Gentle Regulation May Be More Effective

Law professor Samuel Bagenstos argues that recent Title IX excesses follow the pattern of IRB horror stories: the feds threaten drastic action, so university administrators hyper-regulate. He offers disability rights as an example of a less punitive regulatory effort that has produced good results.

[Samuel R. Bagenstos, “What Went Wrong With Title IX?,” Washington Monthly, October 2015.]

OHRP Claims to Be "Working Very Hard" on NPRM

Writing for the Chronicle of Higher Education, Christopher Shea notes that though two years passed between the 2012 Future of Human Subjects Research Regulation conference at the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School and the publication of the conference volume in July 2014, the delay of the next step in regulatory reform--a notice of proposed rulemaking (NPRM)--means that the book remains timely.

[Shea, Christopher. “New Rules for Human-Subject Research Are Delayed and Debated.” Chronicle of Higher Education, November 3, 2014.]

One also hopes that it won't be timely forever. Shea writes,

A spokesman for the Office for Human Research Protections, which is part of the Department of Health and Human Services, could not provide a timetable but told The Chronicle late last month, "I can assure you that this continues to be an HHS priority, and all the relevant parties are still working very hard on this."

Or, as they might have put it, "We have top men working on it right now."

New Book on Human Subjects Research Regulation

MIT Press has published Human Subjects Research Regulation: Perspectives on the Future, eds. I. Glenn Cohen and Holly Fernandez Lynch.

The volume emerges from the May 2012 conference, "The Future of Human Subjects Regulation," sponsored by the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School. (See Against Armchair Ethics: Some Reflections from Petrie-Flom.)

My own contribution is a chapter entitled, "What Is This Thing Called Research?" I have a preliminary version online at SSRN.

Though published three years after the ANPRM, the book has hit print before an NPRM. Pity.

UNC Stops Pretending that IRBs Understand Data Encryption

The Chronicle of Higher Education reports that the University of North Carolina at Chapel Hill and Harvard are asking their IT departments, rather than their IRBs, to design data security protocols for human subjects researchers.

[Voosen, Paul. “Researchers Struggle to Secure Data in an Insecure Age.” Chronicle of Higher Education, September 13, 2013. http://chronicle.com/article/Researchers-Struggle-to-Secure/141591/. (gated)]

IRB Imposed Anonymity on Campus Politics Book

An unnamed IRB prevented two sociologists from identifying the sites of their research, reducing their book's scholarly impact.

[Amy J. Binder and Kate Wood, Becoming Right: How Campuses Shape Young Conservatives (Princeton University Press, 2012).]

What Is This Thing Called Research?

I have posted the paper I prepared for the May 2012 Petrie-Flom conference as "What is this Thing Called Research? (May 7, 2012), http://ssrn.com/abstract=2182297.

A shorter version will appear in a book to be published by the MIT Press, tentatively entitled The Future of Human Subjects Research Regulation.

Here is the abstract:

IRBs Impeded Harvard Dissertation on Addiction and Incarceration

Kimberly Sue, a medical anthropologist in Harvard's MD/PhD program, reports that IRB review can seem "a hassle, a nuisance or a stumbling block, as we seek to enact a more relevant and engaged era of anthropology."

[Kimberly Sue "Are IRBs a Stumbling Block for an Engaged Anthropology?" Somatosphere, 9 August 2012, http://somatosphere.net/2012/08/are-irbs-a-stumbling-block-for-an-engaged-anthropology.html . h/t Michelle Meyer]

Harvard Law Today Reports on ANPRM Conference

Harvard Law Today, published by Harvard Law School, reports on May's conference on the ANPRM, held at the school's Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics.

["The Future of Human Subjects Research Regulation," Harvard Law Today, July 2012.]

The article highlights the plenary address by Greg Koski, former director of OHRP.

Koski said regulation has been dominated by human-subject protectionism and an ethical-review system that has “devolved to regulatory compliance oversight.” The result, he said, is a system that is “inefficient and burdensome.” His recommendation, he said, was to replace the current system with one modeled after medical training and certification.

He said: “If we were able to develop a paradigm of professionalism in human research, it would likely be every bit as effective, less costly, less burdensome and more efficient than the protectionist, compliance-focused system that we are now seeking to reform. I would argue that reform of our current system is perhaps not the most appropriate or even adequate approach to try to achieve the goals that we seek.”

Against Armchair Ethics: Some Reflections from Petrie-Flom

As followers of my Twitter feed will know, I spent Friday and the first half of the Saturday at The Future of Human Subjects Research Regulation, a conference sponsored by the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School.

The conference organizers, led by Professor Glenn Cohen, did a magnifent job bringing together participants with varied views and backgrounds, and as a group we discussed ideas ranging from treating research subjects as workers to including adolescents on IRBs. Those who want the full story should be able to watch videos of the presentations before too long.

I was struck, however, by one recurring theme: the distinction between evidence-based approaches and armchair ethics.

Petrie-Flom Center Posts ANPRM Conference Program

The Petrie-Flom Center for Health Law Policy, Biotechnology and Bioethics at Harvard Law School has circulated the following announcement, concerning a conference at which I will speak. I am happy to post the announcement in full.

Alarmist Views on Harvard Facebook Study

The Chronicle of Higher Ed reports a debate over a study of Facebook profiles, started in 2006 by Jason Kaufman of Harvard's Berkman Center for Internet & Society. The debate suggests that researchers may not be aware of how easy it can be to identify allegedly anonymous institutions and individuals, but that neither IRBs nor outside critics may understand all the implications of a study either.

[Marc Parry, "Harvard's Privacy Meltdown," Chronicle of Higher Education, 10 July 2011.]

Even the Best IRB Can Antagonize Researchers

Judging from Samuel P. Jacobs's story, "Stern Lessons For Terrorism Expert," Harvard Crimson, March 23, 2007, the Harvard IRB is pretty darn good when it comes to non-biomedical research. Policy researcher Jessica E. Stern learned from the IRB to "not learn the names of many of the people she is interviewing—preferring to use pseudonyms—thus protecting the privacy of her interviewees and making her notes less valuable to federal investigators." She states, “Harvard’s IRB is the only one I know of to approve the kind of research I do. They’ve bent over backwards to make what I do possible, which is better than any other IRB.” Law professor Elizabeth Warren has “never encountered an IRB as helpful as Harvard’s."

Yet another researcher finds "the process is so cryptic and idiosyncratic" that "his students often can’t anticipate the reasons why the institutional review board will reject a proposal." And Stern herself, who got valuable help from the IRB, complains that "Before I came to Harvard, I had pretty remarkable interviews with terrorists . . . There are a lot of reasons that those kind of interviews would be hard today. One of them is the post-September 11 environment, but the other is the IRB strictures.” One project, to interview radical black Muslims, died entirely because of the delay in approval. (Note: this is just what Robert Kerr warned us about.)

How can we have the best of both worlds—helpful advice without arbitrary rejections and delays? Voluntary review.