(If there are any questions regarding what does or does not require USAFA IRB review contact Human Research Protection Program (HRPP) support personnel @ 719-333-6593 or usafa.irb@usafa.edu).

Any activity that may meet the definition of both “research” and “human subjects” [32 CFR 219.102] requires review and approval by an IRB. Further, a Principal Investigator (PI) is not authorized to make such determinations for their own activity [DoDI3216.02_AFI40-402, Enclosure 2, 11.c]. USAFA excludes customer satisfaction and post program feedback directly solely at improving activities within a program [USAFA local policies/procedures].

Research: “A systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.” [32 CFR 219.102(d)]

Human Subjects: “A living individual about whom an investigator (whether professional or student) conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information” [32 CFR 219.102(F)].

• Intervention and Interaction: “An intervention includes both physical procedures by which data are gathered and manipulations of the subject or subject’s environment that are performed for research purposes. Interaction includes communication or interpersonal contact between investigator or subject. See CFR 219.102(f) of Reference (c) for more information. Examples include, but are not limited to, a physical procedure, a drug, manipulation of the human subject or subject’s environment, the withholding of an intervention that would have been undertaken if not for the research purpose, or communication such as a survey or interview.” [DoDI3216.02_AFI40-402, Part II]

• Identifiable private information: “includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and or information which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public (for example, a medical record). Private information must be individually identifiable (i.e. the identity of the subject is or may readily be ascertained by the investigator or associated with the information) in order for the information to constitute research involving human subjects. [32 CFR 219.102(f)(2)

AFMSA/SGE-C Guidance Memorandum 2016-0002G: Guidance on Activities that may be Research Involving Human Subjects

AFMSA/SGE-C Guidance Memorandum 2016-0002G Attachment