AFRLI40-402 governs AFRL-conducted and -supported research activities involving humans, human data, human biospecimens, or FDA-regulated activities.
View AFRLI40-402 on armypubs.army.mil
It establishes the AFRL Human Research Protection Program and addresses review, oversight, informed consent, privacy, reporting, and research misconduct. It requires ethical conduct, applicable approvals, prompt reporting of adverse events, and protections for human subjects and research data.
Applies to: This instruction covers all AFRL-conducted or -supported research activities, including tests and evaluation, that involve humans, human data, human biospecimens, or activities regulated by the Food and Drug Administration (FDA).
AFRL will only conduct or support research which is ethical and conducted IAW applicable Federal, DoD, and DAF HRPP requirements. (paragraph 2)
Investigators will report UPIRTSOs to the AFRL IRB as soon as possible but in no event shall notification be later than five days from the time of initial recognition. (paragraph 1-1)
All recruitment procedures and materials (e.g., ads, flyers, email, briefings, telephone scripts, etc.) must be reviewed and approved by the IRB.
PII gathered during a research protocol will be kept confidential and only shared with those individuals who have a “need to know” for oversight purposes or as documented in the IRB approved protocol.
Submit to the AFRL IRB office any allegations of potential noncompliance in human research overseen by the AFRL IRB or conducted by AFRL personnel. (paragraph 1-2)