Wednesday, December 31, 2014

Horror Story Buffet

We end the year with two collections of IRB horror stories.

[Varma, R. “Questioning Professional Autonomy in Qualitative Inquiry.” IEEE Technology and Society Magazine 33, no. 4 (winter 2014): 57–64. doi:10.1109/MTS.2014.2363983; Glenda Droogsma Musoba, Stacy A. Jacob, and Leslie J. Robinson, The Institutional Review Board (IRB) and Faculty: Does the IRB Challenge Faculty Professionalism in the Social Sciences? Qualitative Report 19 (2014), Article 101, 1-14, http://www.nova.edu/ssss/QR/QR19/musoba101.pdf]

Nursing Professors Want IRB Oversight of Interviews with Bereaved

Two professors of nursing warn that "Psychological harm is indeed a risk when interviewing individuals who may be in a fragile state and researchers should not have unfettered access to them." But they offer no evidence that IRBs offer appropriate protection without restricting legitimate research that may directly benefit the people being interviewed.

[Florczak, Kristine L., and Nancy M. Lockie. “IRB Reformation Is Unfettered Access the Answer?” Nursing Science Quarterly 28, no. 1 (January 2015): 13–17. doi:10.1177/0894318414558621.]

Florczak and Lockie rely on the story of "Katie," as in this passage:

Katie knew from conducting numerous interviews that they were not innocuous. Her participants frequently broke down and expressed myriad emotions from anger to fear but most often a profound overwhelming sadness. Dyregrov and colleagues (2011) added credence to Katie’s assumption that interviews are other than insipid conversations. They said that bereavement interviews can unearth painful memories resulting in the participants becoming emotionally exhausted and distressed.

It is not clear from the essay if "Katie" is a pseudonym, a composite, or an entirely fictional creation.

Florczak and Lockie do cite Kari Madeleine Dyregrov, Gudrun Dieserud, Heidi Marie Hjelmeland, Melanie Straiton, Mette Lyberg Rasmussen, Birthe Loa Knizek, and Antoon Adrian Leenaars. “Meaning-Making Through Psychological Autopsy Interviews: The Value of Participating in Qualitative Research for Those Bereaved by Suicide,” Death Studies 35, no. 8 (September 2011): 685–710. doi:10.1080/07481187.2011.553310. And that study did indeed report that "Some bereaved cried or were upset when talking about their loss."

But Florczak and Lockie do not report Dyregrov et al.'s equally important findings that "very few people felt distressed when discussing the suicide and almost all of the participants felt no different or better than usual at the 4-week follow-up" and that "The majority of informants (62%) responded with unambiguous, highly positive statements that were numerous, varied, and spontaneous." This led Dyregrov et al. to warn that "Too often ethical boards delay or stop research projects with vulnerable populations, influenced by presumed rather than empirically documented vulnerability."

Dyregrov et al. attribute the positive results to "the value of talking about the circumstances with a professional who has insight into the reasons and processes around suicides." This suggests that a credentialling system, rather than review of individual protocols, might better serve research participants.

Saturday, December 27, 2014

Canada Embraces Ethical Pluralism

The Canadian Institutes of Health Research, the Natural Sciences and Engineering Research Council of Canada, and the Social Sciences and Humanities Research Council of Canada have released a new version of TCPS2. Though it is not a dramatic change from the 2010 edition, it serves a reinder of how much more nimble the Canadian system is compared to the rigid U.S. regulations.

I was particularly interested in the new acknowledgement that Research Ethics Boards (REBs) do not possess a monopoly on ethical judgment:

"Activities outside the scope of research subject to REB review (see Articles 2.5 and 2.6), as defined in this Policy, may still raise ethical issues that would benefit from careful consideration by an individual or a body capable of providing some independent guidance, other than an REB. These ethics resources may be based in professional or disciplinary associations, particularly where those associations have established best practices guidelines for such activities in their discipline."

Back in 2012, I traveled to Canada to argue that "Scholarly associations know more about the ethics of particular forms of research than do national regulatory bodies," and should be more involved in articulating ethical standards and practices. Coincidence?

Friday, December 26, 2014

National Science Foundation Charged with "Non-Biomedical Science Perspective"

Rereading the e-mails mysteriously "obtained" by Public Citizen, I noticed that the White House has asked the National Science Foundation “to ensure that the ‘non-biomedical perspective is covered" in the forthcoming Notice of Proposed Rulemaking (NPRM), revising the Common Rule. Moreover, NSF "will identify places in the current regulatory text and preamble where edits are necessary to make the NPRM consistent with the January 2014 National Academy of Sciences' report that evaluated the applicability of the ideas presented in the 2011 ANPRM to the social and behavioral sciences."

[Margo Schwab to Andrea Palm, “Annotated draft reg text for Common Rule,” 29 October 2014, reproduced in Michael Carome, “Letter to Secretary Burwell Re: Common Rule NPRM,” November 20, 2014.]

This strikes me as hopeful news. The January 2014 report, though lacking in some respects, makes some sound recommendations for reform. And the NSF, which played only a minor part in writing the 1981 and 1991 regulations, is given a greater role in this round. As the sponsor of a great deal of social science research, NSF is indeed better positioned to take on this role than HHS or any other Common Rule agency.

Friday, December 12, 2014

Blog Day

Eight years of the Institutional Review Blog.

As Inside Higher Ed reported at the time

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.”

Can't be soon enough.

Tuesday, November 25, 2014

Was OHRP Ever an Independent Watchdog?

Public Citizen is upset that NIH will get to write much of the NPRM. I don't understand why that matters.

Internal E-Mails Suggest NPRM is Coming

According to an open letter to HHS secretary Sylvia Mathews Burwell, Public Citizen obtained "very recent internal emails" among officials at the Office of Management and Budget and the Department of Health and Human Services, showing that the latter is actively working on a Notice of Proposed Rulemaking (NPRM) to revise the Common Rule.

I'll write separately about the substantive issue raised by Public Citizen. For now, the news is that as of November 13, 2014, senior officials were actively working to write an NPRM.

Well I, for one, am very interested to see what's going to happen next.

Friday, November 7, 2014

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.

Tuesday, November 4, 2014

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."

Thursday, October 30, 2014

University of Washington IRB Demanded Dangerous Consent Form

The recent Nature story on ethics consultancies includes an example of counterproductive interference by an intransigent IRB.

[Dolgin, Elie. “Human-Subjects Research: The Ethics Squad.” Nature 514, no. 7523 (October 21, 2014): 418–20. doi:10.1038/514418a.]

Wednesday, October 29, 2014

Ethics Consultancies—A Non-Coercive Alternative to IRBs?

For some time, I've thought that the real problem with IRBs may be the coercive power granted to them. This relieves them of the need to make arguments strong enough to persuade researchers, and in some cases leads them instead to make demands based weak or even wrongheaded thinking.

This week, Nature reports on an alternative (or supplementary) model, the ethics consultancy.

[Dolgin, Elie. “Human-Subjects Research: The Ethics Squad.” Nature 514, no. 7523 (October 21, 2014): 418–20. doi:10.1038/514418a.]

Sunday, September 28, 2014

Briefly Noted: Whitney, Bell, Elliott

Lacking time for full comment, I briefly note the publication of these two important, critical essays. Citations omitted from the quoted passages.

Wednesday, August 27, 2014

You Can't Ask That

The Washington Monthly's fall college issue features my essay on IRBs. Nothing that will surprise regular readers of this blog, but perhaps this will reach new readers.

[Schrag, Zachary M. “You Can’t Ask That.” Washington Monthly, September/October 2014.]

Monday, August 25, 2014

Bell: Ethnography Shouldn't Be Like Victorian Sex

Writing in American Anthropologist, Kirsten Bell argues that ethnography should not be seen as a violation to which an informant must consent, and "although the concept of informed consent has now been enshrined in the AAA Code of Ethics for more than 15 years, the reality is that it is not an appropriate standard with which to judge ethnographic fieldwork."

[Bell, Kirsten. "Resisting Commensurability: Against Informed Consent as an Anthropological Virtue." American Anthropologist, July 21, 2014, doi:10.1111/aman.12122.]

Monday, July 21, 2014

Most IRB Chairs Can't Recognize Exempt Research or Non-Research

A study of criminal justice researchers' knowledge of IRB rules has found that IRB chairs can't agree on what makes a project exempt from review and think that IRB review is needed for public records. The authors of the study, one of whom is an IRB chair, seem not to realize the significance of these findings.

[Tartaro, Christine, and Marissa P. Levy. "Criminal Justice Professionals' Knowledge of Institutional Review Boards (IRBs) and Compliance with IRB Protocol." Journal of Criminal Justice Education 25, no. 3 (2014): 321–41. doi:10.1080/10511253.2014.902982.]

Wednesday, July 16, 2014

UCSD Frees Oral History and Journalism

The University of California, San Diego, has determined that most projects by historians and journalists need not be submitted to the IRB.

Tuesday, July 15, 2014

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.

Friday, July 11, 2014

A Reply to Maxine Robertson

In an essay in Research Ethics, Maxine Robertson, Professor of Innovation and Organisation at Queen Mary University of London (QMUL), responds to my essay, "The case against ethics review in the social sciences," published in the same journal in 2011. I wish she had responded to more of the broader ethics-review critique and offered more details about ethics review at her own institution.

[Robertson, Maxine. “The Case for Ethics Review in the Social Sciences: Drawing from Practice at Queen Mary University of London.” Research Ethics 10, no. 2 (June 2014): 69–76. doi:10.1177/1747016113511177]

Microsoft Seeks Ethics Review Without Bottlenecks and Frustration

Duncan Watts of Microsoft Research announces Microsoft will soon launch "an ethics-review process for human-subject research designed explicitly for web-based research." Could such a process avoid the pitfalls of the IRB?

[Watts, Duncan J. “Lessons Learned From the Facebook Study.” Chronicle of Higher Education Blogs: The Conversation, July 9, 2014. h/t Rebecca Tushnet]

Wednesday, July 9, 2014

Those Noisy Voices from the Grave

This afternoon I had the pleasure of speaking on the Kojo Nnamdi Show about the Belfast Project (a.k.a. Boston College’s Oral History Archive on the Troubles in Northern Ireland) and its impact on oral history. I didn't have a lot of time, but I tried to make the case for a shield law, analogous to the protections provided to health research and DOJ-sponsored criminal justice research.

[“Old Wounds & Oral History: The Aftermath of the Belfast Project,” Kojo Nnamdi Show, July 7, 2014.]

Tuesday, July 8, 2014

Computer Scientist: Informed Consent is the Wrong Metaphor

Michael Bernstein, assistant professor of computer science at Stanford and a former postdoctoral scholar on Facebook’s Data Science team, argues that "Hammering ethical protocols designed for laboratory studies onto internet experimentation is fundamentally misguided."

[Bernstein, Michael. “The Destructive Silence of Social Computing Researchers.” Medium, July 7, 2014. https://medium.com/@msbernst/9155cdff659.]

Monday, June 30, 2014

A Bit of Historical Perspective on the Facebook Flap

IRBs and behavioral research are all over the news, as a result of a paper that manipulated the news feeds of 689,003 Facebook users.

[Kramer, Adam D. I., Jamie E. Guillory, and Jeffrey T. Hancock. “Experimental Evidence of Massive-Scale Emotional Contagion through Social Networks.” Proceedings of the National Academy of Sciences 111, no. 24 (June 17, 2014): 8788–90. doi:10.1073/pnas.1320040111.]

Michelle Meyer has posted a detailed analysis of the regulatory context, explaining multiple ways a project like this could have been approved. She concludes that "so long as we allow private entities freely to engage in these practices, we ought not unduly restrain academics trying to determine their effects."

[Meyer, Michelle N. “How an IRB Could Have Legitimately Approved the Facebook Experiment—and Why That May Be a Good Thing.” The Faculty Lounge, June 29, 2014. http://www.thefacultylounge.org/2014/06/how-an-irb-could-have-legitimately-approved-the-facebook-experimentand-why-that-may-be-a-good-thing.html.]

I have little to add to Meyer's excellent post, except a bit of historical perspective. Psychological experiments—whether in the lab, in the field, or online—fall outside my main area of concern, but perhaps I can offer a few relevant points.

Tuesday, June 17, 2014

TCPS Envy

How good is TCPS2, Canada's current framework of research regulation?

Martin Tolich, with co-authors, thinks it's pretty good. He suggests that at the very least, it can serve as a starting point for other countries interested in reforming their systems of research ethics oversight to make them more responsive to the concerns of social scientists and the people they study.

[Tolich, M, and BP Smith. “Evolving Ethics envy—New Zealand Sociologists Reading the Canadian Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans.” Kōtuitui: New Zealand Journal of Social Sciences Online 9, no. 1 (2014): 1–10. doi:10.1080/1177083X.2013.867513; Hoonaard, Will C. van den, and Martin Tolich. “The New Brunswick Declaration of Research Ethics: A Simple and Radical Perspective.” Canadian Journal of Sociology 39, no. 1 (March 31, 2014): 87 – 98]

Friday, May 2, 2014

Canada: When the Subpoena Comes, Universities Should Pay for Independent Legal Advice

In guidance issued in April 2014, the Secretariat on Responsible Conduct of Research finds that "In situations where safeguarding participant information may involve resisting an attempt by legal means to compel disclosure of confidential research information, TCPS 2 requires institutions to provide researchers with financial and other support to obtain independent legal advice or to ensure that such support is provided."

The announcement does not explicitly say so, but I imagine this is somehow a response to the University of Ottawa's earlier refusal to pay the legal costs of researchers who faced a subpoena. On the other hand, the new guidance addresses only "legal advice," not representation.

Wednesday, April 9, 2014

"The Freedoms We Are Committed to Protect"

The Hinckley Institute of Politics, University of Utah, has posted a videorecording of my lecture there last month.

"'The Freedoms We Are Committed to Protect': Political Science, Academic Freedom, and Institutional Review Boards in Historical Perspective.” Keynote address, Symposium on Field Research and US Institutional Review Board Policy, University of Utah, March 2014. http://youtu.be/uwIFyDgLklU

Tuesday, April 8, 2014

IRB Still Isn't Peer Review

A bit off-topic here (this is a health-related study), but here's an illustration of the benefits of IRB shopping.

[Cordner, Alissa, and Phil Brown. “Moments of Uncertainty: Ethical Considerations and Emerging Contaminants.” Sociological Forum 28, no. 3 (September 2013): 469–94. doi:10.1111/socf.12034.]

Wednesday, March 19, 2014

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.

Monday, March 17, 2014

David Wright: OASH "is secretive, autocratic and unaccountable."

David Wright has resigned as director of the Department of Health and Human Services' Office of Research Integrity. In his letter of resignation, obtained by Science Insider, Wright blames a dysfunctional Office of the Assistant Secretary for Health (OASH), which also houses OHRP.

[Kaiser, Joceyln. "Top U.S. Scientific Misconduct Official Quits in Frustration With Bureaucracy." Science Insider, March 12, 2014.]

Sunday, March 2, 2014

Symposium: Field Research and US Institutional Review Board Policy

This month the Political Science Department, University of Utah, will host a symposium entitled, "Field Research and US Institutional Review Board Policy." Sponsored by the Betty Glad Memorial Fund, the symposium will take place March 20 [8:45 am - 5:30 pm] and March 21 [9:00 am - 3:30 pm].

The description follows:

Saturday, February 22, 2014

Belfast Project: No lawyers, few historians (and no IRB)

Discussions of the ill-fated Belfast Project at Boston College often frame the issue as what can happen to an oral history project in the absence of IRB oversight. But a recent account of the project in the Chronicle of Higher Education, as well as subsequent discussion, suggests that the real problem was a lack of involvement by lawyers and historians.

[McMurtrie, Beth. “Secrets From Belfast.” The Chronicle of Higher Education, January 26, 2014.]

Saturday, January 25, 2014

Willingham Denies Misleading UNC IRB

Mary Willingham, accused by the University of North Carolina at Chapel Hill of diverging from the protocol she showed her IRB, states that the IRB always knew her plans.

[Wilson, Robin. “Chapel Hill Researcher’s Findings on Athletes’ Literacy Bring a Backlash.” Chronicle of Higher Education, January 24, 2014.]

Quebec Court Shields Confidential Interview from Police

A Quebec court has quashed a search warrant for an interview given in confidence by accused killer Luka Magnotta to University of Ottawa researchers. The court agrees with the professors that "the public interest in protecting researcher-participant confidentiality in general, and in the specific circumstances of this case, clearly outweighs what minimal contribution, if any, the release of the seized items will make to the prosecution of the accused in the criminal proceeding." (2)

[Parent c. R., 2014 QCCS 132. h/t Will C. van den Hoonaard]

Friday, January 24, 2014

Should IRBs Monitor Research Safety?

Susanne Bahn, Michelle Greenwood, and Harry Van Buren argue that "universities have a legal (and an ethical) duty of care for the safety of their employees and it is therefore reasonable to expect that all risks are identified, disclosed and adequately controlled" and that "highly risky research requires additional safeguards for the protection of the research subjects and researchers alike."

Their article offers scant details on what such safeguards might look like.

[Bahn, Susanne, Michelle Greenwood, and Harry J. Van Buren. “The Nexus of Employee Safety, Professional Integrity and Ethics: Applying Stakeholder Theory to University Researchers.” Research in Ethical Issues in Organizations 9 (2013): 13–29. DOI: 10.1108/S1529-2096(2013)0000009007]

Tuesday, January 21, 2014

UNC Accuses Critics of Unauthorized Research

As I noted briefly before, the UNC-Chapel Hill has accused Mary Willingham of violating human subjects rules in her study of the scholastic abilities of student athletes. Willingham has yet to offer a detailed account of her side of the story, and the university's account remains vague as well.

Saturday, January 18, 2014

Exemptions Don't Come to PRIM&R's Mind

In October, PRIM&R hosted a webinar on "Protecting Human Subjects in Qualitative Research: Ethical Considerations for IRBs and Researchers," hosted by Julie Simpson, director of research integrity services at the University of New Hampshire.

A follow up question, just posted the PRIM&R Blog, suggests that Simpson is unfamiliar with the Common Rule:

AS: Under what circumstances might qualitative research not require IRB review?
JS: None come to mind at this time. If the activity is research and it involves human subjects, then it needs IRB review.

Of course, 45 CFR 46.101 lists several circumstances in which human subjects research does not require IRB review, some of them--particularly (b)(2) and (b)(3)--of enormous importance to qualitative researchers.

To be sure, OHRP is primarily responsible for discouraging institutions from recognizing the exemptions. But it is a pity to see PRIM&R spread such misinformation.

Friday, January 17, 2014

Caught Between an IRB and the Provost

The UNC-Chapel Hill IRB has suspended research on student-athlete literacy after former learning specialist Mary Willingham of UNC-Chapel Hill complied with her provost's demands for the data.

[Kane, Dan. “UNC Board Suspends Whistle-Blower’s Research on Literacy Level of Athletes.” News & Observer, January 16, 2014]

Thursday, January 16, 2014

University of Utah Plans Symposium on IRB Policy

On March 20 and 21, the University of Utah Political Science Department will host a symposium, Field Research and US Institutional Review Board Policy.

I will give the keynote address, "'The Freedoms We are Committed to Protect': Political Science, Academic Freedom, and Institutional Review Boards in Historical Perspective."

Tuesday, January 14, 2014

NRC Report: Where's the Freedom?

My biggest disappointment with the new NRC report is its silence on the question of academic and personal freedom.

Sunday, January 12, 2014

NRC Report: Assess Risk Empirically

One theme running throughout the NRC report is the need to replace the worthless gut reactions decried by Ezekiel Emanuel with a system that would base its judgments on the latest empirical evidence. But the report does not present a clear set of reforms that would effect this change without scrapping the current system of local IRB review.

Saturday, January 11, 2014

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.”

Friday, January 10, 2014

National Research Council Issues IRB Report

The National Research Council has issued its long awaited report, Proposed Revisions to the Common Rule for the Protection of Human Subjects in the Behavioral and Social Sciences.

[National Research Council. Committee on Revisions to the Common Rule for the Protection of Human Subjects in Research in the Behavioral and Social Sciences. Proposed Revisions to the Common Rule for the Protection of Human Subjects in the Behavioral and Social Sciences. Washington, D.C.: The National Academies Press, 2014.]

Tuesday, January 7, 2014

Happy New Year, National Academy of Sciences!

As longtime readers of this blog will know, I used to begin each year by mocking OHRP for failing to issue "a lot of examples and will give more guidance on how to make the decision on what is research and what is not" by the end of 2007, as promised by a former director. That trope got a bit old after a few years, and I didn't recycle it in 2013.

I will note that the National Academy of Sciences pledged to issue a summary of its March 2013 workshop "in summer 2013" and that "the study report will be issued in early winter 2013."

Anyone seen either of those?