IRBs and America's Worst Colleges

Broadcast live streaming video on Ustream

I talk about IRB's as part of the New America Foundation's "America's Worst Colleges" event.

You Can't Ask That

The Washington Monthly's fall college issue features my essay on IRBs. Nothing that will surprise regular readers of this blog, but perhaps this will reach new readers.

[Schrag, Zachary M. “You Can’t Ask That.” Washington Monthly, September/October 2014.]

Those Noisy Voices from the Grave

This afternoon I had the pleasure of speaking on the Kojo Nnamdi Show about the Belfast Project (a.k.a. Boston College’s Oral History Archive on the Troubles in Northern Ireland) and its impact on oral history. I didn't have a lot of time, but I tried to make the case for a shield law, analogous to the protections provided to health research and DOJ-sponsored criminal justice research.

[“Old Wounds & Oral History: The Aftermath of the Belfast Project,” Kojo Nnamdi Show, July 7, 2014.]

Interview by Washington Monthly - Ten Miles Square

Rachel Cohen interviewed me for Ten Miles Square, a Washington Monthly blog.

I guess in this case the ten miles square still includes Arlington.

Cohen, Rachel. “What Are Institutional Review Boards and Why Should We Care? An Interview with Zach Schrag.” The Washington Monthly - Ten Miles Square, November 1, 2013. http://www.washingtonmonthly.com/ten-miles-square/2013/11/what_are_institutional_review047608.php?

Inside Higher Ed Reports on AAUP Recommendations

Inside Higher Ed presents the key points of the newly finalized AAUP report.

[Carl Straumsheim, “AAUP Recommends More Researcher Autonomy in IRB Reform," Inside Higher Ed, March 6, 2013. http://www.insidehighered.com/news/2013/03/06/aaup-recommends-more-researcher-autonomy-irb-reform.
]

Sociologists of Sexuality Voice IRB Complaints

Sociologist Janice Irvine finds that IRBs "play a significant but largely unnoticed role in the marginalization of sexuality research," and that "the IRB closet obstructs a broad production of sexual knowledge—not simply about identities and communities, but also about a range of sexual acts, desires, and attitudes."

[Janice M. Irvine, "Can't Ask, Can't Tell : How Insitutional Review Boards Keep Sex In The Closet," Contexts 2012 11: 28, DOI: 10.1177/1536504212446457. The story has been picked up by the Chronicle of Higher Education: Dan Berrett, "Review Boards Force Sex Research Into the Closet, Survey Suggests," Chronicle of Higher Education, 28 June 2012.]

Washington Post Confuses "Research," "Experiment," and "Medical Experiment"

On January 1, the Washington Post ran an editorial, "Medical Experiments on Humans," claiming that "in 2010, the federal government funded 55,000 experiments worldwide on human subjects" and citing "Moral Science."

But "Moral Science" does not make that claim. Rather, it states that "The federal government supported more than 55,000 human subjects research projects around the globe in fiscal year 2010, mostly in medical and health-related research, but also in other fields such as education and engineering." It does not break the 55,000 figure into experimental and non-experimental approaches.

The editorial shows some awareness of the complexity of human subjects research, noting that many people "take part in projects fueled by federal dollars that focus on social science and education research." But the editorial's headline, "Medical Experiments," does not match the data in the body of the editorial. As we proceed with regulatory reform, I hope editorial boards will learn to read and write more carefully.

Kojo Nnamdi Show on Common Rule Now Online

Yesterday I had the pleasure of joining Jerry Menikoff of OHRP and Kathy Hudson of NIH on an episode of the Kojo Nnamdi Show entitled, "Rethinking the "Common Rule": The Ethics of Research with Human Subjects." We received many thoughtful, informed comments and questions.

I don't think any of us said anything that will surprise those who have followed the ANPRM debate closely, but I was pleased to hear Dr. Hudson concede that "The level to which current IRB protections actually protect participants is a somewhat understudied area. And I would hope that as we put these new rules in place that we can actually try to measure how effective they are in protecting participants in research."

In other words, after 45 years of imposing IRB review on researchers, we might begin asking if it does any good.

The audio recording and a transcript are now online at the link above.

Radio Show to Feature Menikoff, Hudson, and Me

On Monday (November 21) at 1pm, WAMU's Kojo Nnamdi Show will air "Rethinking the 'Common Rule': The Ethics of Research with Human Subjects." Jerry Menikoff of OHRP, Kathy Hudson of NIH, and I will discuss the ANPRM.

The show airs in Washington on 88.5 FM and is streamed online.

New York Times: Menikoff Promises Not to Restrict Public Information

Today's New York Times reports on historians' and social scientists' hopes and concerns about the ANPRM, especially the prospect of deregulating oral history while restricting the reuse of social science data.

[Patricia Cohen, "Questioning Privacy Protections in Research," New York Times, 24 October 2011.]

Wall Street Journal Blogs ANPRM

Christopher Shea, author of the landmark 2000 article, "Don't Talk to the Humans: The Crackdown on Social Science Research," notes Rob Townsend's call to action on the ANPRM.

[Christopher Shea, "Historians and Human-Subjects Research," Wall Street Journal: Ideas Market, 5 August 2011]

Shea writes,

Understandably, some social scientists want to know why historians should get a pass on paperwork and oversight that takes up lots of their own time.

So the question is: How can oral (or, more generally, contemporary) historians escape inappropriate IRB scrutiny without denigrating their own work? Or, to back up a step, should they, in fact, have to go through the same procedures as social psychologists doing lab studies?

Might I interest him in a 4,800-word answer?

Inside Higher Ed Reports on ANPRM

Inside Higher Ed reports on the ANPRM, with emphasis on concerns about the overregulation of the social sciences, humanites and journalism.

[Doug Lederman, "Updating the Common Rule," Inside Higher Ed, 3 August 2011]

The story quotes C. K. Gunsalus, Felice Levine, and your humble blogger. Mostly they are positive about the ANPRM, but Gunsalus and I express reservations. Hers concerns the proposal to extend the regulations to all research conducted at federally funded institutions:

"I have a hard time seeing how it makes sense to cover poets at universities but ignoring" surveys done by companies or research that takes place at fertility clinics or other entities that forgo federal funds. "I don't agree with this choice, and don't think it will solve the problem in the way they think it will."

Elliott Wants to Scrap IRBs

Carl Elliott, author of White Coat, Black Hat: Adventures on the Dark Side of Medicine, calls IRBs "incapable" and wants them replaced.

[Carl Elliott, Useless Pharmaceutical Studies, Real Harm, New York Times, 29 July 2011.]

Report on Research Compliance on ANPRM

The August issue of Report on Research Compliance covers ANPRM.

["Human Research Protections Prerule Mandates Regs for Non-Govt. Studies," Report on Research Compliance, August 2011]

The report has a statement from Art Caplan:

“These are long-overdue changes,” Art Caplan, director of the Center for Bioethics at the University of Pennsylvania, told RRC. “The current system involves too much red tape and paperwork in proportion to the protection given to subjects. In some ways the system of human subjects protection — informed consent and review by IRBs [i.e., institutional review boards] — has been hijacked by legal concerns so that more attention is given to institutional and investigator protection than subject empower- ment. These changes help remedy that problem.”

Your humble blogger is also quoted, complaining about the lack of attention to the experience of other countries. I did overlook ANPRM's footnote 28: "Cribb R. Ethical regulation and humanities research in Australia: Problems and consequences. Monash Bioethics Rev 2004;23(3):39–57." Other than that, has anyone found references to the workings of ethics committees in other countries?

New York Times Reports on ANPRM

Andrew Pollack, "Rule Changes Proposed for Research on Humans," New York Times, 24 July 2011.

Like the Washington Post story, this lacks any explanation of who wrote the ANPRM or why it came out now. But it does have some good quotations:

“It’s a terrible drag on getting good research done,” said Dr. Robert J. Levine, a professor of medicine and a bioethicist at Yale who headed the university’s institutional review board for 31 years. He said Sunday that while he had not thoroughly reviewed the government’s lengthy proposal, he was encouraged by what he had seen.

and

Carl Wieman, associate director for science at the White House Office of Science and Technology Policy, said it was now difficult to observe teachers and students in classrooms to help determine what makes a good teacher, given all the consent required. “You’re not doing anything here except watching people,” he said.

Washington Post Reports on ANPRM

David Brown, "U.S. proposes rule changes for human-subject research," Washington Post, 23 July 2011.

U.S. and British Governments Subpoena Oral Histories

Last month, the United States Attorney’s office filed a subpoena for two tapes that were recorded as part of the Boston College’s Oral History Archive on the Troubles in Northern Ireland. It did so at the request of the Police Service of Northern Ireland, part of the British Government. As reported by the New York Times, British authorities apparently want the tapes for an investigation into murders and kidnappings committed decades ago.

Inside Higher Ed Reports on Li v. Brown University

Inside Higher Ed reports on the Brown University professor who is suing the university over IRB restrictions. The story quotes your humble blogger.

[Dan Berrett, "IRB Overreach?," Inside Higher Ed, 18 March 2011.]

Happy New Year, OHRP

In February 2007, the New York Times reported on scholars' frustration with IRB review of social research. OHRP assured reporter Patricia Cohen that it was working on the problem:

Bernard A. Schwetz, director of the federal Office for Human Research Protections, which administers the regulations, acknowledges that the guidelines covering the boards’ actions have not been clear enough and says he intends to make public new proposed guidelines before the end of the year.

Later in the article, Schwetz "said the new guidelines 'will give a lot of examples and will give more guidance on how to make the decision on what is research and what is not.'" This makes it clear that the 2007 call for comments on expedited review is not what he had in mind.

With the end of 2008, the promised guidelines are more than a year late.

This may be for the best. Schwetz seemed determined to continue OHRP's history of trying to regulate everything, while under Menikoff, we might expect better results. But OHRP and its predecessors have made a lot of empty promises over the years, and it's frustrating to see that tradition continued.

Chronicle of Higher Education on OHRP Training Comments

The Chronicle of Higher Education quotes your faithful blogger in "Scholars Mull Rules for Training in Research Ethics," by David Glenn, 4 November 2008.

The story concerns the eighty or so comments received in response to OHRP's July call for comments on education and training requirements. Glenn notes that by and large, the comments were skeptical about the need for new guidance, and particularly skeptical about regulations. As he reports, "the American Association for the Advancement of Science, the Association of American Universities, the Association of American Medical Colleges, and a consortium of large social-science organizations [all] said that before the federal government issues new rules, it should carefully study whether training actually improves researchers' conduct."

I will offer some of my own comments on the comments in coming posts.