DA/DoD HSR Review

There are several review processes for human subjects research (HSR) that are conducted and supported by the Department of the Army (DA) and the Department of Defense (DoD). Read this information on this page to learn about each one.

DA/DoD Exemption Determination Official (EDO)
An EDO is a federal employee at a DoD institution who, sufficiently qualified through experience and expertise, is designated to review research to determine whether the research involves human subjects and, if so, whether such research is exempt from Part 219 of Title 32, CFR.

EDO review is required for activities conducted by DA investigators that include HSR. The EDO makes a formal determination as to whether an activity is Human Subjects Research (HSR). If the activity is HSR, the EDO determines whether the study meets any of the eight exemption categories found in 32 CFR 219.104(d) and ensures that additional protections are in place for any DoD-affiliated personnel as subjects.

DA/DoD Institutional Review Boards (IRB)
DA/DoD IRBs review non-exempt HSR that is conducted by DoD-affiliated personnel on behalf of a DoD institution. DA/DoD IRBs may review activities conducted by non-DoD institutions if the research is conducted in collaboration with a DoD-institution.  

DA/DoD Human Research Protection Official (HRPO)
A HRPO is a federal employee designated by a DoD Component or institution to conduct administrative review of DoD-supported research in accordance with the requirements of the DFARS, or comparable requirement, and whose review of DoD-supported research is intended to ensure compliance with DoD HSR requirements. DA HRPOs are trained and delegated HRPO authority by AHRPO.

HRPO Review is required for activities conducted by non-DoD institutions receiving financial support from the DoD.
 
See Assistance review for non-financial support.  
 
DA Assistance Review
Assistance is defined as non-financial resources that are provided by the DoD to non-DoD institutions for research, including, but not limited to facilities, equipment, access to information about DoD-affiliated personnel for recruitment, access to DoD-affiliated personnel, data, or specimens (DoDI 3216.02, glossary).

The assistance review is performed when non-DoD investigators will be using non-financial resources provided by the Army for the conduct of HSR. The assistance review has two main purposes:
•         Verify that the HSR activity is overseen by a non-DoD IRB or HRPP, and
•         Ensure that the required protections in DoDI 3216.02, §3.9.f are in place when DoD-affiliated personnel are subjects.

Note: Not all HSR activities receiving assistance from the DoD are eligible for the DA Assistance Review (e.g., greater than minimal risk HSR targeting DoD-affiliated personnel as subjects). These studies would require the full HRPO review. Contact AHRPO for questions on these review processes.
 
Component-Level Administrative Review
A Component-Level Administrative Review (CLAR) is a special review performed by the DoD Component Office for certain classes of research that have additional regulatory requirements and considerations such as research in a foreign country.