Final Rule, three months later

It’s been three months since the announcement of the new Common Rule. Some reactions so far:

First, Do Some Harm, Part IV: Fake Submission to Fake Conference Yields Fake Charge of Misconduct

Professor Jim Vander Putten, who spent six years as chair of the University of Arkansas Little Rock (UALR) IRB, is now charged with violating university rules by conducting research without that board’s approval. The case highlights several problems with the current system, most notably its failure to provide standards for studies designed to expose misbehavior.

[Peter Schmidt, “A Scholar’s Sting of Education Conferences Stirs a Hornet’s Nest,” Chronicle of Higher Education, March 14, 2016, paywalled.]

A/B ≠ A&B

A/B testing is the comparison of two products by providing each, simultaneously, to two randomly selected groups. As Michelle Meyer notes, the practice is less ethically suspect than a common alternative: imposing a new product on all of one’s customers without first testing it.

A&B is an abbreviation for assault and battery. Depending on the jurisdiction, the two may be a single crime or distinct crimes, but everywhere A&B is unlawful.

Law professor James Grimmelmann has confused the two:

Suppose that Professor Cranium at Stonewall University wants to find out whether people bleed when hit in the head with bricks, but doesn’t want to bother with the pesky IRB and its concern for “safety” and “ethics.” So Cranium calls up a friend at Brickbook, which actually throws the bricks at people, and the two of them write a paper together describing the results. Professor Cranium has successfully laundered his research through Brickbook, cutting his own IRB out of the loop. This, I submit, is Not Good.

IRBs for everyone, or you get hit with a brick. I suggest that this parade of horribles is missing its elephant. Blame the IACUC?

Anyway, thanks for the link.

ETA(2:18PM): I originally linked to the wrong Meyer paper. Of course, that one's worth reading too.

A Bit of Historical Perspective on the Facebook Flap

IRBs and behavioral research are all over the news, as a result of a paper that manipulated the news feeds of 689,003 Facebook users.

[Kramer, Adam D. I., Jamie E. Guillory, and Jeffrey T. Hancock. “Experimental Evidence of Massive-Scale Emotional Contagion through Social Networks.” Proceedings of the National Academy of Sciences 111, no. 24 (June 17, 2014): 8788–90. doi:10.1073/pnas.1320040111.]

Michelle Meyer has posted a detailed analysis of the regulatory context, explaining multiple ways a project like this could have been approved. She concludes that "so long as we allow private entities freely to engage in these practices, we ought not unduly restrain academics trying to determine their effects."

[Meyer, Michelle N. “How an IRB Could Have Legitimately Approved the Facebook Experiment—and Why That May Be a Good Thing.” The Faculty Lounge, June 29, 2014. http://www.thefacultylounge.org/2014/06/how-an-irb-could-have-legitimately-approved-the-facebook-experimentand-why-that-may-be-a-good-thing.html.]

I have little to add to Meyer's excellent post, except a bit of historical perspective. Psychological experiments—whether in the lab, in the field, or online—fall outside my main area of concern, but perhaps I can offer a few relevant points.

Michelle Meyer: Miller Interacted, Intervened

Michelle Meyer had more to say about my comments on Geoffrey Miller's fatshaming troll-tweet than would fit in Blogger's comment box. I post her comments here, along with some responses.

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)