OSD Component. Defined in DoD Instruction 5025.01 (Reference (w)).

OT&E. Defined in section 139(a)(2)(A) of Reference (g).

prisoner. Defined in subpart C of Reference (h). Includes military personnel in either civilian or military custody or detainment.

prisoner representative. An individual member on the IRB who shall have working knowledge of the human subject population to be recruited, a reasonable familiarity with the operations of the prison or confinement facility, and any other legally imposed restrictive conditions involved in the research, and appropriate background and expertise to serve in this capacity.

private information. Defined in section 219.102(f) of Reference (c).

research. Any activity that is a systematic investigation, including RDT&E, designed to develop or contribute to generalizable knowledge as defined in section 219.102(d) of Reference (c).

research involving human subjects. Activities that include both a systematic investigation designed to develop or contribute to generalizable knowledge AND involve a living individual about whom an investigator conducting research obtains data through intervention or interaction with the individual or identifiable private information. Activities covered by section 219.101(a) of Reference (c) (including exempt research involving human subjects) and this Instruction.

The following activities conducted or supported by the Department of Defense are NOT research involving human subjects:

Activities carried out solely for purposes of diagnosis, treatment, or prevention of injury and disease in Service members and other mission essential personnel under force health protection programs of the Department of Defense, including health surveillance pursuant to section 1074f of Reference (g) and the use of medical products consistent with DoD Instruction 6200.02 (Reference (x)).

Authorized health and medical activities as part of the reasonable practice of medicine or other health professions undertaken for the sole purpose of patient treatment.

Activities performed for the sole purpose of medical quality assurance consistent with section 1102 of Reference (g) and DoDD 6025.13 (Reference (y)).

Activities performed solely for an OT&E project where the activities and project meet the definition of OT&E as defined in section 139(a)(2)(A) of Reference (g).

Activities performed solely for assessing compliance of individuals and organizations with requirements applicable to military, civilian, or contractor personnel or to organizational units, including such activities as occupational drug testing, occupational health and safety reviews, network monitoring, and monitoring for compliance with requirements for protection of classified information.

Activities, including program evaluation, customer satisfaction surveys, user surveys, outcome reviews, and other methods, designed solely to assess the performance of DoD programs where the results of the evaluation are only for the use of Government officials responsible for the operation or oversight of the program being evaluated and are not intended for generalized use beyond such program.

Survey, interview, or surveillance activities and related analyses performed solely for authorized foreign intelligence collection purposes, as authorized by DoDD 5240.01 (Reference (z)).

research involving a human being as an experimental subject. An activity, for research purposes, where there is an intervention or interaction with a living individual for the primary purpose of obtaining data regarding the effect of the intervention or interaction. Research involving a human being as an experimental subject is a subset of research involving human subjects. This definition relates only to the



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