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  4. So many regulations and policies!

So many regulations and policies!

The AAHRPP reaccredition process has us all thinking about the regulations, policies, and guidances that govern human subject research. And there are an awful lot of regulations, policies and guidances. Do we expect you to remember them all, and what they all say? Of course not. Even those of us who work in IRB-land full time are constantly having to go look things up, and then try to figure out what they mean. That’s what we’re doing when we say to someone, “Hmmm, that’s a good question. Let me do a little research and get back to you.”

Rather than trying to commit all the nitty gritty to memory, we recommend that you keep in mind the most commonly used resources in which to go look things up. The items we refer to most often include:

45 CFR 46 (the Common Rule)

UAMS IRB Policies (some of these will be revised as part of the AAHRPP accreditation process, so check back frequently

The web site of the federal Office for Human Research Protections (OHRP), particularly the Policy and Guidance page, and the Policy index on that page.

For things related to HIPAA, the relevant UAMS Administrative Guide Policy.

Your trusty Institutional Review Board Member handbook (any edition of this book is fine).

And,last but not least, the friendly people in the IRB office.

Posted by Edith Paal on July 16, 2015

Filed Under: Institutional Review Board Members

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