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Human Subjects and/or Research Determinations

Some activities do not meet the statutory/regulatory definition of either “human subject” or “research.” We will review studies to determine if a particular activity involves either non-human subjects or is not research under these definitions.

Definitions from 32 CFR 219

  • §219.102(f): Human subject means a living individual whom an investigator (whether professional or student) conducting research obtains
    1. Data through intervention or interaction with the individual, or
    2. Identifiable private information.
  • §219.102(d): Research means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. Activities which meet this definition constitute research for purposes of this policy, whether or not they are conducted or supported under a program which is considered research for other purposes. For example, some demonstration and service programs may include research activities.

    The Department of Defense has implemented 32 CFR 219 through DoD Instruction 3216.02. Within the Definitions section of the Instruction is the following guidance language used to determine if specific types of activities meet the above definitions of human subject research:

    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) (Title 32, Code of Federal Regulations) (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 10 USC 1074f and the use of medical products consistent with DoD Instruction 6200.02.

    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 10 USC 1102 and DoDD 6025.13.

    Activities performed solely for an OT&E project where the activities and project meet the definition of OT&E as defined in 10 USC 139(a)(2)(A).

    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.

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