Blog Day

The Institutional Review Blog is nine years old today. It continues its original mission of aggregating news and commentary about IRB review of research in the humanities and social sciences, such as Wednesday’s report of an article from Feminist Studies. And it has never been closer to its goal of regulatory reform.

Schrag Reviews Klitzman, Ethics Police?

Just in time for the NPRM comment period, Society has published my review of Robert Klitzman’s book, The Ethics Police?: The Struggle to Make Human Research Safe (New York: Oxford University Press, 2015). I note that “By offering the subjective worldview of IRB members, Klitzman shows how good intentions combine with ethical ineptitude to produce arbitrary decisions.”

Per my agreement with Springer, what follows is the accepted manuscript of the review. The final publication is available at Springer via http://dx.doi.org/10.1007/s12115–015–9935-x.

Blog Day

Eight years of the Institutional Review Blog.

As Inside Higher Ed reported at the time

Schrag said that the problems with IRBs will probably remain for some time. “I think the regulations themselves are poorly drafted, with terms that are not well defined, and I anticipate problems until they are amended,” he said. “Perhaps until then, I’m going to have to keep up the blog.”

Can't be soon enough.

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.]

A Reply to Maxine Robertson

In an essay in Research Ethics, Maxine Robertson, Professor of Innovation and Organisation at Queen Mary University of London (QMUL), responds to my essay, "The case against ethics review in the social sciences," published in the same journal in 2011. I wish she had responded to more of the broader ethics-review critique and offered more details about ethics review at her own institution.

[Robertson, Maxine. “The Case for Ethics Review in the Social Sciences: Drawing from Practice at Queen Mary University of London.” Research Ethics 10, no. 2 (June 2014): 69–76. doi:10.1177/1747016113511177]

"The Freedoms We Are Committed to Protect"

The Hinckley Institute of Politics, University of Utah, has posted a videorecording of my lecture there last month.

"'The Freedoms We Are Committed to Protect': Political Science, Academic Freedom, and Institutional Review Boards in Historical Perspective.” Keynote address, Symposium on Field Research and US Institutional Review Board Policy, University of Utah, March 2014. http://youtu.be/uwIFyDgLklU

Symposium: Field Research and US Institutional Review Board Policy

This month the Political Science Department, University of Utah, will host a symposium entitled, "Field Research and US Institutional Review Board Policy." Sponsored by the Betty Glad Memorial Fund, the symposium will take place March 20 [8:45 am - 5:30 pm] and March 21 [9:00 am - 3:30 pm].

The description follows:

University of Utah Plans Symposium on IRB Policy

On March 20 and 21, the University of Utah Political Science Department will host a symposium, Field Research and US Institutional Review Board Policy.

I will give the keynote address, "'The Freedoms We are Committed to Protect': Political Science, Academic Freedom, and Institutional Review Boards in Historical Perspective."

Emmerich on Schrag, Stark, and van den Hoonaard

Nathan Emmerich of Queen's University, UK, reviews Ethical Imperialism, Behind Closed Doors, and The Seduction of Ethics for Research Ethics.

[Emmerich, Nathan. “Between the Accountable and the Auditable: Ethics and Ethical Governance in the Social Sciences.” Research Ethics 9, no. 4 (December 2013): 175–186. doi:10.1177/1747016113510654.]

Emmerich is particularly frustrated by the lack of accountability of research ethics committees:

"The review process renders research accountable whilst, at the same time, erasing any trace of its own accountability (Stark: 73) or, we might say, its own status as an ethical endeavour . . .

"How systems of governance should themselves be held responsible − to researchers, to research participants, and to society as a whole − remains uninterrogated by applied ethical thinking."

Lecture at Brigham Young University

On Thursday, February 28, I'll speak at Brigham Young University. The talk, "Ignorance Is Strength: Pseudo-Expertise and the Regulation of Human Subjects Research," is an updated version of one I delivered at Virginia Tech in 2011.

SAGE Insight Posts "The Case Against Ethics Review"

My Research Ethics article, "The Case Against Ethics Review in the Social Sciences," has been posted on the SAGE Insight blog. This means you can read it free. Thanks, SAGE!

Limited-Time Offer! Act Now!

SAGE has kindly made my article, "The Case against Ethics Review in the Social Sciences," free to access for a month. Download it while you can!

[Zachary M. Schrag, "The Case against Ethics Review in the Social Sciences," Research Ethics 7 (December 2011): 120-131, doi:10.1177/174701611100700402]

The Case against Ethics Review in the Social Sciences

Research Ethics has published my article, "The Case against Ethics Review in the Social Sciences." The article appeared in print in December 2011, but it has only recently appeared online.

[Zachary M. Schrag, "The Case against Ethics Review in the Social Sciences," Research Ethics 7 (December 2011): 120-131, doi:10.1177/174701611100700402]

(As of 17 May 2012, the DOI is working, but one can find the article at http://rea.sagepub.com/content/7/4/120.abstract.)

The article gathers many of the arguments made in the first five years of this blog.

Feds Ponder Biggest IRB Rules Changes in 30 Years!

On Friday, the U.S. Department of Health and Human Services posted an Advance Notice of Proposed Rulemaking (ANPRM), Human Subjects Research Protections: Enhancing Protections for Research Subjects and Reducing Burden, Delay, and Ambiguity for Investigators, to be published in the July 25 Federal Register.

The ANPRM seeks to "enhance the effectiveness of the research oversight system by improving the protections for human subjects while also reducing burdens, delays, and ambiguity for investigators and research subjects." In 92 pages, it suggests dozens of potential changes, some of them quite major. They would represent the biggest regulatory changes to the US IRB system since the revision of 45 CFR 46 in 1981.

Watch this space for extensive and frequent commentary on specific provisions in the proposal as I draft comments prior to the end of the 60 day comment period. (September 22? How do they count these things?)

For now, I will just register my delight that the federal government has finally acknowledged that the flaws in the present system are not mere anomalies, but represent systematic problems that demand regulatory reform.

Oh, and thanks for the three citations to my work! Attention has been paid!

Belmont's Ethical Malpractice

I complain about the Belmont Report in an essay published today in Bioethics Forum.

Like the blog? You'll love the book!

I am proud to announce the publication of my book, Ethical Imperialism: Institutional Review Boards and the Social Sciences, 1965-2009.

The book and the blog are complementary. The former traces the history of IRB review of research in the social sciences and humanities from its origins in the mid-1960s through last year, while the latter documents the ongoing debate over such review. I hope that everyone with an interest in the present debate will share my interest in its past.

The Johns Hopkins University Press has graciously offered a 25 percent discount to readers of this blog: please download the "Now Available" flyer. Books should begin shipping by the end of next week.

It Can Happen to Anyone

On Saturday, my Journal of Policy History article, "How Talking Became Human Subjects Research: The Federal Regulation of the Social Sciences, 1965–1991," was honored with that journal's Ellis Hawley Prize. In presenting the prize, Professor Hawley--one of the leaders of my profession--mentioned that he himself used to ask his students to interview someone who had lived through the Great Depression. On being told that he would have to submit to IRB review, he abandoned the assignment. If IRBs can deter Ellis Hawley from learning more about the 1930s, we have a problem.

Journal of Policy History

The Journal of Policy History has published my article, "How Talking Became Human Subjects Research: The Federal Regulation of the Social Sciences, 1965–1991." As permitted by the transfer of copyright, I have posted a PDF on my personal website: http://www.schrag.info/research/howtalking.html.

Not much has changed since I posted a version on SSRN in April 2008. The major changes come in the "medical origins" section; the earlier draft underestimated the strength of social scientists' opposition to IRB rules in the late 1960s. Also, the new version better explains the origins of Ithiel de Sola Pool's concern about IRBs (see p. 18).