Is research involving the use of human subjects allowed?

Research that involves human subjects may be subject to additional regulations found in 49 CFR Part 11 (Part 11) as well as other applicable federal and state laws and regulations. Research will be considered to involve human subjects under Part 11 if the research obtains (1) data through intervention or interaction with an individual(s), and/or (2) identifiable private information.

Unless exempt under 49 CFR §11.101(b) or §11.101(i), human subject research must adhere to the regulations of Part 11, which includes review and approval of the research by a federally approved Institutional Review Board (IRB).

Due to the short timeframe associated with Phase I of the SBIR process, U.S. DOT does not recommend the submission of Phase I offers that require the use of human subjects testing. For example, the ability to obtain IRB approval for offers that involve human subjects can take 6-12 months, and that lengthy process can be at odds with the Phase I goal for time to award.

Before U.S. DOT makes any award that involves an IRB or similar approval requirement, the offeror must demonstrate compliance with relevant regulatory approval requirements that pertain to offers involving human protocols. It will not impact U.S. DOT’s evaluation, but requiring IRB approval may delay the start time of the Phase I award, and if approvals are not obtained within two months of notification of selection, the decision to award may be rescinded.