Institutional Review Board

University of Utah investigators and study staff who conduct human subject research must complete training before the IRB will approve a project(s). Please visit Investigator & Research Staff Training for the current University of Utah training requirements and options. Training is valid for three (3) years. If research involving a DoD component requires more frequent or other training requirements in addition to those that the University of Utah requires, the investigator will be responsible for ensuring that the training is completed for those involved in the conduct of the research. Researchers should contact the human research protection officer of the DoD component for their education requirements and obtain documentation confirming the requirements.

When research involves U.S. military personnel as participants in research, the following guidelines apply:

Recruitment and Enrollment

• Officers are not permitted to influence the decision of their subordinates.
• Officers and senior non-commissioned officers may not be present at the time of recruitment.
• Officers and senior non-commissioned officers have a separate opportunity to participate.
• When recruitment involves a percentage of a unit, an independent ombudsman is present.

Compensation

• Participants may be compensated for research participation as long as the participant is involved in the research when not on duty. Enrolled individuals may not receive payment of compensation for research participation during duty hours.
• Federal employees while on duty and non-Federally employed individuals may be compensated for blood draws for research up to $50 for each blood draw.
• Non-Federally employed individuals may be compensated for research participation other than blood draws in a reasonable amount as approved by the IRB.

In general, no Department of Defense component may conduct or use appropriated funds to support research involving a human being as an experimental subject 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 IRB SOP 703: Waiver or Alteration of Consent.

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.

The following are additional requirements regarding the informed consent process for DoD conducted or supported studies.

Disclosure of Research-Related Injury

• Any requirements for disclosure of research-related injury from a DoD component must be included in the informed consent process. See SOP 701 (2.3).

Consent from a Legally Authorized Representative

• If consent is to be obtained from the legally authorized representative of an experimental subject, the research must be intended to provide direct benefit to the individual participant. The determination that the research is beneficial to the individual experimental subject must first be made by the IRB.

Combined DoD and VA Research

• A Department of Defense (DoD) consent document may be employed for active duty military personnel participating in VA research at DoD sites when VA-specific language is not necessary.

As of April 15, 2020, DoD regulations no longer require that the IRB approve an independent research monitor with specific roles and responsibilities for all greater than minimal risk studies supported by the DoD. If a research monitor was previously approved, an amendment must be submitted to remove the research monitor from the protocol.

It is the policy of the University of Utah IRB that if the research involves greater than minimal risk,  a data and safety monitoring plan is required This requirement applies to research supported by the DoD.

Any surveys performed on Department of Defense personnel must be submitted, reviewed and approved by the Department of Defense after the research protocol is reviewed and approved by the IRB.

DoD supported researchers must report the following within 30 days to the DoD human research protection officer.

1. When significant changes to the research protocol are approved by the IRB.
2. The results of the IRB continuing review.
3. Change of reviewing IRB.
4. When the University of Utah is notified by any Federal department, agency or national organization that any part of its HRPP is under investigation for cause involving a DoD-supported research protocol.