CU-Boulder Retracts IRB Claim

The Chronicle of Higher Education reports that Mark Miller, the University of Colorado at Boulder spokesman who had earlier suggested that professors should consult the IRB before teaching controversial subjects, has retracted that suggestion.

[Peter Schmidt, “U. of Colorado’s Response to a Gritty Lecture Worries Sociologists,” Chronicle of Higher Education, December 17, 2013. http://chronicle.com/article/U-of-Colorados-Response-to-a/143653/. (gated)]

CU-Boulder Tells Faculty to Consult IRB Before Teaching

A spokesman for the University of Colorado at Boulder has recommended that university faculty consult the IRB before teaching.

The comment concerns sociology professor Patti Adler's announcement that she plans to retire early rather than risk being fired for classroom teaching that might make students uncomfortable.

[Scott Jaschik, “Tenured Professor at Boulder Says She Is Being Forced out over Lecture on Prostitution," Inside Higher Ed, December 16, 2013. http://www.insidehighered.com/news/2013/12/16/tenured-professor-boulder-says-she-being-forced-out-over-lecture-prostitution.]

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."

Interview by Washington Monthly - Ten Miles Square

Rachel Cohen interviewed me for Ten Miles Square, a Washington Monthly blog.

I guess in this case the ten miles square still includes Arlington.

Cohen, Rachel. “What Are Institutional Review Boards and Why Should We Care? An Interview with Zach Schrag.” The Washington Monthly - Ten Miles Square, November 1, 2013. http://www.washingtonmonthly.com/ten-miles-square/2013/11/what_are_institutional_review047608.php?

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.]

UNC Stops Pretending that IRBs Understand Data Encryption

The Chronicle of Higher Education reports that the University of North Carolina at Chapel Hill and Harvard are asking their IT departments, rather than their IRBs, to design data security protocols for human subjects researchers.

[Voosen, Paul. “Researchers Struggle to Secure Data in an Insecure Age.” Chronicle of Higher Education, September 13, 2013. http://chronicle.com/article/Researchers-Struggle-to-Secure/141591/. (gated)]

Hamburger: IRBs are Worse than McCarthyism

In a brief article in Commentary, Philip Hamburger summarizes his case against IRBs, made in much greater detail in his 2004 article, “The New Censorship: Institutional Review Boards," Supreme Court Review (2004): 271–354. In this version, he argues that the regulation of human subjects research "is the most widespread and systematic assault on freedom of speech and the press in the nation's history. McCarthyism was more overtly political, but IRB licensing is more pervasive and methodical, and its consequences are far more lethal."

[Hamburger, Philip, "The Censorship You’ve Never Heard Of.” Commentary, July 2013, 21-26]

UNM, NYU: Miller's Fatshaming Tweet Wasn't Research

Two IRBs have concluded that Geoffrey Miller's June tweet about "obese PhD applicants" was not human subjects research.

A UNM statement explains,

Miller at first claimed his tweet was part of a research project, but investigations by the Institutional Review Board at New York University where he was a visiting professor, and the IRB at UNM where he is a tenured professor, concluded that was not correct.

The statement also lists the terms of a censure by the university.

For background, see Trolling Isn't Human Subjects Research and Michelle Meyer: Miller Interacted, Intervened

Ignorance Is Strength: Lecture Video Online

I just noticed that Brigham Young University has posted a video of my February 2013 lecture, "Ignorance Is Strength: Pseudo-Expertise and the Regulation of Human Subjects Research." Many thanks to my hosts there and the producers of the video.

Two More Biomedical Members for SACHRP

From the OHRP List:

The Office for Human Research Protections (OHRP) would like to announce two new members who have been invited to join the Secretary's Advisory Committee on Human Research Protections (SACHRP). The invited members are:

• James R. Anderson, Ph.D., Professor of Biostatistics and the Associate Dean for Research at the University of Nebraska Medical Center College of Public Health; and

• Stephen J. Rosenfeld. M.D., M.B.A., Chairperson of Quorum Review IRB

OHRP would like to thank all applicants, and notes that the next SACHRP member solicitation will be published in the Federal Register in approximately six months.

Oh, I've Heard of It

Placeholder for

Hamburger, Philip. “The Censorship You’ve Never Heard Of.” Commentary, July 2013.

h/t Chris Shea.

Michelle Meyer: Miller Interacted, Intervened

Michelle Meyer had more to say about my comments on Geoffrey Miller's fatshaming troll-tweet than would fit in Blogger's comment box. I post her comments here, along with some responses.

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]

Trolling Isn't Human Subjects Research

The Chronicle of Higher Education reports that IRBs at both NYU and the University of New Mexico are investigating the conduct of Professor Geoffrey Miller, now notorious for a June 2 tweet warning "obese PhD applicants" that "if you didn't have the willpower to stop eating carbs, you won't have the willpower to do a dissertation."

According to the Chronicle, Miller "explained his action to university officials in New Mexico by saying he had sent the Twitter message as part of a research project." (In proper troll-speak, one says "social experiment.") But Miller also maintains that "IRB approval was not necessary under his own understanding of federal law."

[Basken, Paul. “In Reversal, NYU Investigates Professor Who Tweeted on Obese Ph.D. Students.” The Chronicle of Higher Education, June 11, 2013.]

SACHRP: Exempt Research May "Be Subject to IRB Review"

As reported by Erica Check Hayden in Nature, at its March meeting, SACHRP endorsed "Considerations and Recommendations Concerning Internet Research and Human Subjects Research Regulations, with Revisions," prepared by Elizabeth Buchanan and Dean Gallant. The guidance offers some common sense, but it struggles with the legacy of the poorly drafted Common Rule. And it threatens to make matters worse by suggesting that some exempt research may "be subject to IRB review."

First Circuit Denies UK Access to Most Boston College Tapes

The US Court of Appeals for the First Circuit has ruled that Boston College need hand over only 11 of the 85 oral history interviews sought by United Kingdom investigators. The Boston Globe, Chronicle of Higher Education, and Inside Higher Ed see this as mostly a win for Boston College.

[Andersen, Travis. “Major Victory for BC in Court Battle over Belfast Project.” Boston Globe, June 1, 2013.]

More complete coverage can be found at Boston College Subpoena News.

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).]

What Good Are Statements of Committee Approval?

Sara Jordan and Phillip Gray argue that public administration journals should follow medical journals' requirements "that all articles describe informed consent and ethics committee approval or why these were waived."

[Sara R. Jordan and Phillip W. Gray. “Reporting Ethics Committee Approval in Public Administration Research.” Science and Engineering Ethics (April 2013): 1–21. Accessed May 6, 2013. doi:10.1007/s11948-013-9436-5.]

Mortifyingly Stupid CITI Training Kills Oral History Course

Writing on H-Oral, Carl Kramer, the retired director of the Institute for Local and Oral History, Indiana University Southeast, reports that Indiana University's requirement of the mortifyingly stupid CITI Program dissuaded him from requiring oral history students to conduct actual interviews:

The issue is whether the training is relevant to oral history. Last year, I planned to have the students in my Oral History course at Indiana University Southeast interview baby boomers who grew up in a nearby former company town. The local library had conducted a similar project of the previous generation about 25 years earlier, and I thought it would be a great follow up. But meanwhile, Indiana University had adopted a national training program for human subjects research that was oriented toward biomedical and psychological standards, including units on dealing with pregnant women and fetuses, HIPPA, medically-oriented conflict of interest issues. It took me approximately seven hours to review the tutorial and take the exam. As an instructor who has conducted hundreds of interviews for many years, I concluded that if it took me that long to take an exam whose content was largely irrelevant to oral history, then I could not reasonably require my students to take it. So I ended up giving them the option of doing an interview or taking a final exam. The split was about 50-50, with the majority opting for the final exam. This was for an expedited review project through the IRB. I retired from the institute under which I taught the course, and I would never again teach a course that required such an irrelevant exam.

His comment comes in reply to a posting by a Kent State graduate student who may lose grant funding because she relied on OHRP's 2003 letter stating that "oral history interviewing activities, in general, are not designed to contribute to generalizable knowledge and, therefore, do not involve research as defined by Department of Health and Human Services (HHS) regulations at 45 CFR 46.102(d) and do not need to be reviewed by an institutional review board (IRB)."

What Can One University Do?

A few weeks ago, a correspondent asked me what reforms individual universities can implement while awaiting systemic, regulatory reform. It's an excellent question, so here's a roundup from material previously covered on the blog.

No university has adopted all of these measures, and at least one of these measures has not been adopted by any. But most of them are in place already, and there's no reason they can't spread.

Boston College Oral History Roundup

I rely on the exceptionally thorough Boston College Subpoena News for updates on the efforts of the United Kingdom and United States governments to get access to oral history interviews of participants in Northern Ireland's Troubles, but I feel I should flag three items of special interest to readers of this blog.

Federal Demonstration Parternship Pilots Exempt Wizard

In response to concern about "Over-review of Exempt Research", the Federal Demonstration Partnership is testing an Exempt Wizard, which would allow researchers to fill in a computer form and learn if their projects are exempt, rather than waiting for an IRB or IRB staff to make that determination.

Boston University, University of Michigan, Michigan State University, College of Charleston, Sacramento State, New York University, and the University of Washington are participating in the trial.

This sounds most promising.

REB Members Beg U of Ottawa to Defend Confidentiality

IRB apologists sometimes argue that IRB review is necessary to ensure that universities will defend researchers and their participants from litigation. Boston College Subpoena News reminds us that ethics approval is no guarantee of such support.

[“News of Interest: Canadian Academics Strongly Defend Research Confidentiality, Call for University Support of Researchers.” Boston College Subpoena News, April 9, 2013. http://bostoncollegesubpoena.wordpress.com/2013/04/09/news-of-interest-canadian-academics-strongly-defend-research-confidentiality-call-for-university-support-of-researchers/.]

Rivera: Faculty Researchers Are Notoriously Poor Judges of Risks

Suzanne Rivera, Associate Vice President for Research at Case Western Reserve University and member of the Secretary's Advisory Committee on Human Research Protections, responds to the AAUP's IRB report by asserting that faculty are inept at making determinations of exemption. I question this claim.

[Rivera, Suzanne A. “Academic Freedom and Responsibility |.” Bill of Health. Accessed March 28, 2013. http://blogs.law.harvard.edu/billofhealth/2013/03/24/academic-freedom-and-responsibility/. h/t Michelle Meyer]

Report from the National Academies Workshop

Last week I attended the Revisions to the “Common Rule” in Relation to Behavioral and Social Sciences Workshop sponsored by the National Academies.

I live-tweeted the event on my @IRBblog account, and I have collected those tweets on Storify.

What follows are what I consider some of the key messages from selected presenters. The statements following each name represent my summary of the remarks, not necessarily a quotation or paraphrase.

National Academies Post Workshop Agenda

The National Academies has posted the agenda for their Workshop on Proposed Revisions to the Common Rule in Relation to Behavioral and Social Sciences, to be held tomorrow and Friday in Washington, D.C.

I plan to attend and to post comments to this blog. If I can establish WiFi, I may also live tweet at @IRBblog.

On Signing the Markingson Petition

By April 1942, the Pentagon was 40 percent over budget, partly because it had been enlarged since first approved, but mostly because the original estimate of $35 million had never been realistic. Lieutenant General Brehon Somervell delayed telling Congress, but in June he finally sent Colonel Leslie Groves to appear before a House Apppropriations subcommittee.

Tolich and Tumilty Explain TEAR

Martin Tolich and Emma Tumilty explain the origins and aims of The Ethics Application Repository (TEAR)

[Tolich, Martin, and Emma Tumilty. “Making Ethics Review a Learning Institution: The Ethics Application Repository Proof of Concept. Tear.otago.ac.nz.” Qualitative Research (January 3, 2013). doi:10.1177/1468794112468476.]

National Academies Run Workshops on Common Rule Revisions

The National Academies are running workshops on "Revisions to the Common Rule for the Protection of Human Subjects in Research in the Behavioral and Social Sciences." I was unaware of the first two meetings in January, but I hope to attend the upcoming meetings on March 21 and 22.

ANPRM Is Mostly Dead

The Chronicle of Higher Education reports that the regulatory reform process that began with the 2011 ANPRM "appears to be stuck, with little optimism for a way forward."

[Basken, Paul. “Federal Overhaul of Rules for Human Research Hits Impasse.” Chronicle of Higher Education, March 7, 2013, sec. Government. http://chronicle.com/article/Overhaul-of-Rules-for-Human/137811/ (paywall)]

Inside Higher Ed Reports on AAUP Recommendations

Inside Higher Ed presents the key points of the newly finalized AAUP report.

[Carl Straumsheim, “AAUP Recommends More Researcher Autonomy in IRB Reform," Inside Higher Ed, March 6, 2013. http://www.insidehighered.com/news/2013/03/06/aaup-recommends-more-researcher-autonomy-irb-reform.
]

AAUP Publishes Final Report, Regulation of Research on Human Subjects: Academic Freedom and the Institutional Review Board

The American Association of University Professors has published the final version of Regulation of Research on Human Subjects: Academic Freedom and the Institutional Review Board, prepared by a subcommittee (of which I am a member) of the Association’s Committee A on Academic Freedom and Tenure.

The report explains,

As things now stand, the IRB system assembles local committees whose members have no special competence in assessing research projects in the wide range of disciplines they are called on to assess, whose approval is required for an only minimally restricted range of research projects and who are invited to bring to bear in assessing them an only minimally restricted body of what they take to be information, who are only minimally restricted in the demands they may make on the researchers, and whose judgments about whether to permit the research to be carried out at all are, in most institutions, final. When one steps back from it, one can find oneself amazed that such an institution has developed on university campuses across the country.

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."

Journal Retracts Interview-Based Article for Lack of IRB Approval

Retraction Watch reports that Social Science & Medicine has retracted an article based on interviews with Costa Rican healthcare providers, apparently because it did not receive the IRB approval it claimed.

[“Social Sciences Paper Retracted for Lack of Ethical Approval.” Retraction Watch, February 25, 2013. http://retractionwatch.wordpress.com/2013/02/25/social-sciences-paper-retracted-for-lack-of-ethical-approval/; Goldade, Kate, and Kolawole S. Okuyemi. “RETRACTED: Deservingness to State Health Services for South–South Migrants: A Preliminary Study of Costa Rican Providers’ Views.” Social Science & Medicine 74, no. 6 (March 2012): 882–886. doi:10.1016/j.socscimed.2011.06.045.]

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.

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.

New Brunswick Declaration Seeks Respect for Researchers and Participants

Back in October, I participated in the Ethics Rupture summit, hosted by the University of New Brunswick and St. Thomas University of Fredericton, New Brunswick.

One product of that conference is the New Brunswick Declaration: A Declaration on Research Ethics, Integrity and Governance. It's only a page long and therefore hardly bears summarizing, but I would note its desire to "encourage regulators and administrators to nurture a regulatory culture that grants researchers the same level of respect that researchers should offer research participants." That shouldn't be a radical demand, but it is.

Dingwall Links Ethics Review to University "Command and Control"

Robert Dingwall argues that ethics regulation is just one part of a corporate model that threatens innovative research in universities.

[Dingwall, Robert. “How Did We Ever Get into This Mess? The Rise of Ethical Regulation in the Social Sciences.” Studies in Qualitative Methodology 12 (2012): 3–26. doi:10.1108/S1042-3192(2012)0000012004.]

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.]

Puglisi: ANPRM Is Stalled; Write Your Own Common Rule

Tom Puglisi, director of the Office of Research Oversight in the Department of Veterans Affairs and former director of human subject protections at OHRP, writes that the Common Rule needs reform but believes that the ANRPM is "stalled." He offers the Veterans Health Administration's interpretation of the Common Rule as a partial fix, but he does not address the implications of letting agencies rewrite the Common Rule for their specific needs.

[Puglisi, Tom. “Reform Within the Common Rule?” Hastings Center Report 43, no. s1 (2013): S40–S42. doi:10.1002/hast.140.]

Faden et al. Question Research-Treatment Distinction

Writing in a special report of the Hastings Center Report, a team of prominent ethicists and researchers "argue that conceptual, moral, and empirical problems surround the received view that we can and should draw sharp distinctions between clinical research and clinical practice." Yet they decline to detail the implications of any regulatory change for IRB review of medical research, much less research in the social sciences and humanities.

[Kass, Nancy E., Ruth R. Faden, Steven N. Goodman, Peter Pronovost, Sean Tunis, and Tom L. Beauchamp. "The Research-Treatment Distinction: A Problematic Approach for Determining Which Activities Should Have Ethical Oversight." Hastings Center Report 43, no. s1 (2013): S4–S15. doi:10.1002/hast.133. h/t Yashar Saghai]

British Government Denies Conducting Research

I have reported in the past on the ability of U.S. federal officials to avoid IRB review of their work by asserting that they are not conducting research, even as university scholars doing the same kind of work face sanctions if they proceed without IRB approval.

It turns out that British officials take similar positions:

Having considered these guidance notes, their definitions of social research and the report in question, I can confirm that I do not consider ‘Listening to Troubled Families’ as being within the definition of Government social research and thus the scope of the guidance. My rationale for this is that this report falls more properly within the description ‘dipstick/informal information gathering’.

(Reply from Jane Todorovic, Head of Profession for the Government Social Research (GSR) service at DCLG, 3 October 2012)

[“Policy Based on Unethical Research.” Poverty and Social Exclusion. Accessed January 25, 2013. http://www.poverty.ac.uk/news-and-views/articles/policy-built-unethical-research. h/t Robert Dingwall]

Armchairs vs. Evidence in the Journal of Law, Medicine & Ethics

Last week I promised some comments on the Winter 2012 issue of the Journal of Law, Medicine & Ethics, which features a symposium entitled "Research Ethics: Reexamining Key Concerns."

The contributions reinforced my sense that the IRB debate is in part a contest between evidence-based approaches and armchair ethics.

New Comment Policy

As I try to reduce the time I spend maintaining this blog, I will no longer publish comments that do not include the author's first and last names, and institutional affiliation as appropriate. I find that commenters who identify themselves post more helpful responses.

Bell and Salmon Warn of Dangerous Assumptions

Kirsten Bell and Amy Salmon, both of the University of British Columbia, warn that in trying to protect people they consider vulnerable, ethics committees ignore empirical evidence that some measures are counterproductive.

[Bell, Kirsten, and Amy Salmon. “Good Intentions and Dangerous Assumptions: Research Ethics Committees and Illicit Drug Use Research.” Research Ethics 8, no. 4 (December 2012): 191–199. doi:10.1177/1747016112461731.]

Journal of Law, Medicine & Ethics Symposium Reexamines Research Ethics

The Winter 2012 issue of the Journal of Law, Medicine & Ethics features presented at a November 2011 Wake Forest University Center for Bioethics, Health, and Society presented a conference entitled "Research Ethics: Reexamining Key Concerns."

Should We Expect an NPRM in April?

The Report on Research Compliance notes that the December 21 Current Regulatory Plan and the Unified Agenda of Regulatory and Deregulatory Actions projects a Notice of Proposed Rulemaking (NPRM) in April 2013 as the next step in a revised Common Rule.

RRC also cautions that "federal agencies are notorious for missing specified dates," so I won't hold my breath.