Wednesday, May 31, 2017

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.

Friday, April 21, 2017

Friday, February 17, 2017

Institutional Review Blog past and future

This winter, the Institutional Review Blog passed two milestones. In December it turned 10 years old, and in January it reported on the largest reform in U.S. human subjects regulations since 1981. This seemed like a good time to archive another batch of postings, so I have deposited a second PDF with the the Mason Archival Repository Service. Now all postings from the start of the blog through the end of January 2017 can be found at http://hdl.handle.net/1920/8642. Many thanks to Wally Grotophorst, Associate University Librarian, George Mason University, for making this possible.


I am less sure about the future of this blog. In ten years I have posted about 445,000 words, a considerable investment of time and effort. I see no reason to formally close the blog, but I may be posting a good deal less frequently as I focus on completing my book about the Philadelphia riots of 1844.

Thursday, January 19, 2017

You know, it's very strange

On 19 January 2007, Inside Higher Ed reported the launch of this blog. Here is the kicker from that story:


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.”


Ten years later, to the day, the amended regulations are in the Federal Register.


You know, it’s very strange—I have been in the revenge business so long. Now that it’s over, I don’t know what to do with the rest of my life.


Should I consider piracy?

Why is Felice Levine satisfied?

Inside Higher Ed reports that Felice J. Levine, executive director of the American Educational Research Association, is happy with the final rule. I’m curious about why; it doesn’t seem to give her anything she asked for in 2011.


[Scott Jaschik, “U.S. Issues Final Version of ‘Common Rule’ on Research Involving Humans,” Inside Higher Ed, January 19, 2017.]

[Edited at 11:12AM to mention the normal educational practices in penultimate paragraph.]

A social scientist’s guide to the Final Rule

On 18 January 2017, sixteen federal agencies announced revisions to the Federal Policy for the Protection of Human Subjects. As I noted earlier, this marks a huge victory for historians, who have spent the last 20 years working to end the inappropriate interference of IRBs with oral history research.


In addition, the final rule includes several provisions of note to scholars in the humanities and social sciences. Here are some of them; I don’t claim it is a complete list.

Wednesday, January 18, 2017

United States of America Frees Oral History!

detail of sheet music for 'Victory' by  M. K. Jerome, Jack Wilson, Ben Bard, 1918

This morning sixteen federal agencies announced revisions to the Federal Policy for the Protection of Human Subjects, effective 19 January 2018. The final rule preserves and clarifies the NPRM’s deregulation of oral history. This is a great victory for freedom of speech and for historical research.

Saturday, January 7, 2017

Common Rule reform still in suspense

A proposed final rule on human subjects protections made it to the Office of Management and Budget on Wednesday, January 4.


Jeannie Baumann of Bloomberg thinks this means that we’ll see it in the Federal Register before January 20. But she also quotes Lisa Nichols, director of research and regulatory reform for Council on Governmental Relations, predicting that Congress will overturn the reform, since it appears on the House Freedom Caucus hit list.


Wake me up when it’s over.


[Jeannie Baumann, “White House Takes Final Steps to Revamp Medical Research Rule,” Bloomberg BNA, January 6, 2017.]

Monday, January 2, 2017

Reforms for “21st century science” would have been good for the 20th too

A group of 11 researchers and IRB professionals, most of them affiliated with the University of California, San Diego, report on a brainstorming session from early 2015. They argue that readable consent forms, expert review, a less punitive system, and more exemptions would better serve researchers and participants. While they present their ideas as “a human research protections system that is responsive to 21st century science,” the measures they propose are equally valid for research as it has been practiced for decades.


[Cinnamon Bloss et al., “Reimagining Human Research Protections for 21st Century Science,” Journal of Medical Internet Research 18, no. 12 (2016): e329, doi:10.2196/jmir.6634.]

Thursday, December 15, 2016

Calls for Ethical Pluralism

In separate essays, Nathan Emmerich and Igor Gontcharov argue for more flexible systems that would avoid imposing biomedical ethics on the social sciences. Emmerich calls for an emphasis on professional ethics, while Gontcharov seeks “a set of ethical principles that would better reflect the position of [social sciences and humanities] researchers and participants.” I am left unsure what either proposed reform would look like in practice.


[Nathan Emmerich, “Reframing Research Ethics: Towards a Professional Ethics for the Social Sciences,” Sociological Research Online 21, no. 4 (2016): 7, DOI: 10.5153/sro.4127; Igor Gontcharov, “A New Wave of Positivism in the Social Sciences: Regulatory Capture and Conceptual Constraints in the Governance of Research Involving Humans,” SSRN Scholarly Paper (Rochester, NY: Social Science Research Network, October 31, 2016), DOI: 10.2139/ssrn.2861908.]