Big Data researchers call for IRB review, based on shaky premises

Jacob Metcalf of the Data & Society Research Institute and Kate Crawford of Microsoft Research, MIT Center for Civic Media, and New York University Information Law Institute (I think those are three different things) want to subject Big Data research to IRB review, at least in universities. Their argument rests on shaky premises.

[Jacob Metcalf and Kate Crawford, “Where Are Human Subjects in Big Data Research? The Emerging Ethics Divide,” Big Data & Society 3, no. 1 (January–June 2016): 1–14, doi:10.1177/2053951716650211.]

Bioethicists learn from history

Now that I’ve had my rant about the Belmont Report’s year of publication, I can turn to the more substantive arguments of Barron Lerner and Arthur Caplan’s recent essay, “Judging the Past: How History Should Inform Bioethics." These scholars wisely argue against simplistic condemnations of past behavior, yet they also reject the other extreme of attributing all past misbehavior to the age rather than the individual. By understanding what choices were open to actors in the past, we can better assess the morality of their actions and the choices that we ourselves face.

[Barron H. Lerner and Arthur L. Caplan, “Judging the Past: How History Should Inform Bioethics,” Annals of Internal Medicine 164, no. 8 (April 19, 2016): 553–57, doi:10.7326/M15–2642.

The Belmont Report was published in 1978, goddammit!

Bioethicists Barron Lerner and Arthur Caplan have published a nice essay about using history to make better decisions today. I will comment on their main points in a separate post, but I want to address separately the authors’ repetition of a common error: the suggestion that the Belmont Report was published in 1979.

The Belmont Report was published in 1978, goddammit!

[Barron H. Lerner and Arthur L. Caplan, “Judging the Past: How History Should Inform Bioethics,” Annals of Internal Medicine 164, no. 8 (April 19, 2016): 553–57, doi:10.7326/M15–2642.

Oral Historians as Ethical Proofreaders

Kevin Bradley and Anisa Puri of the Australian Generations Oral History Project explain that the ethical challenges they faced came after they had conducted the interviews.

[Kevin Bradley and Anisa Puri, “Creating an Oral History Archive: Digital Opportunities and Ethical Issues,” Australian Historical Studies 47, no. 1 (2016): 75–91, doi:10.1080/1031461X.2015.1122072.]

My NPRM Comments

Perhaps 2016 will be the year when OHRP makes good on its 2007 promise to “give more guidance on how to make the decision on what is research and what is not,” in the form of a promulgated revision to the Common Rule. If so, Happy New Year, OHRP!

Wth these hopes, I have submitted my own comments on the NPRM. I have posted a copy of the PDF I submitted, and below is a web version with links.

Historians Love the NPRM

Fifteen scholarly organizations, including the American Council of Learned Societies, the American Historical Association, the American Political Science Association, the Oral History Association, and the Organization of American Historians, have signed a letter endorsing the NPRM’s proposed exclusion of “oral history, journalism, biography, and historical scholarship activities that focus directly on the specific individuals about whom the information is collected."

The letter (whose authors kindly consulted me in its early stages) is unequivocal:

We concur with this recommendation of full exclusion of such activities from IRB oversight. It reflects an appreciation that these activities should not be evaluated under frameworks originally designed with the sciences in mind. It recognizes the value and attributes of these forms of scholarship. It eliminates any ambiguity about review, regulation and enforcement, and thus removes an enormous and contentious burden for both scholars and IRBs.

Don’t change a thing!

Does PRIM&R Welcome History Exclusion?

In its response to the 2011 ANPRM, PRIM&R denied that an exclusion for “certain fields of study” was “even worth considering.”

Now, in comments on the NPRM, PRIM&R Executive Director Elisa Hurley writes, “some of the exclusions proposed in the NPRM will likely be widely welcomed, such as the explicit exclusion of journalism, oral history, biography, and historical scholarship activities.”

As Ellen Bresler Rockmore reminds us, passive constructions (“will … be widely welcomed”) can disguise meaning, and that is the case here; is Hurley among those who will welcome the change?

I hope so. But in any case, PRIM&R seems to be finally acknowledging the grievances of historians and journalists and the need for reform.

NPRM: Freedom for Historians, If They Can Keep It

The notice of proposed rulemaking (NPRM) promises long-sought relief for historians, journalists, and biographers. For these groups, the goal will be to ensure that the proposed rules are enacted as currently written.

[This post has been cross-posted to the Petrie-Flom Center's Bill of Health, which is conducting an online NPRM Symposium.]

11 September 2015: See update at the bottom of this post.

NPRM Proposes Freedom for Historians!

The long awaited Notice of Proposed Rulemaking: Federal Policy for the Protection of Human Subjects, released today, suggests the complete deregulation of “oral history, journalism, biography, and historical scholarship activities that focus directly on the specific individuals about whom the information is collected.”

In the coming 90-day comment period, historians will need to insist that this remains an unqualified exclusion. Still, despite this last peril, we have much to celebrate.

"Great joy in camp we are in View of the Ocian, this great Pacific Octean which we been So long anxious to See."

McCarthy's Mysterious Mythmaking

PRIM&R has launched "People & Perspectives (P&P)," described as a "digital story-telling library." The site features a blurb by Joan Rachlin, PRIM&R's soon-to-retire executive director, who calls it "an enduring and dynamic record of our historical antecedents, how and when we come together."

But is anyone going to vet the accuracy of stories posted on the site?

That question is raised by a 4-minute clip (taken from a much longer November 2013 interview) with Charlie McCarthy, director of the Office for Protection from Research Risks from 1978 to 1992.

I have not watched the full interview (not transcribed, and therefore a chore). But the four minutes and 12 seconds on "social-behavior research" is by itself a disturbing stew of faulty memory and misinformation.



Here are some of the key inaccuracies.

NRC Report: Liberate Oral History

For historians, the most exciting passage in the new National Research Council report—the passage that had me cheering out loud—is the recommendation that the Common Rule be amended to explicitly exclude historical interviews, as well as other forms of information gathering that do not constitute “human-subjects research specifically in the biomedical, behavioral, and social sciences.”

A Credible Social Assurance

I am reading Alex John London's claims that IRBs help to "provide a 'credible social assurance' to the American people that social institutions, funded by their tax dollars and empowered to advance their health and well-being, work to: respect and affirm the moral equality of all community members; prevent the arbitrary exercise of social authority; and help create a 'market' in which the diverse stakeholders, often working to advance diverse ends, collaborate in a way that advances the common good."

I am reading Carl Elliott's accounts of the difficulties he has faced trying to use the IRB system at a public university to achieve any accountability for the burying of a drug study after it did not deliver the results a drug company wanted.

And I am re-reading Allan Brandt's Cigarette Century, which explains how tobacco companies reacted to early findings that cigarette smoking causes lung cancer. They promoted the use of filter tips, which didn't trap carcinogens but did turn brown as the cigarette burned. In 1966, Philip Morris executives noted that "the illusion of filtration is as important as the fact of filtration."

George Mason University Adopts Shelton Definition, Solicits Faculty Advice

My own institution, George Mason University, has adopted two significant IRB reforms: clarifying the regulatory definition of research, and establishing a faculty advisory board to help shape IRB policies.

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.'"

Public Health Scholars Question Bioethics Framework

Amy L. Fairchild and David Merritt Johns, both with the Center for the History and Ethics of Public Health, Department of Sociomedical Sciences, Mailman School of Public Health, Columbia University, find that bioethics is "the wrong framework of accountability for some domains of inquiry."

[Amy L. Fairchild and David Merritt Johns. “Beyond Bioethics: Reckoning With the Public Health Paradigm,” American Journal of Public Health 102, no. 8 (August 2012): 1447–1450, DOI: 10.2105/AJPH.2012.300661.]

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?

Berkeley Historian Defends IRB Review of Oral History

Martin Meeker, a historian with the Regional Oral History Office (ROHO) at the University of California, Berkeley, argues that "Historians of the recent past, many of whom use interviews as a source, need to be more systematic about doing oral histories as a form of research [and] that cooperation with IRBs offers one way to do that." What he really means, I think, is that cooperation with IRBs may help historians get legal help from their universities.

[Martin Meeker, "The Berkeley Compromise: Oral History, Human Subjects, and the Meaning of 'Research,'" in Doing Recent History: On Privacy, Copyright, Video Games, Institutional Review Boards, Activist Scholarship, and History That Talks Back, edited by Claire Bond Potter and Renee C. Romano (Athens: University of Georgia Press, 2012).]

Beauchamp and Saghai on the Mystery of Generalizable Knowledge

Philosophers Tom L. Beauchamp and Yashar Saghai find that although never defined, "the criterion of generalizable knowledge . . . is the foundation stone of the [National] Commission's conceptual and moral scheme in Belmont and beyond.

[Tom Beauchamp and Yashar Saghai. "The Historical Foundations of the Research-Practice Distinction in Bioethics," Theoretical Medicine and Bioethics 33, no. 1 (2012): 45–56. DOI 10.1007/s11017-011-9207-8. h/t Nathan Emmerich.]

Reverby Reviews Ethical Imperialism

Writing in the April American Historical Review, Susan Reverby very kindly reviews Ethical Imperialism:

Schrag is not alone in his critiques of the IRB process, but this is the first historical account of the problems IRBs pose to the social sciences. Officials in the federal government are currently considering revisions to the decades‐old Common Rule; Schrag's work has already begun to have an impact on their thinking, as evidenced by footnotes to his scholarship in their most recent report. This book ought to be required reading for those concerned about the political forces that make our work possible, and sometimes not possible at all.

[Susan M. Reverby, Review of Zachary M. Schrag, Ethical Imperialism: Institutional Review Boards and the Social Sciences, 1965–2009, American Historical Review 117, No. 2 (April 2012), pp. 484-485, DOI: 10.1086/ahr.117.2.484a, http://www.jstor.org/stable/10.1086/ahr.117.2.484a.]

Hospital Blocks Access to 18th Century Records

Pennsylvania Hospital has refused a graduate student's request to see 18th century medical records, citing HIPAA concerns.

[Melissa Dribben, Health-record privacy impeding medical research," Philadelphia Inquirer, 13 March 2012. h/t Michelle Meyer.]