Hi!
Do you need IRB review for your SBIR (Phase I or Phase II) – You Might be Surprised!
It’s easy to remember that you need an IRB review (Institutional Review Board) of a biomedical research proposal. For example, here’s that the FDA has to say about IRB oversight. “Under FDA regulations, an Institutional Review Board is group that has been formally designated to review and monitor biomedical research involving human subjects. In accordance with FDA regulations, an IRB has the authority to approve, require modifications in (to secure approval), or disapprove research. This group review serves an important role in the protection of the rights and welfare of human research subjects.”
But did you know that collecting data about humans or from humans, including for software or AI purposes, ALSO can require an IRB review and oversight?...
As always if you need some help, we have an online course as well as personal coaching to help you put together an award-worthy proposal.
