Additional Requirements for Department of Defense Research

1. When appropriate, research protocols must be reviewed and approved by the IRB prior to the Department of Defense approval. Consult with the Department of Defense funding component to see whether this is a requirement.
   1. Modifications that significantly change the original protocol (i.e., new primary or secondary aim(s), elimination of safety procedures or addition of new procedures, the addition or removal of protected subject populations) will require that a new scientific review be performed and filed with the IRB before the study can be reapproved. Consult with the Department of Defense funding component to see whether this is a requirement.
2. Civilian researchers attempting to access military volunteers should seek collaboration with a military researcher familiar with service-specific requirements.
3. Employees of the Department of Defense (including temporary, part-time, and intermittent appointments) may not be able to legally accept payments to participate in research and should check with their supervisor before accepting such payments. Employees of the Department of Defense cannot be paid for conducting research while on active duty.
4. Service members must follow their command policies regarding the requirement to obtain command permission to participate in research involving human subjects while on-duty or off-duty.
5. Components of the Department of Defense might have stricter requirements for research-related injury than the DHHS regulations.
6. There may be specific educational requirements or certification required.
7. When assessing whether to support or collaborate with this institution for research involving human subjects, the Department of Defense may evaluate this institution’s education and training policies to ensure the personnel are qualified to perform the research.
8. When research involves U.S. military personnel, policies and procedures require limitations on dual compensation:
   1. Prohibit an individual from receiving pay of compensation for research during duty hours.
   2. An individual may be compensated for research if the participant is involved in the research when not on duty.
   3. Federal employees while on duty and non-Federal persons may be compensated for blood draws for research up to $50 for each blood draw.
   4. Non-Federal persons may be compensated for research participating other than blood draws in a reasonable amount as approved by the IRB according to local prevailing rates and the nature of the research.
9. Surveys performed on DOD personnel must be submitted, reviewed, and approved by the DOD Information Management Control Officer (IMCO) after the research protocol is reviewed and approved by the IRB. When a survey crosses DOD components, additional review is required. Consult with the Department of Defense funding component to coordinate this review.
10. When research involves large scale genomic data (LSGD) collected on DOD-affiliated personnel, additional protections are required:
    1. Additional administrative, technical, and physical safeguards to prevent disclosure of DoD-affiliated personnel’s genomic data commensurate with risk (including secondary use or sharing of de-identified data or specimens)
    2. Research will apply an HHS Certificate of Confidentiality
    3. DoD Component security review
11. Data or information sent to a DOD component under a pledge of confidentiality for exclusively statistical purposes must be used exclusively for statistical purposes and may not be disclosed in identifiable form for any other purpose, except with the informed consent of the respondent.
12. When conducting multi-site research, a formal agreement between institutions is required to specify the roles and responsibilities of each party.
13. The following must be reported to the applicable DOD Component Office of Human Research Protections within 30 days:
    1. When significant changes to the research protocol are approved by the IRB or EC:
       1. Changes to key investigators or institutions.
       2. Decreased benefit or increased risk to participants in greater than minimal risk research.
       3. Addition of vulnerable populations as participants.
       4. Addition of DOD-affiliated personnel as participants.
       5. Change of reviewing IRB.
    2. When the organization is notified by any federal body, state agency, official governing body of a Native American or Alaskan native tribe, other entity, or foreign government that any part of an HRPP is under investigation for cause involving a DOD-supported research protocol.
    3. Any problems involving risks to participants or others, suspension or termination of IRB approval, or any serious or continuing noncompliance pertaining to DOD-supported human participant research.
    4. The results of the IRB’s continuing review, if required.
    5. Change in status when a previously enrolled participant becomes pregnant, or when the researcher learns that a previously enrolled participant is pregnant, and the protocol was not reviewed and approved by the IRB in accordance with 45 CFR 46, Subpart B.
    6. Change in status when a previously enrolled participant becomes a prisoner, and the protocol was not reviewed and approved by the IRB in accordance with 32 CFR 219, Subpart C.
    7. Closure of a DOD-supported study.
14. For human participant research that would not otherwise be approved but presents an opportunity to understand, prevent, or alleviate a serious problem affecting the health or welfare of pregnant participants, fetuses, or neonates, written approval from the DOD Office for Human Research Protections must be obtained through the DOD Component Office of Human Research Protections prior to research starting.
15. Other specific requirements of the Department of Defense research be found in the “Additional Requirements for Department of Defense (DOD) Research” section in the IRB’s HRP-318 – WORKSHEET – Additional Federal Agency Criteria.