Version
1.0
Date Updated
Saturday, March 17, 2012
Descripton

Approved by:  Human Protections Administrator, Director of OPRS, and Executive IRB Chair
AAHRPP REF#: 619
AAHRPP Elements I.1.A., I.1.E., I.1.F., I-3, I.5.D.,  II.2.D., II.2.E., II.2.F., II.2.G., II.3.A., II.3.B., II.3.C.1, II.3.F.,  II.3.G., II.4.A, II.4.B., II.5.A., II.5.B., III.1.A., III.1.C., III.1.D., III.1.E., III.1.F., III.2.D.


POLICY


 
  1. Research funded or supported by the Department of Defense (DoD) must be reviewed by the IRB under an additional set of federal regulations [32CFR219].  The DoD follows the DHHS and FDA regulations on human subjects research, but also applies DoD regulations for protection of human subjects at 32 CFR 219 and DoD Instruction 3216.02 “Protection of Human Subjects and Adherence to Ethical Standards in DoD-Supported Research.” 
  2. UIC has signed a DoD Addendum (F50423) issued by the Air Force to its Federalwide Assurance (FWA) that signifies UIC applies DoD requirements for the protection of human research subjects when conducting, reviewing, approving, overseeing, supporting or managing DOD-supported research involving human subjects.  This assurance addendum is recognized by all branches of the DoD.
  3. This policy primarily reflects the general requirements for any DoD-component contained in DoD Instruction 3216.02 (11/08/2011).  Additional DoD-component specific requirements may exist.  It is the responsibility of the investigator to identify and notify the IRB of any additional requirements.
  4. The investigator is responsible for providing the DoD-component with the required records and following the prescribed record keeping schedule.   
  5. Research involves the DoD when any of the following apply:
    1. Research is funded by a component of the DoD;
    2. Research involves cooperation, collaboration, or other type of agreement with a component of DoD;
    3. Research uses property, facilities, or assets of a component of DoD, or
    4. Subject population will intentionally include personnel (military or civilian) from a component of DoD.
  6. DoD policies and requirements do not apply when DoD personnel incidentally participate in research that is not supported by DoD, and DoD personnel are not the intended population of the research.
  7. DoD Components
    1. Department of the Navy
    2. Office of Naval Research
    3. U.S. Naval Observatory
    4. Naval Academy
    5. Department of the Army
    6. U.S. Army Corps of Engineers
    7. Military Academy (West Point)
    8. Department of the Air Force
    9. Air Force Academy
    10. Marines
    11. Coast Guard
    12. National Guard
    13. Missile Defense Agency
    14. Defense Advances Research Projects Agency (DARPA)
    15. Pentagon Force Protection Agency
    16. Defense Intelligence Agency
    17. National Geospatial-Intelligence Agency
    18. National Security Agency
    19. Under Secretary of Defense (Personnel and Readiness)
  8. Definitions
    1. Detainees: any person captured, detained, held or otherwise controlled under the control of DoD personnel (military and civilian or contractor employee). It does not include persons primarily being held for law enforcement purposes, except where the US is the occupying power. Examples include lawful and unlawful enemy combatants, enemy prisoner of war, civilian internee and retained person.
      1. Enemy Prisoner of war: individuals under the custody or control of the US DoD according to Geneva Convention Relative to the Treatment of Prisoners of War, August 12, 1949 [DoD Directive 2310.01E, September 5, 2008].
    2. Experimental Subjects: The DoD defines “Research Involving a Human Being as an Experimental Subject” as an activity, for research purposes, where there is an intervention or interaction with a human subject for the primary purpose of obtaining the effect of the intervention or interaction (32 CFR 219.102(f)). This definition does not include activities that are not considered research involving human subjects, activities that meet the exemption criteria at 32  CFR 219.101(b), and research involving the collection or study of existing data, documents, records, or specimens from living individuals (DoDI 3216.02, 11/8/2011).
    3. Research: any activity that is a systematic investigation, including research, development, training and evaluation designed to develop or contribute to generalizable knowledge.
    4. Minimal Risk: When determining the risk level for DoD-supported research, the definition of minimal risk as “…ordinarily encountered in daily life or during the performance of routine physical or physiological examinations or tests” shall not be interpreted to include the inherent risks certain categories of human subjects face in their everyday life. For example, the risks imposed in research involving human subjects 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) or having a medical condition (e.g., frequent medical tests or constant pain).