Schrag on Whitney, Balanced Ethics Review

The Oral History Review has posted my review of Simon Whitney’s 2016 book, Balanced Ethics Review: A Guide for Institutional Review Board Members. (I think that’s three distinct uses of “review,” right?)

[Zachary M. Schrag, “Balanced Ethics Review: A Guide for Institutional Review Board Members. By Simon N. Whitney,” Oral History Review, accessed May 30, 2017, doi:10.1093/ohr/ohx030.]

I note,

Whitney’s approach is basically utilitarian, arguing that the good research creates outweighs its harms. In this vein, he values social science research as the equivalent of medical research . . but what of research that, like much humanities research and a fair amount of social science, aims only to increase human knowledge?

I conclude:

As Whitney well understands, IRB members face considerable pressure to overregulate. The universities or medical schools in which they work may ask them to review research (including oral history) beyond the scope of regulations, or to protect institutions from lawsuits. They will learn that they themselves are far more likely to be sued for letting one controversial study (like SUPPORT) proceed than for needlessly impairing dozens of less risky projects. And if they do receive training from the dominant institutions, they are likely to hear that “efficiency itself is not a moral imperative or an ethical value” (25). Whitney pushes back against this pressure. His book is well crafted to promote its stated goal: balance.

Oxford University Press asks that I not post a link to a free-access version of the review here, but it does allow me to post that link on my personal website.

Call for Chapters: Virtue Ethics in the Conduct and Governance of Social Science Research

Nathan Emmerich has secured a contract for a 2017 book on Virtue Ethics in the Conduct and Governance of Social Science Research. He seeks additional contributors. See the call for chapters.

New Book: The Ethics Rupture

The University of Toronto Press has published The Ethics Rupture: Exploring Alternatives to Formal Research-Ethics Review, edited by Will C. van den Hoonaard and Ann Hamilton. My chapter is entitled, “Ethical Pluralism: Scholarly Societies and the Regulation of Research Ethics.”

More Balanced Instructions for IRB Members?

Simon Whitney, critic of conventional handbooks for IRB members, is about to publish his own. Should be interesting.

[Simon N. Whitney, Balanced Ethics Review: A Guide for Institutional Review Board Members, (Springer, 2015).]

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.

Earnest Member Reads the Belmont Report

My favorite portion of The Censor’s Hand is Schneider’s invention of Earnest Member, a conscientious gentleman with good intentions but no ethical training until he is appointed to the IRB and handed copies of what Schneider terms the Sacred Texts.

Schneider: IRB System Is A Model of How to Regulate Badly

In an interview about his new book, The Censor’s Hand: The Misregulation of Human-Subject Research, law professor Carl Schneider charges that IRB abuses are inherent to the design of the system.

[Scott Jaschik, “‘The Censor’s Hand’,” Inside Higher Ed, June 3, 2015.]

New Books on IRBs: Israel, Klitzman, Schneider

Within the past few months, Mark Israel has published a second edition of Research Ethics and Integrity for Social Scientists, and Robert Klitzman and Carl Schneider have published substantial new works on the IRB debate.

At some point I hope to find the time to review these in depth. For now, here's the bibliography:

Israel, Mark. Research Ethics and Integrity for Social Scientists: Beyond Regulatory Compliance. Second Edition edition. London; Thousand Oaks, Calif.: SAGE Publications Ltd, 2014.

Klitzman, Robert. The Ethics Police?: The Struggle to Make Human Research Safe. 1 edition. Oxford ; New York: Oxford University Press, 2015.

Schneider, Carl E. The Censor’s Hand: The Misregulation of Human-Subject Research. Cambridge, Massachusetts: The MIT Press, 2015.

New Book on Research Confidentiality

Ted Palys and John Lowman have published Protecting Research Confidentiality: What Happens When Law and Ethics Collide.

[Palys, Ted, and John Lowman. Protecting Research Confidentiality: What Happens When Law and Ethics Collide. Toronto: James Lorimer & Company, 2014.]

Over the years, I've learned a great deal from these two scholars about the ethics and law of research confidentiality in the social sciences, and I look forward to reading this compendium of what they have learned from their studies and their own struggles with their university.

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.

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."

Gontcharov Reviews van den Hoonaard

Igor Gontcharov, a fellow participant in last year's Ethics Rupture conference, reviews Will van den Hoonaard's Seduction of Ethics and explains its relation to the conference's "New Brunswick Declaration."

[Igor Gontcharov, “Methodological Crisis in the Social Sciences: The New Brunswick Declaration as a New Paradigm in Research Ethics Governance?” Transnational Legal Theory 4, no. 1 (2013): 146–156. doi:10.5235/20414005.4.1.146.]

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).]

Dreger Reviews Stark: It Is Lawyers All The Way Down

Alice Dreger reviews Laura Stark's Behind Closed Doors for the Journal of American History:

Contrary to the self-aggrandizing story bioethicists like to tell about how IRBs arose out of concern for human subjects of research, Stark shows that, when you dig into this history, it is lawyers all the way down . . . She argues that IRB work was decentralized not to make it more ethical, but to protect the NIH from lawsuits. Stark convincingly concludes that IRBs today do not primarily enact ethical principles; they manage procedures.

[Dreger, Alice. “Behind Closed Doors: IRBs and the Making of Ethical Research.” Journal of American History 99, no. 4 (March 2013): 1328–1328. doi:10.1093/jahist/jas666.]

I Review Stark, Behind Closed Doors

The American Journal of Sociology has published my review of Laura Stark's Behind Closed Doors. I describe it as an "illuminating account of how ethics review really works," but note that "Stark’s reluctance to condemn [IRB] behavior sets her apart from other observers of IRBs in action" and that it is "a stretch for Stark to claim that today’s IRBs use 'a decision-making model that stabilized in the 1950s and 1960s.'"

[Zachary M. Schrag, Review of Behind Closed Doors: IRBs and the Making of Ethical Research by Laura Stark. Chicago: University of Chicago Press, 2012. Pp. Viii+229. $85.00 (cloth); $27.50 (paper).” American Journal of Sociology 118, no. 2 (September 2012): 494–496. www.jstor.org/stable/10.1086/664671]

For my comments on Stark's dissertation, on which the book is based, see "How IRBs Decide--Badly: A Comment on Laura Stark's 'Morality in Science.'"

I Review van den Hoonaard, The Seduction of Ethics

Contemporary Sociology has published my review of Will C. van den Hoonaard's Seduction of Ethics, which I term "a powerful, combined-arms assault on the system of ethics review of the social sciences."

[Zachary M. Schrag, review of The Seduction of Ethics: Transforming the Social Sciences by Will C. van den Hoonaard, Contemporary Sociology: A Journal of Reviews 41, no. 5 (September 2012): 678–679, doi:10.1177/0094306112457769oo.]

I Hope You All Get Pox

This is a little off-topic for the blog, but to understand the IRB system, it helps to understand the history of the U.S. Public Health Service, and to understand the history of the U.S. Public Health Service, it helps to read Michael Willrich's Pox: An American History, which I just finished reading and am very glad to plug.

The history of public health is a struggle between the desire for liberty and the desire for health, since many of the most effective public health measures--quarantine, health codes, compulsory vaccination, and perhaps bans on 20-ounce soft drinks--are also infringements of liberty. Willrich's account of smallpox at the turn of the twentieth century does a marvellous job at presenting both sides of this struggle. It explains laypeople's legitimate fears about the doctors and health officers who came to snatch them and their children, but also why those health officers took pride in their snatching. We may wonder who in today's IRB debate most resembles the arrogant vaccinators of a century ago: researchers seeking scientific progress, or ethics boards seeking to restrain them?

Inside Higher Ed Interviews Stark

Laura Stark speaks about her new book, Behind Closed Doors, with Inside Higher Ed.

[Mitch Smith, "Behind Closed Doors," Inside Higher Ed, 8 February 2012.]

Stark explains, "It would seem that fairness is not the only criteria used in IRB evaluations."

e-Thical Imperialism

Ethical Imperialism: now on Kindle.