DODI3216.02_DAFI40-402 — Protection of Human Subjects and Adherence to Ethical Standards in Department of the Air Force-Conducted and -Supported Research

DODI3216.02_DAFI40-402 governs human subject protection and ethical standards in DAF-conducted and -supported research.

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  • Publication number: DODI3216.02_DAFI40-402
  • Title: Protection of Human Subjects and Adherence to Ethical Standards in Department of the Air Force-Conducted and -Supported Research
  • Date: 2024-01-17

View DODI3216.02_DAFI40-402 on armypubs.army.mil

It addresses human research protection training, submittal documents, IRB oversight, engaged institutions, and Limited HRPP plans. It requires documentation such as approved protocols, current FWA and IRB registration numbers, institutional approvals, and command or Component approval when applicable.

Applies to: It applies to all DAF entities, including the Regular Air Force, Air National Guard, Air Force Reserve, and United States (U.S.) Space Force.

Topics covered

  • Human subject protection training
  • Mandatory HSR submittal documents
  • IRB-approved protocol documents
  • FWA and IRB registration numbers
  • HSR oversight transfer
  • Engaged institutions in non-exempt HSR
  • Limited HRPP plans

Questions and answers

What training documentation is required for exempt human subject research?

Include documentation of key investigators’ human research protection training. (paragraph 3)

What informed consent documentation is required when research involves human subjects?

If the HSR will involve interactions or interventions with human subjects, provide documentation of consideration of the Belmont Report requirement to obtain informed consent (such as through submission of an information sheet for human subjects). (paragraph 3)

How often are Component HRPP assessments conducted?

Conducts Component HRPP assessments every other year. (paragraph 4)

What must be submitted for DoD-supported research that is exempt or does not involve human subjects?

For DoD-supported research that is exempt or does not involve human subjects, must submit institutional documentation of the determination that the research is either not HSR, exempt HSR, or limited IRB review to the HRPO, to include all protocol documents. (paragraph 8)

What must be submitted before research begins under a Limited HRPP?

Submit the signed Limited HRPP to the DAF COHRP at usaf.pentagon.af-sg.mbx.afmsa-sgec@health.mil prior to initiation of the research. (paragraph 2)

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