PRIM&R is pleased to bring you a post from Dawnett Watkins, a member of the PRIM&R Blog Squad at the 2011 Advancing Ethical Research Conference. The PRIM&R Blog Squad is composed of PRIM&R members who are devoted to blogging prior to, live from, and after our conferences.

During the 2011 Advancing Ethical Research (AER) Conference, I attended a session in the Federal Regulations track in which a representative of the Office of Human Research Protections (OHRP) spoke. This speaker revealed that protocols approved under CFR 46.101(b)(5) are often approved under this exempt category in error. The speaker explained the OHRP realizes that there is some misunderstanding with this designation and that they are working on fixing this. Based on her comments, I deduced that OHRP is not coming down hard on folks who make this error, but needless to say, this was still an “ah-ha” moment for me.

So, what exactly should be approved in this category? It seems as though the only protocols that should be approved are those that are approved by a federal department agency head, such as studies on federal public benefit or service programs.

I went home and reviewed chart six of the OHRP’s decision tree and was able to connect what the speaker had said with the content of the regulations. The first sentence of the regulations reads, “Is the research or demonstration project conducted or approved by the Department or Agency Head?” Take note of the capitalization in this sentence—I, mistakenly, did not do so. Department and Agency Head being capitalized here refers to the Feds. Who knew? Definitely not me!

Our institutional review board (IRB) met a couple weeks after I returned from the conference, so I decided to use this as a training item during our meeting. My board’s reaction was that the capitalization makes sense now, but that the Feds could do a better job of making this very clear on the decision charts. After reviewing the website, I found the OHRP’s guidance on 45 CFR 46.101(b)(5).

There it was in black and white; we should be consulting with the Department of Health and Human Services funding agency before approving protocols under exemption five. Furthermore, the examples provided are ones of federal programs. To me, this means that we cannot, and should not, be approving local or state programs in which the head or director of the program has asked one of our investigators to study the effectiveness of said program.  Our IRB minds may tell us that if a director of a state or local agency, which provides a benefit or service to the community, requests an evaluation on his or her program by one of our investigators, it is a slam dunk decision and exempt category five is where approval lies. Our IRB minds would be incorrect. It seems to me that, for the most part, we need to forget that exemption five is available, because my guess is that for most of us, our investigators will not be asked by a federal agency to evaluate a public benefit or service agency.

Our IRB will re-evaluate the handful of protocols that have been granted approval under this exemption as soon as possible (and hope that nice lady from OHRP either doesn’t read this blog or that she really is nice!).