Do you need IRB review for your SBIR (Phase I or Phase II) – You Might be Surprised!

IRB can prove to be a big problem for a lot of SBIR teams, even those NOT in the life sciences space!

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.”

Do the right thing, especially if it's hard.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?  This can include AI data for training a system, it can include having humans test software (i.e. alpha testing) or human interviews.  And so agencies like the NSF have strict rules and if you aren’t ready, you may find you have to scramble to get an IRB review in place before getting your award (which also may put that same award at risk!)

So the question is, how do you get an IRB review?  Well, if you have a university partner, the university will either have or direct you to their IRB.  If that’s the case, it is most likely that only university personnel will be able to see/oversee the human interaction and any PII.  There are also commercial IRB’s that you can pay.  These often cost several thousand dollars, so if you need one, make sure you get a quote to include in your proposal!  If you are working with a Native American Nation, they often have their own IRB’s to protect their members from inappropriate research.

This is not a trivial issue, and, as I mentioned, may be required even for something that seems as simple as some alpha testing of software.  So, don’t overlook something that might cost you your award!

If you haven’t gone through our SBIR course, Develop a Winning SBIR Strategy – Insights From The Review Process, I invite you to do so.  Remember that my perspective as a reviewer of many, many proposals gives you an advantage as you prepare your Phase I and/or your Phase II proposal.

If you want more in depth help, either a proposal review or help developing your proposal, you can apply for a spot in our one-on-one VentureWrench SBIR Coaching after you’ve gone through the course.  Email us at venturewrenchcommunity [at] with questions.

And if you need help with any part of your SBIR process – proposal (Phase I or II), TABA, proposal management, or contract finalization, just email us!

Don’t forget, if you need more help, check out our online course, Develop a Winning SBIR Strategy, and don’t forget your free guide below!

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