Desk Reference
Human Subject Research
All research involving human subjects, to include use of human biological specimens and human data, shall comply with federal and agency regulations for human subject protection (see following links). Please note that the offeror is responsible for understanding and adhering to all applicable regulations and policies pertaining to human subject research even if not listed below.
DoD
- http://www.dtic.mil/biosys/ (follow link to "human use")
- 32 Code of Federal Regulations Part 219, The Common Rule
- DoD Directive 3216.02, Protection of Human Subjects and Adherence to Ethical Standards in DoD-Supported Research
- 10 USC 980, Limitation on Use of Humans as Experimental Subjects
Air Force
DTRA
- DTRA's implementation of the oversight process relies on "federal assurance" of Institutional Review Boards (IRBs) conducted by other DoD activities or DHHS. The PI must submit the federal assurance and IRB results to the DTRA Human Research Oversight Board (HROB) before receiving an award.
DARPA
Department of the Navy Human Research Protection Program (DON HRPP)
- http://www.onr.navy.mil/About-ONR/compliance-protections/Research-Protections/Human-Subject-Research.aspx
- http://www.onr.navy.mil/sci_tech/34/34c/
If you have any suggestions or comments regarding this Desk Reference, please send them via the SBIR/STTR Help Desk or phone 866-SBIRHLP (866-724-7457).