliates) have a Memorandum of Understanding (MOU) with the University of Utah designating the University of Utah IRB as the IRB of record. The University of Utah IRB has oversight of research conducted at affiliated institutions.
2. Key study personnel are individuals engaged in the conduct of research activity, including investigators and research personnel who are directly involved in conducting research with study participants or who are directly involved in using study participants’ identifiable private information during the research.

POLICY

The IRB Director or designee establishes the educational and training requirements for IRB staff and IRB members. IRB staff and IRB members receive initial training and continuing education regarding the responsible review and oversight of human subject research including the University of Utah IRB standard operating procedures (SOPs).

IRB members must complete initial training and continuing education on human subject research ethics and regulations. As appropriate, instruction pertaining to existing or new IRB SOPs is provided to IRB members.

Investigators and key study personnel conducting research at the University of Utah and its affiliates must complete the Collaborative IRB Training Initiative (CITI) human subject research training program. The individual must complete the modules pertinent and applicable to their field of research (that is, biomedical or social/behavioral sciences). All investigators and key study personnel conducting a clinical trial must also complete Good Clinical Practice (GCP) training regardless of funding sources or federal oversight. CITI and GCP training must be recertified every three years. Investigators and key study personnel conducting research under the Single IRB (SIRB) model must complete SIRB training before the research can be activated at the University of Utah.

PROCEDURES

1. IRB Staff Training
   1. IRB staff must complete human subject research training. IRB staff may complete the training offered for researchers that is approved by the University of Utah IRB. Verification of training is recorded in the University of Utah Electronic Research Integrity and Compliance Administration system (ERICA).
   2. IRB staff must complete initial training and continuing education. A training and education plan approved by the IRB Director is provided to IRB staff. Training and continuing education requirements are outlined in the plan. IRB staff members should retain documentation of the completion of any required training.
   3. IRB staff are encouraged to attend workshops and other educational opportunities focused on IRB functions and human subject research. The University of Utah IRB supports such activities to the extent possible and as appropriate for staff responsibilities. Attendance may be used toward continuing education requirements as determined by the IRB Director or designee. Certificates of completion should be retained by the IRB staff member.
2. IRB Member Training
   1. IRB members must complete human subject research training. IRB members may complete the training offered for researchers that is approved by the University of Utah IRB. Verification of training is recorded in ERICA.
   2. IRB members must complete initial training and continuing education in areas germane to their responsibilities. The options for training and continuing education must be approved by the IRB Director or designee. The method of documenting completion of training or continuing education is determined by an IRB Manager or designee.
   3. IRB members are encouraged to attend workshops and other educational opportunities focused on IRB functions and human subject research. The University of Utah IRB supports such activities to the extent possible and as appropriate for member responsibilities. Certificates of completion should be retained by the IRB member and may submitted to the IRB office as necessary.
   4. IRB Chair(s) and IRB Vice-Chair(s) receive supplementary training in areas germane to their additional responsibilities as necessary.
3. Investigator and Study Personnel Training
   1. Investigators and key study personnel must provide a certification of completion or recertification to the University of Utah IRB to conduct human subject research. Verification of training is recorded in ERICA.
   2. Investigators and key study personnel must provide a certificate of completion for other required training (e.g., GCP training, SIRB training) to the University of Utah. Verification of training is recorded in ERICA.
   3. Investigators and key study personnel may complete required training concurrently during the initial IRB review process of the research. The IRB coordinator verifies the completion of required training program(s) by investigators and key study personnel before notification of final approval is issued and the application is moved to an approved status in ERICA.
   4. The Office of the Vice President for Research offers continuing education and training opportunities through the Office of Research Education (REd) designed to support, develop, and maintain a standardized body of knowledge and best practice methodology for all research personnel at the University of Utah. Investigators and key study personnel have an open invitation to attend or complete as many of the educational sessions as available. Certificates of completion should be retained by the individual completing the training or continuing education.

PURPOSE

The University of Utah Institutional Review Board (IRB) staff provides expertise, and administrative support to IRB panels. IRB staff is a link between the board members and the research community. The University of Utah IRB staff is a vital component in the effective operation of the University of Utah Human Research Protection Program (HRPP). This SOP describes the general hiring and supervision of

SCOPE

This SOP applies to the staff of the University of Utah IRB.

DEFINITIONS

1. Administrative staff includes administrators, coordinators, and additional support staff.
2. For the scope of this policy and procedure, the IRB Director designee may be the IRB Associate Director or an IRB Manager.

POLICY

The University of Utah Department of Human Resources determines the policies for recruiting and hiring University of Utah IRB staff. The University of Utah Department of Human Resources determines the policies for identifying, documenting, and retaining formal staff interactions (such as performance reviews, termination procedures, etc.).

Staffing levels and function allocation will be determined according to University of Utah policy, management assessment of support requirements, and budget constraints. The review of staffing levels and function allocation occurs annually as part of standard University of Utah budget negotiations.

IRB staff are not responsible for business development for the University of Utah. IRB staff are the only individuals responsible for daily IRB operations, including the review processes. All members of the IRB staff will have a description of the responsibilities for their respective positions including expectations for performance and training.

PROCEDURES

1. Hiring and Ongoing Performance Evaluations
   1. The Associate Vice President for Research Integrity conducts a performance review of the IRB Director annually.
   2. The IRB Director hires the IRB Associate Director and IRB managers. The IRB Director or designee oversees the hiring of remaining IRB administrative staff.
   3. The IRB Director or designee establishes personnel requirements (i.e., initial training requirements, ongoing education requirements, etc.) of the IRB Associate Director and IRB managers. The IRB Director oversees the IRB managers in establishing personnel requirements for remaining administrative staff.
   4. Performance reviews of IRB staff are conducted annually by the appropriate supervisor.

The University of Utah IRB reviews both federally-funded research and non-federally funded research. Generally, the University of Utah IRB will apply the Federal Policy for the Protection of Human Subjects (the Common Rule) to all human subject research conducted at this institution and its affiliates, regardless of the source of funding. Non-federally funded research is subject to the same scrutiny except where otherwise described in the University of Utah Policy.

Specifically, non-federally funded research is not subject to the same requirements for:

• Approval periods and expiration dates (see SOP 307: Approval Period and Determination of Expiration)
• Continuing Review (See SOP 404: Continuing Review)
• Exemption from IRB review (see SOP 401b: Research Activities Exempt from IRB Review)
• Informed Consent requirements (see SOP 701: General Requirements of Informed Consent)
• Reporting to OHRP if the IRB takes any of the followings actions (see SOP 905: Institutional Reporting Procedures):
  • Determines that an event represents an unanticipated problem involving risks to participants or others
  • Determines that non-compliance was serious or continuing
  • Suspends or terminates approval of research

DEFINITIONS

POLICY

Studies initiated before January 21, 2019 will be grandfathered and continue to be subject to the pre-2018 Common Rule. Studies initiated (approved) on or after January 21, 2019 are subject to the Final Rule.

The University of Utah IRB (UUIRB) did not elect to transition any studies during the delay period of July 19, 2018 through January 20, 2019.

The UUIRB will allow for a grandfathered study to transition to comply with the Final Rule. The IRB must document the date and the determination to transition a study to the Final Rule. Transitioned studies must adhere to all aspects of the Final Rule, not individual components.

The FDA intends to harmonize, to the extent possible, the FDA’s regulations with the Final Rule but has not yet done so as of date of this policy (see version date). Until such a time when harmonized regulations have been finalized, the UUIRB will review studies subject to FDA regulations as follows:

• Informed Consent
  • The informed consent requirements related to the content, organization and presentation of information included in the consent form and process as well as the basic and additional elements of informed consent in the Final Rule are not inconsistent with the FDA’s current policies and guidance. The UUIRB may approve a consent process for an FDA-regulated study that is consistent with the Final Rule.

• Expedited Review

  • The FDA regulation 21 CFR 56.110(b) allows for expedited UUIRB review procedures for certain kinds of research appearing on the published list in the Federal Register, 19981. In order to use the expedited review procedure, the IRB reviewer must find that the research involves no more than minimal risk.

    The Final Rule changed the expedited review procedures in 45 CFR 46.110(b). The Final Rule states that the IRB may use expedited procedures for research appearing on the published list unless the IRB determines that the study involves more than minimal risk. Because the FDA has not revised its regulations, the UUIRB must continue to comply with the FDA’s regulation (21 CFR 56.110(b)) for FDA-regulated studies, including studies that are subject to both HHS and FDA regulations.

• Continuing Review
  • The FDA regulation 21 CFR 56.109(f) states that IRBs are required to conduct continuing review of research at intervals appropriate to the degree of risk, but not less than once per year.The Final Rule eliminated the requirement to conduct continuing review in certain circumstances (45 CFR 46.109(f)(1)). Because the FDA has not revised its regulations, the UUIRB must continue to comply with the FDA’s regulation (21 CFR 56.109(f)) for FDA-regulated studies, including studies that are subject to both HHS and FDA regulations.

PROCEDURES

1. Procedures for the Transition of Grandfathered Studies to the Final Rule
   1. IRB staff will evaluate grandfathered studies during the pre-review of continuing review applications to determine whether the study is recommended for transition to the Final Rule. Factors that will influence recommendation to transition include but are not limited to:
      • Studies with closed enrollment
      • Studies that are in long-term follow-up
      • Chart reviews
      • Expedited studies with no consent document
   2. If a study is ideal for transitioning to the Final Rule, the IRB staff member responsible for the internal review will notify the investigator. If necessary, guidance will be provided to the investigator about compliance to the Final Rule. Investigators are not compelled to transition a grandfathered study to the Final Rule and may decline the invitation to transition the study.
   3. Investigators may request that a grandfathered study be transitioned to the Final Rule. Requests to be transitioned to the Final Rule may be made via an amendment application or in a continuing review application.
   4. Documentation that the grandfathered study will be transitioned to the Final Rule is made in the internal checklist and study record in ERICA. The date of transition determination is the approval date of the continuing review or the amendment. The date of transition determination also serves as the date the study is in compliance with the Final Rule. Investigators will receive documentation of the transition determination in the approval letter.

PURPOSE

This SOP outlines the specific authority granted to the University of Utah Institutional Review Board (IRB) to review, approve, and monitor research involving human subjects as a component of the Human Research Protection Program at the University of Utah.

SCOPE

This SOP applies to the University of Utah IRB and those with signatory authority for the IRB.

DEFINITIONS

1. Affiliated institutions (i.e., affiliates) have a Memorandum of Understanding (MOU) with the University of Utah designating the University of Utah IRB as the IRB of record. The University of Utah IRB has oversight of research conducted at affiliated institutions.
2. The Federalwide Assurance (FWA) is an assurance of compliance with the U.S. federal regulations for the protection of human subjects in research.
3. The Institutional Official is ultimately responsible for the oversight and conduct of the Human Research Protection Program of which the IRB is a component.

POLICY

The Vice President for Research has been designated by the Board of Trustees and the University of Utah President to serve as the Institutional Official on the University of Utah’s Federalwide Assurance with the Office of Human Research Protection (OHRP) which also serves as the Food and Drug Administration (FDA) registration for IRBs.

The University of Utah Administration through the Vice President for Research grants the University of Utah IRB authority to approve research activity, specify modifications required to secure IRB approval of the research activity, or disapprove any research activity overseen and conducted by the University of Utah and its affiliates. The University of Utah IRB may suspend or terminate approval of research that is not being conducted in accordance with the IRB’s policies, is not in compliance with federal regulations, or that is associated with unexpected, serious harm to participants. The University of Utah IRB also has the authority to observe or have a third party observe the consent process, and the conduct of the research.

Research that has been approved by the University of Utah IRB may be subject to further review and approval or disapproval by officials of the University of Utah, as appropriate. However, University of Utah officials may not approve the research if it has not been approved by the University of Utah IRB.

The IRB Director, IRB Chair(s), and IRB Vice Chair(s) are authorized to sign any documents in connection with the review and approval of research projects involving the humans subjects, which have been reviewed and approved pursuant to University of Utah IRB policies and procedures. The IRB Chair may designate signatory authority to qualified IRB members and IRB staff members, as appropriate. In all cases, individuals must sign their own name and indicate their title under their signature.

Electronic signatures via the Electronic Research Integrity and Compliance Administration system (ERICA) are considered valid. Individuals must electronically approve items using their secure login. ERICA is password protected and limited to only those individuals directly connected with the project and the appropriate regulatory staff. ERICA records the individual by name and their electronic approval (i.e., electronic signature), and all actions taken by that individual. The results of IRB review, actions, and decisions are issued through ERICA and is further described in IRB SOP 305: Documentation.

Any action, letters, memos, or emails between the IRB, and/or members of the faculty or staff of the University of Utah that provides information concerning the review of research protocols by the IRB or IRB staff which do not imply or appear to imply approval of the research protocol, may be signed by designated IRB staff members.

Any letters or memos sent to agencies of the federal government, funding agencies (whether private or public) or their agents on behalf of the University of Utah IRB are signed by the Institutional Official, IRB Director, IRB Chair or designee. Letters or memos may be signed with an electronic signature.

Any letters, memos or email sent representing the decision or opinions of the IRB Chair or designee, may be signed by the IRB Chair or designee, as long as such correspondence does not imply review and approval of research projects.

PURPOSE

The University of Utah Institutional Review Board (IRB) is composed of members in accordance with federal regulations. This SOP outlines the composition of the IRB and the procedure to appoint members. Additionally, this SOP outlines the evaluation of IRB members and IRB resources.

SCOPE

This SOP applies to the University of Utah IRB.

DEFINITIONS

1. Alternates are board members appointed on any of the other University of Utah IRB panels. These members may substitute for another member on a different panel if his/her role (non-scientist or scientist) are comparable as determined by the IRB Administrator.
2. Nonscientific members may include individuals whose main concerns are unambiguously in nonscientific areas. Nonscientific members are individuals whose education, training, work, experience, or other interests are not solely in medical, biological, or other scientific areas.
3. Scientific members may include physicians and Ph.D. level physical, biological, or behavioral scientists, nurses, pharmacists, and other biomedical health professionals. Such members satisfy the requirement for at least one scientist.
4. Unaffiliated members have no affiliation with the University of Utah or its Human Research Protection Program, either self or immediate family member. Unaffiliated members, who can be either scientific or nonscientific reviewers, should be knowledgeable about the local community and be willing to discuss issues and research from that perspective. Consideration should be given to recruiting individuals who speak for the communities from which the University of Utah will draw its research subjects. The unaffiliated members should not be vulnerable to intimidation by the professionals on the IRB, and their services should be fully utilized by the IRB.

POLICY

The University of Utah IRB evaluates the acceptability of proposed research in terms of institutional commitments and regulations, applicable law, and standards of professional conduct and practice. The University of Utah IRB strives to foster respect for its advice and counsel in safeguarding the rights and welfare of human subjects.

Each University of Utah IRB panel must consist of at least five regular, voting members. The institution will make every effort to have a diverse membership appointed to the University of Utah IRB, within the scope of available expertise needed to conduct its functions. Composition of the University of Utah IRB is to be adequate in light of the anticipated scope and complexity of the University of Utah’s research activities, the types of subject populations likely to be involved, and the size and available resources of the institution.

Each University of Utah IRB panel includes at least one scientific member and at least one nonscientific member whose primary concerns are in nonscientific areas. Each panel must include at least one unaffiliated member. A single member can be unaffiliated with the institution and have a primary concern in a non-scientific area. This individual would satisfy two of the regulatory membership requirements.

Because the University of Utah IRB regularly reviews VA Salt Lake City Healthcare System (VASLCHCS) research, compensated VA employees serve as voting members. Officials in Research and Development administration including, but not limited to the Associated Chief of Staff for Research and Development and the Administrative Officer for Research and Development, do not serve as voting members of the IRB.

The University of Utah IRB includes members who are knowledgeable about the concerns of participants who may be vulnerable (e.g., children, prisoners, and individuals with impaired decision-making capacity, etc.). Examples of such members might be nurses, social workers, chaplains, teachers, or previous prisoners. In general, a member representing a vulnerable group of participants should provide at least one of the following:

• A direct affiliation to the special group(s)
• Work or life experience with the special group(s)
• Research experience with special group(s)
• Hold certification or licensures that permits the treatment, counseling, or other direct relationship of the special group(s)

Individuals responsible for business development at the University of Utah or affiliated institutions will not serve as voting members of the IRB. This may include, but is not limited to, the following individuals:

• Employees of the institutions’ granting or research contracting offices
• Employees of the institutions’ Vice President for Research offices

The management of the membership of the IRB panels and oversight of member appointments, IRB related activities, communications, and other administrative details are the responsibility of the IRB Director or designee.

The Academic Senate, Vice President for Research and/or the Associate Vice President for Research Integrity and the VA Medical Center Director (for VA representation) in consultation with the IRB Chair and IRB Director have the authority to appoint members to the IRB. Members will be solicited from the University of Utah and greater Salt Lake communities.

Participation by University of Utah faculty, staff, or students is considered a component of their job responsibilities as established by their supervisors. Regular members who are not affiliated with the University of Utah shall receive reimbursement for parking and other miscellaneous expenses upon request. Members have liability insurance coverage as part of their IRB membership in their capacity as agents of the University of Utah.

The IRB Chair will be a highly respected individual, from the University of Utah or its affiliated institutions, fully capable of managing the IRB and the matters brought before it with fairness and impartiality.

The University of Utah Vice President for Research along with the University of Utah Associate Vice President for Research Integrity & Compliance and IRB Director review the resources allocated to the IRB and other components of the University of Utah Human Research Protection Program (HRPP).

PROCEDURES

1. Appointing IRB Members
   1. The IRB Director and assigned IRB staff member(s) conduct an annual review of IRB membership to ensure the composition of the IRB meets regulatory and organizational requirements.
   2. Based upon the annual evaluation or any interim need to adjust the composition of the IRB, the IRB Director requests appointment of new IRB members. The Academic Senate, Vice President for Research and/or the Associate Vice President for Research Integrity & Compliance and the VA Medical Center Director (for VA representation) in consultation with the IRB Chair and IRB Director appoint members to the IRB.
   3. The VASLCHCS Medical Center Director officially appoints VA IRB members and alternates in writing. The VA IRB member must be appointed for 3 years and may be re-appointed indefinitely.
   4. Appointed members, including the IRB Chair and alternates, will serve on the IRB for a term of three years. Reappointment for additional terms may occur, by mutual agreement of the IRB Chair, Vice President for Research, and Associate Vice President for Research Integrity & Compliance, and the VASLCHCS Medical Center Director (for VA representation).
2. Appointment of the IRB Chair(s)
   1. The IRB Director sends written notification to Department heads and current IRB members regarding a vacancy for the appointment of IRB Chair(s). The written notification requests any nominations or persons who wish to volunteer be submitted to the IRB Director. The IRB Director will review the nominations and volunteers with the Associate Vice President for Research Integrity & Compliance and the current IRB Chair(s) for qualified candidates.
   2. Qualified candidates will be selected based on (but not limited to) their current standing with the University and community, IRB experience (if any), research experience with human subjects (if any), education and professional background, professional and personal interests.
   3. Once qualified candidates have been determined, the Associate Vice President for Research Integrity, the IRB Director and current IRB Chair(s) will conduct interviews with each individual. In a collaborative effort, the three most qualified candidates will be selected from the interview process and will be re-interviewed with the Vice President of Research, the Associate Vice President for Research Integrity & Compliance, the IRB Director, and current IRB Chair. The Vice President for Research will make the final appointment of the qualified candidate for IRB Chair.
3. Evaluation of IRB Members
   1. IRB members are evaluated at the conclusion of the first year of service and at the end of each term by the IRB Director or assigned IRB staff member using an evaluation tool. Interim evaluations of the IRB members may occur more frequently, as determined by the IRB Director or assigned IRB staff member.
   2. A member may be removed at the discretion of the IRB Director before the conclusion of the term. A member may resign before the conclusion of the term. Vacancies are filled as quickly as possible.
   3. The IRB Chair(s) is evaluated by the Vice President for Research (and may include the Associate Vice President for Research Integrity & Compliance and IRB Director) at the conclusion of the first year of service and at the end of each term as chair. Interim evaluations of the IRB Chair(s) may occur more frequently, as determined by the Vice President for Research, Associate Vice President for Research Integrity & Compliance, or the IRB Director.
   4. A summary of the evaluation will be provided by the IRB Director to the IRB Chairs and IRB members via email or in-person. The evaluation tool may be retained as part of the member’s profile in University of Utah Electronic Research Integrity and Compliance Administration system (ERICA).
4. Maintaining Roster and Board Member Information
   1. To ensure that board members meet the needs of the IRB in its review of research, board member information forms and current CV’s/résumés are completed or updated at least annually by IRB members in ERICA. A Confidentiality Agreement and Recusal Agreement are electronically submitted in ERICA by each board member at the beginning of their term of service.
   2. In order to maintain rosters of IRB membership, the following information is collected and maintained in ERICA: member names; earned degrees; scientific status; representative capacity; indications of experience sufficient to describe each member’s chief anticipated contribution to the IRB’s deliberations; employment or other relationship between each member and the IRB and/or the University of Utah (e.g., full-time employee, etc.); affiliation status; and office/membership status (e.g., vice-chair, etc.).
5. Maintaining Sufficient IRB Resources
   1. The University of Utah provides meeting space and sufficient staff to support the IRB’s review and recordkeeping duties. The University of Utah will provide the IRB staff with resources sufficient to conduct IRB duties.
   2. The adequacy of the existing IRB(s) is evaluated at least annually by the Associate Vice President for Research Integrity & Compliance and IRB Director to meet the anticipated scope of research activities and the types of participant populations likely to be involved and the appropriateness of the proposed and initial and continuing review procedures in light of probable risks, and the size and complexity of the University of Utah.
   3. The IRB Director requests a report from the ERICA Systems Analyst consisting of but not limited to the following:
      • Number of new studies submitted;
      • Number of studies according to risk assessment;
      • Review process (i.e., expedited, convened board) for initial studies, amendments, continuing review, and unanticipated problems, if applicable;
      • Time required for approval of each type of application;
      • Number of studies from Social/Behavioral Research versus Biomedical Research;
      • Number of studies involving vulnerable populations.
   4. The Associate Vice President for Research Integrity & Compliance and the IRB Director discuss the findings of the report to evaluate whether the number of IRB panels is appropriate for the volume and types of human subject research being reviewed, and whether the review process is being accomplished in a thorough and timely manner.

PURPOSE

It is anticipated that each member of the University of Utah Institutional Review Board (IRB) will contribute meaningfully to the deliberations of the convened board meetings and be prepared to provide thoughtful reviews of human subject research. This SOP outlines the duties of IRB members.

SCOPE

This SOP applies to University of Utah IRB members.

Ad hoc consultants are individuals with competence in special areas who are invited to assist in the review of issues which require expertise beyond or in addition to that of available IRB panel members. Ad hoc consultants not voting members of the Institutional Review Board.

B. Nonscientific members may include individuals whose main concerns are unambiguously in nonscientific areas. Nonscientific members are individuals whose education, training, work, experience, or other interests are not solely in medical, biological, or other scientific areas.

C. Scientific members may include physicians and Ph.D. level physical, biological, or behavioral scientists, nurses, pharmacists, and other biomedical health professionals. Such members satisfy the requirement for at least one scientist.

D. Unaffiliated members have no affiliation with the University of Utah or its Human Research Protection Program, either self or immediate family member. Unaffiliated members, who can be either scientific or nonscientific reviewers, should be knowledgeable about the local community and be willing to discuss issues and research from that perspective. Consideration should be given to recruiting individuals who speak for the communities from which the University of Utah will draw its research subjects. The unaffiliated members should not be vulnerable to intimidation by the professionals on the IRB, and their services should be fully utilized by the IRB.

DEFINITIONS

1. Ad hoc consultants are individuals with competence in special areas who are invited to assist in the review of issues which require expertise beyond or in addition to that of available IRB panel members. Ad hoc consultants not voting members of the Institutional Review Board.
2. Nonscientific members may include individuals whose main concerns are unambiguously in nonscientific areas. Nonscientific members are individuals whose education, training, work, experience, or other interests are not solely in medical, biological, or other scientific areas.
3. Scientific members may include physicians and Ph.D. level physical, biological, or behavioral scientists, nurses, pharmacists, and other biomedical health professionals. Such members satisfy the requirement for at least one scientist.
4. Unaffiliated members have no affiliation with the University of Utah or its Human Research Protection Program, either self or immediate family member. Unaffiliated members, who can be either scientific or nonscientific reviewers, should be knowledgeable about the local community and be willing to discuss issues and research from that perspective. Consideration should be given to recruiting individuals who speak for the communities from which the University of Utah will draw its research subjects. The unaffiliated members should not be vulnerable to intimidation by the professionals on the IRB, and their services should be fully utilized by the IRB.

POLICY

Each IRB member’s primary duty is the protection of the rights and welfare of the individual human beings who are serving as the subjects of that research. The IRB member must understand that he or she is not serving on the IRB to expedite the approval of research, but to be a gatekeeper between the Investigator and the research subjects. In order to fulfill their duties, IRB members are expected to be versed in regulations governing human subject protection, biomedical and behavioral research ethics, and the policies of University of Utah germane to human subject protection.

The IRB(s) is/are appointed as Institutional Committees. As such, the IRB members serve the University of Utah as a whole, rather than a particular department. Therefore, regular IRB members and ad hoc consultants (see SOP 306: Ad Hoc Consultant Reviewers for policy regarding ad hoc consultants) must not allow their own interest or that of their department to supersede their duty to protect the rights and welfare of research subjects. These members and ad hoc consultants must understand and comply with current University of Utah Conflict of Interest policies.

The task of making the IRB a respected part of the institutional community will fall primarily on the IRB members. IRB members must maintain the IRB’s reputation for being fair and impartial, as well as invulnerable to pressure from the institution’s administration, research faculty, study investigators, or any other professional and nonprofessional sources.

Unaffiliated members are expected to provide input regarding their knowledge about the local community and be willing to discuss issues and research from that perspective.

Nonscientific members are expected to provide input on areas germane to their knowledge, expertise and experience, professional and otherwise. Nonscientific members should advise the IRB if additional expertise in a nonscientific area is required to assess if the research proposal adequately protects the rights and welfare of subjects.

Scientific members are expected to contribute to the evaluation of a study on its scientific and statistical merits and standards of practice. Additionally, these members may also advise the IRB in a nonscientific area to assess if the research proposal adequately protects the rights and welfare of subjects.

PROCEDURES

1. Duties of IRB Members
   1. IRB members must complete currently required training on ethics and regulations as outlined in SOP 102: Training and Education.
   2. IRB members should regularly attend convened meetings and complete reviews using board member checklists, as assigned. IRB members are invited to share input and participate in discussion at convened meetings.
   3. IRB members who are designated expedited reviewers should complete assigned reviews using board member checklists, as assigned.
   4. Board members should communicate with IRB staff if they are unable to complete reviews, have conflicts of interest, or cannot attend a meeting. Board members should communicate with IRB staff if they require additional information or guidance.
2. Duties of IRB Chair
   1. In addition to the above responsibilities, the IRB Chair conducts meetings of the IRB. The IRB Chair performs expedited review, as assigned.
   2. IRB Co-Chair(s) or IRB Vice-Chair(s) may assist or act on behalf of the IRB Chair in particular IRB matters and at IRB meetings, either as a general procedure, or on a case-by-case basis.
   3. The IRB Chair also may delegate any of his/her responsibilities as appropriate to other qualified individual(s). Any such delegation of responsibility is documented in writing and maintained by the IRB staff.
   4. The IRB Chair designates the board members qualified to conduct expedited reviews. Qualified members will be selected based on 1) at least six months of IRB experience, research experience, any life experiences or background applicable to human subject research, and 2) any other qualification the IRB Chair deems appropriate. The designation of expedited reviewers is documented in writing and is maintained by the IRB staff.

POLICY

IRB members often rely solely on the documentation submitted by Investigators for initial and continuing review. Therefore this material must provide IRB members with enough information about a study to assess if it adequately meets the IRB’s criteria for approval.

Research submission requirements for new studies, continuing reviews and amendments are found on the IRB website.

The ERICA system uses a smart form application which requires specific information based upon the responses of the applicant (e.g. if an investigator indicates that the study will be a placebo-controlled trial, an additional page in the application will be required). Applications which are incomplete cannot be submitted electronically.

A submitted proposal will be scheduled for IRB review once the IRB staff determines that the information and materials submitted present an adequate description of the proposed research. A research proposal (and associated documents) is submitted via the ERICA electronic system. The submission by a Principal Investigator in ERCIA is considered an electronic signature, legally valid as if the research proposal was submitted in paper format with a printed signature.

If the IRB or IRB staff determines that the submitted information is not adequate, Investigators may be required to submit additional information, or their presence may be required to answer questions or explain the details of the study. Incomplete submissions will not be reviewed by the IRB.

Complete submissions as outlined in the research submission requirements are made available to IRB members for expedited and convened review via the ERICA system.

POLICY

The efficiency and effectiveness of the IRB is supported by administrative procedures that ensure that IRB members not only have adequate time for thorough assessment of each proposed study, but that the documentation they receive is complete and clear enough to allow for an adequate assessment of study design, procedures, and conditions.

PROCEDURES

1. Procedures for Administrative Review
   An administrative review (pre-review) of all new study, continuing review and amendment applications is conducted by an IRB administrator or IRB coordinator using checklists developed to determine if sufficient information has been provided for IRB review.An IRB administrator or IRB coordinator is assigned as the administrative reviewer based upon the type of application (i.e. new study application, continuing review or amendment) and the date of submission.The assigned administrative reviewer may request revisions of the investigative staff to ensure sufficient information for the IRB review.
   1. 1.  New Studies – Upon completion of the pre-review for new study applications, an assigned administrative reviewer makes a primary risk assessment. Based on the primary risk assessment, the administrative reviewer proceeds with the appropriate action as described below.
         

         Primary Risk Assessment	Review Requirements
         Non-Research/Non-Human Subject Research	Review and determination completed by an IRB administrator as outlined in SOP 401a.
         Exempt	Review and determination completed by an IRB administrator (who must be an IRB member) as outlined in SOP 401b.
         Minimal	Assigned to a Primary Reviewer for Convened Board Review (see SOP 403) unless eligible for Expedited Review. Primary and Secondary Reviewers are assigned to review studies involving vulnerable populations. If eligible for Expedited Review (see SOP 402), assigned to IRB Chair or a designated expedited reviewer for review.
         Greater than Minimal Risk	Assigned to Primary and Secondary Reviewers for Convened Board Review (see SOP 403).

          

      2. Continuing Reviews – Upon completion of the pre-review for continuing review applications, an assigned administrative reviewer proceeds with the appropriate action based upon the determined risk assessment and the current status of the study. If research did not qualify for expedited review at the time of initial review, it does not qualify for expedited review at the time of continuing review except in limited circumstances as described in expedited categories (8) and (9) of 63 FR 60364-60367 (see Expedited Review of Research Guidance on the IRB website).
         

         Determined Risk Assessment	Review Requirements
         Minimal	Assigned to a Primary Reviewer for Convened Board Review (see SOP 404) unless eligible for Expedited Review. Unless determined otherwise continuing review is not required for eligible expedited review if the study was approved on or after the implementation of the Final Rule (January 21, 2019), or the study was transitioned to the Final Rule. If Expedited Review (see SOP 402) is appropriate it is assigned to IRB Chair or a designated expedited reviewer for review.
         Greater than Minimal Risk	Assigned to Primary Reviewer for Convened Board Review (SOP 404) unless eligible for Expedited Review. If eligible for Expedited Review (see SOP 402), assigned to IRB Chair or a designated expedited reviewer for review.

      3. Amendments – Upon completion of the pre-review for amendment applications, an assigned administrative reviewer proceeds with the appropriate action based upon whether the administrative reviewer determines that the amendment proposes minor changes and involves no more than minimal risk to the participant. Amendments to exempt studies will be reviewed to determine whether the changes alter the initial exempt determination.
         

         Amendment Type	Review Requirements
         Amendments to exempt studies	Substantial changes which alter exempt status will be reviewed using initial review procedures.
         Amendments proposing minor administrative changes and involve no additional risk to participants	Assigned to an IRB administrator for review and approval.
         Amendments proposing changes which have been requested by a convened board	Assigned to a designated expedited reviewer for review. Full board discussion is not required for these submissions.
         Amendments proposing minor changes and involves no more than minimal risks to the participant	Assigned to designated expedited reviewer for review. Full Board discussion is not required for these submissions.
         Amendments proposing substantial changes or may represent a greater than minimal risk to the participant	Assigned to Primary Reviewer for Convened Board Review (see SOP 405) regardless of the determined risk assessment of the study (i.e. minimal, greater than minimal).

         
         

2. Procedures for the Assignment of Reviewers and Preparation of an Agenda
   1. The assignment of designated expedited reviewers, primary reviewers and secondary reviewers is the responsibility of the IRB coordinator. The IRB coordinator makes assignments with the help of a Reviewer Assignment Sheet and IRB panel rosters. The IRB coordinator assigns reviewers with the appropriate scientific and scholarly expertise to conduct an in-depth review of the protocol. Based upon the research proposal, the IRB coordinator assigns reviewers who are knowledgeable about or experienced in working with vulnerable participants, if necessary. If the IRB coordinator finds there is no IRB member with appropriate scientific and scholarly expertise to conduct an in-depth review, IRB coordinator will consult with the IRB administrator or IRB Director for assistance in obtaining consultation or whether deferral to another IRB meeting will be required.
   2. The assignment of convened board reviewers (primary and secondary reviewers) are made at least seven calendar days in advance of the convened board meeting. If the assignment is made less than seven calendar days before a convened meeting, extenuating circumstances must exist and the assignment must be made no less than two working days prior to the meeting. The assignment of designated expedited reviewers is conducted concurrently with the assignment of convened board reviewers. All reviewers receive an e-mail automatically generated from the ERICA system stating the assignment.
   3. The ERICA online system creates an electronic agenda for convened meetings based upon the reviewer assignments. The IRB coordinator is responsible for the accuracy of the agenda and for completing any other components of the agenda in the ERICA system. A copy of the agenda and attached materials is maintained with the meeting minutes within the ERICA online system.
   4. Complete applications as described in SOP 301 (Research Submission Requirements) are available to all IRB members, via the electronic agenda beginning at least seven calendar days in advance of the convened meeting. Complete applications are made available to any alternate members attending the meeting in place of a regular member. Ad hoc consultant reviewers receive copies of material that pertain to their requested input.

POLICY

A thorough evaluation of all research proposals submitted for review is conducted by IRB members allowing the IRB to determine if the study meets the minimum criteria for initial approval (see SOP 403: Initial Review – Criteria for IRB Approval) and the minimum criteria for continuing approval (see SOP 404: Continuing Review). IRB members review changes in approved research during the period for which approval has already been given to determine if the study meets minimum criteria for ongoing review (see SOP 405: Review of Amendments to Research Studies).

At a minimum, all members of a convened board are expected to be familiar with all IRB applications scheduled for review in advance of convened board meetings. Board members are expected to be familiar with the agenda and items (as described above) for the meeting they will attend.

Additionally, the IRB relies upon an assigned reviewer system. A primary reviewer is assigned to each application (e.g. new study, continuing review, amendment, report form, etc.) reviewed at the convened board. A secondary reviewer may be assigned to new studies reviewed at the convened board as outlined in SOP 302: Administrative Review and Distribution of Materials. For studies eligible for expedited review, the primary reviewer is a designated expedited reviewer.

Assigned IRB reviewers perform an in-depth review of all documentation and materials submitted by the IRB staff and Investigator. Assigned reviewers may be required to review additional material requested by the IRB for the purpose of study approval.

Comments are not limited to the assigned reviewer(s). All members of the IRB panel have access to the submitted documents and may provide comments regarding any proposed research. Any board member, at his/her discretion, can request any of (but are not limited to) the following:

• Ad hoc consultant review;
• Any additional necessary information beyond what has been provided by the investigator;
• Third-party verification of information submitted by the Investigator.

PROCEDURES

1. Primary reviewers are required to review all submitted documents in advance of convened meetings in enough depth to be familiar with and be prepared to discuss the protocol. Primary reviewers are responsible for presenting his/her findings, providing an assessment of the merits and safety of the protocol, reviewing the consent process (in the absence of a secondary review) and recommending specific actions to the IRB. He/she leads the discussion of the study at the convened meeting.
   1. For studies qualifying for expedited review, designated expedited reviewers are expected to perform an in-depth review of all documents submitted by the Investigator. In addition to completing the Board Member checklist, the reviewer indicates the applicable expedited category. If the expedited reviewer determines the study does not qualify for an expedited review, the expedited reviewer notifies the IRB coordinator. The study will then be referred to the convened board for review.
2. Secondary reviewers, if assigned, are expected to review all submitted documents in advance of the meeting, are responsible for reviewing the consent process outlined by the protocol, and add to the discussion as necessary.
3. Each assigned reviewer completes a Board Reviewer Checklist that describes his/her findings, and determines whether the study meets the minimum criteria for initial approval, the minimum criteria for continuing approval, or the minimum criteria for ongoing review. Additional checklists are required when a study necessitates additional consideration by the IRB (e.g. the study involves a vulnerable group, use of a medical device, use of an investigational drug, etc.). Completed Board Reviewer Checklists are submitted via ERICA, becoming part of the electronic record and forming the basis for communication to the Investigator.
4. Notification of IRB Review. The IRB coordinator notifies the Investigator of the IRB’s determination within seven business days of the convened board meeting. For studies reviewed using expedited procedures, the IRB coordinator notifies the Investigator of the IRB’s determination within seven business days of the expedited review. The written notification includes the IRB’s decision with requested revisions or requested clarification, when applicable.
5. Review of Requested Revisions. Based on the terms of approval at the time of initial review, the IRB will review the Investigator’s response to requested revisions as outlined in SOP 407: Categories of Action. Final approval will not be granted until all of the board or expedited reviewer recommendations and requests are appropriately addressed.

DEFINITIONS

POLICY

Except when an expedited review procedure is used, the IRB will review proposed research at convened meetings at which a quorum is present. Each IRB Panel will meet monthly, or at some other frequency determined by the IRB Chair and the IRB Director. Meeting space will be made available for the IRB.

PROCEDURES

1. Procedures for Maintaining Quorum
   1. The IRB meeting may not convene until quorum is established. It is the responsibility of the IRB coordinator and/or the IRB administrator to inform the IRB Chair when quorum has been established.
      1. An alternate member may attend in the place of an absent regular member in order to meet the quorum requirements as defined in this policy.
      2. Ad hoc consultant reviewer(s) may not be used to establish a quorum.
   2. The IRB coordinator and/or IRB administrator are responsible for monitoring the meeting for late arrivals and departures of members.
   3. It is the responsibility of the IRB coordinator and/or the IRB administrator to inform the IRB Chair if quorum is lost during a meeting. If quorum is lost during the course of a meeting, the IRB Chair will not allow any further action or votes to be taken until quorum is restored. Quorum as defined in this policy (see “Definitions” above) must be maintained for each vote to occur.
2. Procedures for Voting
   1. A majority of members must vote in favor of an action for that category of action to be accepted by the IRB. Majority is defined as more than half of the total number of IRB members attending the meeting at which the vote takes place. Only regular and alternate members acting in place of absent regular members may vote.
   2. The IRB coordinator and/or IRB administrator are responsible for counting and documenting all votes.
3. Procedures for the Use of Conferencing Technology During a Convened Meeting
   1. Convened Meeting with a Member Joining Remotely
      Should a member not be able to be physically present during a convened meeting, but is available remotely, the meeting can be convened using video or audio conferencing. The member who is not physically present will be connected to the rest of the members via conferencing technology. The member must be able to hear the discussion and be heard by the convened members. In this manner, all members will be able to discuss the protocol even though one or more members are not physically present. Members participating by audio or video conferencing may vote, provided they have had an opportunity to review all the material the other members have reviewed.
   2. Meetings Conducted Via Conferencing Technology (Virtual Meetings)
      Meetings may be convened via audio or video conferencing. To allow for appropriate discussion, all members must be connected simultaneously for an audio or video conference to take place. All members must be able to hear one another to allow for discussion. 3.2.1. A quorum (as defined above) must participate for the conference call meeting to be convened.
      1. To allow for the IRB coordinator and/or administrator to take minutes during the virtual meeting, an IRB staff member may be assigned as the virtual meeting facilitator. The virtual meeting facilitator will not count toward quorum for the meeting.
      2. Members not present at the convened virtual meeting via audio or video technology may not vote on an issue discussed during that meeting. Voting by proxy is not permitted).
      3. Contacting members individually via telephone is not acceptable as a method to conduct a virtual meeting. However, using conferencing technology tools to poll members present in a virtual meeting is acceptable.
4. Procedures for Managing Conflicts of Interest
   1. Each meeting agenda includes a statement reminding IRB members to declare any potential conflict(s) of interest he/she may have with research that is reviewed.
   2. The IRB Chair begins each meeting with a statement requesting IRB members to declare any potential conflict(s) of interest he/she may have with items on the agenda. A verbal declaration of any such conflict is recorded by the IRB coordinator and/or administrator in the minutes of the meeting. When the IRB coordinator and/or administrator is aware of conflicts prior to the meeting, he/she will inform the IRB Chair. The IRB coordinator and/or administrator will document specific IRB member recusals as they occur throughout a meeting in the meeting minutes.
      1. IRB members are required to electronically sign the IRB Member Recusal Agreement initially and annually. The IRB Member Recusal Agreement is maintained in the ERICA system.
      2. Ad hoc consultant reviewers are required to disclose to the IRB any real or potential conflicts of interests involving the review of any specific research protocol. The IRB administrator and/or coordinator provides the ad hoc consultant with the IRB Conflict of Interest Disclosure prior to the review of a research protocol. If a conflict of interest is disclosed, the IRB will not permit the requested ad hoc consultant to review the research project forming the basis for the conflict.
      3. IRB members, alternates, or others with a conflicting interest may not participate in any portion of the review of research activities except to provide information requested by the IRB and must excuse themselves from the meeting during the IRB’s deliberative discussion and vote on the affected research.
      4. IRB members, ad hoc consultants, and other attendees may excuse themselves from the discussion and vote for any reason, if he/she feels it is necessary to avoid any appearance of a conflicting interest.
5. Procedures for Maintaining IRB Confidentiality Agreements
   1. All material received by the IRB will be considered confidential and will be distributed only to meeting participants (regular members, alternate members and ad hoc consultant reviewers) for the purpose of review. All application materials will be stored in ERICA, which is a secured site, with access limited to the IRB members and staff.
   2. Ad hoc consultants and visitors will be expected to sign the IRB Confidentiality Agreement and will receive printed copies of applicable documents as necessary. The IRB administrator or IRB coordinator is responsible to have each ad hoc consultant(s) or visitor(s) sign the IRB Confidentiality Agreement prior to the start of the meeting. These agreements will be maintained and filed by the IRB Executive Secretary.
   3. IRB members are required to electronically sign the IRB Confidentiality Agreement initially and annually. These agreements are maintained in the ERICA system.

PURPOSE

This SOP outlines the procedure for documenting University of Utah Institutional Review Board (IRB) review of research applications, and the related discussion, decisions or actions, and findings.

SCOPE

This SOP applies to the University of Utah IRB.

POLICY

The University of Utah IRB documents discussions, decisions or actions, and findings through minutes of convened meetings. Copies of the minutes and pertinent materials are maintained within the Electronic Research Integrity and Compliance Administration system (ERICA).

When the expedited procedure for review is used, documentation of decisions or actions, and findings are made in the IRB reviewer checklist. Reviewer checklists and pertinent materials are maintained in ERICA.

Investigators are notified of IRB decisions and findings by email through ERICA.

PROCEDURES

1. Recording Minutes
   1. Minutes document discussions, decisions, and findings made during convened IRB meetings. IRB coordinators prepare minutes with support from IRB administrators and are responsible to record the following: • Meeting attendance.
      • When an alternate member replaces a regular member.
      • Attendance of members or alternate members who participate through teleconference or videoconference. It should be noted whether the meeting was conducted in-person or virtually.
      • The presentation and discussion of each agenda item (new studies, continuing review, and review of amendments, etc.). Eash item will be discussed and voted individually, including a description for the basis of requiring changes in or disapproving the research.
      • Summary of the discussion of controverted issues and resolution.
      • Recommendations documented in the IRB reviewer checklists submitted prior to the meeting may deviate from board decisions after a discussion at a convened meeting. In the event that recommendations in the IRB checklist are not consistent with the conclusions resulting from the board discussion, the minutes will document the final decisions and determinations.
      • Voting results include number for, opposed, and abstaining. This will include only voting members present at the meeting when the vote is called. The names of the members absent for the vote will be documented. Members who recused themselves for a conflicting interest will be recorded in the minutes.
      • Determination of the level of risk (minimal, greater than minimal).
      • For initial and continuing review, the approval period.
      • If applicable, determinations required by regulation and protocol specific findings justifying those determinations for: waiver or alteration of informed consent and/or authorization; waiver of documentation of consent; research involving pregnant women, human fetuses, and neonates; research involving children, research involving prisoners; research involving participants with diminished capacity to consent.
      • If applicable, the rationale for significant risk/non-significant risk device determinations.
      • If applicable, the rationale for conducting continuing review on research that otherwise would not require continuing review.
      • If applicable, the rationale for an expedited reviewer’s determination that research appearing on the expedited review list is more than minimal risk.
2. Distribution of Minutes
   1. IRB coordinators are responsible for preparing the meeting minutes. Finalized meeting minutes are made available at the subsequent meeting of that panel via ERICA. Meeting minutes are retained in ERICA and are also retained for each item in the electronic file of its respective study.
   2. Items approved using expedited procedures are also accessible in the electronic meeting minutes.
   3. The R&D Committee of the VA Salt Lake City Healthcare System (VASLCHCS) may access finalized meeting minutes via ERICA.
3. Results of Reviews, Actions, and Decisions
   1. The results of reviews and actions taken by the convened IRB that grant or may appear to grant investigators with initial or continuing approval of research involving human subjects, are signed off by the IRB Chair or IRB Vice Chair except when the convened IRB votes to approve research as submitted. All results and actions taken by the IRB are reflected and recorded in ERICA.
   2. If the convened IRB approves research as submitted, documentation of the board’s determination in the minutes is sufficient and subsequent electronic approval by an IRB Chair or IRB Vice Chair is not required.
   3. The results of reviews and actions taken by the IRB via expedited review that grant or may appear to grant investigators with initial or continuing approval of research projects involving human subjects, must be signed off by the IRB Chair, IRB Vice Chair, or IRB member designated by the IRB Chair (i.e., designated expedited reviewer). All results and actions taken by the IRB are reflected and recorded in ERICA.
   4. For research involving veterans, the IRB notifies the VASLCHCS R&D Committee of its decision to approve or disapprove a proposed research activity, or of modifications required to secure IRB approval via notification from ERICA. Notification is a copy of the investigator’s approval letter, or a copy of the IRB minutes with the actions of the IRB. Approval letters are sent via ERICA and received by the VASLCHCS Research Compliance Officer or designee. IRB minutes are made available within 4 weeks of the meeting date and accessible by the VASLCHCS Research Compliance Officer or designee.
   5. Projects which are classified as exempt from IRB review and involve veterans must be reviewed by the VASLCHCS R&D Committee prior to initiation. The exempt status must be approved by the IRB Chair, IRB Vice Chair, or IRB member designated by the IRB Chair.
4. Notification of IRB Decisions and Findings
   1. IRB coordinators are responsible for notifying the investigator of the IRB’s decision within seven business days after the convened meeting or expedited review. Notifications are sent via ERICA. As required, notifications will be sent to other offices according to IRB SOP 905: Institutional Reporting Procedures.
   2. If the IRB approves the application, the approval notification includes the date of approval, the expiration of approval (as appliable), and the effective date. The date of approval is the date the board voted to approve the application or the expedited reviewer electronically approved the application. The date of the expiration is explained in IRB SOP 307: Approval Period and Determination of Expiration. The approval is effective as of the day the approval notification is issued.
   3. If the IRB disapproves the application, the notification includes the reason(s) for disapproval and instructions to the investigator for appeal of the decision.
   4. If the IRB requires additional materials or a response from the investigator or sponsor, the notification describes the request(s) of the IRB in detail. The notification also states the IRB must receive the response within 30 days of the date of notification; however, this period may be extended if the investigator or sponsor communicates a need for an extension.

POLICY

The IRB will, at its discretion, invite individuals with competence in special areas to assist in the review of issues which require expertise beyond or in addition to that of available IRB panel members. Ad hoc consultants are not voting members of the IRB. Ad hoc consultants are subject to the IRB’s policy regarding conflicts of interest and confidentiality (see SOP 304: Convened IRB Meeting Administration). Ad hoc consultants may be requested regardless of the field of research being conducted.

PROCEDURES

1. It is the responsibility of the Primary Reviewer to make the determination that a consultation for additional expertise is needed beyond the expertise available to the board. The primary reviewer contacts the secondary reviewer (if applicable) to notify him/her of the needed expertise and notifies the IRB coordinator or IRB Chair in a timely manner (i.e. before the convened meeting, if possible).
2. The board member may consult with a known expert in the field or contact the IRB office for assistance in obtaining an ad hoc consultant reviewer. The IRB office may contact department chairs of the appropriate discipline for references of qualified individuals. This will preferably be handled before the study is reviewed at a convened board meeting to allow for dissemination of any applicable information and/or comments from the ad hoc consultant reviewer.
3. Ad hoc consultants are provided with all printed materials from the ERICA online system submitted by the Investigator and any other materials requested by the IRB (see SOP 301: Research Submission Requirements). Ad hoc consultants must review the materials and provide the IRB with a written assessment and evaluation of a risk-benefit ratio, any ethical concerns, identify any additional safety concerns or procedures which may pose serious harm to subjects, and respond to other specific requests made by the IRB. This written assessment is made available to IRB members via the ERICA online system and becomes part of the permanent electronic record. The IRB coordinator or administrator attaches the written assessment to the appropriate study for accessibility and documents the consultant’s review within the minutes at a convened board meeting.
4. In the event that additional expertise is requested during the convened board review of a study, discussion will be deferred until an ad hoc consultant with additional expertise can provide more information. The study will be reviewed at the next available board meeting.
5. In the event that there is no member with appropriate scientific and scholarly expertise to provide an in-depth review of a protocol and ad hoc consultation is not available, the IRB requires a protocol be deferred to another IRB meeting where the appropriate consultation or expertise is available for in-depth review of a protocol.

PURPOSE

The approval period of a study, whether during initial or continuing review is determined by the University of Utah Institutional Review Board (IRB). This SOP outlines how the expiration date is calculated. This SOP also outlines the expiration of IRB approval.

SCOPE

This policy applies to non-exempt human subject research conducted at the University of Utah.

DEFINITIONS

• The approval date is the date the convened board voted to approve, the date the convened board voted to approve with modifications, or the date the designated expedited reviewer approved the research.
• The approval effective date is the date the approval letter is sent to the investigator through the University of Utah Electronic Research Integrity and Compliance Administration system (ERICA).
• The expiration date is the last day of approval and the date by which continuing review must occur.

POLICY

The length of the approval period for a study is determined by the University of Utah IRB considering the degree of risk, and according to the standards outlined in SOP 404: Continuing Review. When an approval period is determined, an expiration date is calculated to indicate the date by which continuing review must occur and approval ends.

ERICA populates the expiration date based on the determined approval period. For example, a study approved for one year would receive an expiration date that is one day earlier in the following year than the date the convened board approved the research. If the IRB determines the study requires continuing review more or less frequently than annually, the expiration date is manually adjusted in ERICA according to the IRB’s determination.

For research that is approved with modifications by the convened board, the approval period is not effective and does not begin until the changes are accepted by the IRB Chair and the approval letter is sent.

Review of a change in a protocol (i.e., modification or amendment) does not alter the expiration date because continuing review is review of the full protocol, not simply a change to it.

Investigators are sent two automatic notifications regarding the need to apply for continuing review prior to the expiration date. There is no grace period extending the conduct of the research beyond the expiration date of IRB approval. Extensions beyond the expiration date will not be granted. A continuing review application must be submitted in ERICA to be reviewed by the IRB even if the continuing review cannot be conducted before the expiration date. For research which is expired and is reviewed after the expiration date, a new expiration date will be calculated as described above. The lapse in approval due to the expiration of the study and the dates of the lapsed approval are documented in ERICA. If required by the IRB, the investigator will provide the IRB with an action plan to prevent any future lapses in approval.

If the investigator fails to submit a continuing review application by the expiration date, the study will be administratively closed by an IRB staff member. Once the study is closed, the investigator must submit a new study application for initial review and approval to continue with the study.

All research activities must cease upon expiration of IRB approval or study closure.

Expiration of IRB approval does not require a report as a suspension or termination of IRB approval according to IRB SOP 904: Administrative Hold, Suspension and Termination of Approved Research, and IRB SOP 905: Institutional Reporting Procedures.

PROCEDURES

1. Assignment of Expiration Dates
   1. During the initial and continuing review application review, the assigned board reviewer selects the approval period in the board reviewer checklist in ERICA. For expedited review, the board reviewer checklist documents the determined approval period. For convened board review, the minutes document the determined approval period.
   2. The IRB administrator or coordinator selects the appropriate approval period based on the determined approval period (e.g., one year, no further continuing review, etc.) in ERICA. The IRB administrator or coordinator is responsible for verifying the correct expiration date when processing the study.
2. Expiration of Approved Studies
   1. Once IRB approval for a study expires, an expiration notice is automatically generated and sent from ERICA to the investigator. The expiration notice informs the investigator the research is expired and no research activity may continue until the application for continuing review is approved by the IRB. The notice also informs the investigator that no new participants may be enrolled.
   2. For VA research that has expired, the investigator must immediately submit to the IRB Chair a list of participants who could be harmed by stopping specified study interventions or actions. The VA Research Compliance Officer receives a copy of expiration notices for studies involving the VA Salt Lake City Healthcare System (VASLCHCS) and may contact the investigator for follow-up of the required actions. The IRB Chair, in consultation with the VA Chief of Staff will determine within 2 business days whether participants on the list may continue participating in the research interventions or interactions.
   3. In order to conduct any study-related procedures after IRB approval expires, investigators must make a request in writing to the IRB Chair for review and approval. If the IRB Chair determines that subjects participating in an expired study would suffer a hardship because research procedures/medication must be discontinued, appropriate research procedures may continue beyond the expiration date for a reasonable amount of time. The IRB Chair will address on a case-by-case basis those rare instances where failure to enroll new subjects would seriously jeopardize the safety or well-being of an individual. Prospective research data cannot be collected until a continuing review application or other progress report is reviewed and approved. The IRB Chair will notify the Investigator of the decision by way of written documentation and this documentation will be attached permanently to the continuing review form, accessible by all IRB members. Documentation will be retained in ERICA.

POLICY

IRB files are maintained in a manner that contains a complete history of all IRB actions related to review and approval of a protocol, including continuing reviews, amendments and report forms. All records regarding a submitted proposal are retained as required by regulatory requirements and institutional policy. Records are kept regardless of whether the submitted proposal is approved. These records indicate clearly what documents the IRB has actually approved.

Records are accessible for inspection and copying by authorized representatives of the Sponsor, funding department or agency, regulatory agencies and institutional auditors at reasonable times and in a reasonable manner.

This policy applies to both paper files and electronic files in the ERICA system.

PROCEDURES

1. Study-Related Document Retention
   The IRB Office retains all records regarding an application (regardless of whether it is approved) indefinitely. For all applications that are approved and the research initiated, the IRB Office must retain all records regarding that research indefinitely after completion of the research.

   VA research must be retained in accordance with the Department of Veterans Affairs record Control Schedule 10-1 (RCS 10-1).

   Adequate documentation of each IRB’s activities will be prepared, maintained and retained in a secure location. Retained documents include but are not limited to:

   • Copies of all original research protocols reviewed, scientific evaluations, if any, that accompany the proposals, approved consent documents, progress reports submitted by Investigators, and report forms submitted by Investigators
   • Agendas and minutes of all IRB meetings
   • Copies of all submitted monitoring reports, site visit reports, progress reports, and other continuing review activities
   • Copies of all correspondence between the IRB and the Investigators. For research involving the VASLCHSC, copies of all correspondence between the IRB and R&D Committee

2. IRB Administration Document Retention
   The IRB Office maintains and retains all records regarding IRB administrative activities that affect review activities indefinitely. Retained documents include:

   • Current and obsolete copies of the Standard Operating Policies and Procedures

   • Delegation of specific functions, authorities, or responsibilities by the IRB Chairperson

   • Current Federalwide Assurance with OHRP

   • IRB registrations, as required

3. Destruction of Copies

   Any material received by the IRB, which is considered confidential and in excess of the required original documentation and appropriate controlled forms, will be destroyed by a method deemed appropriate by the Associate Vice President for Research Integrity.
   
   

4. Archiving and Destruction

   All documents and materials germane to IRB determinations will be archived according to institutional policy. Archiving policies of the University of Utah will determine when such archived records may be destroyed.

PURPOSE

The University of Utah Institutional Review Board (IRB) oversees research involving human subjects. This policy provides the definitions that pertain to the determination of whether an activity meets the definition of human subject research and which activities will require IRB review.

SCOPE

This policy applies to activities that are potentially considered research conducted at the University of Utah.

DEFINITIONS

1. Food and Drug Administration (FDA) regulations define clinical investigations as: a) use of a drug other than the use of an approved drug in the course of medical practice; b) use of a medical device other than the use of an approved medical device in the course of medical practice; c) gathering data that will be submitted to or held for inspection by FDA in support of a FDA marketing permit for a food, including a dietary supplement that bears a nutrient content claim or a health claim, an infant formula, a food or color additive, a drug for human use, a medical device for human use, a biological product for human use, or an electronic product. In the above criteria “approved” means “approved by the FDA for marketing.” FDA has defined clinical investigation to be synonymous with research.
2. Activities are human subject research when they meet the Department of Health and Human Services (DHHS) definition of “research” and involves the DHHS definition of a “subject”, or that meets the FDA definition of “clinical investigations” and involves the FDA definition of a “subject”.
3. DHHS regulations define interaction as communication or interpersonal contact between investigator and subject.
4. DHHS regulations define intervention as physical procedures by which data are gathered (for example, venipuncture) and manipulations of the subject or the subject’s environment that are performed for research purposes.
5. DHHS regulations define private information as information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public (for example, a medical record). Private information must be individually identifiable (i.e., the identity of the subject is or may readily be ascertained by the investigator or associated with the information) for obtaining the information to constitute research involving human subjects.
6. Research
   1. DHHS defines research as a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.
   2. FDA defines research as activities that meet the definition of “clinical investigations”.
7. Subject
   1. Under DHHS regulations subject means a living individual about whom an investigator (whether professional or student) conducting research (1) obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or (2) obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens.
   2. Under FDA regulations, individuals are considered a subject when they become a participant in research, either as a recipient of the test article or as a control. If the research involves a medical device, individuals are considered a “subject” when they participate in an investigation, either as an individual on whom or on whose specimen an investigational device is used or as a control.

POLICY

The University of Utah IRB will review activities conducted at the institution and its affiliates when it is:

1. Human subject research as defined in FDA regulations.
2. Human subject research as defined in DHHS regulations.
3. Human subject research that meets the DHHS definition of research, regardless of the source of funding.

The University of Utah has agreed to a federalwide assurance (FWA) to apply the DHHS regulations. The terms of the assurance apply to all federally funded research conducted at the institution. Generally, the University of Utah IRB applies the DHHS regulations to all human subject research conducted at the institution and its affiliates, regardless of the source of funding. Research that is not federally funded and that is outside of the FWA is subject to the same scrutiny except where otherwise described in University of Utah IRB policy.

Research that does not meet the definition of research involving human subjects must be determined by the University of Utah IRB staff, not an individual investigator, with certain exceptions (see exceptions below).

• The University of Utah IRB has a list of datasets/repositories that it has found to be stripped of identifiers and which is publicly available. As a result, research using this data does not rise to level of “human subject research”. Research projects involving analysis of secondary data from these pre-approved, publicly available datasets/repositories do not require prior University of Utah IRB approval (see Investigator Guidance Series: Secondary Analysis of Existing Datasets).
• Medical Case Reports may not require prior University of Utah IRB approval (see SOP 408: Medical Case Reports).

For the purposes of his policy, the following activities are not considered research:

• Scholarly and journalistic activities (e.g., oral history, journalism, biography, literary criticism, legal research, and historical scholarship), including the collection and use of information, that focus directly on the specific individuals about whom the information is collected.
• Public health surveillance activities, including the collection and testing of information or biospecimens, conducted supported, requested, ordered, required, or authorized by a public health authority.
• Collection and analysis of information, biospecimens, or records by or for a criminal justice agency for activities authorized by law or court order solely for criminal justice or criminal investigative purposes.
• Authorized optional activities (as determined by each agency) in support of intelligence, homeland security, defense, or other national security missions.

The University of Utah IRB has an abbreviated application (Request for Non-Human Subject Research Review) that may be submitted to obtain a determination of non-human subject research.

All research proposals that appear to meet the DHHS and/or FDA definition of human subject research require a full new study application and IRB review as with any other new study application.

PROCEDURES

1. Non-Human Subject Research
   1. Investigators who believe their research activities do not meet the regulatory definition of human subject research should submit a “Request for Non-Human Subject Research Review” through the University of Utah Electronic Research Integrity and Compliance Administration system (ERICA). If a full new study application is submitted that does not meet the regulatory definition of research, it may still receive a determination of non-human subject research.
   2. All information submitted by the investigator is reviewed using the IRB internal checklist. Determinations of non-human subject research are made by IRB staff who may consult with the IRB Chair or IRB Director, if necessary. Additional information may be requested via ERICA, as needed.
   3. If a determination of non-human subject research is made, the investigator is notified via ERICA.
   4. If the IRB staff member determines that the project meets the regulatory definition of human subject research, the review proceeds as with any other new study application.

PURPOSE

The University of Utah Institutional Review Board (IRB) oversees research involving human subjects. This policy defines what research may be exempt from IRB review and the procedures for determining when research may be exempt from IRB review.

SCOPE

This policy applies to research conducted at the University of Utah.

DEFINITIONS

1. Limited IRB review is a process that is required only for certain exemptions and does not require an IRB to consider all the IRB approval criteria in 45 CFR 46.111. In limited IRB review, the IRB must determine that certain conditions, which are specified in the regulations are met.
2. Minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.

POLICY

Human subject research that is categorized as exempt research is exempt from most of the requirements in the federal regulations for protection of human subjects. Exempt research must be no greater than minimal risk and must fit within an exemption category. Investigators are expected to adhere to principles of sound research design and ethics and follow any applicable state laws and University policies.

The University of Utah IRB utilizes the exemption categories 1-6 as outlined in 45 CFR 46.104 for federally funded research. University of Utah IRB does not utilize broad consent and the exemption categories intended for research using broad consent (categories 7-8) are not applied at the University of Utah. The University of Utah IRB designated additional exemption categories (A-E) for research with no federal oversight. The exemption categories (federal and non-federal) are posted on the University of Utah IRB web site.

For the purposes of this policy, IRB staff who are designated IRB members are termed IRB reviewers. Exemptions are determined by an IRB reviewer. In limited circumstances, investigators may obtain an exemption determination using a guided application process in the University of Utah Electronic Research Integrity and Compliance Administration system (ERICA). Guided exemptions are only offered for eligible projects based on answers in the new study application and cannot be requested by investigators. Investigators have the option to request that an IRB reviewer make the exemption determination rather than relying on the guided application process.

Exemption determinations are recorded and stored in ERICA. If an IRB reviewer believes that a study proposal may be eligible for exemption but poses ethical concerns, it will be reviewed as with any other new study application.

All exempt reviews conducted by an IRB reviewer meet the requirements of a limited IRB review by ensuring that when appropriate, the research plan includes adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data. Investigators are not given an option to use the guided exemption if a limited IRB review is required. The University of Utah retains the authority to suspend or terminate IRB approval of research approved with a limited review.

Continuing review is not required for studies determined to be exempt. To keep the study open and active with the University of Utah IRB and Human Research Protection Program (HRPP), an Annual HRPP Progress Update must be submitted.

Substantive changes to the exempt study must be submitted via amendment application to ensure the study still qualifies for exempt status considering the changes. Exempt studies must adhere to the University of Utah IRB reporting requirements for unanticipated problems and deviations. Exempt studies must be closed with the IRB once the research activities are complete.

PROCEDURES

1. Exempt Research
   1. The investigator submits a new study application in ERICA.
   2. Based on the responses provided in the new study application, some study proposals may be eligible for a guided exemption. If eligible, the investigator is given the option to receive a guided exemption or to request that the application be referred to an IRB reviewer for an exemption determination. If the investigator opts for the guided exemption, the investigator will follow all prompts and agree to all stipulations in ERICA in order to receive confirmation from ERICA of the exemption determination.
   3. The IRB reviewer conducts a review of the research proposal using the IRB internal checklist (Determining if Human Research is Exempt from IRB review) within ERICA. When one or more of the exemption categories are applicable to the research, the IRB reviewer documents the applicable category(ies) using the internal checklist and makes the final exemption determination.
   4. VA research determined exempt from IRB review must be reviewed by the R&D Committee prior to initiation and must be included in annual R&D Committee Review of research projects.
   5. All exemption determinations are communicated to the investigator via ERICA, and includes the applicable category(ies) justifying the exemption determination.
   6. If the IRB reviewer determines the proposal is not eligible for an exempt determination, including limited review, the IRB reviewer will move the application to an expedited or convened board review. The research may only be tabled or disapproved by the convened IRB.

DEFINITIONS

POLICY

Expedited review procedures consist of a review of research involving human subjects by the IRB Chair, IRB Vice-Chair or by an experienced reviewer designated by the IRB Chair from among IRB members (see SOP 202 for a full description of the procedure used to designate expedited reviewers). In this policy, the IRB Chair’s designee refers to an IRB Vice-Chair or a designated expedited reviewer.

The IRB Chair or designee may exercise all of the authorities of the IRB, except that he/she may not table or disapprove the research. A research proposal may be tabled or disapproved only after review by the convened IRB.

The categories of research that may be reviewed by the IRB through an expedited review procedure include research activities that (1) present no more than minimal risk to human subjects, and (2) involve only procedures listed in one or more of the specific categories listed in the regulations at Federal Register (FR) Volume 63, No 216 and (3) the research is not classified. The criteria for approval using the expedited procedure are the same as those for review by a convened IRB.

IRB staff and IRB members follow OHRP guidance concerning expedited review procedures of a continuing review application. The IRB is permitted to use expedited review for initial and continuing review of research that involves solely one or more of the activities published at 63 FR 60364-60367. If research did not qualify for expedited review at the time of initial review, it does not qualify for expedited review at the time of continuing review except in limited circumstances as described in expedited categories (8) and (9) of 63 FR 60364-60367.

Unless the IRB determines otherwise, continuing review of research is not required for research eligible for expedited review if:

• The study was approved on or after the implementation of the Final Rule (January 21, 2019).
• The study was transitioned to the Final Rule.

The IRB Chair or designee may use the expedited review procedure to review minor modifications to previously approved research during the period for which approval is authorized if the following conditions are met:

• The proposed modifications are administrative changes or similar minor changes; or
• The research was previously determined to be eligible for expedited review under FR categories 1-7 and/or 9, and the proposed modifications do not change the study’s expedited determination; or
• The research was previously determined to be exempt and the proposed modifications do not change the study’s exempt status.

Any modification that possibly entails more than a minimal risk to the participants must be reviewed by the full IRB at a convened meeting.

The IRB Chair or designee may use the expedited review procedure to review amendments proposing changes which have been requested by a convened board. In such cases, changes must be stipulated by the convened board and no additional changes may be added to the amendment that would require convened board review.

When the expedited review procedure is used, all IRB members shall be informed of actions taken by the IRB at least monthly. A report is generated by way of the ERICA online system and made available to all voting members of the IRB for their review. This report is sent via e-mail or made available within the ERICA online system by an IRB administrator or IRB coordinator.

The approval of research using expedited procedures for a study involving veterans must be reviewed by the Research and Development Committee of the Veteran Affairs Salt Lake City Health Care System before initiation. This review is conducted concurrently or after the approval is granted by the University of Utah IRB. The research study will also be included in the annual review of research projects by the Research and Development Committee of the Veteran Affairs Salt Lake City Health Care System.

PROCEDURES

1. Procedures for Expedited Review
   1. The IRB administrator or IRB coordinator conducts an administrative review of the new study, continuing review or amendment application using the IRB internal checklist within the ERICA online system. If the IRB administrator or IRB coordinator determines the application may qualify for expedited review using the Internal Checklist. The Internal Checklist also serves as documentation of the determination. Please see SOP 302 –Administrative Review and Distribution of Materials for the full description of the procedure for administrative review.
   2. The IRB Chair or designee is assigned as an expedited reviewer. Assigned expedited reviewers perform an in depth review of pertinent documentation and materials submitted by the Investigator (SOP 301) and IRB staff.

      • For new study and continuing review applications, the assigned expedited reviewer completes a Board Reviewer checklist documenting whether the application meets one or more of the expedited categories and whether the study meets the criteria for IRB approval. The reviewer documents the applicable expedited category.

      • For amendment applications, the assigned expedited reviewer completes a Board Reviewer checklist documenting whether the amendment to the previously approved research is eligible for expedited review and the modification involves no more than minimal risk to participants.
   3. If the expedited reviewer determines the application does not qualify for an expedited review, the reviewer notifies the IRB administrator or IRB coordinator who will assign the study for the next available convened IRB meeting.
   4. If the expedited reviewer recommends that the study be tabled or disapproved, the reviewer notifies the IRB administrator or IRB coordinator who will move the item to the agenda for discussion at a convened IRB meeting. The research may only be tabled or disapproved by the convened IRB.
   5. If the expedited reviewer determines that the criteria for approval of the application have been met, the reviewer may approve the application.

POLICY

All research proposals that intend to enroll human subjects must meet certain criteria before study related procedures can be initiated. Three core principles: respect for persons, beneficence and justice, as discussed in the Belmont Report are the basis of the criteria for IRB approval. All regulatory criteria must be met and any applicable state or local laws apply. In addition, certain other criteria that are unique to the University of Utah and the VASLCHCS may apply and must be met as well. In order to assure that all regulatory criteria and any other applicable requirements are met, the IRB uses a checklist system.

The criteria for approval and other applicable requirements are included in the board member checklist. Assigned IRB reviewers must complete the board member checklist to ensure that the criteria for approval and other applicable requirements are met.

More detailed information about the criteria for approval and other applicable requirements is provided according to specific topics. Board members may access supplemental guidance on the IRB website or in the ERICA system.

PURPOSE

The University of Utah Institutional Review Board (IRB) must conduct continuing review of approved protocols to ensure human subject protections remain appropriate and to determine if it is appropriate for the study to continue as is, or with modifications. This SOP outlines the standards the IRB must follow in considering continuing review.

SCOPE

This policy applies to human subject research conducted at the University of Utah.

POLICY

When considering whether to renew a study, the IRB revisits the same criteria used to grant initial approval. The IRB will not approve protocols submitted for continuing review, if, due to interim changes in IRB policies and procedures, the IRB would not approve that same protocol as a new proposal.

During continuing review, the IRB determines whether the study can be renewed at the same risk level, or if new information has changed that determination. As an outcome of continuing review, the IRB may require that the research be modified or halted altogether. Additionally, the IRB may need to impose new precautions or revise those it had previously imposed on the research protocol. The IRB will reassess the approval period for each continuing review application.

Investigators are required to submit a continuing review application in the University of Utah Electronic Research Integrity and Compliance Administration system (ERICA) system prior to the expiration of the study. Please see SOP 307: Expiration of IRB Approval for the policy regarding the expiration of a study.

The continuing review application must describe the progress of the study; enrollment and withdrawals; adverse events, complaints, and other problems that have occurred; and safety monitoring results. Submission requirements are outlined on the IRB website. Investigators have the option to add an amendment in combination with the continuing review. The amendment will be reviewed and approved in combination with the continuing review.

Continuing review must occur at intervals appropriate to the degree of risk. Continuing review is not required for studies determined to be exempt. Documentation of the length of the approval period is made in the board member checklist and, if applicable, the minutes of the convened board meeting. The determination of the length of the approval period is made by the IRB considering the degree of risk, and according to the following standards.

Continuing review for research subject to FDA regulation ¹ or Grandfathered studies

For studies that are subject to FDA or pre-2018 Common Rule requirements, the following standards of continuing review apply:

• For studies reviewed at a convened meeting, continuing review must occur within one (1) year from the date of the convened meeting at which the IRB reviewed and approved the research study.
• For studies approved using expedited review procedures, continuing review must occur within one (1) year from the date the IRB Chair or designated expedited reviewer gives final approval to the protocol.

Continuing review for research not subject to FDA regulation

• For studies reviewed at a convened meeting, the continuing review must occur within one (1) year from the date of the convened meeting at which the IRB reviewed and approved the research study.
• Unless the IRB determines otherwise, continuing review of research is not required for research eligible for expedited review ² .
• Unless the IRB determines otherwise, continuing review of research is not required for research that has progressed to the point that it involves only one or both of the following ³, which are part of the IRB-approved study:
• Data analysis, including analysis of identifiable private information or identifiable biospecimens, or
• Accessing follow-up clinical data from procedures that subjects would undergo as part of clinical care.

Extended Approval Periods

For minimal risk studies not subject to federal oversight and not federally funded, the University of Utah IRB permitted ⁴ continuing review to occur within two (2) years from the date of the convened meeting at which the IRB approved the research or from the date the IRB Chair or designated expedited reviewer gave final approval. For studies that were granted two-year approval, the ongoing use of the two-year approval for studies undergoing continuing review is acceptable.

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POLICY

During the period for which approval has already been given, changes in approved research may not be initiated without prior IRB review (full or expedited review, as appropriate) and approval, except where necessary to eliminate apparent immediate hazards to human subjects.

Investigators must submit requests for proposed changes to the IRB using an amendment application in the ERICA system. Amendment applications should be submitted no later than 30 days upon receipt of changes from sponsors, collaborators, etc.

During amendment review, the IRB determines whether the research with the proposed changes continues to meet the regulatory criteria for approval and any other applicable requirements are met. Amendments to exempt studies are evaluated to determine whether changes alter the original exempt determination. Determinations are made using the board member checklist.

If an investigator makes changes that are necessary to eliminate apparent immediate hazards, a protocol deviation outlining the circumstances and any documents used must be submitted to the IRB (please see SOP 902: Protocol Deviations).

POLICY

The completion or termination of the study is a change in activity and must be reported to the IRB. A final project report is submitted by the Investigator to notify the IRB of the completion or termination of a project, including studies determined to be exempt. A final project report provides information to the IRB regarding the final status of the project and allows the IRB to close the study file. In the event that the Investigator fails to apply for continuing review or fails to submit a final project report, the IRB must administratively close the study. When final project reports are acknowledged by the IRB, the study file is closed and no further activity related to the study may be conducted. Study files are retained as described in SOP 308 (Document Management).

Guidance for determining when a final project report should be submitted is posted on the IRB website. Additionally, the Investigator may not submit a final project report in the ERICA system if he/she is unable to verify such criteria are met.

PROCEDURES

1. Procedures for Submission of Final Project Reports
   1. Final project reports should be submitted within 30 days after completion or termination of the study.
   2. The following documentation is required for IRB Review.
      • Final project report application (initiated through a Continuing Review application in the ERICA system).
      • Preliminary or final results, if available.
      • Sponsor documentation of study completion or termination, if it exists.
2. Procedures for IRB Review of Final Project Reports
   1. A designated member of the IRB Staff reviews all final project reports and, if needed, requests further information from the Investigator to clarify any questions that may arise.
   2. Once the IRB has determined that sufficient information is provided, the Investigator will receive acknowledgement of the final project report and closure of the study.
3. IRB Administrative Closure
   1. If a study is expired and an application for continuing review or a final project report has not been submitted, the study will be administratively closed by the IRB. See SOP 307 (Approval Period and Determination of Expiration) for a description of procedures regarding expired studies.

POLICY

Except when the expedited review procedure is used, the following actions will be taken by a vote of a majority of the regular and alternate members present at a convened board meeting. Majority means more than half of the total number of IRB members attending the meeting at which the vote takes place. When an application is reviewed using expedited procedures, the IRB Chair or designee may take any of the following actions except to table or to disapprove a study.

The IRB Chair or designee is responsible for ensuring the appropriateness of all IRB decisions and actions. The IRB Chair may confer with the IRB administrator or coordinator to verify that all IRB decisions and actions are based on institutional and regulatory requirements.

IRB decisions and actions are documented by way of board reviewer checklists and official minutes of the convened meeting approved by the IRB Chair or designee.

The IRB reports decisions and actions to the VASLCHSC within four weeks after each convened board meeting by way of IRB minutes accessible within ERICA to an authorized representative of the VA. Other ancillary committees and institutional offices (e.g., the Office of Sponsored Projects, Clinical Cancer Investigations Committee, Radiological Health Committee, Conflict of Interest Committee, Primary Children’s Medical Center, Center for Clinical and Translational Sciences, etc.) are provided decisions and actions upon request by way of IRB minutes. Appropriate institutional officials (i.e. IRB Executive Committee, Associate Vice President for Research Integrity, Vice President for Research, etc.) receive IRB reports of decisions and actions upon request or as needed by way of IRB minutes. IRB minutes are either made available to authorized members of the parties listed within ERICA or are provided via e-mail or hard copy by any IRB staff member.

The Clinical Cancer Investigations Committee, Radiological Health Committee, Conflict of Interest Committee, VASLCHSC, Center for Clinical and Translational Sciences, Office of Sponsored Projects, and other designated committees are responsible for additional review and approval or disapproval of research approved by the IRB. IRB approval is contingent upon approval by ancillary committees.

PROCEDURES

1. IRB Actions
   The IRB may take one of the following actions as a result of its review of research submitted for initial review or for continuing review, including review of amendments. Actions are recorded in the minutes when reviewed by a full convened board. When an IRB Chair or designee takes one of the following actions as a result of his/her expedited review of research, it is recorded in the reviewer checklist.
   1. Approval as Submitted. If the IRB approves an application as submitted, approval commences on that day. The application and accompanying documents are approved as submitted.

      The IRB may issue approval pending the receipt of administrative changes (e.g. verification of training, etc.). In such cases, the IRB staff withholds the release of the approval letter and approved documents until the administrative changes are completed as requested.

      The approval is effective as of the day the approval notification is sent to the investigator (see SOP 305).

   2. Approval upon Receipt of Required Modifications.
      The IRB may stipulate minor modifications of, or additions to, a protocol or accompanying document(s) are required. These changes or modifications must stipulate specific revisions that require simple concurrence by the investigator. The Investigator will be informed in writing of the required changes or requested information and must provide the IRB with the changes or information.

      The IRB Chair or designee has the authority to review the requested revisions or information via expedited review unless the IRB specifies that the material or information must be reviewed by a convened IRB, the primary reviewer or another individual delegated by the IRB to review the response.

      Any response from the Investigator which is pertinent and relevant to judgments required by a convened IRB will be returned to a convened IRB for review and approval.

   3. Tabled.
      If the convened IRB requests substantive clarifications or modifications regarding the protocol or informed consent documents that are directly relevant to the determinations required by the IRB under the regulations, the study is tabled pending subsequent review by the convened IRB of responsive material.

      If a designated expedited reviewer believes a study should be tabled, the reviewer documents the recommendation in the reviewer checklist and contacts the IRB coordinator. The IRB coordinator moves the item to the agenda for discussion by the convened board.

   4. Disapproval.
      If the proposal fails to meet one or more criteria used by the IRB for approval of research, the IRB may disapprove the application. Disapproval cannot be given through the expedited review procedure. A study proposal may only be disapproved by majority vote at a convened meeting of the IRB. If a designated expedited reviewer believes a study should be disapproved, the reviewer documents the recommendation in the reviewer checklist and contacts the IRB coordinator. The IRB coordinator moves the item to the agenda for discussion by the convened board.

      Criteria for disapproval may include but is not limited to the following:

      • The study violates any laws or regulations of the United States, the state of Utah, or the University of Utah.
      • Risks to subjects outweigh the benefits to them or society.
      • Unnecessary risks are created.
      • Selection of subjects is inequitable.
      • Procedures for obtaining and documenting informed consent are inadequate.
      • Payment or other offered inducements are likely to influence subjects’ judgment.
      • The study is poorly or improperly designed such that meaningful conclusions cannot be derived.
      • The study is promotional (seeding), and not scientific in nature.

POLICY

If an author develops a case report with no prior research intent, the University of Utah IRB does not require review if the report does not meet the regulatory definition of research.

In many instances, case reports do involve a human subject(s) by definition, and may contribute to generalized knowledge by presentation or publication. A case report (3 or fewer patients) generally does not meet the definition of a systematic investigation. A case report describes an interesting treatment, presentation or outcome. A critical component is that nothing was done to the patient(s) with prior “research” intent.

PROCEDURES

1. The author of a case report must determine whether the IRB requires submission of a new study application by using the Case Report Using Existing Data – Author Worksheet found on the IRB website.
2. Submission for IRB review is not required if the author determines through the use of the worksheet that the case report is not a systematic investigation. The author should retain a copy of the worksheet.
3. Submission for IRB review is required if the author cannot determine through the use of the worksheet that the case report is not a systematic investigation. The author should submit a new study application to the IRB for review.
   1. If the report does not meet the definition of human research, the IRB will provide a letter that indicates such a determination.
   2. If it is the conclusion of the IRB administrator that the submitted proposal meets the definition of research, the IRB will review the project.
4. A new study application may be submitted if the author wishes to have the project assessed by the IRB. If a new study application is submitted, the IRB administrator will review the proposal. The author should attach a copy of the Case Report Using Existing Data – Author Worksheet.
   1. If the report does not meet the definition of human research, the IRB will provide a letter that indicates such a determination.
   2. If it is the conclusion of the IRB Administrator that the submitted proposal meets the definition of research, the IRB will review the project.

DEFINITIONS

POLICY

The University of Utah, with the approval of the Institutional Official (IO), may agree to joint IRB review arrangements, rely upon the review of another qualified IRB, or make similar arrangements for avoiding duplication of effort as allowed and upon modification of the institutional Federal-wide Assurance agreements (FWA) as necessary.

The University of Utah IRB (UUIRB) and the University of Utah Human Research Protection Program (UUHRPP) work together to ensure that the University of Utah adheres to all applicable federal regulations, state laws, and institutional policies when using joint and alternative IRB review arrangements. UUIRB staff members provide primary oversight of the process for alternative IRB arrangements and negotiation of reliance agreements. The Institutional Official has authority to enter into master reliance agreements. Once executed, the IRB Director has the authority to accept and confirm the reliance for any individual projects subject to a master reliance agreement.

University of Utah IRB Performing Review for External Institutions

The UUIRB may review and approve a research project conducted at an External Institution. The UUIRB adheres to the NIH Policy on the Use of a Single Institutional Review Board for Multi-Site Research. As such, the UUIRB may be a reviewing SIRB for domestic sites of NIH-funded multi-site studies where each site will conduct the same protocol involving non-exempt human subjects research.

Prior to the UUIRB agreeing to become the IRB of record for a research project conducted at an External Institution, including becoming the SIRB for a multi-site study, a reliance consultation will take place. The External Institution must enter into a Reliance Agreement with the University of Utah and provide any requisite documents to the UUIRB including any local context information, as necessary. Agreements will specify the type(s) of research or the individual research project conducted under the agreement and outlines the duties and responsibilities of the UUIRB and the External Institution/Investigator.

Copies of any agreements and any accompanying documentation must be retained by both the UUIRB and the External Institution. The UUIRB retains such agreements electronically in the ERICA system with the research proposal or in the UUIRB Agreements system or another electronic system where the agreement was originated (e.g., SMART IRB).

Relying on the Review by an External IRB for Research Conducted at the University of Utah

If the UU relies on another IRB (i.e., use of a central IRB for cooperative group clinical trials or ceding review to a Single IRB) for research conducted at the University of Utah:

• The University of Utah retains ultimate responsibility for maintaining a human research protection plan including, but not limited to: o Safeguarding the rights and welfare of human research participants within the local context. The UUIRB retains the responsibility to maintain oversight for local unanticipated problems involving risks to participants or others and non-compliance. The UUIRB retains the authority to conduct audits to ensure compliance.
  • Conduct conflict of interest review for University of Utah investigators.
  • Educating members of the University of Utah’s research community to establish and maintain compliance of federal regulations and institutional policies relevant to human research participants.
  • Implementing appropriate oversight mechanisms, within the local context, to ensure compliance with the determinations of the reviewing IRB.
• Respective responsibilities of the UUHRPP and the IRB of record must be put in writing. The agreement will document, at a minimum, the following items:
  • Role and responsibility of the IRB of record;
  • The authority of the IRB of record to oversee the study;
  • The responsibility of the IRB of record for oversight and continuing review.

Prior to ceding review to another IRB of record, a reliance consultation will take place considering the adequacy of the proposed SIRB considering the scope and purpose of the research, as well as the participant populations likely to be involved, the appropriateness of initial and continuing review considering probable risks, and the size and complexity of the institution. The proposed IRB is evaluated to ensure policies and procedures are in place which provide arrangements for communication with participating sites to provide sufficient knowledge of the conditions surrounding the conduct of the research, and to ensure that risks to subjects are minimized and assure that the IRB of record will be made aware of unexpected problems in a timely manner.

The UUIRB Reliance Agreement Staff make the final decision of whether to enter into an agreement allowing for another IRB to review research conducted at the University of Utah. Copies of any agreements are signed by the University of Utah’s Institutional Official and must be retained by both the University of Utah HRPP and the External Institution. The UUIRB Reliance Agreement Staff is responsible for ensuring copies of such agreements are retained in the UUIRB Agreements system or another electronic system where the agreement was originated (e.g., SMART IRB).

Research Activities Conducted at the University of Utah by Unaffiliated Investigators: The UUIRB will acknowledge recruitment of subjects for research conducted by an unaffiliated investigator at the University of Utah (or an affiliated institution) when:

• The UUIRB does not act as the ethical review board; and
• Research activities are not conducted at the University of Utah (or an affiliated institution).

The UUIRB will defer the approval process of recruitment of subjects only to the specific University Department or department head/authority. If the unaffiliated investigator wishes to conduct recruitment AND research activities at the University of Utah (or an affiliated institution), the UUIRB requires that the unaffiliated investigator obtain an affiliated faculty sponsor at the University of Utah who will act as the principal investigator at the University of Utah. A complete research application for review and approval is required before any recruitment or research activities occur.

POLICY

The University of Utah IRB has the authority to a) approve research activity, b) specify modifications required to secure IRB approval of the research activity or c) disapprove any research activity overseen and/or conducted by the University of Utah. The IRB has the authority to suspend or terminate approval of research that is not conducted in accordance with IRB policies, is not in compliance with applicable Federal Regulations, or that is associated with unexpected serious harm to participants (see SOP 904: Administrative Hold, Suspension and Termination of Research).

Research approved by the IRB may be subject to further review by officials of the University of Utah as part of the Human Research Protection Program (HRPP), as appropriate. HRPP officials may override the IRB’s decision to approve research; however, they may not approve the research if it has not been approved by the IRB or overrule other decisions made by the IRB.

Investigators may appeal:

• revisions required by the IRB;
• IRB determinations of non-compliance, serious non-compliance, continuing non-compliance or an unanticipated problem involving risks to participants or others;
• IRB disapproval of research; and
• termination of an approved protocol by the IRB.

If the appeal is denied, the investigator’s institution cannot override the IRB decision. Documentation of appeal including all correspondence relating to the appeal is retained with the research protocol in the ERICA system.

PROCEDURES

1. Procedures for Appealing Revisions Required by the IRB
   1. If an investigator disagrees with a revision requested by the IRB, the investigator may submit a written appeal to the IRB administrator or coordinator who was responsible for issuing the request. The investigator should include information supporting any arguments made in the appeal.
   2. For research reviewed using the expedited review procedure, the appeal is reviewed by the expedited reviewer who requested the revisions. The expedited reviewer may either (a) make a decision on the appeal, or (b) refer the appeal to the convened board. If the investigator disputes the decision of the expedited reviewer, the appeal is then referred to the convened board for resolution.
   3. For research reviewed by the convened IRB, the appeal is reviewed by the convened IRB. The investigator may be invited to a convened meeting to provide clarification or additional information to the IRB. The investigator may also request to be in attendance at a convened meeting to provide clarification or additional information to the IRB. The investigator may not be present for the vote on the appeal.
   4. The expedited reviewer or convened IRB may accept the appeal, request different revisions, or deny the appeal. The investigator is notified in writing of the decision.
      • If the appeal is accepted, the investigator is not required to submit the requested revisions.
      • If different revisions are requested, the investigator must submit those revisions.
      • If the appeal is denied, the IRB decision is final and the revisions must be made prior to approval.
2. Procedures for Appealing Determinations made by the IRB
   1. For the purposes of this policy, the term “IRB determination” means a determination of non-compliance, serious non-compliance, continuing non-compliance or an unanticipated problem involving risks to participants or others.
   2. If an investigator disagrees with an IRB determination, the Investigator may submit the appeal and any information supporting the appeal in a new Report Form in the ERICA system within 60 days of being notified of the determination.
   3. For IRB determinations made through administrative review (review conducted by an IRB administrator or the IRB Chair or his/her designee), the appeal is reviewed by the individual who made the determination. The administrative reviewer makes a decision on the appeal. If the investigator disputes the decision of the administrative reviewer, the appeal is then referred to the convened board for resolution.
   4. For IRB determinations made by the convened IRB, the appeal is reviewed by the convened IRB. The investigator may be invited to a convened meeting to provide clarification or additional information to the convened IRB. The investigator may also request to be in attendance at a convened meeting to provide clarification or additional information to the IRB. The investigator may not be present for the vote on the appeal.
   5. The administrative reviewer or convened IRB may accept the appeal or deny the appeal. The investigator is notified in writing of the decision.
      1. If the appeal is accepted, a new determination is made using the information provided in the new Report Form.
      2. If the appeal is denied, the IRB decision is final, and the original determination stands.
3. Procedures for Appealing the IRB Decision to Disapprove or Terminate a Study
   1. If an investigator disagrees with the IRB decision to disapprove or terminate a study, the investigator may submit a written appeal of the decision to disapprove to the IRB Chair and IRB Director within 60 days of being notified of the decision. The appeal should address the specific concerns of the IRB and the IRB basis for disapproval.
   2. The appeal is reviewed by the convened IRB. The investigator may be invited to the convened meeting to provide clarification or additional information to the IRB. The investigator may also request to be in attendance at a convened meeting to provide clarification or additional information to the IRB. The investigator may not be present for the vote on the appeal.
   3. The convened IRB votes to accept or deny the appeal. The investigator is notified in writing of the decision.
      1. If the appeal to the decision to disapprove a study is accepted, the investigator is invited to submit a new study application to the IRB for review and approval, according to the conditions set forth by the IRB in accepting the appeal.
      2. If the appeal to the decision to terminate a study is accepted, the investigator may resume research activities after any conditions set forth by the IRB are met. In some cases, the IRB may require the investigator to submit a new study application for review and approval prior to resuming research activities.
      3. If the appeal is denied, the IRB decision is final, and the study may not be approved or resume.

POLICY

The inclusion of certain groups of participants who may be vulnerable to undue influence or coercion may require additional protections. When the IRB reviews research involving vulnerable populations, the IRB applies any additional federal regulations, VA requirements, state and local laws, as applicable. The IRB evaluates whether additional safeguards have been included in the study to protect the rights and welfare of participants who may be vulnerable to undue influence. The IRB requires at least one or more individuals who are knowledgeable about or have experience in working with these participants to be part of the review process.

New study submissions including prisoners as potential research participants are reviewed by the convened IRB with a designated prisoner representative present, and cannot be reviewed under expedited procedures. Subsequent review of amendment and continuing review applications involving prisoners may also be reviewed by a convened board. Expedited review procedures may be allowed, where the expedited reviewer is an IRB member who is a designated prisoner representative. New study submissions, amendment and continuing review applications involving other vulnerable populations may be reviewed by the convened board or by expedited review.

The IRB reviews research involving vulnerable populations according to applicable requirements and guidelines and makes determinations using the IRB reviewer checklist. If the research includes a vulnerable population that does not have additional protections specified in the federal regulations, the board will evaluate the research proposal to ensure that precautions are taken to protect the participants.

The IRB adheres to guidelines posted on the IRB website regarding vulnerable populations and any required additional protections that the IRB must consider.

POLICY

The University of Utah IRB requires investigators to provide a plan to ensure the proper handling of investigational or unlicensed test articles.

The University of Utah IRB ensures compliance with federal, state or local regulations governing investigational or unlicensed test articles.

PROCEDURES

1. Procedures for Review of Clinical Research Involving Investigational Drugs and Biologics
   
   All initial requests for IRB approval of a study that includes the use of an investigational drug, agent, or biologic will be reviewed and approved by the IRB.

   An investigator responsible for a drug study where drugs are stored and dispensed by the research Investigational Pharmacy must abide by FDA regulations. The investigator must also abide by the University of Utah Hospitals and Clinics Policy Manual (Department of Pharmacy Services Policy Manual Investigational Drug Studies Program) and Investigational Drug Studies Policy for Primary Children’s Hospital.

   Investigator responsibilities for drug studies are provided for the investigator/study staff on the IRB website.

   1. Investigators must submit all information and documents required by the IRB for the use of investigational test articles in the New Study Application (including, as applicable, Informed Consent, etc.).
   2. If the research involves the use of a drug other than a marketed drug in the course of medical practice, the drug must either have an IND or the research must meet one of the FDA exemptions from the requirement to have an IND. The investigator will provide the IND or confirm the study’s eligibility for exemption from the IND requirements. The IRB reviewer(s) will complete the Reviewer Checklist documenting that the IND has been provided or that the IND exemption criteria are met.
   3. The IRB will review the proposed research, informed consent documents, the procedure for obtaining informed consent, and additional information, when applicable, to determine whether the study meets criteria for approval. The IRB reviewer(s) will complete the Reviewer Checklist documenting how the criteria are met.
      1. The assigned IRB reviewer(s) of the research protocol involving the investigational drug will evaluate whether the plan to control for the investigational drug is adequate, and may seek clarification from a representative of the Investigational Drug Studies (IDS) Pharmacy or other qualified representatives who are not IRB members that are knowledgeable about the control of investigational drugs.
      2. The assigned IRB reviewer(s) may contact a qualified person who is not an IRB member that is knowledgeable about the drug with any concerns that may affect the risk/benefit assessment. They may also request a literature review from a medical librarian at the Spencer S. Eccles Health Sciences Library at the University of Utah Health Sciences Center.
2. Procedures for Review of Clinical Research Involving Investigational Devices

   All initial requests for IRB approval of a study that includes the use of an investigational device will be reviewed and approved by the IRB. Research on medical devices for which (i) an investigational device exemption application (21 CFR Part 812) is not required; or (ii) the medical device is cleared/approved for marketing and the medical device is being used in accordance with its cleared/approved labeling may be reviewed using expedited review procedure.

   Investigator responsibilities for device studies are provided for the investigator/study staff on the IRB website.

   1. Investigators must submit all information and documents required by the IRB for the use of investigational test articles in the New Study Application (including, as applicable, Informed Consent, etc.).
   2. The IRB will review the proposed research, informed consent documents, the procedure for obtaining informed consent, and additional information, when applicable, to determine whether the study meets criteria for approval. The IRB reviewer(s) will complete the Reviewer Checklist documenting how the criteria are met.
      1. The assigned IRB reviewer(s) of the research protocol involving the investigational device will evaluate whether the plan to control for the investigational device is adequate, and may seek clarification from other qualified representatives who are not IRB members that are knowledgeable about the control of investigational devices.
      2. The assigned IRB reviewer(s) may contact a qualified person who is not an IRB member that is knowledgeable about the device with any concerns that may affect the risk/benefit assessment. They may also request a literature review from a medical librarian at the Spencer S. Eccles Health Sciences Library at the University of Utah Health Sciences Center.
   3. The IRB will determine whether, in the context of the study or by the nature of the investigational medical device (see significant risk devices list and IDE requirements exemption criteria), the study presents a significant risk (SR) of harm to study subjects, a non-significant risk (NSR) of harm to study subjects, or if the study meets criteria for exemption from IDE requirements. This assessment will be based on the information provided by the Investigator and/or the Sponsor. In deciding whether or not a medical device is a significant risk, the IRB considers if the device:
      • Is intended as an implant and presents a potential for serious risk to health, safety, or welfare of a participant.
      • Is purported or represented to be for a use in supporting or sustaining human life and presents a potential for serious risk to the health, safety, or welfare of a participant.
      • Is for a use of substantial importance in diagnosing, curing, mitigating, or treating disease or otherwise preventing impairment of human health and presents the potential for serious risk to the health, safety, or welfare of a participant.
      • Otherwise presents a potential for serious risk, safety, or welfare of a participant.
   4. The assigned IRB reviewer or designated expedited reviewer completes the board reviewer checklist (Risk Determination for Devices portion) documenting the risk determination. If the convened IRB disagrees with the determination made in the checklist, the minutes will reflect the discussion, resolution and final risk determination.
   5. If the IRB agrees with the NSR determination, the study may begin after IRB notification and FDA does not need to be notified.
   6. If the IRB determines that an investigation, presented for approval as a non-significant risk device involves a significant risk device, the IRB administrator or IRB coordinator notifies the investigator and, where appropriate, the sponsor. The IRB will not approve the study until the FDA issues a device determination of significant risk or non-significant risk and all associated requirements are met.
3. Procedures for IRB Oversight of a Humanitarian Use Device

   An approved Humanitarian Device Exemption (HDE) authorizes marketing of a Humanitarian Use Device (HUD). An HUD is a device that is intended to benefit patients in the treatment and diagnosis of diseases or conditions that affect or is manifested in fewer than 8,000 individuals in the United States per year.

   Before an HUD under an approved HDE can be used at the University of Utah or its affiliates for clinical care, approval by an IRB is required, with the exception of emergency use.

   1. The convened IRB must review the initial application. A continuing review of an HUD may be done by way of an expedited procedure (similar to the expedited procedure described in section 56.110(b)) unless the IRB determines that a convened board must review the application.
   2. The IRB does not require a review and approval process for each individual use of an HUD. The IRB may approve the use of the HUD without any further restrictions, use of the device under a protocol, or use of the device on a case-by-case basis.
   3. The IRB requires that full informed consent and documentation of consent be obtained when treating or diagnosing a patient with an HUD. The convened board will consider exceptions to the requirement of full informed consent and documentation of consent on a case by case basis.

POLICY

The University of Utah IRB requires that special consideration be given during the review of studies involving genetic research and information, given the potential predictive power of some genetic information, the familial nature of some genetic research and information, and the potential risks associated with genetic information.

The IRB requires investigators to provide a plan to ensure the privacy and confidentiality of participants, minimize the risks associated with genetic research, and provide adequate disclosure of genetic results that may be clinically relevant to the participant.

The IRB guidelines regarding genetic research are posted on the IRB website.

PROCEDURES

1. Procedure for Review of Genetic Research
   1. Investigators must submit all information and documents required by the IRB for genetic research in the new study application.
   2. The IRB reviews the proposed research, informed consent documents, and additional information, when applicable, to determine whether:
      1. The plan to ensure the privacy and confidentiality of participants is adequate;
      2. The risks associated with genetic research are minimized;
      3. The plan to disclose genetic results or incidental findings to the participant is adequate.
2. Procedures for Review of Gene Transfer Research
   1. Investigators must submit all information and documents required by the IRB for gene transfer research in the new study application. This information must include the following:
      1. delivery methods
      2. target population
      3. required follow-up
   2. The assigned IRB reviewer(s) may contact a qualified member of the University of Utah Biosafety Committee and external consultants, as necessary, to provide independent guidance to the IRB.
   3. Research involving gene transfer to human subjects may be reviewed and approved by the National Institutes of Health Recombinant DNA Advisory Committee prior to IRB approval. Monitoring must be adequate and a DSMB is required.

POLICY

The IRB allows the placement of research materials—including informed consents; case report forms; laboratory, radiology, or other clinical reports; psychiatric records; surveys or questionnaires; or any other records generated from human subjects research—in research participants’ medical records for research conducted under a covered entity.

If an investigator does not want to include research materials in medical records, a request to exclude data from the electronic medical record (EMR) must be approved by the covered entity where the research is conducted. Investigators should inform the IRB if a request to exclude data from the EMR has been approved and research materials are allowed to be excluded from the medical record.

The IRB model HIPAA authorization language that is provided on the IRB website states that research materials will be included in the participant’s medical record. If an request to exclude data from the EMR is granted, the IRB may approve modified HIPAA authorization language in the consent document.

POLICY

The University of Utah IRB requires investigators to follow the federal regulations for the emergency use of a test article and planned emergency research.

PROCEDURES

1. Procedures for Exemption from IRB Review Requirements for Emergency Use of a Test ArticleFDA regulations [21 CFR 56.104(c)] permit the emergency use of a test article without prospective IRB review, as described in this policy. Emergency use is defined as the use of a test article on a human participant in a life-threatening situation in which no standard acceptable treatment is available and in which there is not sufficient time to obtain IRB approval [21 CFR 56.102(d)]. FDA regulations require that any subsequent use of the investigational product at the institution have prospective IRB review and approval. Data from an emergency use may not be reported in a way that implies that the activity was a prospectively planned systematic investigation designed to develop or contribute to generalizable knowledge.
   1. Investigators must notify the IRB before the test article is administered. The investigator submits an Emergency Use of a Test Article application in ERICA. The IRB Chair or designee reviews the notification using the Emergency Use Checklist to confirm whether the FDA requirements for emergency use of a test article are met.
      1. If the IRB Chair or designee agrees that it meets the FDA requirements for emergency use of a test article in a life-threatening situation, a letter is sent to the investigator through the ERICA system. This letter must not be construed as an approval for emergency use by the IRB.
      2. If the IRB chair or designee finds that it does not meet the FDA requirements for emergency use of a test article in a life-threatening situation, the application will be referred to a convened IRB meeting.
   2. If immediate use of the test article is required to save the life of the participant and there is not sufficient time to contact the IRB, the investigator may proceed with the emergency use. In this case, the investigator must submit the Emergency Use of a Test Article application in ERICA within 5 working days of the emergency use of a test article. The IRB Chair or designee reviews the reported emergency use using the Emergency Use Checklist to confirm whether the FDA requirements for emergency use of a test article are met.
      1. If the IRB Chair or designee agrees that the reported activity meets the FDA requirements for emergency use of a test article, a letter is sent to the investigator through the ERICA system. This letter must not be construed as an approval for emergency use by the IRB.
      2. If the IRB Chair or designee finds that the investigator failed to comply with the regulatory requirements for emergency use of a test article, appropriate corrective action will be taken according to SOP 903, HRPP and Non-Compliance.
2. Procedures for Exception from Informed Consent RequirementsThe investigator must obtain informed consent of the subject or the subject’s legally authorized representative for emergency use of a test article. However, the FDA provides an exception from the requirements of informed consent [21 CFR 50.23].
   1. The investigator must submit required documentation to the IRB for review within 5 working days after use of the test article using the Report of Emergency Use of a Test Article in ERICA.
   2. The IRB Chair or designee will review the documentation using the Emergency Use Checklist (Exception from Informed Consent portion).
      1. If the IRB Chair or designee determines that the documentation meets the FDA requirements for exception from informed consent before the use of a test article, a letter is sent to the investigator through the ERICA system.
      2. If the IRB Chair or designee determines that the investigator failed to comply with the regulatory requirements for exception from informed consent before the use of a test article, appropriate corrective action will be taken according to SOP 903, HRPP Requirements and Non-Compliance.
3. Procedure for Exception from Informed Consent Requirements for Planned Emergency ResearchThe IRB may review and approve applications for planned use of a test article in an emergency setting. The IRB may approve a request for a waiver of informed consent for planned emergency research in accordance with the exception in FDA regulation [21 CFR 50.24] and under DHHS regulation ¹.

   The Veterans Health Administration (VHA) does not conduct planned emergency research. VA researchers are not permitted to use these provisions.

   Research subject to Department of Defense requirements is prohibited from using an exception from consent in emergency medicine research unless a waiver is obtained from the Secretary of Defense.

   1. If an investigator wishes to waive consent under this policy, the investigator must complete a Request for Waiver of the Informed Consent for Planned Emergency Research. The completed request may be obtained from the IRB office and must be attached to the new study application in ERICA.
   2. For research subject to FDA regulations – If the IRB approves a request for a waiver of informed consent for planned emergency research, all of the required determinations under 21 CFR 50.24 and in Federal Register, Vol. 61, No. 192, pp. 51531-51533, October 2, 1996 will be made by a convened IRB.
   3. For research not subject to FDA regulations – If the IRB approves a request for a waiver of informed consent for planned emergency research that is not subject to FDA regulations, all of the required determinations in Federal Register, Vol. 61, No. 192, pp. 51531-51533, October 2, 1996 will be made by a convened IRB.
   4. If an IRB determines that it cannot approve the proposed waiver of informed consent because the investigation does not meet the criteria in the exception provided in the federal regulations (as cited above) or because of other relevant ethical concerns, the IRB will document its findings and provide these findings promptly in writing to the investigator and to the sponsor.

^{1. See http://www.hhs.gov/ohrp/policy/hsdc97-01.html↩}

POLICY

The Food and Drug Administration’s Expanded Access Program allows the use of an investigational medical product (drug, biologic or medical device) for treatment outside of clinical trials when there are no comparable or satisfactory therapies. Expanded access, sometimes called “compassionate use” is not considered a clinical investigation, however, FDA submission and IRB review are necessary. Expanded access does not involve the conduct of “research” as defined at 45 CFR 46 because there is no intent to develop generalizable knowledge. Guidance regarding expanded access to investigational test articles is provided for investigators on the IRB website.

Please note that this policy does not describe the emergency use of a test article (please see SOP 506: Emergency Use of a Test Article and Planned Emergency Research). For single-patient emergency use, investigators should follow instructions for Emergency Use of a Test Article available on the IRB website.

Under the FDA’s current regulations, there are three categories of expanded access to investigational drugs for treatment use ¹:

• Expanded access for individual patients, including for emergency use
• Expanded access for intermediate-size patient populations (generally smaller than those typical of a treatment IND or treatment protocol — a treatment protocol is submitted as a protocol to an existing IND by the sponsor of the existing IND)
• Expanded access for widespread treatment use through a treatment IND or treatment protocol (designed for use in larger patient populations)

Prior to treating a patient under expanded access for non-emergent use, the physician must obtain approval from the IRB. Approval from the IRB is intended to protect the rights, safety and well-being of human subjects. In non-emergency situations, treatment may not begin until the IRB has approved the Expanded Access plan.

Expanded access to investigational drugs for treatment for individual patients, may be approved by the IRB Chair or Vice-Chair. Expanded access for intermediate size-patient populations or for widespread treatment will be reviewed by the convened IRB.

Under the FDA’s current regulations, there are three types of expanded access for medical devices.²

• Emergency Use: Use of an investigational device when an individual patient is in a life-threatening situation and needs immediate treatment (there are no alternative options and no time to use existing procedures to get FDA approval for the use).
• Compassionate Use (for Individual Patient/Small Group Access): Use of an investigational device to treat or diagnose and individual or small group of patients with a serious disease or condition when there are no available alternative options.
• Treatment Investigational Device Exemption: Use of an investigational device to treat or diagnose a group of patients with a serious or immediately life-threatening disease or condition when the device is also being studied for the same use under an approved Investigational Device Exemption.

Expanded access as compassionate use of an investigational device must be approved by the FDA prior to use. The concurrence of the IRB Chair is required. Expanded access as treatment investigational device exemption will be reviewed by the convened IRB.

PROCEDURES

1. Expanded Access to Investigational Drugs
   1. Investigators must submit a new study application in ERICA. Applications must include the following:
      • Documentation of the FDA determination of expanded access
      • Investigator’s Brochure or a package insert for the drug
      • Informed consent document
   2. The IRB staff pre-reviews the application to determine that the submission is complete. If the FDA has provided an acknowledgement that a single patient IND may proceed, the IRB staff pre-reviewer will assign the application to the IRB Chair or Vice-Chair. The IRB Chair or Vice-Chair reviews the application for expanded access plan for use of an investigational medical product.
   3. If the IRB Chair or Vice-Chair agrees with the single patient expanded access plan, the treatment may be acknowledged. If the IRB Chair or Vice-Chair has questions about or believes that the treatment justifies discussion at a convened board meeting, it may be referred to the convened IRB for review. If the IRB Chair or Vice-Chair disagrees with the expanded access plan, it should be referred to the convened IRB for review. The convened IRB may approve or disapprove the expanded access plan.
   4. Expanded access for intermediate size-patient populations or for widespread treatment will referred to and reviewed by the convened IRB.
   5. Emergency use for single-patient use will be handled according to the policy outlined in SOP 506: Emergency Use of a Test Article and Planned Emergency Use.
2. Expanded Access Plan for Investigational Devices
   1. Investigators must submit a new study application to the IRB. Applications must include the following:
      • Informed consent document
      • Documentation of the FDA concurrence with the compassionate use
   2. The IRB staff pre-reviews the application to determine that the submission is complete.
   3. Expanded access as compassionate use may be assigned to the IRB Chair or Vice-Chair. The IRB Chair or Vice-Chair reviews the application for expanded access plan for compassionate use of an unapproved device. If the IRB Chair or Vice-Chair concurs with the compassionate use, the approval may be issued. If the IRB Chair or Vice-Chair has questions about or believes that the treatment justifies discussion at a convened board meeting, it may be referred to the convened IRB for review. If the IRB Chair or Vice-Chair disagrees with the compassionate use, it should be referred to the convened IRB for review. The convened IRB may concur with compassionate use or disapprove the plan.
      1. The physician may not proceed with the compassionate use until the FDA concurrence with the compassionate use has been received by the IRB and there is IRB Chair or Vice- Chair concurrence.
      2. The physician must submit reports after the compassionate use and reports of problems as dictated by the FDA.
   4. Expanded access as a treatment investigational device exemption will be referred to and reviewed by the convened IRB.
   5. Emergency use of an investigational device will be handled according to the policy outlined in SOP 506: Emergency Use of a Test Article and Planned Emergency Use.

POLICY

The University of Utah IRB may approve a research proposal in which an investigator will obtain information or biospecimens for the purpose of screening, recruiting, or determining eligibility of prospective subjects without the informed consent of the subject or the subject’s legally authorized representative if either of the following conditions are met:

1. The investigator will obtain information through oral or written communication with the prospective subject or legally authorized representative; or
2. The investigator will obtain identifiable private information or identifiable biospecimens by accessing records or stored identifiable biospecimens.

Investigators must abide by the HIPAA Privacy Rule, when applicable (see SOP 802: Privacy and Confidentiality).

The IRB will evaluate recruitment processes (including advertisements) to ensure an equitable selection of participants. Additionally, the IRB considers advertising or soliciting for study participants to be the start of the informed consent process. Therefore, the IRB reviews proposed recruitment processes and advertisements to ensure that they do not violate the regulatory requirements of consent. Advertisements should be included as part of the initial study application.

The Investigator must obtain IRB approval prior to the use of all television, radio, print advertisements, e-mail solicitations, letters, websites, and other recruitment methods and materials intended for the recruitment of prospective research participants.

When advertisements are to be taped for broadcast, the IRB must review the final audio or video advertisement prior to approval. The IRB may review and approve the script of an advertisement prior to taping to preclude re-taping because of inappropriate wording. The review of the final recorded message prepared from the IRB approved script may be conducted via expedited procedures.

The IRB reviews “direct advertising for research participants” which is defined as advertising that is intended to be seen or heard by prospective participants to solicit their participation in a study. This includes any sponsor-provided advertisements or Investigator-drafted advertisements.

Advertisements must be submitted to the IRB in their final form in order to receive IRB final approval for use.

The IRB adheres to the advertising guidelines posted on the IRB website (see Investigator Guidance Series: Recruitment Methods and Investigator Guidance Series: Advertisements).

PROCEDURES

1. Investigators must describe the plan for screening, recruiting (including any advertising materials), or determining eligibility in the new study application.
2. Investigators must include any advertising materials in the new study application. Any advertising materials developed after IRB approval must be submitted via amendment application.
3. Changes in currently approved procedures for screening, recruiting (including any advertising materials), or determining eligibility must be submitted in the form of an amendment to the IRB for approval prior to implementation.
4. The IRB Chair or designee may review changes to approved procedures for screening, recruiting, or determining eligibility via expedited review (see SOP 402: Expedited Review). Changes to advertising materials (when changes are easily compared to the consent document) may also be reviewed via expedited review. However, the Chair or designee may refer the amendment application to the convened IRB if the IRB reviewer has doubts or other complicated issues are involved.

POLICY

The IRB reviews payment arrangements to research participants to ensure an equitable selection of subjects by only approving payment methods that are not coercive and do not present undue influence. The description of payment arrangements is also part of the consent process. Therefore, the IRB must review statements regarding payment arrangements in the consent document to prevent any statements that are misleading, inaccurate or otherwise violate the regulatory requirements of consent.

Payment to research participants for participation in studies is not considered a benefit. Payments for participation are provided to reimburse participants for their time, effort or other expenses. The University of Utah IRB uses the term “compensation” for such payments to participants.

The IRB adheres to the compensation guidelines posted on the IRB website (see Investigator Guidance Series: Compensation).

PROCEDURES

1. Investigators must provide the total amount of compensation and the schedule of payments to participants, if any. Such information must be provided in the application and in the consent document during initial review.
2. The IRB reviews both the amount of payment and the proposed method and timing of disbursement to ensure that compensation is appropriate. The IRB reviews the consent document to ensure that an accurate description of compensation is presented. Documentation is made in the IRB reviewer checklist.

PURPOSE

The University of Utah Institutional Review Board (IRB) adheres to the regulatory requirements for informed consent. This SOP outlines how the University of Utah IRB determines that the applicable requirements for informed consent are met.

SCOPE

This policy applies to non-exempt human subject research conducted at the University of Utah. This policy applies to adult consent and parental permission.

DEFINITIONS

1. A legally authorized representative (LAR) is an individual or judicial or other body authorized under applicable law to consent on behalf of a prospective subject to the subject’s participation in the procedure(s) involved in the research.

POLICY

Investigators are required to obtain legally valid informed consent from each participant or their legally authorized representative before involving them in research. The University of Utah IRB may approve a consent procedure which does not include, or which alters some or all the elements of informed consent as outlined in IRB SOP 703: Waiver or Alteration of Consent.

The University of Utah IRB reviews the research application and any written consent documents to ensure that the required elements of informed consent and when appropriate, the additional elements of informed consent are included in the informed consent process. Additional information or language to be included in informed consent may be required based upon the study. The University of Utah IRB provides investigators with informed consent checklists which outline required elements, and sample language or information that must be provided during the consent process.

The University of Utah IRB adheres to the following regulations, as applicable:

• Department of Health and Human Services (DHHS): 45 CFR 46.116
  • The University of Utah IRB does not utilize the option for broad consent (45 CFR 46.116(d)).
• Food and Drug Administration (FDA): 21 CFR 50.25
  • The informed consent requirements related to the content, organization and presentation of information included in the consent form and process as well as the basic and additional elements of informed consent in the Final Common Rule are not inconsistent with the FDA’s current policies and guidance. The University of Utah IRB may approve a consent process for an FDA-regulated study that is consistent with the Final common Rule.
• Veterans Affairs (VA): 38 CFR 16.116
• Department of Defense (DoD): 32 CFR 219.116

For studies that are not federally funded, the pre-2018 Common Rule requirements for informed consent are required. The informed consent requirements related to the content, organization and presentation of information included in the consent form and process as well as the basic and additional elements of informed consent in the Final Common Rule are not required but may be included.

Whether written or oral, the general requirements for informed consent are:

• Before involving a human subject in research, the investigator must obtain legally effective informed consent from the participant or the participant’s legally authorized representative.
• Consent is sought under circumstances which provide the prospective participant or the legally authorized representative with sufficient opportunity to ask questions and consider whether to participate. Further, the possibility of coercion or undue influence must be minimized.
• The information that is given to the participant or the legally authorized representative shall be in language understandable to the participant or legally authorized representative.
• Any information that a reasonable person would want to have in order to make an informed decision about participation should be provided to the participant or legally authorized representative.
• For studies subject to the Final Common Rule, consent must begin with a concise and focused presentation of the key information that is most likely to assist a prospective participant or legally authorized representative in understanding the reasons why an individual may or may not want to participate in the research.
• The information must be presented in sufficient detail and organized and presented in a way that does not merely provide lists with isolated facts, but rather facilitates the understanding of why one may or may not want to participate.
• No informed consent may include any exculpatory language through which the participant is made to waive or appear to waive legal rights or releases or appears to release the Investigator, the Sponsor, or the University of Utah from liability for negligence.
• In seeking informed consent, the required elements of informed consent must be provided to the prospective participant or their legally authorized representative.

PROCEDURES

1. General Requirements for Informed Consent
   1. Based on the investigator’s proposal for obtaining informed consent, the IRB determines whether the plans for obtaining consent meet the general requirements for informed consent (see above). Documentation is made using the reviewer checklist in the University of Utah Electronic Research Integrity and Compliance Administration system (ERICA).
2. Basic and Additional Elements of Informed Consent
   1. The IRB determines whether the information provided to the potential participant includes the basic required elements of informed consent and when appropriate, the additional elements of informed consent as provided in the applicable regulations cited above. Documentation is made using the reviewer checklist in ERICA.
   2. For studies that are no more than minimal risk, the additional elements of informed consent provided in the regulations cited above will not be required. However, if the IRB determines any of the additional elements of informed consent should be included, it will be documented using the reviewer checklist.
   3. For studies that are greater than minimal risk, the additional elements of informed consent provided in the regulations cited above are generally required. The IRB determines if any of the additional elements of informed consent may be omitted. Such a determination will be based upon situations in which the elements are not applicable as defined in the reviewer checklist.
   4. Any elements of informed consent required specifically for VA or DoD studies will be required as outlined in the respective regulations.
3. University of Utah Requirements for Informed Consent
   1. The IRB determines that the University of Utah IRB requirements are included in the informed consent process. Documentation is made using the reviewer checklist.
   2. The University of Utah IRB requires the use of standard language (e.g., research-related injury, etc.), as applicable. Any change to the standard language may be subject to ancillary review and must be approved by the IRB.
   3. The IRB follows applicable Federal, State, or local laws, which require additional information to be disclosed for informed consent to be legally valid. If applicable, this information must be provided.
   4. In addition to information specifically required by applicable regulations, the IRB may require that information, be given to the participants when in the IRB’s judgment the information would meaningfully add to the protection of the rights and welfare of participants.

PURPOSE

This SOP outlines the requirements and acceptable methods for documentation of informed consent. The University of Utah Institutional Review Board (IRB) may also approve a waiver of documentation of consent under limited circumstances as outlined in this policy.

SCOPE

This policy applies to non-exempt human subject research conducted at the University of Utah. This policy applies to investigators obtaining adult consent and parental permission for participation in research.

DEFINITIONS

1. A legally authorized representative (LAR) is an individual or judicial or other body authorized under applicable law to consent on behalf of a prospective subject to the subject’s participation in the procedure(s) involved in the research. The University of Utah IRB will accept consent from an LAR given that the researcher has established that the consenting individual has legal authority to do so (provided the IRB determined there is adequate justification for the inclusion of an LAR in the consent process).

POLICY

Documenting informed consent occurs after the investigator or designated study personnel has conducted a consent process (i.e., explains the research, answers questions, etc.). The signature of the participant or the participant’s legally authorized representative indicates consent to participate. The signature of the person obtaining consent indicates that they conducted a consent process, and the research has been explained to the participant.

The University of Utah IRB may approve procedures for documentation of informed consent which involves (a) a written consent document signed and dated by the participant or the participant’s legally authorized representative; (b) a short form written consent stating that the required elements of informed consent have been presented orally; or (c) in limited circumstances, waiver of documentation of consent. It is the responsibility of the University of Utah IRB to determine whether the proposed method of documentation of consent or waiver of documentation of consent is appropriate in protocols that it reviews. Investigators must describe the method of documentation of consent or request a waiver of documentation of consent in the IRB application submitted in the Electronic Integrity and Compliance Administration system (ERICA).

PROCEDURES

1. Documentation of Informed Consent with a Written Consent Document
   1. In most circumstances, the University of Utah IRB requires that informed consent is documented using a written consent document approved by the IRB. The written consent document should be signed and dated by the participant or the participant’s legally authorized representative prior to enrollment or any participation in the study. The investigator should allow the participant or the participant’s legally authorized representative adequate opportunity to read the consent document and ask questions before it is signed and dated. A copy of the document must be given to the person signing.
      1. The IRB may approve a process that allows the written informed consent document to be delivered by mail, electronic mail or facsimile to the potential participant or the potential participant’s legally authorized representative and to conduct the consent interview by telephone or video call when the participant or the participant’s legally authorized representative can read the consent document as it is discussed. All other applicable conditions for documentation of informed consent must also be met when using this procedure.
      2. Illiterate persons who understand English may have the written informed consent document read to them and “make their mark,” under Utah state law. If written consent is obtained from illiterate persons outside the state of Utah, persons will ‘make their mark’ as appropriate according to the laws applicable in each state or country.
   2. For all studies, including those involving veterans, IRB approval of the written informed consent is documented by an electronic stamp that indicates the date of the most recent IRB approval of the document. If the consent is amended, the date stamp must be that of the most recent approved consent.
   3. For all studies, including those involving veterans, the written consent document must be signed and dated by:
      • The participant or the participant’s legally authorized representative.
      • The person obtaining the informed consent. The IRB may waive this requirement if no physical contact with the participant will occur.
      • A witness, if required by the IRB. The role of the witness is to witness the participant’s or the participant’s legally authorized representative’s signature only unless the sponsor or IRB requires the witness to witness the informed consent process. The witness cannot be the person who obtained informed consent from the participant but may be another member of the study team or may be a family member.
2. Documentation of Informed Consent with a Short Form

   The University of Utah IRB approves a standard short form document (written in English) for general use. All panels must vote for approval of the standard short form document at a convened meeting prior to the document being made available for use on the IRB website.

   Once the English version of the standard short form has been approved by the University of Utah IRB, translated versions are certified by the Research Translation Office and are also made available for use general on the IRB website.

   The short form consent documentation process must be approved by the IRB on a per study basis prior to the use of short forms. Once the process is approved for a study, any standard University of Utah short form may be used. The short form documents do not need to be attached to the ERICA application. If an investigator wishes to use an alternative to the standard short form or translate their own version, it must be reviewed and approved by the IRB prior to use.

   1. As an alternative to standard written informed consent documents, oral presentation of informed consent information is allowed under 45 CFR 46.117(b)(2) and 21 CFR50.27(b)(2). In such cases, the participant must be provided with IRB approved versions of both: • A short form written informed consent document stating that the elements of informed consent as required above have been presented orally to the participant or the participant’s legally authorized representative.
      • A written summary of the information that is presented orally.
      • A witness to the oral presentation is required. The witness must sign and date both the short form written informed consent document and a copy of the written summary.
   2. The participant or the participant’s legally authorized representative must sign and date the short form written consent document.
   3. The person obtaining consent must sign and date a copy of the written summary of the information that is presented orally. The person obtaining consent may not act as the witness to the consent process.
   4. An oral presentation may be documented using the short form with participants who do not speak English or have limited English proficiency (LEP).
      1. The oral presentation and the short form written informed consent document should be in a language understandable to the participant.
      2. The IRB-approved English language informed consent document may serve as the summary.
      3. The witness should be fluent in both English and the language of the participant. Interpreters may serve as the witness.
      4. Once a consent process using a short form for documentation of consent is approved for a study, use of the University of Utah IRB approved short form in any of the languages posted on the IRB website is permitted.
      5. If an investigator wishes to use their own translation, expedited review is acceptable if the IRB has already approved the protocol, the full English language informed consent document, the English version of the short form document, and verification of translation is provided.
3. Waiver of the Requirement to Obtain Written Documentation of the Consent Process
   1. The convened IRB or a designated IRB reviewer using the expedited procedure determines and documents whether the waiver of written documentation can be granted by using the appropriate section of the Reviewer Checklist.
      1. The IRB may waive the requirement for the investigator to obtain a signed consent document for some or all participants if it is not subject to FDA regulation and it finds either: That the research presents no more than minimal risk of harm to participants and involves no procedures for which written consent is normally required outside of the research context; or
      2. That the only record linking the participant and the research would be the consent document and the principal risk would be potential harm resulting from a breach of confidentiality. Each participant will be asked whether he/she wants documentation linking the participant with the research, and the participant’s wishes will govern. In such cases, investigators must submit a description of the information that would be disclosed or a consent document for participants who wish to have their consent documented.
      3. If the participants or the participant’s legally authorized representatives are members of a distinct cultural group or community in which signing forms is not the norm, that the research presents no more than minimal risk of harm to subjects and provided there is an appropriate mechanism documenting that informed consent was obtained.
   2. There may be circumstances in which the investigator requests that the IRB waive the requirement for the investigator to obtain a signed consent document and would like to use translated versions of the University of Utah IRB-approved short form to facilitate a consent process with participants who do not speak English or have limited English proficiency (LEP). In these cases, investigators may use the University of Utah IRB-approved short form(s) without obtaining signatures on the short form once a waiver of documentation of consent and the consent procedure including the interpretation process is approved by the IRB.

PURPOSE

The University of Utah Institutional Review Board (IRB) may waive the regulatory requirement to obtain consent or may approve a consent procedure that alters elements of informed consent. This SOP outlines how the University of Utah IRB determines that a waiver or alteration of consent is granted.

SCOPE

This policy applies to non-exempt human subject research conducted at the University of Utah. This policy applies to consent and parental permission, as described. This policy does not describe the waiver of informed consent for planned emergency research or exceptions from informed consent (see SOP 506: Emergency Use of a Test Article and Planned Emergency Use).

POLICY

The University of Utah IRB may approve a consent procedure that does not include, or which alters, some or all the elements of informed consent (see SOP 701: General Requirements of Informed Consent) if the IRB finds and documents that the research meets specific criteria outlined in 45 CFR 46.116(f).

The waiver or alteration of consent for public benefit or service programs is generally not used at the University of Utah. However, the IRB may waive the requirement to obtain informed consent if it meets the specific criteria outlined in 45 CFR 46.116(e).

The University of Utah IRB does not utilize the option for broad consent.

The University of Utah IRB requires that investigators submit a request for alteration of consent for research involving deception in addition to an informed consent document.

If the University of Utah IRB determines that a research protocol is designed for conditions or for a participant population for which parental or guardian permission is not a reasonable requirement to protect the participants (for example, neglected or abused children), it may waive the consent requirements, provided an appropriate mechanism for protecting the children who will participate as participants in the research is substituted, and provided that the waiver is not inconsistent with federal, state, or local law. The choice of an appropriate mechanism would depend upon the nature and purpose of the activities described in the protocol, the risk and anticipated benefit to the research participants, and their age, maturity, status, and condition.

In general, no Department of Defense department may conduct or use appropriated funds to support research involving a human being as an experimental subject1 without the prior informed consent of the subject. However, a waiver of consent may be granted for research involving a human being as an experimental subject if a waiver is obtained from the Assistant Secretary of Defense for Research and Engineering. If the research participant does not meet the definition of an “experimental subject”, the IRB may waive the consent process as described in this policy.

^{1. An activity, for research purposes, where there is an intervention or interaction with a human being for the primary purpose of obtaining data regarding the effect of the intervention or interaction. Examples of interventions or interactions include, but are not limited to, a physical procedure, a drug, a manipulation of the subject or subject’s environment, the withholding of an intervention that would have been}

PROCEDURES

1. Waiver or Alteration of Informed Consent
   1. Investigators may request that the IRB waive informed consent or alter elements of informed consent by completing the appropriate request(s) in the IRB application in the University of Utah Electronic Research Integrity and Compliance Administration system (ERICA). The investigator provides protocol-specific justification for the waiver or alteration of consent.
   2. The convened IRB or a designated IRB reviewer (for studies reviewed using the expedited procedure) reviews this information and concurs or requires changes and/or clarification before final approval. The reviewer checklist is used to determine and document whether the waiver can be granted. Alternatively, determinations may be documented in IRB meeting minutes.
   3. Research which involves deception or is designed in such a way that providing a complete disclosure of information during the consent process will invalidate the study, requires an informed consent document and a request for an alteration of informed consent. The investigator must complete the appropriate section of the IRB application in ERICA and must meet the criteria for waiver or alteration of informed consent. The IRB may require a debriefing or disclosure of the missing consent information after the participant has completed the study.

^{undertaken if not for the research purpose. This does not include: (1) Activities carried out for purposes of diagnosis, treatment, or prevention of injury and disease in members of the armed Forces and other mission essential personnel under Force Health Protection programs of the Department of Defense. (2) Authorized health and medical activities as part of the reasonable practice of medicine or other health professions. (3) Monitoring for compliance of individuals and organizations with requirements applicable to military, civilian, or contractor personnel or to organizational units. This includes such activities as drug testing, occupational health and safety monitoring, and security clearance reviews. (Department of Defense Directive 3216.02 section E2.1.3.)}

PURPOSE

The University of Utah Institutional Review Board (IRB) follows the regulatory requirements for making adequate provisions to obtain the assent of children in research as outlined in this policy. Additionally, the University of Utah IRB requires adequate provisions be made to obtain the assent of adults with diminished decision-making capability, as outlined in this policy.

SCOPE

This policy applies to non-exempt human subject research conducted at the University of Utah.

DEFINITIONS

1. Assent means a participant’s affirmative agreement to participate in research. Mere failure to object absent affirmative agreement, should not be construed as assent.

POLICY

The principle of “respect for persons” requires that the choice of an autonomous person be respected. Under the usual conditions of research, this is accomplished by soliciting the informed consent of the prospective research participant. In the case of an adult with diminished decision-making capacity or non-autonomous child, applying the principle of respect for persons is problematic. Therefore, permission of either the parent or legally authorized representative is required (see SOP 701: General Requirements of Informed Consent). However, individuals capable of some degree of understanding (generally, a child of seven or older, or an adult with diminished decision-making capacity) should participate in research only if they assent. When assent is required by the IRB, if the individual dissents from participating in research, the individual’s decision should be respected.

In instances where the participant is a child or where the participant has diminished decision-making capacity, the IRB must find that adequate provisions are made for soliciting the assent of the participant, when in the judgment of the IRB the participant is capable of providing assent.

In determining whether participants are capable of assenting, the investigator and the IRB considers the age, maturity, and psychological state of the participant involved. This judgment may be made for all participants under a particular protocol, or for each participant, as the IRB deems appropriate. The assent of the participant is not a necessary condition for proceeding with the research if the IRB determines:

1. The capability of some or all of the participants is so limited that they cannot reasonably be consulted;
2. The intervention or procedure involved in the research holds out a prospect of direct benefit that is important to the health or well-being of the participant and is available only in the context of the research;
3. The research meets the same conditions as those for waiver or alteration of informed consent in research (see SOP 703: Waiver or Alteration of Informed Consent).

Informed consent is an on-going process throughout the duration of a research project. When a child who was enrolled in research with parental/guardian permission subsequently reaches the legal age of consent to the procedures involved in ongoing research, the investigator should seek and obtain legally effective informed consent, as described in SOP 701: General Requirements of Informed Consent for the now-adult participant for any ongoing interactions or interventions with the participants unless the IRB determines that the requirements for obtaining informed consent can be waived. Prior parental permission and child assent are not equivalent to legally effective informed consent for the now-adult participant.

The IRB has the discretion to determine the appropriate manner, if any, of documenting child assent.

For those participants who may recover an adequate amount of decision-making capacity during the course of the study, the IRB will consider plans to obtain full informed consent from the participant.

PROCEDURES

1. Assent for Children
   1. If children capable of some degree of understanding (generally, age seven or older) are involved in a proposed study, investigators must provide the IRB with a plan to obtain assent or justification why assent is not required.
   2. The IRB determines whether all, none, or some of the children are capable of assent. If assent is required not required for some or all of the children, justification is documented in the reviewer checklist (children checklist).
   3. If the IRB determines that assent is a requirement for some or all of the children, the IRB determines and documents in the reviewer checklist (assent checklist) whether the proposed assent process is acceptable and whether documentation of assent is required.
2. Assent for Participants with Diminished Decision-Making Capability
   1. If individuals with impaired decision-making capacity are involved in a proposed study, investigators should provide the IRB with a plan to obtain assent or justification why assent is not required.
   2. The IRB determines whether an assent process should be included along with the informed consent from a legally authorized representative (LAR). If assent is required, additional considerations are made regarding whether a re-assenting process should occur and whether obtaining full informed consent from the participant may occur should they recover an adequate amount of decision-making capacity. Determinations are made in the reviewer checklist.

POLICY

The University of Utah IRB will follow and adhere to the University’s Conflict of Interest policy. The full policy (1-006) is posted on the University Regulations website. All investigators engaged in research are required to comply with the policy. The IRB requires financial interests of investigators, study personnel, and relevant institutional officials to be managed so that they do not adversely affect participant protections or the credibility of the human research protection program.

The protection of human subjects requires objectivity in communicating risks, selecting subjects, promoting informed consent, and gathering, analyzing, and reporting data. Therefore, the IRB will consider conflict of interest issues in its deliberations of applications.

All principal investigators must complete a disclosure form within the University of Utah Business Relationship Reporting online system, declaring any significant potential financial interests related to the research. The ERICA online system communicates with the Business Relationship Reporting online system to determine if disclosure forms for individuals listed in the IRB application are completed and up to date as per the standards described in University Policy 1-006.

The Conflict of Interest Committee is required to report all conflicts of interest determinations related to human subject research and provide management plans to the IRB. Management plans are accessible to the IRB within the ERICA system. The IRB will review the conflict of interest decisions and management plans to consider the effect of financial interests on participant protections. The IRB may request that the investigator update the IRB application and/or consent documents to comply with the conflict of interest management plan if it has not already been updated. The IRB has the final authority to decide whether the conflicting interests and management plans adequately protect participants and allow research to be approved.

POLICY

It is the policy of the University of Utah IRB (UUIRB) to assure that the privacy and confidentiality protections are adequate for all research participants. The UIRB provides guidance to IRB members and Investigators regarding privacy and confidentiality. Such guidance is available on the UUIRB website and within the ERICA online system.

Investigators must describe provisions to protect the privacy interests of participants in the IRB application. The UUIRB determines and documents whether privacy protections are adequate.

The Investigators must describe provisions to maintain the confidentiality of data in the IRB application. Investigators are required to abide by HIPAA Privacy Rule, when applicable. For researchers to gain access to health information that is stored at any HIPAA “covered entity”, investigators must provide the covered entity with written assurances describing how the health information will be used and protected.

A covered entity may use or disclose protected health information for research, regardless of the source of funding of the research, provided that investigators’ requests for health information receive prior approval through a Privacy Board or the University of Utah Institutional Review Board. Information about designated covered entities affiliated with the UUIRB is available on the IRB website.

For studies that have been issued a Certificate of Confidentiality, investigators should follow the guidance provided in the Investigator Guidance Series: Certificates of Confidentiality available on the IRB website.

PROCEDURES

1. Procedures for Review
   1. Upon review of the investigator’s submission, the UUIRB determines whether the investigator’s proposal for protection the privacy and confidentiality of research participants is adequate. The determination is documented in the reviewer checklist.
   2. For research subject to the HIPPA Privacy Rule, investigators may request that the use of protected health information for research. The UUIRB may approve the investigator’s proposal to obtain HIPAA Authorization from individuals to use their protected health information (PHI). Generally, HIPAA Authorization is obtained in conjunction with Informed Consent but may be separate.

      If HIPAA Authorization is not obtained from individuals, the investigator must obtain approval for one of the following:

      • Alteration of (HIPAA) Authorization
      • Waiver of (HIPAA) Authorization
      • Use of a de-identified Data Set that contains no PHI
      • Use of a Limited Data Set with an effective Data Use Agreement in place, as applicable
      • Research on Decedents’ Information
   3. Investigators submit requests for any of the above by completing the applicable form in the ERICA system. The UUIRB may grant approval of HIPAA Authorization or any of the other methods for conducting HIPAA-compliant research as described in this policy. The determination of approval is documented in the Reviewer Checklist. If a waiver or alteration of HIPAA Authorization is granted, protocol-specific findings justifying the board’s determination to grant such a waiver or alteration is documented in the Reviewer Checklist. The approved study protocol in ERICA will include documentation of approved method(s) of accounting for HIPAA compliance.

POLICY

The University of Utah Institutional Review Board will assure that research participants have knowledge of compensation and treatment availability for injury that may occur as a result of participation in research activities. This policy does not apply to remuneration or other compensation for research participation. For commercially sponsored studies, compensation or payment of immediate necessary care for injury related to participation in research activities shall be provided according to the Informed Consent Document. The contractual agreement between the sponsor and the University of Utah made through the Office of Sponsored Projects will have a general statement which explains that the description of who will be responsible for medical care costs stemming from research related injuries is found in the Informed Consent Document.

PROCEDURES

1. The Investigator will insert language into the informed consent document regarding immediate necessary care in the event of a research related injury.
2. For research conducted at the Veteran Affairs Salt Lake City Health Care System (VASLCHCS), the investigator will insert language regarding the immediate necessary care in the event of a research related injury.
3. For commercially sponsored studies, the investigator will include language regarding compensation or payment of immediate necessary care for injury related to participation in research activities. The contractual agreement between the sponsor and the University of Utah made through the Office of Sponsored Projects will have a general statement which explains that the description of who will be responsible for medical care costs stemming from research related injuries is found in the Informed Consent Document.
4. The IRB will review and approve the proposed compensation and injury language as a part of the new study submission.
5. The IRB will render its determination for approval of compensation or medical treatment for medical injury as follows:
   1. The IRB will verify that the template language for injury is contained in the informed consent document.
   2. The IRB will review the injury language to assure readability and understandability, and non-exculpation in relation to the proposed target study population.
6. In the event the sponsor requests conflicting language in the contract during negotiation with the Office of Sponsored Projects, the contract may not be finalized until the Informed Consent Document is verified to be congruent with the sponsor’s contract language. The Office of Sponsored Projects and the IRB staff will work together to ensure the accuracy of the language. If any changes are made to the approved Informed Consent Document, they must be approved by the IRB.

DEFINITIONS

POLICY

It is the policy of the University of Utah IRB to require researchers to submit reports of events that may represent unanticipated problems involving risks to participants and others including unexpected and related adverse events. Researchers are required to submit the report as soon as possible after the Site Investigator learns of the event and in all cases within ten working days.

PROCEDURES

1. The PI reports problems under this policy by completing and electronically submitting a Report Form in the ERICA System. The list of reportable events/problems is posted on the IRB website.
2. Researchers are required to submit the report as soon as possible after the PI learns of the event and in all cases within ten working days.
3. The submission is assigned by the IRB staff through the ERICA system to an IRB administrator for review an evaluation. The IRB administrator may subsequently assign a member of the IRB Unanticipated Problems Subcommittee to for review the submission.
4. The assigned IRB administrator or subcommittee member may request clarifications, corrections, or revisions to the report from the PI if further information is needed to evaluate the event.
5. If the IRB administrator determines that the problem is not an unanticipated problem involving risks to participants or others as defined in this policy, the reviewer completes a checklist indicating the event is not considered to be an unanticipated event involving risks to participants. ERICA notifies the PI via e-mail. No further action is taken.
6. If the IRB administrator determines the problem might be an unanticipated problem involving risks to participants or others as defined by this policy, the event is referred to a member of the IRB Unanticipated Problems Subcommittee for review. If the IRB administrator determines the problem is likely to be an unanticipated problem involving risks to participants or others as defined by this policy, the event is referred to the convened board for review.
7. If the IRB subcommittee member determines that the problem is not an unanticipated problem involving risks to participants or others as defined by this policy, the IRB subcommittee member completes a checklist indicating the event is not considered to be an unanticipated event involving risks to participants. ERICA notifies the Principal Investigator via e-mail. No further action is taken.
8. If the IRB subcommittee member determines the problem might be an unanticipated problem involving risks to participants or others as defined by this policy, the event is referred to the convened IRB for review.
9. When problem reports are reviewed by the convened IRB, the IRB staff ensures board members are notified and the documents listed below are made available in the ERICA system three or more working days prior to the meeting. All IRB members are expected to review the information and be prepared to discuss it at the meeting.
   • Report Form;
   • the currently approved protocol;
   • the currently approved consent document;
   • previous reports of unanticipated events and problems involving risks to participants or others, if they exist;
   • the Investigator’s Brochure, if one exists.
10. Based on the nature of the event and the expertise required to assess it, the IRB Chair or designee acts as the primary reviewer and presents his/her findings to the convened IRB. The convened IRB evaluates the event by considering whether the problem is an unanticipated problem involving risks to participants or others as defined by this policy. The convened IRB votes on whether the report is an unanticipated problem involving risks to participants or others. IRB staff records the discussion, rationale for any action and vote in the minutes.
11. If the convened IRB determines that the problem is not an unanticipated problem involving risks to participants or others as defined by this policy, the convened IRB acknowledges the event as submitted, indicating the event is not considered to be an unanticipated event involving risks to participants. ERICA notifies the PI via e-mail. No further action is taken.
12. If the convened IRB determines that the problem is an unanticipated problem involving risks to participants or others as defined by this policy, the convened IRB may consider any of the following actions, but is not limited to:
    • modification of the protocol
    • modification of the information disclosed during the consent process provided by the investigator
    • providing additional information to current participants (this must be done whenever the information may relate to the participant’s willingness to continue participation)
    • providing additional information to past participants
    • requiring current participants to re-consent to participation
    • alteration of the frequency of continuing review
    • observation of the research or the consent process
    • requiring additional training of the investigator
    • notification of investigators at other sites
    • obtaining additional information
    • administrative hold, termination or suspension of the research according to SOP 904, Administrative Hold, Suspension, Termination and Non-compliance of Approved Research
13. If the IRB determines that the event was an unanticipated problem involving risks to participants or others, the matter is referred to the IRB staff to handle according to SOP 905, Reporting Procedures.

POLICY

It is the policy of the University of Utah IRB to require Principal Investigators to report deviations which meet one or more of the following criteria:

• Intended to eliminate apparent immediate hazard to a research participant; or
• Caused possible harm to participants or others, or placed them at increased risk of harm – including physical, psychological, economic, or social harm); or
• Possible serious or continued noncompliance

Any changes in the research protocol during the period, for which the IRB approval has already been given, may not be initiated without submission of an amendment for IRB review and approval.

Any report of a deviation to the IRB should be made in a timely fashion but no later than within 10 working days of its occurrence or identification. For VA research, the report form must be submitted within 5 working days.

PROCEDURES

1. The Principal Investigator reports deviations by completing and electronically submitting a Report Form in the ERICA online system. Examples of reportable deviations are posted on the IRB web site.
2. An IRB administrator performs a thorough review and evaluation of the deviation. Requests for clarifications, corrections or revisions to the report from the PI are made if further information is needed to evaluate the deviation.
3. The deviation is evaluated to determine if it had a significant effect on the participants’ rights, safety, or welfare, or corrupted the integrity of the resultant scientific data. The IRB Chair may be consulted at any time during this process for assistance.
4. Any corrective actions taken should be described and the Principal Investigator’s proposed preventive action plan should include an active process addressing the causal elements so the reviewer would conclude that the investigator has a serious, viable plan in place for assuring the safety of research participants and the oversight of data integrity.
5. After review and evaluation of the incident the following actions may be taken:
   • The deviation is completed with the determination indicated.
   • The deviation is returned to the PI to be submitted as an adverse event and/or unanticipated problem involving risks to participants or others. Please see SOP 901, Unanticipated Problems Involving Risks to Participants or Others.
   • If the IRB administrator determines that the deviation possibly meets the definition of serious or continuing non-compliance according to SOP 903, the deviation is handled according to SOP 903, HRPP and Non-Compliance.

DEFINITIONS

POLICY

The IRB has the authority to suspend or terminate approval of research that is not being conducted in accordance with the IRB policies, is not in compliance with Federal Regulations or that has been associated with unexpected serious harm to participants. Suspensions and terminations will be reported to OHRP, FDA and appropriate institutional officials when applicable as listed in SOP 905 (Reporting Procedures).

An investigator may also place a voluntary administrative hold on previously approved research when in the judgment of the investigator an administrative hold is appropriate to protect the rights or welfare of participants.

In this policy, an IRB designee refers to the following: The IRB Chair, IRB Vice-Chair, IRB Director, Institutional Official, or a person designated in writing to temporarily assume the role of one of these persons.

PROCEDURES

1. Procedures for Administrative Holds
   1. An investigator may place a research study on administrative hold. Some or all research activities may be placed on administrative hold until additional information can be obtained in order to determine if a change in the risk/benefit assessment of the research has occurred, or if potential areas of non-compliance exist in a currently approved research protocol.
   2. The IRB or IRB designee in consultation with the investigator determines whether any additional procedures need to be followed to protect the rights and welfare of current participants as described in SOP 906 (Protection of Research Participants).
   3. The IRB or IRB designee in consultation with the investigators determine how and when currently enrolled participants will be notified of the administrative hold.
   4. Investigators must:
      • Notify the IRB in writing that the investigator is voluntarily placing a study on administrative hold.
      • Provide a description of the research activities that will be stopped. Research activities may include but are not limited to recruitment, screening/enrollment, research intervention/interaction, follow-up, or all research activities.
      • Provide a list of all currently enrolled participants’ status within the study, and the proposed actions to be taken (if needed) to protect the rights and welfare of current participants during the administrative hold action according to SOP 906 (Protection of Research Participants).
      • Provide a written description of actions that will be taken prior to IRB approval of proposed changes in order to eliminate apparent immediate harm.
   5. After written notification from the investigator has been received, the IRB staff is notified by the IRB Chair or designee of the study on administrative hold and actions to be taken.
   6. An IRB administrator initiates an inquiry process and considers if the additional information gathered during the inquiry stage of an investigation determines that no change to the risk/benefit ratio has occurred, the rights or welfare of participants have not been compromised, and issues of non-compliance have been ruled out. The inquiry may necessitate a for-cause audit according to SOP 908 (Routine and For-Cause Audits) to obtain the needed information.
   7. The IRB administrator writes a report of the findings. The IRB Chair or designee notifies the investigator in writing of these findings and what corrective actions are necessary, if any, and allows the study to return to active status. Determinations of unanticipated problems involving risks to participants or others or non-compliance that are a result of these findings will be made according to SOP 901 (Unanticipated Problems Involving Risks to Participants or Others) and SOP 903 (HRPP and Non-Compliance).
2. Procedures for Suspension or Termination of IRB Approved Research by the Convened IRB or IRB Designee for Cause
   1. If research is not being conducted in accordance with the policies, requirements, and determinations of the IRB, or federal rules or regulations including the requirements of the VHA Directive 1200.5 governing human subject research, or has been associated with unexpected serious harm to participants, the convened IRB or designee may suspend or terminate some or all research activity to protect the rights or welfare of participants.
   2. The IRB designee considers whether any actions need to be implemented to protect the rights and welfare of current participants as described in SOP 906 (Protection of Research Participants), and orders any actions that need to be taken during the investigation process.
   3. The IRB designee notifies IRB staff of the suspension and actions ordered.
   4. The IRB Chair or designee notifies the investigator of the suspension in writing that there are reasonable concerns that infractions have occurred and an investigation has been initiated. This letter is drafted following Procedures for Communication of Terminations and Suspensions below.
   5. An IRB administrator initiates an investigation process and considers if the additional information gathered during the inquiry stage of an investigation determines that no change to the risk/benefit ratio has occurred, the rights or welfare of participants have not been compromised, and issues of non-compliance have been ruled out. The investigation may necessitate a for-cause audit according to SOP 908 (Routine and For-Cause Audits) to obtain the needed information.
   6. The IRB administrator writes a written report detailing the findings of the investigation as well as appropriate corrective actions for any problems or deficiencies. The written report is sent to the convened IRB, IRB Chair, IRB Director, and other Institutional Officials and other units within the University or the covered entity as appropriate.
   7. The convened IRB considers the written report and whether any actions need to be implemented to protect the rights and welfare of current participants as described in SOP 906 (Protection of Research Participants) and votes on the actions to be taken. Possible actions the convened IRB considers may include, but are not limited to the following:
      • Continuing interventions that are being administered to currently enrolled participants under the research protocol, at least temporarily, when those interventions hold out the prospect of direct benefit to the subjects or when withholding those interventions poses increased risk to subjects.
      • Transferring currently enrolled participants to another institution engaged in the research so that participation of the subjects may continue.
      • Transitioning currently enrolled participants to medical management outside of the research context.Determinations of unanticipated problems involving risks to participants or others or non-compliance that are a result of the findings will be made according to SOP 901 (Unanticipated Problems Involving Risks to Participants or Others) and SOP 903 (HRPP and Non-Compliance).
   8. The convened IRB votes to lift the suspension, continue or modify the suspension, or terminate the study.
   9. The IRB administrator and coordinator document in the IRB minutes the reasons for the suspension or termination and if applicable, any actions ordered to take place.
   10. IRB staff communicates with the investigator following Procedures for Communication of Terminations and Suspensions below.
3. Procedures for Communication of Terminations and Suspensions to Investigators
   1. The IRB staff drafts a letter to the investigator. The IRB Chair reviews and signs the letter. Copies are to be provided to the Institutional Official, IRB Director, IRB members, and the immediate supervisor or department chair of the Investigator. The letter includes:
      • The activities to be stopped;
      • Actions to be taken by the Investigator;
      • An explanation of the reasons for the decision;
      • A request to immediately notify the IRB Chair with a list of names of participants who might be harmed by stopping research procedures and a rationale as to why they might be harmed.
   2. The investigator may appeal or respond to the convened IRB in writing.
   3. IRB staff will follow the SOP 905 (Institutional Reporting Procedures) on reporting the suspension or termination of approved research by the IRB to appropriate organizational officials, sponsors, coordinating centers and regulatory agencies.

POLICY

It is the policy of the University of Utah IRB that before an administrative hold, suspension, or termination is put into effect, the convened IRB or IRB designee considers whether any additional procedures need to be followed to protect the rights and welfare of current participants.

In this policy, an IRB designee refers to the following: The IRB Chair, IRB Vice-Chair, IRB Director, Institutional Official, or a person designated in writing to temporarily assume the role of one of those persons.

PROCEDURES

1. The IRB requires the Investigator to submit proposed procedures for withdrawal of currently enrolled subjects that considers their rights and welfare. The convened IRB or IRB designee reviews the proposed procedures. These procedures may include but are not limited to:
   1. Submitting a list of all currently enrolled participants including their status within the study;
   2. Transferring participants to another investigator;
   3. Making arrangements for clinical care outside the research;
   4. Allowing continuation of some research activities under the supervision of an independent monitor; or
   5. Requiring or permitting follow-up of participants for safety reasons.

      The convened IRB or IRB designee may approve or request changes to the proposed procedures for withdrawal of enrolled subjects.

2. The IRB requires the Investigator to submit a proposed script or letter notifying all currently enrolled and former participants that are affected by the administrative hold, suspension, or termination. The convened IRB or IRB designee reviews the proposed script or letter and may approve or request changes to the proposed script or letter.
3. If follow-up of subjects for safety reasons is permitted/required by the IRB, participants should be so informed, and any unanticipated problems involving risks to participants or others must be reported to the IRB and others as required by the protocol and organizational policies and procedures.
4. The IRB may mandate oversight or transfer responsibility to another investigator to assure implementation of the above procedures.

POLICY

The University of Utah IRB is committed to the protection of research participants. Research participants are encouraged to express any concerns or complaints regarding the involvement in a research study.

Consent documents must include the investigator’s contact information for any questions, complaints and/or concerns the participant or legal representative may have about the research or related matters. Consent documents must also include contact information for the IRB office and for the Research Participant Advocate. Such contact information is made available for the reporting of questions, complaints and/or concerns. Information about how to report complaints or concerns is also provided on the IRB website. Additionally, the IRB provides a Participant Survey on the IRB website.

The IRB will investigate all complaints or concerns received regarding human subject research conducted under its jurisdiction. All complaints or concerns will be handled in a confidential manner. This includes any reporting of an alleged violation of investigator compliance.

PROCEDURES

1. Complaints received by an investigator or members of the research staff must be reported to the IRB according to SOP 901(Unanticipated Problem Involving Risks to Participants or Others). Complaints directly reported to the IRB will be documented using the Report Form for Research Concerns or Complaints and handled according to SOP 901 (Unanticipated Problems Involving Risks to Participants or Others).
2. The IRB Director, an IRB Administrator, or designee will attempt to find a suitable resolution and response to the complaint or concern in a timely manner. As necessary, complaints may be brought to the IRB Executive Committee for discussion and recommendation.
3. If the concern or complaint involves possible non-compliance or research misconduct, the complaint will be handled according to SOP 903 (HRPP and Non-Compliance).

POLICY

An IRB administrator or IRB designee may perform routine and for-cause audits using systematic methods to evaluate compliance with federal regulations, state and local laws, and University of Utah policies and procedures, and to verify that research is conducted in accordance with the IRB-approved protocols.

The objective of a routine IRB audit is to ensure proper documentation, record keeping, data analysis, and adherence to applicable Federal regulations and IRB policy in order to monitor, measure, and improve the effectiveness of the human research protection program. The audit assesses the study conduct procedure, identifies errors and omissions, and is a means to provide the investigator with recommendations for corrections and improvements in order to protect the rights and welfare of research participants.

In this policy, an IRB designee refers to a person designated in writing by the IRB Chair to assume the role of an ad-hoc auditor. The IRB may also accept audits conducted by the Research Compliance Officer at the VA.

PROCEDURES

1. Procedures for Initiating a Routine Audit
   1. The IRB administrator or designee selects an Investigator or study for a routine audit based on criteria which includes, but is not limited to, the following:
      • Studies involving procedures that are greater than minimal risk to subjects
      • Studies involving vulnerable populations
      • Investigator-Initiated drug/device studies
      • Investigators conducting a large number of studies
      • Studies approved using expedited procedures that are not subject to continuing review
   2. The IRB administrator or designee contacts the Investigator and establishes a time and place for the audit to take place. The IRB administrator informs the Investigator which documents are necessary for the audit. The Investigator must make such documents available at the time of the audit. Any other materials the IRB administrator deems necessary to accurately understand the research process under investigation shall be made available by the Investigator upon request.
2. Procedure for Initiating a For-Cause Audit
   1. The convened IRB, IRB Chair, Subcommittee, or IRB Director may direct the IRB administrator or designee to conduct an audit in response to a particular concern. Concerns which may prompt a for-cause audit include, but are not limited to, the following:
      • Complaints or concerns made by a research participant, family member of the research participant, research team member, or an employee of the University or the covered entity.
      • Reports of audits or monitoring conducted by other committees affiliated with the HRPP, federal agencies, data and safety monitoring committees, or other agencies involved in the conduct of a study.
      • Issues of non-compliance.
   2. The IRB administrator or designee contacts the Investigator and establishes a time and place for the audit to take place. The IRB administrator informs the investigator which documents are necessary for the audit. The Investigator must make such documents available at the time of the audit. Any other materials the IRB administrator deems necessary to accurately understand the research process under investigation shall be made available by the Investigator upon request.
3. Procedure for Conducting an Audit
   1. Using the University of Utah IRB auditing worksheets and the investigator self-assessment checklist (if completed), the IRB administrator reviews some or all of the aspects of the research records. These checklists become part of the final written report.
4. Procedures for Completing an Audit
   1. After an audit, the Investigator is informed of the result of the review in a written report from the IRB administrator or designee. The written report is also sent to the IRB Chair, IRB Director, and other Institutional Officials and other units within the University or the covered entity as appropriate.
   2. If the audit does not identify any problems, no action is taken.
   3. If the audit identifies problems or deficiencies, the IRB administrator includes appropriate corrective actions in the written report. The Investigator is expected to respond or comply with the corrective actions in a time frame determined by the IRB administrator. The IRB administrator is responsible for reviewing these corrective actions and follows up with the Investigator to ensure these corrective actions are completed. The IRB administrator may accept confirmation of completion for the corrective actions through a statement from the Investigator, other documentation from the Investigator, or a follow-up audit.
   4. If the corrective actions are not completed, the IRB administrator may recommend to the convened IRB that a suspension be considered for the study that was audited or for the studies that an Investigator is conducting, according to the procedures in SOP 904 (Administrative Hold, Suspension and Termination of Approved Research).
   5. If the audit identifies non-compliance, such as lack of oversight, deliberate falsification or omission, failure to comply with the requirements and determinations of the IRB, significant protocol violations, or deviations or frequent occurrences of such, the IRB follows SOP 903 (Human Research Protection Program and Non-Compliance). The IRB may request additional corrective actions as per this policy.
   6. If the audit identifies a problem that might be an unanticipated problem involving risks to participants or others the IRB follows SOP 901 (Unanticipated Problems Involving Risks to Participants or Others). The IRB may request additional corrective actions as per this policy.

POLICY

The University of Utah Human Research Protection Program provides information to the research community regarding the rights of a research participant as a volunteer. The IRB encourages and promotes community outreach efforts through feedback materials, surveys, and presentations on campus whenever possible.

PROCEDURES

1. Procedures for Maintaining Community Outreach Efforts Offered by the University of Utah IRB
   1. The IRB provides resources for research participants, prospective participants, researchers and community.
      • The IRB staff maintains a section of the IRB web site entitled Participant Resources which includes, but is not limited to the following information: • Research Participant’s Bill of Rights
      • Research Participant Brochure
      • Research Participant Survey
      • Contact information for the IRB for questions, complaints, concerns or for additional information concerning rights as a research participant
      • Contact information for someone independent of the IRB to obtain answers to questions, express concerns or to provide input regarding the Human Research Protection Program
      • IRB Customer Service Survey

        The IRB staff provides hard copies of any of the above materials as requested.

   2. Investigators are provided with a link to the IRB Customer Service Survey in each approval letter sent through the ERICA system.
   3. The IRB website includes links to web sites which provide additional information the rights of research participant such as:
      • Office for Human Research Protections
      • Food and Drug Administration
      • Belmont Report
   4. IRB members or staff conduct trainings or make presentations upon request regarding the rights of research participants.
2. Procedures for Improving Community Outreach Efforts Offered by the University of Utah IRB
   The Vice President for Research, Associate Vice President for Research Integrity, IRB Director, or designee(s) will evaluate, make changes, and implement changes to the outreach program as needed. These individuals may consult with the Education Director of the Office of the Vice President for Research Integrity, consider any complaints, concerns, suggestions, and other input from participants or others within the research community, and consider other departmental outreach efforts on University campus.
   1. Periodic assessments of outreach efforts and the outreach program are done at least annually, and more frequently, if needed, as determined by the Vice President for Research, Associate Vice President for Research Integrity, IRB Director, or designee(s).

DEFINITIONS

POLICY

It is the policy of the University of Utah to address both allegations and confirmed reports of any non-compliance in accordance with 45 CFR Part 46 and 21 CFR Part 50 the policies, requirements and determinations of the IRB and the VHA Handbook 1058.01: Research Compliance Reporting Requirements. This policy applies to the research investigative team, the IRB and IRB staff.

Members of the research community must report apparent non-compliance to the IRB. The determination that non-compliance is serious or continuing rests with the IRB.

PROCEDURES

1. Procedures for Addressing Allegations of Non-Compliance
   1. Allegations of non-compliance are investigated by an IRB administrator, the IRB Chair, or a designated IRB Vice-Chair.
      • The IRB administrator conducts a pre-inquiry review for preliminary informal checking of the facts to determine if there is a reasonable basis for the allegation and if the allegation can be supported or proved by the evidence. • If the allegation of non-compliance is determined by the IRB administrator not to be a credible confirmed report of non-compliance in fact by definition, the inquiry stops and no further action is taken.
      • If the allegation of non-compliance is determined by the IRB administrator to be a credible, confirmed report of non-compliance in fact by definition, the inquiry proceeds as outlined in this policy. The allegation of non-compliance is considered a confirmed report of non-compliance by definition.
2. Procedures for Addressing Confirmed Reports of Non-Compliance
   1. The IRB administrator reviews the confirmed report of non-compliance.
      1. The IRB administrator determines whether the confirmed report of non-compliance either does not represent serious or continuing non-compliance or might represent serious or continuing non-compliance as defined in this policy. 2.1.1. If the IRB administrator determines that the confirmed report of non-compliance is neither serious nor continuing non-compliance, as defined by this policy, the IRB administrator or designee consider, but is not limited to, the following actions:
         • Acknowledgement of the problems, requiring no sanctions but with instructions regarding the necessity to establish procedures and policies to avoid further infractions.
         • Require additional education and training applicable to human research participant protections of the Investigator and/or staff.
         • Request a corrective action plan from the Investigator.
         • Approve the submitted corrective action plan.
         • No further action.
      2. If the IRB administrator determines that the confirmed report of non-compliance might represent either serious or continuing non-compliance, as defined by this policy, the IRB administrator may refer the confirmed report of non-compliance to the IRB Chair or IRB Vice-Chair with his/her evaluation. At the discretion of the IRB administrator, he/she may also refer the confirmed report of non-compliance to the convened IRB with his/her evaluation (skip to 2.3 for procedures to be followed in this case).
   2. The IRB Chair or IRB Vice-Chair reviews the confirmed report of non-compliance.
      1. If the IRB Chair or IRB Vice-Chair determines that more information is needed because the inquiry discloses a reasonable basis for concern that significant infractions have occurred, he/she directs further investigation by the IRB administrator. The investigator is notified in writing of the directed investigation by the IRB administrator or designee.
      2. The IRB Chair or IRB Vice-Chair determines whether the confirmed report of non-compliance either does not represent serious or continuing non-compliance or might represent serious or continuing non-compliance as defined in this policy.
      3. If the IRB Chair or IRB Vice-Chair determine that the confirmed report of non-compliance is neither serious non-compliance nor continuing non-compliance, as defined by this policy, the IRB Chair or IRB Vice-Chair considers but is not limited to the following actions:
         • Acknowledgement of the problems, requiring no sanctions but with instructions regarding the necessity to establish procedures and policies to avoid further infractions.
         • Require additional education and training applicable to human research participant protections of the Investigator and/or staff.
         • Request a corrective action plan from the Investigator.
         • Approve the submitted corrective action plan.
         • No further action.
      4. If the IRB Chair or IRB Vice-Chair determines that the confirmed report of non-compliance might represent serious non-compliance and/or continuing non-compliance, as defined by this policy, the IRB Chair or IRB Vice-Chair refers the confirmed report of non-compliance to the convened IRB with his/her evaluation.
   3. When issues of non-compliance are reviewed by the convened IRB, the IRB staff prepares the documents listed below, if they apply, and makes them available to all members of the convened IRB for review three working days prior to the meeting, either in ERICA or in paper form. All IRB members are expected to review the information and be prepared to discuss it at the meeting.
      • The current ERICA application;
      • The Informed Consent Document;
      • The Investigator Brochure;
      • The confirmed report of non-compliance;
      • The audit report (investigation report) including a list of witnesses and documents reviewed;
      • Previous reports of non-compliance and the past record of the investigator and his/her team;
      • The evaluation of the confirmed report of non-compliance by IRB Chair or IRB Vice-Chair;
      • All additional pertinent documents or portions thereof (e.g., primary data).
   4. An IRB staff member assigns a primary reviewer based on scientific expertise to perform an in-depth review of the documents. The primary reviewer will present his/her findings. The primary reviewer and the IRB Chair or IRB Vice-Chair will lead the discussion during the convened IRB meeting.
   5. For VA Research: The IRB Chair or designee must consult the relevant Office of Research Oversight (ORO) Regional Office (RO) if the significance of a reported event is not clear.
   6. The convened IRB votes on whether the confirmed report of non-compliance represents serious non-compliance and/or continuing non-compliance as defined by this policy. IRB staff records the discussion, rationale for any action and vote in the minutes.
   7. If the convened IRB determines that the confirmed report of non-compliance is neither serious non-compliance nor continuing non-compliance, as defined by this policy, the IRB considers but is not limited to the following actions:
      • Acknowledgement of the problems, requiring no sanctions but with instructions regarding the necessity to establish procedures and policies to avoid further infractions.
      • Require additional education and training applicable to human research participant protections of the Investigator and/or staff.
      • Request a corrective action plan from the Investigator.
      • Approve the submitted corrective action plan.
      • No further action.
   8. If the convened IRB determines the confirmed report of non-compliance represents serious non-compliance and/or continuing non-compliance, as defined by this policy, the IRB considers but is not limited to the following actions: • Verification that participant selection is appropriate.
      • Observation of the research and the informed consent process by an IRB administrator.
      • Modifications of the protocol.
      • Request an increase in monitoring of the research activity via an independent data safety monitor or board.
      • Safety intervention as necessary such as visits to the activity site and continuing evaluation of the site by an IRB administrator.
      • Request audit and progress reports from the sponsor monitor or CRO.
      • Request a directed audit of targeted areas of concern by an IRB administrator.
      • Request a status report after each participant receives intervention from the Investigator.
      • Modify the frequency of the continuing review cycle.
      • Request additional Investigator and staff education focused on human research protections from appropriate available sources (e.g., GCP Training, OHRP conferences, NIH tutorial, human research protections seminars).
      • Notify current subjects, if the information about the non-compliance might affect their willingness to continue participation.
      • Provide additional information to past participants.
      • Suspend IRB approval of the respective study pending a written plan for the correction and /or prevention of the non-compliance.
      • Remove the Principal Investigator of the research study.
      • Suspend or terminate some or all of the research study and possibly other studies being conducted by the Principal Investigator as well (See IRB SOP 904 for suspension and termination procedures and IRB SOP 905 for reporting procedures).
   9. If the IRB determines that the confirmed report of non-compliance was either serious non-compliance or continuing non-compliance, as defined by this policy, the matter is referred to the IRB staff to handle according to SOP 905 (Reporting Procedures).

POLICY

It is the policy of the University of Utah IRB to comply with all applicable local, state, and federal regulations in the conduct of research studies and to communicate certain actions to entities that may have an interest in the status of the research being conducted. The IRB will notify institutional officials, funding sources, regulatory agencies, as appropriate, once the IRB takes any of the following actions:

• Determines that an event represents an unanticipated problem involving risks to participants or others
• Determines that non-compliance was serious or continuing
• Suspends or terminates approval of research

For research conducted at the VASLCHCS, reporting will be performed according to the VHA Handbook 1058.01.

The IRB must report to the Association for the Accreditation of Human Research Protection Programs (AAHRPP) within 48 hours after the University of Utah or any researchers (if the researcher is notified rather than the University of Utah) becomes aware of:

• Any negative actions taken by a government oversight office, including, but not limited to, OHRP determination letters, FDA warning letters, FDA 483 Inspection Reports with official action indicated, FDA restrictions placed on IRBs or researchers.
• Any litigation, arbitration, or settlements initiated related to human research protections.
• Any press coverage (including but not limited to radio, TV, newspaper, online publications) of a negative nature regarding the University of Utah HRPP

Allegations of research misconduct will be reported by the IRB Director, IRB Chair or Co-/Vice-Chair to the Associate Vice President for Research Integrity, who will coordinate the inquiry, investigation and hearing phases as needed. All investigations and reporting to appropriate officials will be conducted according to the University of Utah Policy for Research Misconduct.

PROCEDURES

1. An IRB administrator or designee prepares a letter that contains the following information:
   • The nature of the event (unanticipated problem involving risks to participants or others, serious or continuing non-compliance, suspension or termination of approval of research);
   • Name of the institution conducting the research;
   • Title of the research project and/or grant proposal in which the problem occurred;
   • Name of the principal investigator on the protocol;
   • Number of the research project assigned by the IRB and the number of any applicable federal award(s) (grant, contract, or cooperative agreement);
   • A detailed description of the problem including the findings of the organization and the reasons for the IRB decision;
   • Corrective actions and/or sanctions the institution is taking or plans to take to address the problem (e.g., revise the protocol, suspend subject enrollment, terminate the research, revise the informed consent document, inform enrolled subjects, increase monitoring of subjects, etc.);
   • Plans, if any, to send a follow-up or final report by a specific date or when an investigation has been completed or a corrective action plan has been implemented.
   • For suspensions or terminations of IRB approval of FDA-regulated studies, the letter will also include:
     • The name of the drug, biologic, or device
     • The IND number; or the IDE number/non-significant risk (NSR) status of the device
     • The address(es) of the clinical investigator(s)
2. The IRB Chair reviews the letter and modifies the letter as needed.
3. The IRB Chair electronically approves the letter.
4. The IRB administrator or designee sends a copy of the report to the following as applicable. Reporting to a regulatory agency is not required if the event occurred at a site that was not subject to the direct oversight of the organization, and the agency has been notified of the event by the investigator, sponsor, another organization, or other mechanisms.
   • Principal investigator;
   • Sponsor, if the study is sponsored;
   • The Institutional Official at the University of Utah and when appropriate, Officials of the institutions that have a Memorandum of Understanding (MOU) with the University of Utah IRB
   • Chairman or supervisor of the principal investigator and/or offending investigator;
   • The IRB, by providing the determination letter;
   • The Institutional Representative(s) identified in a relevant IRB reliance agreement if the University of Utah IRB is responsible for review and oversight of the study;
   • The Privacy Officer of a covered entity, if the event involved unauthorized use, loss, or disclosure of individually-identifiable patient information from that covered entity;
   • The Information Security Officer of an organization if the event involved violations of information security requirements of that organization;
   • University of Utah Office of Risk Management;
   • University of Utah Clinical Research Compliance & Education (CRCE) FDA Compliance Officer;
   • OHRP, if the study is subject to DHHS regulations or subject to a DHHS Federal Wide Assurance;
   • Other federal agencies when the research is overseen by those agencies, if they require reporting separate from that to OHRP;
   • FDA, if the study is subject to FDA regulations;
   • For VA research
     • Local Research and Development Committee;
     • Associate Chief of Staff for Research;
     • Local Medical Center (Facility) Director;
     • Regional Office of Research Oversight;
     • VA Privacy Office, when the report involves unauthorized use, loss, or disclosure of individually identifiable patient information;
     • VHA Information Security Officer when the report involves violations of VA information security requirements;
     • VA Central Office, if an unanticipated problem involving risks to participants or others is an adverse event;
   • The Department of Defense, if the research is conducted under the terms of the Department of Defense Addendum Federal-Wide Assurance
   • The IRB administrator or designee can provide copies to others as deemed appropriate by the Institutional Official or IRB chair.
5. The IRB administrator or designee will ensure that all steps of this policy will be completed within 30 days of the initiating action. For more serious actions, the IRB administrator or designee will expedite reporting.