IRB Tip #1

One of the reasons for starting this blog was to help investigators and research assistants and coordinators in an unofficial way. Don't get me wrong, I think I'm a pretty helpful guy in real life, but there are limits to what is proper in an official setting.

However, this blog gives me a good opportunity to expose the "secrets" of IRB functionality. And they really aren't secrets at all. But my sense is that IRBs generally do a poor job of educating, and researchers do a poor job of passing on information from staff to staff due to high turnover. Let's be honest, some (many?) PIs know little to nothing about an IRB submission and they can't teach their staffs what they don't know.

Although the idea here is for most tips to be specific to the IRB I know best, other IRBs follow similar policies. These policies, after all, have basis in federal regulations. Still, it's remarkable even to me--a "professional"--how varying IRBs work from institution from institution. Nevertheless, I will try to provide helpful tips to readers of this blog as best as I am able. Contact your own IRB for specific consideration. And feel free to let me know if their handling/processing is different from what I've described.

And with that, my first IRB Tip of GTMR:

IRB Tip #1
When your IRB takes forever to review and approve a new study, and you just want "administrative approval," you can get it pretty easily but only if you haven't submitted the full IRB application already.

Federal regulations (45 CFR 46.118) permit approval of a study prior to review by the IRB when "lacking definitive plans for involvement of human subjects."

This is a particularly good option when you can't access your grant money until IRB approval is obtained or if you're applying for a Certificate of Confidentiality from the NIH. Sometimes the NIH accepts it, other times they don't. But when it takes 3 months to get a CoC, it's worth trying to apply early, isn't it?

Frankly, I think many investigators should request administrative approval under 45 CFR 46.118, especially if your IRB is notorious for being slow or "picky."

Here's how you do it: In a simple letter, explain that you've been awarded X grant and wish to prepare the IRB application but cannot until you get IRB approval to release those funds. Provide your assurance that you will not initiate research involving human subjects until you obtain prospective IRB approval. State the title of the grant, the title of the study, and include a copy of the grant application (the protocol is sufficient). Complete the first 2 pages of the IRB application. Turn it in. That's it. Really. IRB approval is on its way. You can thank me another time.