From the Director: Now that the (NPRM) Dust Has Settled…

Elisa Hurley

The last few months have been a bit of blur. The long-awaited NPRM to revise the Common Rule was released in September, setting off something of a firestorm of commentary, concern, and clamor around what was in the proposal, and what wasn’t; what might work, and what wouldn’t; and of course, how it would all look in the “real world” of ethical research oversight. Here at PRIM&R we spent a good deal of time over the three-month comment period crafting our response to the NPRM, and bringing you resources—such as the NPRM Resources page on our website and content at our Advancing Ethical Research Conference—to help you both understand what was being proposed and develop your own comments. And of course the holiday season was thrown in there, too.

Now that the comment period has closed and the proverbial dust has settled, I thought this was a good time to take a breath, remind us all that the NPRM isn’t a final rule– so don’t start thinking about how to implement it yet!– and review where we stand.

The Office for Human Research Protections (OHRP), which is coordinating the NPRM process, has received more than 2,100 hundred comments on the proposed rule. Comments came from individual lay people, from large research institutions (such as Yale University, the American Medical Association, and others), and from organizations whose raison d’etre is research ethics (like the Secretary’s Advisory Committee on Human Research Protections (SACHRP), PRIM&R, and many more).

[See the list of organizations who provided their institutional information during the submission process here. Note that not all submitters provided this information, nor is it required in the commenting process].

I was encouraged to see comments from across the US, and even outside of it. One commenter from Alberta, Canada recommended that OHRP look at a Canadian decision tool, which among other things, helps identify those projects which clearly require REB (research ethics board, the Canadian equivalent of an IRB) review when crafting its own.

Comments ranged from formal, detailed reviews (like PRIM&R’s response) to one or two sentence assertions of agreement (or disagreement) with a particular proposal. In all, it is clear that there is a healthy interest in, and many strong opinions about, this process—and by extension, a healthy interest in the conduct of ethical research with human subjects. This can only be considered a good thing for those of us who work in this field.

Before the comment period ended (but possibly lost in the holiday rush), the New York Times published an opinion piece by Rebecca Skloot, author of The Immortal Life of Henrietta Lacks, and past PRIM&R conference speaker, entitled, “Your Cells. Their Research. Your Permission?“, which largely welcomed the biospecimen research provisions proposed by the NPRM. PRIM&R responded with this Letter to the Editor, which echoes the point we made in responding to the NPRM; namely, that “broad consent” as proposed in the NPRM falls far short of genuine informed consent, and therefore doesn’t serve the NPRM’s stated goals of respecting subjects’ autonomy interests.

Biospecimens is possibly the most debated proposal in the NPRM, but there are a range of proposals that will impact all our work. But, again, it is important to remember that the NPRM is still just a proposal. It is possible that a final rule will not include all of the provisions included in the NPRM. It would thus be premature for IRBs, researcher teams, or institutions to start implementing any of these provisions, or to make changes to how they conduct and review human subjects research.

We don’t know when a final rule will be published, although there is some indication that the federal agencies would like to see a final rule in place before the end of the Obama administration.

It is unquestionably an exciting time for all of us involved in the human subjects research enterprise, albeit an uncertain one. Clearly the conversation is going to continue, and we can assume significant changes are coming, we just don’t know how long we will have to wait, or just what is in store. Has your thinking changed about the NPRM since the comment period closed and you were able to read others’ comments? How?