What Can One University Do?

A few weeks ago, a correspondent asked me what reforms individual universities can implement while awaiting systemic, regulatory reform. It's an excellent question, so here's a roundup from material previously covered on the blog.

No university has adopted all of these measures, and at least one of these measures has not been adopted by any. But most of them are in place already, and there's no reason they can't spread.

Report from the National Academies Workshop

Last week I attended the Revisions to the “Common Rule” in Relation to Behavioral and Social Sciences Workshop sponsored by the National Academies.

I live-tweeted the event on my @IRBblog account, and I have collected those tweets on Storify.

What follows are what I consider some of the key messages from selected presenters. The statements following each name represent my summary of the remarks, not necessarily a quotation or paraphrase.

Meyer: "IRB Review Has Only One Step"

Writing on Bill of Health, the blog of the Petrie-Flom Center, Michelle Meyer argues that while human subjects "regulations in theory establish three risk-based tiers of review — human subjects research (HSR) otherwise subject to IRB review that the regulations nevertheless exempt; HSR that is eligible for expedited review; and HSR that requires review by a fully convened IRB (everything else) — in practice, the first two tiers tend to collapse into the third. In this sense, and now I borrow from Matthew Stephenson and Adrian Vermeule, IRB review has only one step."

[Meyer, Michelle. “Exempt Research & Expedited IRB Review: Curb Your Enthusiasm |.” Bill of Health, October 22, 2012. https://blogs.law.harvard.edu/billofhealth/2012/10/22/exempt-human-subjects-research-expedited-irb-review-curb-your-enthusiasm/]

I think this implies that even projects that are not federally funded, that don't meet the regulatory definition of human subjects research, or that fit one of the exemption categories are apt to go to full board review.

While it's easy enough to find examples of projects that suffered more scrutiny than required by the regulations, I would note that the exempt and expedited categories remain large. For example, the University of Michigan reports that only 11 percent of projects brought to the Health Sciences and Behavioral Sciences Institutional Review Boards required full review. (Table 4)

Video of my Michigan Talk Now Online

The University of Michigan Center for Bioethics and Social Sciences has kindly posted a video recording of my February 1 talk:

Zachary Schrag talk, February 1, 2012 from CBSSM Developers on Vimeo.

and the subsequent panel discussion, featuring Cleo Caldwell, Carl Schneider, and Alford Young, Jr.:

Ethical Imperialism: The Case Against IRB Review of the Social Sciences, 2/1/12 Panel Discussion from CBSSM Developers on Vimeo.

Wednesday Talk at the U. of Michigan

I will speak about my work on IRBs on Wednesday afternoon at the University of Michigan's Center for Bioethics and Social Sciences in Medicine.

U of Michigan Reports Some Progress

The University of Michigan has released the results of a 2009 survey of investigator experiences in human research. The survey suggests that matters have improved somewhat since the university launched its HRPP Policy Innovation and Demonstration Initiative in 2007, but that more work remains to be done.

[Survey Research Center, Institute for Social Research, University of Michigan, "2009 Follow-Up Survey of Investigator Experiences in Human Research," December 2010. h/t: Human Research Protections Blog.]