First, Do Some Harm, Part IV: Fake Submission to Fake Conference Yields Fake Charge of Misconduct

Professor Jim Vander Putten, who spent six years as chair of the University of Arkansas Little Rock (UALR) IRB, is now charged with violating university rules by conducting research without that board’s approval. The case highlights several problems with the current system, most notably its failure to provide standards for studies designed to expose misbehavior.

[Peter Schmidt, “A Scholar’s Sting of Education Conferences Stirs a Hornet’s Nest,” Chronicle of Higher Education, March 14, 2016, paywalled.]

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.

Robert Levine: We Should Have Done a Careful Study of Social and Behavioral Research

The June issue of the Journal of Clinical Research Best Practices features an interview with Robert Levine about his service as consultant to the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. Levine concedes that the commission did not sufficiently explore "sociology, anthropology, education and other vast areas of research."

[Mark Barnes, "Bob Levine on the Making of the Belmont Report," Journal of Clinical Research Best Practices 9, no. 6 (June 2013). h/t Michelle Meyer]

OHRP's New Website

On January 3, the Office for Human Research Protections launched its redesigned website.

Of particular note to those interested in the history of IRBs is the new section on Related Resources, which contains more key documents than the previous website did, including all the reports (with appendices) produced by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research.

I am sorry to see that the website features none of the four items I requested when OHRP asked for comments in January 2009.

Moreover, the "Human Subjects Protection Federal Register Notices 1973 - 2007" on the Related Resources page overlooks Department of Health, Education, and Welfare, "Secretary's Interpretation of 'Subject at Risk,'" Federal Register 41 (28 June 1976): 26572, despite my drawing that omission to OHRP's attention in a follow-up e-mail to my comments.

The 1976 notice includes the curious claim that "The types of risk situations against which the regulations were designed to protect are suggested by the areas of concern which were addressed in the legislative hearings held in conjunction with the enactment of section 474 of the Public Health Service Act, 42 USC 2891-3 (added by Pub. L. 93-348) . . ."

As I note in my book, neither before or after this notice did federal regulators restrict their rule-making to areas of concern addressed in congressional hearings.

A Horror Anthology

Mark Kleiman takes on IRBs at The Reality-Based Community. On April 14 he asked his readers for IRB horror stories, and on May 2 he posted some of the responses.

The saddest concerns a group of law students who wished "to send testers of different races in different styles of clothing to the restaurant over some period of time to test whether they enforced their dress code in a discriminatory manner." Law school administrators told them they would have to secure IRB approval. This discouraged the students, who did not want to go through the time and effort of the approval process.

This was not the intent of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. At its 15 April 1978 meeting, the commission discussed just such a scenario (pp. II-5 to II-21 of the transcript), and all the members seemed to agree that such testing for discrimination should not require IRB review. But, as I've noted before, the commission wrote a definition of human subjects research that plausibly includes a great deal of activity the commission did not seek to regulate. Thirty years later, justice suffers as a result of the commission's sloppiness.

NOTE: In honor of Professor Kleiman's search, I have gone back through this blog to add the "horror stories" tag to some posts that should have had it to begin with. Clicking on that tag now yields more than a dozen posts, with even more documented horror stories.

Must Employees Consent?

Two recent items concerning IRBs and studies of job performance caught my eye.

The more prominent item was a December 30, 2007, New York Times op-ed, "A Lifesaving Checklist" by Dr. Atul Gawande. Gawande describes efforts by the Johns Hopkins University and the Michigan Health and Hospital Association to offer five-step checklists to intensive-care providers, to help them remember to wash their hands and take other steps to avoid infection. OHRP shut the project down, even though it had been ruled exempt by the Hopkins IRB. (So much for local control.)

Although I try to keep this blog focused on issues concerning the humanities and social sciences, and to avoid issues concerning strictly medical research, I was struck by OHRP's determination that "the subjects of the research were both the healthcare providers at the participating ICUs and their patients." Are healthcare providers really human subjects in a case like this?

A similar question arose in a non-medical setting a few weeks later. In her pseudonymous blog on Education Week, eduwonkette complained that New York City teachers were being studied without their consent and without the approval of an IRB. Since eduwonkette herself concedes that "teachers did not need to consent in this case, as they are government employees and their employers can collect whatever data they want," I don't understand why she thought an IRB should be involved. But it does suggest that the question of studying employee effectiveness is not limited to medical contexts.

Poking around in my research notes, I find that at the July 1977 meeting of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, Dr. Karen Lebacqz raised just this issue as a hypothetical:

"Suppose you want to do a study that involves changing the delivery of services in a mental institution ward. The patients in the institution are the ones that you want to study in terms of what the impact is on their recovery rates and so on. The staff who work on that ward will also be very directly impacted by the research. Do they constitute subjects, even though the design and the purpose of the research is not set up to study the impact on them of what you are going to do?"

While Albert Jonsen initially suggested that the staff would constitute subjects, other commissioners disagreed:

Lebacqz. “There is a very direct impact on the licensed staff.

Ryan. “Then the administrator can force it on them as a condition of employment.

Turtle. “Yes, I was going to say, that is the whole key, it is a condition of employment. Many things that, while I am a great libertarian here, lots of things I ask the people who work for me to do, I don’t ask them for their informed consent.”

[National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, Transcript, Meeting #32, July 1977 (Bethesda: The Commission, 1977), 133-135.]

After this exchange, the commission moved onto another subject, suggesting a consensus that employees are not human subjects whose informed consent is required. In its recent determination letters on the checklist project, OHRP has ruled the opposite.

I don't expect the compliance officers at OHRP to be familiar with the commission's deliberations, and I fault the commission for not defining human subjects more carefully. But it's worth noting how far OHRP has strayed from the commission whose work nominally informs its decisions.