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- 45 CFR 46: Title 45, Part 46 of the Code of Federal Regulations, Protection of Human Subjects. Most recently updated in June 1991 (Subpart B in 2002), these regulations govern human subject research conducted by all federal agencies. Together, this body of regulations governs the conduct of human subject research today.
- 510(K) Device: A medical device that is considered substantially equivalent to a device that was or is being legally marketed. A sponsor planning to market such a device must submit notification to the FDA 90 days in advance of placing the device on the market. If the FDA concurs with the sponsor, the device may then be marketed. 510(k) is the section of the Food, Drug and Cosmetic Act that describes premarket notification; hence the designation “510(k) device.”
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- Adjuvant Therapy: Therapy provided to enhance the effect of a primary therapy; auxiliary therapy.
- Adverse Effect: An undesirable and unintended, although not necessarily unexpected, result of therapy or other intervention (e.g., headache following spinal tap or intestinal bleeding associated with aspirin therapy).
- Adverse Event (AE): Any experience or abnormal finding that has taken place during the course of a research project and was harmful to the subject participating in the research, or increased the risks of harm from the research, or had an unfavorable impact on the risk/benefit ratio; Any untoward or unfavorable medical occurrence in a clinical research study participant, including any abnormal sign (e.g. abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participants’ involvement in the research, whether or not considered related to participation in the research.
- Arm: A group or subgroup of participants in a clinical trial that receives specific interventions, or no intervention, according to the study protocol. This is decided before the trial begins.
- Assent [DOC]: An agreement by an individual not competent to give legally-valid informed consent (e.g., a child aged 7+ or cognitively-impaired person) to participate in research
- Assent of a Child: Assent means a child’s affirmative agreement (verbal or written) to participate in a clinical investigation. Mere failure to object may not, absent affirmative agreement, be construed as assent.
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- Baseline: The initial time point in a clinical trial that provides a basis for assessing changes in subsequent assessments or observations. At this reference point, measurable values such as physical exam, laboratory tests, and outcome assessments are recorded.
- Belmont Report: A statement of basic ethical principles governing research involving human subjects issued by the National Commission for the Protection of Human Subjects in 1978
- Beneficence: An ethical principle discussed in the Belmont Report that entails an obligation to protect persons from harm. The principle of beneficence can be expressed in two general rules: (1) do not harm; and (2) protect from harm by maximizing possible benefits and minimizing possible risks of harm.
- Bias: A point of view or preference which prevents impartial judgment in the way in which a measurement, assessment, procedure, or analysis is carried out or reported.
- Biologic: Any therapeutic serum, toxin, anti-toxin, or analogous microbial product applicable to the prevention, treatment, or cure of diseases or injuries.
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- Data and Safety Monitoring Board (DSMB)[PDF]: A committee of scientists, physicians, statisticians, and others that collects and analyzes data during the course of a clinical trial to monitor for adverse effects and other trends (such as an indication that one treatment is significantly better than another, particularly when one arm of the trial involves a placebo control) that would warrant modification or termination of the trial or notification of subjects about new information that might affect their willingness to continue in the trial.
- Data Management: The processes of handling the data collected during a clinical trial from development of the study forms/CRFs through the database locking process and transmission to statistician for final analysis.
- Data Management Plan (DMP): A plan that documents the processes for handling the flow of data from collection through analysis. Software and hardware systems along with quality control and validation of these systems, as relevant are described.
- Data Safety Monitoring Plan: Data and Safety Monitoring means the process to ensure and maintain the scientific integrity of human subject research and to protect the safety of human subjects, a system for appropriate oversight and monitoring to ensure the safety of participants and the validity of the data. The section of a protocol that describes the steps to identify physical, social, or psychological occurrences that may result from participation in the research study and explains in detail how such occurrences will be handled and reported. A DSMP describes the timing, tools and/or method(s) for monitoring and evaluation, procedures for treatment or resolution (including circumstances which would result in halting or terminating research), procedures for and timing of reports to oversight bodies, and description of oversight bodies involved with the study (e.g. FDA, IRB, or Data and Safety Monitoring Board). A study does not need to have a Data and Safety Monitoring Board to have a DSMP.
- Data Transfer Agreement/Data Use Agreement: A Data Use Agreement (DUA) is a contractual document used for the transfer of data that has been developed , where the data is nonpublic or is otherwise subject to some restrictions on its use. Often this data is a necessary component of a research project and it may or may not be human subject data from a clinical trial, or limited data set information as defined in HIPAA. Universities will want to ensure that DUA terms protect confidentiality when necessary, but permit appropriate publication and sharing of research results in accordance with institution policies, applicable laws and regulations, and federal requirements. DUAs are similar to confidentiality agreements.
- Debriefing [PDF]: Giving subjects previously undisclosed information about the research project following completion of their participation in research. (Note that this usage, which occurs within the behavioral sciences, departs from standard English, in which debriefing is obtaining rather than imparting information).
- Deception in Research [PDF]: Deception is the intentional misleading of subjects or the withholding of full information about the nature of a research experiment or procedure. Misleading or omitted information might include the purpose of the research, the role of the researcher, or what procedures in the study are actually experimental.
- Declaration of Helsinki: A code of ethics for clinical research approved by the World Medical Association in 1964 and widely adopted by medical associations in various countries. It has been revised several times, most recently in October, 2000.
- Device Determination, Non-significant Risk Device: An investigational medical device that does not present significant risk to the patient.
- Device Determination, Significant Risk Device: An investigational medical device that presents a potential for serious risk to the health, safety, or welfare of the subject.
- Devices, CLASS I, II, III Devices: Classification by the Food and Drug Administration of medical devices according to potential risks or hazards.
- Double Blind Masking: A type of masking in which two or more parties involved with the clinical trial do not know which participants have been assigned which interventions. Typically, this includes the investigator and participant.
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- Efficacy: Indication that the clinical trial intervention produces a desired therapeutic effect on the disease or condition under investigation.
- Eligibility Criteria: List of criteria guiding enrollment of participants into a study. The criteria describe both inclusionary and exclusionary factors, (e.g. inclusion criterion – participants must be between 55 and 85 years old; exclusion criterion – must not take drug X three month prior to the study).
- Emergency Use: The FDA defines “emergency use” as the use of a test article on a human subject 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 [21CFR 56.102 (d)].
- Exculpatory: Pertaining to that which relieves of a responsibility, obligation, or hardship; clearing from accusation or blame.
- Expanded Access: A process regulated by the Food and Drug Administration (FDA) that allows manufacturers to provide investigational new drugs to patients with serious diseases or conditions who cannot participate in a clinical trial.
- Expedited Review [PDF]: Review of proposed research by the IRB Chairperson or a designated voting member or group of voting members rather than by the entire IRB. Federal rules permit expedited review for certain kinds of research involving no more than minimal risk and for minor changes in approved research.
- Expired Study: When a continuing review of the research does not occur prior to the end of the approval period specified by the IRB, IRB approval expires automatically. The study expires on the date specified on the approval letter and the informed consent document. No activities can occur on the expiration date or after.
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- Federal-Wide Assurance (FWA): A standing agreement on file with the Office for Human Research Protections that describes in detail the procedures it will use to protect the rights and welfare of the human subjects.
- FERPA: (Family Education Rights and Privacy Act) was enacted in 1974. It is a set of regulations that applies to those institutions that receive funding from the Department of Education. FERPA was written specifically for students and guarantees them the right to inspect and review their education records, the right to seek to amend education records, and the right to have some control over the disclosure of information from those education records. Departments may not release non-directory or personally identifiable information about a student to a third party (parents included) without the student’s written authorization.
- Food and Drug Administration (FDA): An agency within the U.S. Department of Health and Human Services (DHHS) responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, nation’s food supply, cosmetics, and products that emit radiation.
- Final Project Reports: Once a study is completed, this form is submitted to close out the study.
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- Gene Therapy: The treatment of genetic disease accomplished by altering the genetic structure of either somatic (non-reproductive) or germline (reproductive) cells.
- Good Clinical Practice (GCP): A standard for the design, conduct, performance, monitoring, auditing, recording, analyses, and reporting of clinical trials that provides assurance that the data and reported results are credible and accurate, and that the rights, integrity, and confidentiality of trial participants are protected.
- Grandfathered: To exempt an existing or in progress study from new regulations.
- Guardian: An individual who is authorized under applicable State or local law to consent on behalf of a child to general medical care when general medical care includes participation in research. It also means an individual who is authorized to consent on behalf of a child to participate in research.
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- Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule: The first comprehensive Federal protection for the privacy of personal health information. The Privacy Rule regulates the way certain health care groups, organizations, or businesses, called covered entities under the Rule, handle the individually identifiable health information known as protected health information (PHI).
HIPAA Terminology:
- Authorization: Permission from individuals to use or disclose their Protected Health Information; generally required for research involving PHI. Certain statements are required; similar to but in addition to the Common Rule’s informed consent; can be added to a consent form. (45 CFR 164.508)
- Covered Entity: Defined as health care providers who conduct certain financial and administrative transactions electronically, such as billing and fund transfers; also, all health plans and health care clearinghouses. (45 CFR 160.103) Covered Entities must comply with HIPAA. (45 CFR 160.103 [PDF]).The University of Utah’s Covered Entity includes nearly all parts of the University of Utah Health Sciences Center. Contact the HIPAA Regulatory Office (587-9241) or go to Covered Entity for information on the University offices that are inside or outside the Covered Entity.
- Disclosure: The release, transfer, provision of access to, or divulging in any other manner of information outside the Covered Entity holding the information (45 CFR 164.501 [PDF]).
- Protected Health Information (PHI): Information about the past, present, or future physical or mental health of an individual that identifies or could be used to identify the individual and is created or received by a Covered Entity. (45 CFR 160.301, 164.501; information about the provision of health care and payment for health care is included; some educational and employment records are excluded.)
- Humanitarian Device Exemption: An HDE is a pre-market approval application submitted to the FDA (see also Investigational Device Exemption, Medical Device, Humanitarian Use Device [PDF]).
- Humanitarian Use Device (HUD): A Humanitarian Use Device (HUD) is a device that is intended to benefit patients by treating or diagnosing a disease that affects fewer than 4,000 individuals in the United States per year. To be considered for HUD status, a device sponsor must complete a humanitarian device exemption (HDE) application with the FDA. An approved HDE application authorizes the applicant to market the HUD. The labeling for the HUD must state that the device is an HUD and that the effectiveness of the device has not been demonstrated.
- Human Participants: Individuals whose physiologic or behavioral characteristics and responses are the object of study in a research project. Under the federal regulations, human participants are defined as: living individual(s) about whom an Investigator conducting research obtains: (1) data through intervention or interaction with the individual; or (2) identifiable private information. NOTE: FDA’s regulations define human subject as an individual and do not use the adjective “living.”
- Human Participants Research: This term applies to federally regulated research in which human participants (see definition above), their data, tissue, genetic material or other is investigated in a systematic fashion. It includes clinical trials, retrospective studies (subject to IRB oversight or exempt from continuing IRB oversight), outcome studies, surveys, etc.
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- Legally Authorized Representative (LAR): A person authorized either by statute or by court appointment to make decisions on behalf of another person. In human subject research, 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. There are several considerations that must be addressed when the inclusion of an LAR is proposed, such as, whether periodic re-consenting is warranted, and whether the probability of benefit is greater than the probability of harm.
- Limited Data Set:A limited data set could include the following (potentially identifying) information:
- Admission, discharge, and service dates;
- Dates of birth and, if applicable, death;
- Age (including age 90 or over); and
- Five-digit zip code or any other geographic subdivision, such as state, county, city, precinct and their equivalent geocodes (except street addresses).
Covered entities must condition the disclosure of the limited data set on execution of a “data use agreement,” which
- establishes the permitted uses and disclosures of such information by the recipient, consistent with the purposes of research, public health, or health care operations;
- limits who can use or receive the data; and
- requires the recipient to agree not to re-identify the data or contact the individuals.
In addition, the data use agreement must contain adequate assurances that the recipient will use appropriate physical, technical and administrative safeguards to prevent use or disclosure of the limited data set other than as permitted by HIPAA and the data use agreement, or as required by law.
- Longitudinal Study: A study designed to follow subjects forward through time.
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- Manual of Procedures (MOP): A set of procedures describing study conduct. A MOP is developed to facilitate consistency in protocol implementation and data collection across study participants and clinical sites.
- Masking/Blinding: A procedure in which the investigator administering the assessments and intervention as well as the participants in a clinical trial are kept unaware of the treatment assignment(s). Single blinding usually refers to the study participant(s) being unaware, and double blinding usually refers to the study participant(s) and any of the following being unaware of the treatment assignment(s): investigator(s), monitor, and data analyst(s).
- Material Transfer Agreement: A Material Transfer Agreement (MTA) is a document that is used by scientists and their institutions to transfer materials to other scientists and institutions. MTAs provided by outside organizations may contain clauses that are not consistent with the University of Utah policies and procedures and/or federal law. Signing one of these agreements could severely impede a scientist’s ability to carry out his or her research or to publish in a timely fashion. It is important that all MTAs are evaluated and signed by an authorized TVC representative. The Technology Venture Commercialization Office handles and processes these agreements.
- Medical Device: According to the FDA, a device is: “An instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is:
- recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them,
- intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or
- intended to affect the structure or any function of the body of man or other animals, and which does not achieve any of it’s primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of any of its primary intended purposes.” (See: Is The Product A Medical Device?).
- Metabolism (of a drug): The manner in which a drug is acted upon (taken up, converted to other substances, and excreted) by various organs of the body.
- Minimal Risk: 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 (45 CFR 46.102(i)). For example, the risk of drawing a small amount of blood from a healthy individual for research purposes is no greater than the risk of doing so as part of routine physical examination. This is not interpreted to include the inherent risks certain categories of human subjects face in their everyday lives. For example, the risks imposed in research focused on a special population should not be evaluated against the inherent risks encountered in their work environment (e.g., emergency responder, pilot, soldier in a combat zone).In addition, the IRB generally subscribes to the recommendations related to 45 CFR 46.404 from SACHRP regarding research involving children.
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- New Drug Application (NDA): An application submitted by the manufacturer of a drug to the FDA, after the clinical trial has been completed, for a license to market the drug for a specified indication.
- NIH: National Institutes of Health: a federal agency within the Public Health Service, DHHS, comprising 21 institutes and centers. It is responsible for carrying out and supporting biomedical and behavioral research.
- Non-Affiliated Member: Member of an Institutional Review Board who has no ties to the parent institution, its staff, or faculty. This individual is usually from the local community (e.g., minister, business person, attorney, teacher, homemaker).
- Non-Inferiority Design: A non-inferiority trial compares a test treatment to a control treatment of established effectiveness and seeks to show that the test treatment is not materially worse than or inferior to the control treatment. A non-inferiority trial seeks to show that any difference between the two treatments is small enough to allow a conclusion that the test treatment has at least some effect or, in many cases, an effect that is not significantly less than the active control. A non-inferiority trial may proceed under 21 CFR 50.24 if it meets the requirements of the regulation.For a non-inferiority trial to be informative, there would need to be clear data about the effectiveness of the control treatment (to make the non-inferiority study interpretable) and about known safety or other problems associated with the control treatment. Non-inferiority trials are generally used in situations where a placebo-controlled trial would be unethical and where there are no data to suggest the new treatment would be more effective than the standard treatment.
- Non-Therapeutic Research: Research that has no likelihood or intent of producing a diagnostic, preventive, or therapeutic benefit to the current subjects, although it may benefit subjects with a similar condition in the future.
- Non-Viable Fetus: An expelled or delivered fetus which, although it is living, cannot possibly survive to the point of sustaining life independently, even with the support of available medical therapy [45 CFR 46.203 (d) and (e)]. Although it may be presumed that an expelled or delivered fetus is nonviable at a gestational age less than 20 weeks and weight less than 500 grams [Federal Register 40 (August 8, 1975): 33552], a specific determination as to viability must be made by a physician in each instance. (See also: Viable Infant.)
- Null Hypothesis: The proposition, to be tested statistically, that the experimental intervention has “no effect,” meaning that the treatment and control groups will not differ as a result of the intervention. Investigators usually hope that the data will demonstrate some effect from the intervention, thereby allowing the investigator to reject the null hypothesis.
- Nuremberg Code: A code of research ethics developed during the trials of Nazi war criminals following World War II and widely adopted as a standard during the 1950s and 1960s for protecting human subjects.
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- Observational Study: A clinical study in which participants identified as belonging to study groups are assessed for biomedical or health outcomes. Participants may receive diagnostic, therapeutic, or other types of interventions, but the investigator does not assign participants to specific interventions (as in an interventional study).
- Office for Human Research Protections (OHRP): A federal government agency within the Department of Health and Human Services (DHHS) charged with the protection of human subjects participating in government funded research. It issues assurances and oversees compliance of regulatory guidelines by research institutions.
- Office of Sponsored Projects (OSP): The Office of Sponsored Projects is responsible for preparing, interpreting, negotiating, and executing agreements on behalf of the University of Utah for projects funded by federal and state agencies, foundations, and other public and private sources. They also draft, negotiate, and execute awards and sub-awards for collaborative research.
- Open-Label (Open-Label Trial): Describes a clinical trial in which masking is not used. This means that all parties involved with the trial know which participants have been assigned which interventions.
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- Parallel Design: Describes a clinical trial in which two or more groups of participants receive different interventions. For example, a two-arm parallel design involves two groups of participants. One group receives drug A, and the other group receives drug B. So during the trial, participants in one group receive drug A “in parallel” to participants in the other group who receive drug B.
- Parental Permission: The agreement of parent(s) or guardian to the participation of their child or ward in research [45 CFR 46.402(c)].
- Pharmacokinetics (PK): The process (in a living organism) of absorption, distribution, metabolism, and excretion of a drug or vaccine.
- Pharmacology: The scientific discipline that studies the action of drugs on living systems (animals or human beings).
- Phase 1, Phase 2, Phase 3, Phase 4 Clinical Trial: See “Clinical Trial”.
- Phenotype: The physical manifestation of a gene function.
- Placebo: A placebo is an inactive pill, liquid, powder, or other intervention that has no treatment value. In clinical trials, experimental treatments are often compared with placebos to assess the treatment’s effectiveness.A method of investigation in which an inactive substance/treatment (the placebo) is given to one group of participants, while the test article is given to another group. The results obtained in the two groups are then compared to see if the investigational treatment is more effective in treating the condition.
- Principal Investigator (PI): The person who is responsible for the scientific and technical direction of the entire clinical study (for example, for all sites of a multisite study).
- Prisoners [PDF]: An individual involuntarily confined in a penal institution, including persons: (1) sentenced under a criminal or civil statue; (2) detained pending arraignment, trial, or sentencing; and (3) detained in other facilities (e.g., for drug detoxification or treatment of alcoholism) under statutes or commitment procedures providing such alternatives to criminal prosecution or incarceration in a penal institution. The definition of “minimal risk” for research involving prisoners differs somewhat from that given for non-institutionalized adults.
- Privacy: Control over the extent, timing, and circumstances of sharing oneself (physically, behaviorally, or intellectually) with others.
- Proband: The person whose case serves as the stimulus for the study of other members of the family to identify the possible genetic factors involved in a given disease, condition, or characteristic.
- Prophylactic: Preventive or protective; a drug, vaccine, regimen, or device designed to prevent, or provide protection against, a given disease or disorder.
- Prospective Studies: Studies designed to observe outcomes or events that occur subsequent to the identification of the group of subjects to be studied. Prospective studies need not involve manipulation or intervention but may be purely observational or involve only the collection of data.
- Protocol: A document that describes the objective(s), design, methodology, statistical consideration, and organization of a trial.
- Protocol Amendments: A written description of a change(s) to or formal clarification of a protocol.
- Protocol Deviations: Failure to conduct a study as described in the protocol. The failure may be accidental or due to negligence and in either case, the protocol deviation should be documented. This also includes failure to comply with federal laws and regulations, the institution’s commitments and policies, and standards of professional conduct and practice. Examples of noncompliance include:
- failure to obtain/maintain approval for research,
- failure to obtain informed consent when required,
- failure to file adverse event reports,
- performance of an unapproved study procedure,
- performance of research at an unapproved site,
- failure to file protocol modifications and
- failure to adhere to an approved protocol.
- Protocol Deviation Report: Internal document created as part of the ongoing quality control process summarizing compliance with the protocol and listing protocol deviations and/or violations.
- Protocol Review and Monitoring Committee (PRMC): The Protocol Review and Monitoring Committee (PRMC) was formed in 1993 to comply with National Cancer Institute guidelines in establishing a scientific review and monitoring system of cancer studies – it is a mechanism for quality assurance. The PRMC membership includes faculty, statisticians, pharmacy, imaging, patient advocate, research nurse and other ad hoc reviewers from various disciplines within the Health Sciences. The PRMC reviews cancer-related protocols for scientific merit and progress, including participant accrual. It also prioritizes cancer protocols that may compete for the same patient population. Its function is complementary to that of the Institutional Review Board, which focuses on the protection of human subjects in research. If a study is designed to involve cancer patients, it must receive PRMC approval before it can be IRB approved. If a study includes cancer patients by default (as part of a broader patient population) and not by study design, it doesn’t need PRMC review.
- Protected Health Information (PHI): Information about the past, present, or future physical or mental health of an individual that identifies or could be used to identify the individual and is created or received by a Covered Entity. (45 CFR 160.301, 164.501; information about the provision of health care and payment for health care is included; some educational and employment records are excluded.)
- Protocol Summary: This document is completed by the PI and includes a summary of the protocol or can be the study plan for the entire study. Protocol summaries are required for all studies submitted to the IRB.
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- Quality Assurance/Quality Improvement (QA/QI): These are activities designed to improve the quality of a process or assess its overall function. Such activities do not satisfy the definition of “research” under 45 CFR 46.102(d), which is “…a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge…” Therefore the HHS regulations for the protection of human subjects do not apply to such quality improvement activities, and there is no requirement under these regulations for such activities to undergo review by an IRB, or for these activities to be conducted with provider or patient informed consent.The clinical, practical, or administrative uses for such performance measurements and reporting could include, for example, helping the public make more informed choices regarding health care providers by communicating data regarding physician-specific surgical recovery data or infection rates. Other practical or administrative uses of such data might be to enable insurance companies or health maintenance organizations to make higher performing sites preferred providers, or to allow other third parties to create incentives rewarding better performance.
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- Radioactive Drug Research Committee (RDRC): An institutional committee responsible for the use of radioactive drugs in human subjects for research purposes. Research involving human subjects that proposes to use radioactive drugs must meet various FDA requirements, including limitations on the pharmacological dose and the radiation dose. Furthermore, the exposure to radiation must be justified by the quality of the study and the importance of the information it seeks to obtain. The committee is also responsible for continuing review of the drug use to ensure that the research continues to comply with FDA requirements, including reporting obligations. The committee must include experts in nuclear medicine and the use of radioactive drugs, as well as other medical and scientific members [21 CFR 36.1].The University of Utah’s radiation safety program is designed to prevent unnecessary radiation exposures, and to control those that are necessary. RDRC is an ancillary committee to the University of Utah Institutional Review Board, which is responsible for the review and approval of research protocols involving human participants and radiation exposure, and the administration or use of radioactive drugs. Clinical investigations that include exposing human participants to radiation (x-rays, etc.) require RDRC approval before IRB approval may be granted.
- Radiopaque Contrast Agents: Materials that stop or attenuate radiation that is passed through the body, creating an outline on film of the organ(s) being examined. Contrast agents, sometimes called “dyes,” do not contain radioisotopes. When such agents are used, exposure to radiation results only from the X-ray equipment used in the examination. The chemical structure of radiopaque contrast agents can produce a variety of adverse reactions, some of which may be severe — and possibly life-threatening — in certain individuals.
- Randomization: The process of assigning clinical trial participants to treatment or control groups using an element of chance (e.g. like flipping a coin) to determine the assignments in order to reduce bias.
- Recombinant DNA Technology: “The ability to chop up DNA, the stuff of which genes are made, and move the pieces, [which] permits the direct examination of the human genome,” and the identification of the genetic components of a wide variety of disorders [Holtzman (1989), p. 1]. Recombinant DNA technology is also used to develop diagnostic screens and tests, as well as drugs and biologics for treating diseases with genetic components.
- Recruitment Plan: The plan that outlines how individuals will be recruited for the study and how the study will reach the recruitment goal.
- REM: Acronym for Roentgen Equivalent in Man; the unit of measurement for a dose of an ionizing radiation that produces the same biological effect as a unit of absorbed does (1 rad) of ordinary X-rays. One millirem is equal to 1/1000 of a rem.
- Remission: A period in which the signs and symptoms of a disease are diminished or in abeyance. The term “remission” is used when one cannot say with confidence that the disease has been cured.
- Remuneration: Payment for participation in research. (NOTE: It is wise to confine use of the term “compensation” to payment or provision of care for research-related injuries.)
- Research Involving a Human Being as an Experimental Subject: According to the Department of Defense Directive 3216.02 section E2.1.3., this means 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 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.
- Respect for Persons: An ethical principle discussed in the Belmont Report requiring that individual autonomy be respected and persons with diminished autonomy be protected.
- Retention Plan: The plan that details the methods in which the study will use in order to retain study participation in the clinical trial.
- Retrospective Study: Research conducted by reviewing records from the past (e.g., birth and death certificates, medical records, school records, or employment records) or by obtaining information about past events elicited through interviews or surveys. Case control studies are an example of this type of research.
- Risk Determinations: The probability of harm or injury (physical, psychological, social, or economic) occurring as a result of participation in a research study. Both the probability and magnitude of possible harm may vary from minimal to significant. Federal regulations define only “minimal risk.” (See also: Minimal Risk.) These can include:
- Moderate Risk: The subject will undergo procedures that will increase their risks above those normally encountered in daily life. Equivalent term is “more than minimal risk.” These can include, but are not limited to: clinical drug trials, device trials, genetic studies, and risks that include insurability and employability.
- Minimal Risk: The subject will undergo procedures that do not appear to increase the risks above those normally encountered in daily life. These can include but are not limited to studies that involve survey, questionnaire, interview, medical records review, observation of behaviors, drawing a small amount of blood from a healthy individual, etc.
- Exempt: These studies are not usually reviewed by board members, but are reviewed by the chairman. These have been determined to fit certain federal regulations as exempt from IRB review.
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- Safe Harbor De-Identification [PDF]: Potential identifiers include obvious ones like name and social security number, and also:
- All geographic subdivisions smaller than a state, including street address, city, county, precinct, zip code, and their equivalent geocodes, except for the initial three digits of a zip code if, according to the current publicly available data from the Bureau of the Census: the geographic unit formed by combining all zip codes with the same three initial digits contains more than 20,000 people; and [t]he initial three digits of a zip code for all such geographic units containing 20,000 or fewer people is changed to 000.
- All elements of dates (except year) for dates directly related to an individual, including birth date, admission date, discharge date, date of death; and all ages over 89 and all elements of dates (including year) indicative of such age, except that such ages and elements may be aggregated into a single category of age 90 or older;
- Voice and fax telephone numbers;
- Electronic mail addresses;
- Medical record numbers, health plan beneficiary numbers, or other health plan account numbers;
- Certificate/license numbers;
- Vehicle identifiers and serial numbers, including license plate numbers;
- Device identifiers and serial numbers
- Internet Protocol (IP) address numbers and Universal Resource Locators (URLs);
- Biometric identifiers, including finger and voice prints;
- Full face photographic images and any comparable images; and
- Any other unique identifying number, characteristic, or code.
Under HIPAA’s “safe harbor” standard, information is considered de-identified if all of the above have been removed, and there is no reasonable basis to believe that the remaining information could be used to identify a person.
- Screening Log: An essential document that records all individuals who entered the screening process. The screening log demonstrates the investigator’s attempt to enroll a representative sample of participants.
- Screening Process: A process designed to determine individual’s eligibility for participation in a clinical research study.
- Secondary Data: Secondary data is data collected by someone other than the user. Common sources of secondary data for social science include censuses, surveys, organizational records and data collected through qualitative methodologies or qualitative research. Primary data, by contrast, are collected by the investigator conducting the research.
- Serious Adverse Event (SAE): Any adverse event that:
- Results in death
- Is life threatening, or places the participant at immediate risk of death from the event as it occurred
- Requires or prolongs hospitalization
- Causes persistent or significant disability or incapacity
- Results in congenital anomalies or birth defects
Is another condition which investigators judge to represent significant hazards
- Sham Comparator Arm: A group of participants that receives a procedure or device that is made to be indistinguishable from the actual procedure or device being studied but does not contain active processes or components.
- Short Form Consent Document: The Short Form was created in an effort to increase the University’s compliance with regard to non-English speaking participants. The regulations state that informed consent information should be presented “in a language understandable to the subject”, and in most situations, that informed consent be documented in writing. This means that participants who do not speak English should be presented with a consent document written in a language understandable to them. Any time a study proposes to use the Short Form as an alternative consent process, the form and the process must be approved by the convened board. The Board should determine whether or not the process is adequate and appropriate for the study, or if a fully-translated consent document should be required.
- Source Document: Original documents, data, and records (e.g., hospital records, clinical and office charts, laboratory notes, memoranda, participant diaries, recorded data from automated instruments, x-rays, etc.) that are used in a clinical trial.
- Sponsor-Investigator: An individual who both initiates and actually conducts – alone or with others – a clinical investigation. Corporations, agencies, or other institutions do not qualify as Sponsor-Investigators.
- Standard Operating Procedures (SOPs): Detailed written instructions to achieve uniformity of the performance of a specific function across studies and patients at an individual site.
- Stopping Rules: Established safety criteria that would either pause or halt a study due to reasons including but not limited to futility or risk(s) to the participants.
- Stratification: Separation of a study cohort into subgroups or strata according to specific characteristics such as age, gender, etc., so that factors which might affect the outcome of the study, can be taken into account.
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- Technology & Venture Commercialization Office (TVC): The Technology & Venture Commercialization Office (TVC) at the University of Utah has managed the University’s intellectual property developed by faculty, staff and students since 1967. Through the establishment of commercial partnerships with industry and the development of products from these technologies, the TVC benefits the public and promotes economic growth.
- Tissue/Specimen Banking: Specimen collection banks, whether they are described as “banks” or not, are many and varied. They cover the spectrum from individual clinicians’ research specimen collections, (often gathered with no specific project in mind) to institutional “Tissue Banks” (such as cancer center shared resource banks) to multi-center, industry-sponsored drug trials which usually collect at least some blood or tissue for unspecified future research.
- Tracked Changes: In word processing, track changes is an editing command that is commonly used when you create an original document and make changes and want to keep track of the changes that are made to that original document. It is also a useful tool for collaborating on a document, as it allows multiple users to make revisions without losing the context of the original document.Changes to text and formatting are noted in a number of different ways, depending on the word processing software you use. Tracking changes allows the IRB staff and board members to clearly see what changes, modifications, updates, and additions have been made to study documents. For a tutorial on how to track changes in a document, please go to the A-Z Index page
- Translation Certification Letter [DOC]: Certifies the authenticity of the translation of a translated Consent Document. A reference template for the Translation letter can be found on the IRB website.
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- Unanticipated Problem (UP):Unanticipated problems are defined as any incident, experience or outcome that occurs during the course of a study that meets all of the following criteria:
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- Unforeseen (not expected by the researcher or the research participant) given the research procedures and the subject population being studied.
- Related or probably related to participation in the research or if the event or problem probably or definitely affects the safety, rights and welfare of current participants; and
- Suggests that the research places subjects or others at a greater risk of harm (including physical, psychological, economic or social harm) than was previously known or recognized.
- Unmasking/Unblinding: A procedure in which one or more parties to the trial are made aware of the treatment assignment(s).
- Utah Population Database (UPDB): The Utah Population Database (UPDB) at the University of Utah is one of the world’s richest sources of in-depth information that supports research on genetics, epidemiology, demography, and public health. For more than 30 years, researchers at the University of Utah and other institutions have used UPDB to identify and study individuals and families that have higher than normal incidence of cancer or other diseases, to analyze patterns of genetic inheritance, and to identify specific genetic mutations. In addition, demographic studies have shown trends in fertility transition and changes in mortality patterns for both infants and adults.The central component of the UPDB is an extensive set of Utah family histories, in which family members are linked to demographic and medical information. The UPDB includes diagnostic records about cancer, cause of death, and medical details associated with births. It also includes claims data from statewide inpatient hospital discharge records as well as ambulatory surgery records from hospital outpatient departments and ambulatory surgery centers. The UPDB provides access to information on more than 7.3 million individuals and supports over 100 research projects. This information can only be used for biomedical and health-related research.Support for the UPDB is provided by the Pedigree and Population Resource (PPR), which is directed by Ken R. Smith, PhD. The Utah Resource for Genetic and Epidemiologic Research (RGE) and an Institutional Review Board (IRB) administer access to files through a review process. PPR is supported by Huntsman Cancer Institute as well as the University of Utah. RGE and the IRB are administered through the Office of the Vice President for Research at the University of Utah.
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- Viable Infant: When referring to a delivered or expelled fetus, the term “viable infant” means likely to survive to the point of sustaining life independently, given the benefit of available medical therapy [45 CFR 46.203(d)]. This judgment is made by a physician. In accordance with DHHS regulations, the Secretary, HHS, may publish guidelines to assist in the determination of viability. Such guidelines were published in 1975, and specify an estimated gestational age of 20 weeks or more and a body weight of 500 grams or more as indices of fetal viability [Federal Register 40 (August 8, 1975): 33552]. These indices depend on the state of present technology and may be revised periodically. (See also: Nonviable Fetus.)
- Vulnerable Populations: Individuals whose willingness to volunteer in a clinical trial may be unduly influenced by the expectation, whether justified or not, of benefits associated with participation, or of a retaliatory response from senior members of a hierarchy in case of refusal to participate. Examples are members of a group with a hierarchical structure, such as medical, pharmacy, dental and nursing students, subordinate hospital and laboratory personnel, employees of the pharmaceutical industry, members of the armed forces, and persons kept in detention. Other vulnerable subjects include patients with incurable diseases, persons in nursing homes, unemployed or impoverished persons, and patients in emergency situations, ethnic minority groups, homeless persons, nomads, refugees, minors, and those incapable of giving consent.
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- Waiver of Authorization: In some situations, the IRB can waive the requirement that research subjects sign an Authorization Form. To qualify for a Waiver of Authorization, the research use of the health information should not represent more than a minimal risk to privacy, and the researcher should indicate that the research could not be done without the requested health information, that it would not be practical to obtain signed authorizations from the research subjects, and that the specific elements of health information that are requested are not more than the minimum necessary to accomplish the goals of the study.
- Waiver of Documentation: An IRB may waive the requirement for the investigator to obtain a signed consent form for some or all subjects if it finds either:(1) That the only record linking the subject and the research would be the consent document and the principal risk would be potential harm resulting from a breach of confidentiality. Each subject will be asked whether the subject wants documentation linking the subject with the research, and the subject’s wishes will govern; or
(2) That the research presents no more than minimal risk of harm to subjects and involves no procedures for which written consent is normally required outside of the research context.
- Waiver of Informed Consent: Occasionally there are reasons to waive written consent or to alter the requirements of consent. Only the IRB can make the determination to waive some (written) or all (written and verbal) consent requirements. In order to qualify for a Waiver of Consent, the following conditions should be met: 1) that the research pose no more than minimal risk to subjects; 2) no adverse effects as a result of the waiver or alteration; 3) without the waiver or alteration the research in question could not be carried out; and 4) information will be provided after participation is completed, if appropriate.
- Wards of State: A ward means a child who is placed in the legal custody of the State or other agency, institution, or entity, consistent with applicable Federal, State, or local law. The term “ward of State” may be used interchangeably with “ward” in this document. For inclusion in a study, a number of additional considerations must be made.
- Washout Period: The action or process of progressively reducing the concentration of a substance (i.e. drug) in a subject. Washout periods are used in some drug trials to prevent medications the subject is already taking from interacting with the test drug. Under the Placebo Guidelines, board reviewers must ensure that the proposed placebo exposure (and any corresponding washout periods) is of a specified duration such that evidence supports the exposure as no more than minimal risk. These are reviewed by the IRB on a case-by-case basis.
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