Monday, December 31, 2012

Sociologists Call for IRB Moratorium

To close out the year, I briefly note a piece that appeared online at the start of 2011, but which I came across only recently. Three sociologists call for a "moratorium on IRB review for social scientific audit research involving non-institutionalized, mentally competent adult subjects," but their reasons are unclear.

[Hessler, Richard M., D. J. Donnell-Watson, and John F. Galliher. "A Case for Limiting the Reach of Institutional Review Boards." American Sociologist 42, no. 1 (January 29, 2011): 145–152. doi:10.1007/s12108-011-9122-5.]

Thursday, December 27, 2012

Sunday, December 23, 2012

Dunn and Hunter Defend Mandatory Review

The Journal of Medical Ethics has published two responses to Murray Dyck and Gary Allen's August 2012 article, “Is Mandatory Research Ethics Reviewing Ethical?” The responses do little to grapple with what I take to be the article's major's proposal.

[Michael Dunn, “Getting the Justification for Research Ethics Review Right.” Journal of Medical Ethics (October 31, 2012). doi:10.1136/medethics-2012-100943; David Hunter, “How Not to Argue Against Mandatory Ethics Review.” Journal of Medical Ethics (December 12, 2012). doi:10.1136/medethics-2012-101074.]

Monday, December 17, 2012

Law Professor Decries, Ponders IRB Variability

Christopher Robertson, associate professor at the James E. Rogers College of Law, University of Arizona, laments the variation in IRB policies and practices from one institution to another and sees it as an opportunity for research.

[Christopher Robertson, "Variability in Local IRB Regulation: A Gold Mine for Future Research," Bill of Health, November 24, 2012.]

Friday, December 14, 2012

Prisoners Find Interview Research Rewarding

A team of researchers finds that prisoners who participated in interview research "reported some intangible benefits and no harms or negative consequences. They also reported the interviews as being a positive and rewarding experience and uniformly said that they had not been subject to coercive persuasion."

[Heith Copes, Andy Hochstetler, and Anastasia Brown. “Inmates’ Perceptions of the Benefits and Harm of Prison Interviews.” Field Methods (November 21, 2012). doi: 10.1177/1525822X12465798. h/t Dan T. A. Eisenberg]

Thursday, December 13, 2012

Northeastern U. IRB Makes Sex Research Untenable

Carey Noland, associate professor of communcation studies at Northeastern University, complains that "many IRBs . . . seem to have difficulty accurately assessing the potential harm involved with qualitative research on sex."

[Carey M. Noland, “Institutional Barriers to Research on Sensitive Topics: Case of Sex Communication Research Among University Students.” Journal of Research Practice 8, no. 1 (November 24, 2012): Article M2,]

Wednesday, December 12, 2012

Expedited Review Reaches the Institutional Review Blog

Today this blog is six years old. Proud as I am of its reception and impact, I find it increasingly difficult to comment on all relevant items while fulfilling my other professional responsibilities.

In the hope of reducing burden, delay, and ambiguity for myself and my readers, I plan to note briefly some items I come across, offering only a line or two of commentary rather than the more thorough analysis I have aimed for in many of my entries.

If this goes well I may adopt this format for the bulk of items I mention. I hope this will allow me to bring readers' attention to otherwise disparate items in less time than I have spent in the past.

Wednesday, December 5, 2012

NIH Policy Makes Interviewing Children Easier

Susan Ridgely, assistant professor of religious studies at the University of Wisconsin at Oshkosh, finds that IRBs can cause trouble for qualitative researchers who want to talk with children, but that IRB review has some benefits. Moreover, since the NIH started calling for children to be included in medical studies, she is finding it easier to get IRB permission to speak to children.

[Susan B. Ridgely, “Doing Ethnography with Child Consultants: Making the IRB Process Work.” Journal of American Folklore 125, no. 3 (2012): 474–485.]

Saturday, December 1, 2012

Marakowitz Reviews Ethical Imperialism

Ellen Marakowitz, a lecturer in the Department of Anthropology at Columbia University and a member of the Columbia IRB, reviews Ethical Imperialism for Academe, the magazine of the American Association of University Professors. She finds it "a well-documented history of the impact of institutional review boards on social science research in the United States," but wishes I had paid more attention to IRBs' potential to help researchers "think critically about their practices, including potential risks to subjects."

[Ellen Marakowitz, "Regulated Research" (Review of Ethical Imperialism: Institutional Review Boards and the Social Sciences, 1965–2009 by Zachary M. Schrag), Academe November-December 2012.]

Wednesday, November 28, 2012

What Is This Thing Called Research?

I have posted the paper I prepared for the May 2012 Petrie-Flom conference as "What is this Thing Called Research? (May 7, 2012),

A shorter version will appear in a book to be published by the MIT Press, tentatively entitled The Future of Human Subjects Research Regulation.

Here is the abstract:

Palys and Lowman on Boston College: "Be Suspicious of Universities"

Ted Palys and John Lowman of the School of Criminology at Simon Fraser University provide a helpful overview of the Boston College Belfast Project oral history legal case while condeming Boston College's actions before and after the arrival of the subpoena. Though the article is marred by an incomplete understanding of U.S. human subjects regulations, it makes a strong case that universities need to practice "ethical and legal due diligence" before promising confidentiality to research participants.

[Ted Palys and John Lowman. “Defending Research Confidentiality ‘To the Extent the Law Allows:’ Lessons From the Boston College Subpoenas.” Journal of Academic Ethics 10, no. 4 (2012): 271–297. doi:10.1007/s10805-012-9172-5.]

Autoethnographer Finds REB Review Intimidating

Lee Murray describes getting REB approval for her doctoral research at the University of Saskatchewan. Though she was able to devise a proposal that passed the committee "without taking away from what I want to accomplish," she was left feeling she "would not want to make the journey again."

[Lee Murray, Debbie Pushor, and Pat Renihan. “Reflections on the Ethics-Approval Process.” Qualitative Inquiry 18, no. 1 (January 2012): 43–54. doi:10.1177/1077800411427845.]

Monday, November 26, 2012

Meyer: "IRB Review Has Only One Step"

Writing on Bill of Health, the blog of the Petrie-Flom Center, Michelle Meyer argues that while human subjects "regulations in theory establish three risk-based tiers of review — human subjects research (HSR) otherwise subject to IRB review that the regulations nevertheless exempt; HSR that is eligible for expedited review; and HSR that requires review by a fully convened IRB (everything else) — in practice, the first two tiers tend to collapse into the third. In this sense, and now I borrow from Matthew Stephenson and Adrian Vermeule, IRB review has only one step."

[Meyer, Michelle. “Exempt Research & Expedited IRB Review: Curb Your Enthusiasm |.” Bill of Health, October 22, 2012.]

I think this implies that even projects that are not federally funded, that don't meet the regulatory definition of human subjects research, or that fit one of the exemption categories are apt to go to full board review.

While it's easy enough to find examples of projects that suffered more scrutiny than required by the regulations, I would note that the exempt and expedited categories remain large. For example, the University of Michigan reports that only 11 percent of projects brought to the Health Sciences and Behavioral Sciences Institutional Review Boards required full review. (Table 4)

Monday, November 5, 2012

Is Boston College Still Clueless about Oral History?

H-Oralhist is running a thread of responses to an oral historian who is seeking IRB approval. One response came from Jillian Maxey, a Ph.D. candidate in Comparative Theology at Boston College.

She writes,

I am working through my IRB proposal right now. I am interviewing key scholars in my field and will be identifying them by name in my dissertation. One person to whom I spoke who serves on the IRB balked at this at first. When I insisted that it was necessary she gave me some tips for articulating the need to the IRB. I'm just wondering if anyone has experience with this or knows of any oral history publications that name participants that I could use to backup my proposal.

Can it be that a year and a half into an international legal controversy involving oral history recordings stored at Boston College, its IRB still doesn't know that oral historians identify their narrators by name? If so, that's all the more reason to think that IRB oversight is not the right response to the Boston College case.

Friday, November 2, 2012

What Has OHRP Told Huron It Hasn't Told Me?

The Huron Consulting Group is advertising a free webinar on November 7 entitled "OHRP Regulatory Interpretations That You Need To Know, But Have Never Been Told." The press release explains:

The Health and Human Services (HHS) human subjects regulations aren't always clear-cut and often times Institutional Review Boards (IRBs) and researchers struggle with how to interpret them. During this webinar, the presenters will share the knowledge Huron has gained through communications with Office for Human Research Protections (OHRP) about topics such as:
  • How to handle "protocol exceptions for a single subject"
  • When an unanticipated problem involving risks to subjects or others does not have to be reported to OHRP
  • Whether the IRB has to require the submission of the names of all study staff on a research study
  • When Subpart C does not apply to a subject who becomes incarcerated

I am troubled by the premise of this webinar: that OHRP has passed on important information to a private consulting firm without posting it for public use. For some topics, this may be puffery by Huron. For example, OHRP has issued public guidance on "What happens if a human subject becomes a prisoner during the course of a research study?" But I don't know of similar guidance on topics like "protocol exceptions for a single subject." If OHRP has in fact made such regulatory interpretations, why aren't they on its website?

Tuesday, October 30, 2012

College Freshmen Don't Mind Research Use of Public Facebook Profiles

An interdisciplinary team of researchers "investigated publicly available Facebook profiles of freshmen undergraduate students within one large state university Facebook network" and invited 188 of those freshmen to be interviewed for a health study. At the end of the interview, they told the freshmen that they had been selected using their public Facebook profiles. "Participant responses included endorsement (19.7%), fine (36.4%), neutral (28.8%), uneasy (9.1%), and concerned (6.1%)." The researchers acknowledge that 6 percent minority but conclude that "publicly available Facebook profiles of older adolescents are viewed as public spaces by both the adolescents themselves as well as the legal system."

[Moreno, Megan A., Alison Grant, Lauren Kacvinsky, Peter Moreno, and Michael Fleming. “Older Adolescents’ Views Regarding Participation in Facebook Research.” Journal of Adolescent Health 51, no. 5 (November 2012): 439–444. doi:10.1016/j.jadohealth.2012.02.001]

Health Researchers Learn that Ethics Review Really Is Creepy

Three Canadian scholars with backgrounds in various approaches to health research and bioethics find that, contrary to their expectations, many REB members and staffers believe that "ethics creep" is real. The authors have collected interesting thoughts from REB staff and members, but the authors' analysis and their own proposals for reform are unclear.

[Adrian Guta, Stephanie A. Nixon, and Mike G. Wilson, "Resisting the Seduction of 'Ethics Creep': Using Foucault to Surface Complexity and Contradiction in Research Ethics Review," Social Science & Medicine available online 25 September 2012, DOI: 10.1016/j.socscimed.2012.09.019.]

Monday, October 29, 2012

U of Sheffield REC Suspended Professor for Discussing Research

The Times Higher Education reports that in 2010, the director of research in the University of Sheffield Management School told Professor Stuart Macdonald to suspend his research, even though the professor had done nothing but mention another professor's research during a "discussion on research ethics and integrity."

[Paul Jump, "Found guilty until proven innocent over unapproved research claims," Times Higher Education, 25 October 2012.]

The story reports, "Fifteen days later, [Macdonald] received an email from the chair of the research ethics committee, Richard Jenkins, saying a 'misunderstanding' had occurred, although he was offered no apology or further explanation."

Macdonald filed a formal complaint about his treatment by the REC, but it was dismissed.

The case echoes the experience of Bernadette McCauley, who also received an order to suspend all research from an ethics committee that had no idea of what it was doing.

Farewell, Fredericton!

I made it home from the Ethics Rupture conference in time to defend my basement against Hurricane Sandy.

It was delightful to meet so many scholars--several of whom have been cited in this blog over the years--with such deep knowledge of the problems of ethics review and creative ideas for improving it.

The conference was recorded, and a podcast should appear before too long. Also, we hope to publish a conference volume. As time permits, I will blog some of the things I learned there.

I thank all those who organized and hosted the conference, especially Will van den Hoonaard.

Saturday, October 27, 2012

New Zealand Offers Voluntary Ethics Review—for Some

At the Ethics Rupture conference, Martin Tolich described his work as convenor of the New Zealand Ethics Committee, described on its site as "a national ethics advisory committee, based in Dunedin, serving any researcher not eligible for health or institutional ethics review."

Tolich listed several innovations, the boldest of which is the voluntary nature of the review. "No researcher is mandated to submit his or her proposal to NZEC," the site explains."It is a voluntary service and fees are based on koha." If the committee wants to attract proposals, it will have to persuade researchers of its wisdom, rather than threatening them with penalties.

New Zealand researchers affiliated with health institutions or universities are still stuck with mandatory review. But it will be fascinating to see what ethics review looks like when it is no longer mandatory.

Friday, October 26, 2012

One Year Since ANPRM Comment Deadline

Today marks the first anniversary of the deadline for comments on the ANPRM. The federal government received more than 1100 comments in response to its proposals and queries. I have heard nothing official, and only vague and contradictory rumors, about what progress, if any, has taken place in the past year.

Meanwhile, I am attending Will C. van den Hoonaard's Ethics Rupture conference, and I am delighted to meet in person so many people with whom I have corresponded and whose work I have read. But I am saddened to hear Canadian scholars' frustration that the revision of the TCPS has not done more to allow them to conduct research according to the ethical and methodological standards of their disciplines.

Thursday, October 25, 2012

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.]

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.'"

Wednesday, October 10, 2012

Mark Israel Questions Lists of Vulnerabilities

Mark Israel, Winthrop Professor of Law at the University of Western Australia, sees problems with mandatory ethics review but doubts that they can be fixed by limiting such review to projects involving "specific vulnerable groups."

[Mark Israel, “Rolling Back the Bureaucracies of Ethics Review.” Journal of Medical Ethics (October 2, 2012), DOI:10.1136/medethics-2012-100942.]

Saturday, September 29, 2012

SACHRP Still Lacks Social Scientists

OHRP has announced new members of the Secretary's Advisory Committee on Human Research Protections (SACHRP):

  • Chair Designate: Jeffrey R. Botkin, M.D., M.P.H., Professor of Pediatrics and Medical Ethics, Associate Vice President for Research, University of Utah. Term: October 15, 2012 - October 15, 2016
  • Thomas Eissenberg, Ph.D., Professor, Department of Psychology and Institute for Drug and Alcohol Studies; Director, Clinical Behavioral Pharmacology Laboratory, Virginia Commonwealth University. Term: October 9, 2012 - October 9, 2016
  • Owen Garrick, M.D., M.B.A., President and CEO, Bridge Clinical Research, Inc. Term: October 15, 2012 - October 15, 2016
  • Pilar Ossorio, J.D., Ph.D., Associate Professor of Law and Bioethics, University of Wisconsin-Madison. Term: October 15, 2012 - October 15, 2016

Eissenberg's PhD is in Experimental Psychology, and his "primary area of research is the behavioral pharmacology of drugs of abuse, focusing primarily on nicotine/tobacco." Ossorio's PhD is in Microbiology and Immunology. So that's four new members with background in biomedical research of one kind or another, none whose primary interests are in non-medical research.

Tuesday, September 25, 2012

Schrag Responds to Responses to Schrag

The June 2012 issue of Research Ethics features four responses to my December 2011 essay, "The Case Against Ethics Review in the Social Sciences." Three scholars based in Canada wrote a joint response, while three in Britain wrote individual replies. I am grateful to all of the respondents for their attention, kind words, and challenging critiques.

  • Nicholls, Stuart G., Jamie Brehaut, and Raphae Saginur. “Social Science and Ethics Review: A Question of Practice Not Principle.” Research Ethics 8, no. 2 (June 2012): 71–78. doi:10.1177/1747016112445435
  • Hedgecoe, Adam. “The Problems of Presumed Isomorphism and the Ethics Review of Social Science: A Response to Schrag.” Research Ethics 8, no. 2 (June 2012): 79–86. doi:10.1177/1747016112445437
  • Jennings, Sean. “Response to Schrag: What Are Ethics Committees for Anyway? A Defence of Social Science Research Ethics Review.” Research Ethics 8, no. 2 (June 2012): 87–96. doi:10.1177/1747016112445423
  • Bond, Tim. “Ethical Imperialism or Ethical Mindfulness? Rethinking Ethical Review for Social Sciences.” Research Ethics 8, no. 2 (June 2012): 97–112. doi:10.1177/1747016112445423

Since the responses overlap somewhat in their themes, I think it best for me to respond to them collectively.

Friday, September 21, 2012

U of Illinois Launches Ethics CORE

The University of Illinois at Urbana-Champaign has officially launched Ethics CORE (, an online resource for education in research ethics.

Monday, September 17, 2012

Fredericton to Host Summit on Research-Ethics Review Alternatives

Will C. van den Hoonaard, author of The Seduction of Ethics, is organizing a conference to be held next month in Fredericton, New Brunswick, entitled "Ethics Rupture: An Invitational Summit about Alternatives to Research-Ethics Review."

Sunday, September 16, 2012

Could Guidance and Feedback Replace Rote Compliance?

Murray Dyck and Gary Allen, both of Griffith University in Australia, argue that "the review process should be an advisory and collegial one—not one that focuses on compliance, enforcement and gatekeeping."

[Murray Dyck and Gary Allen. “Is Mandatory Research Ethics Reviewing Ethical?” Journal of Medical Ethics (August 3, 2012), DOI: 10.1136/medethics-2011-100274.]

Wednesday, September 12, 2012

I Review van den Hoonaard, The Seduction of Ethics

Contemporary Sociology has published my review of Will C. van den Hoonaard's Seduction of Ethics, which I term "a powerful, combined-arms assault on the system of ethics review of the social sciences."

[Zachary M. Schrag, review of The Seduction of Ethics: Transforming the Social Sciences by Will C. van den Hoonaard, Contemporary Sociology: A Journal of Reviews 41, no. 5 (September 2012): 678–679, doi:10.1177/0094306112457769oo.]

Sunday, September 9, 2012

OHRP Calls for 2013 SACHRP Nominations Without Announcing 2012 Appointments

OHRP is calling for nominations to fill two SACHRP positions that will open in 2013.

OHRP has not, to my knowledge, announced the new members for 2012, including replacements for two members whose terms expired in July.

How is the public to suggest appropriate names for 2013 when we do not know what qualifications the 2012 appointments will bring to the committee?

Friday, September 7, 2012

Can an IRB Ban a Researcher?

In July, the Sacramento Bee reported that the University of California, Davis, had ordered two doctors--J. Paul Muizelaar and Dr. Rudolph J. Schrot--"to halt all human research activity 'except as necessary to protect the safety and welfare of research participants.'" Schrot told the Bee that "To be banned from clinical research makes a career in academic medicine challenging, to say the least."

The Common Rule (45 CFR 46.113) empowers IRBs to "suspend or terminate approval of research that is not being conducted in accordance with the IRB's requirements or that has been associated with unexpected serious harm to subjects," but it does not explicitly empower them to ban a researcher from all research.

Tuesday, September 4, 2012

AAUP Posts New IRB Report

The American Association of University Professors has posted "Regulation of Research on Human Subjects: Academic Freedom and the Institutional Review Board," a report prepared by a subcommittee of the Committee A on Academic Freedom and Tenure. I served on that subcommittee, which was chaired by Professor Judith Jarvis Thomson of MIT.

The AAUP press release explains,

In July 2011, the federal government took what may be the first step toward the most substantial change in the regulations since 1981, issuing an advance notice of proposed rulemaking, or ANPRM. More than 1,100 individuals and associations have submitted formal comments.

The AAUP report notes that “out of respect for liberty, it is normally expected that government regulation of behavior will consist in listing what is forbidden, all else being permitted.” The report goes on to suggest ways in which the regulations could be rewritten along these lines.

The Association welcomes comments on the report through September 28.

Saturday, September 1, 2012

REB Member: Make Review Process Educative, Not Regulatory

Dominique Rivière, an education researcher at the University of Toronto, reports that REB service left her somewhat less critical of the ethics-review process, but she still calls for significant reform.

[Dominique Rivière, "Looking from the Outside/In: Re-thinking Research Ethics Review." Journal of Academic Ethics 9, no. 3 (2011): 193–204. DOI: 10.1007/s10805-011-9139-y]

Friday, August 31, 2012

Institutional Review Blog: Archival Edition

For some time, I have been meaning to create an archival backup of this blog, not dependent on Google's whims. With the help of BlogBooker and the Mason Archival Repository Service, I have posted a PDF of all the entries and comments on this blog from its launch in December 2006 through the start of this week. The compilation and individual entries can be downloaded under a Creative Commons Attribution-NonCommercial-NoDerivs 3.0 Unported License.

Thursday, August 23, 2012

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.]

Thursday, August 16, 2012

IRBs Impeded Harvard Dissertation on Addiction and Incarceration

Kimberly Sue, a medical anthropologist in Harvard's MD/PhD program, reports that IRB review can seem "a hassle, a nuisance or a stumbling block, as we seek to enact a more relevant and engaged era of anthropology."

[Kimberly Sue "Are IRBs a Stumbling Block for an Engaged Anthropology?" Somatosphere, 9 August 2012, . h/t Michelle Meyer]

Tuesday, August 14, 2012

Elliott Decries IRB Opacity

Writing for the Chronicle of Higher Education's Brainstorm Blog, Carl Elliott argues that the "by any reasonable estimate [the IRB] oversight system has been a failure . . . yet so many people are professionally invested in the current oversight system that they cannot imagine replacing it, only tinkering with it." He particularly condemns the secrecy of the system.

[Carl Elliott, “When Medical Muckraking FailsChronicle of Higher Education, Brainstorm, August 2, 2012.]

Friday, July 20, 2012

Geographer: Unnecessary IRB Delay Threatens NSF Grants

In the fifth and final Professional Geographer essay, Scott M. Freundschuh, Professor of Geography at the University of New Mexico, notes that many IRBs "unnecessarily require research protocols to be reviewed by the full IRB, therefore impeding the progress of research projects." Rather than suggesting structural changes to the IRB system, he counsels geographers to work within existing rules.

[Scott M. Freundschuh, "Institutional Review for Research in the Social Sciences from the Federal Perspective," Professional Geographer 64, no. 1 (2012): 43-48, DOI:10.1080/00330124.2011.596791]

Thursday, July 19, 2012

IRB Chair Denies Being a Vampire

Patricia Price, a geographer and IRB chair at Florida International University, assures us that her board is not "a malevolent, vampirish entity."

[Patricia L. Price, "Geography, Me, and the IRB: From Roadblock to Resource," Professional Geographer 64, no. 1 (2012): 34-42, DOI:10.1080/00330124.2011.596789]

Wednesday, July 18, 2012

Can Macalester's Divisional Review Work Elsewhere?

In his contribution to the Professional Geographer special issue, Dan Trudeau of Macalester College writes that "IRBs can be a pedagogical asset, particularly if institutional review practices cultivate the habits of mind and strategies necessary for engaged and reflexive research." The key, his article suggests, may be the devolution of review to specialized committees rather than the general-purpose IRBs that are the norm. But Trudeau does not stress the degree to which Macalester's sucess depends on its departure from federal standards.

[Dan Trudeau, "IRBs as Asset for Ethics Education in Geography," Professional Geographer 64, no. 1 (2012): 25-33, DOI: 10.1080/00330124.2011.596786.]

Tuesday, July 17, 2012

Common Rule Is "Out of Place" on the Streets of Bogotá

In the second article in the Professional Geographer special issue, Amy Ritterbusch argues that "when lives are at risk, socially and politically responsible action in the field becomes the driving force of human subjects protection," but that "standard human subjects protection procedures often pull initial field relations in the opposite direction, establishing distance and difference between the researcher and research population through a temporally and spatially restrictive web of institutional categorizations and paperwork that predefine participants’ identities and role in the research project."

She finds that "Although well intentioned, 45 CFR 46 is a bureaucratic discourse that positions youth in problematic ways and is out of place in the world of Bogotana street girls."

[Amy Ritterbusch, “Bridging Guidelines and Practice: Toward a Grounded Care Ethics in Youth Participatory Action Research,” Professional Geographer 64, no. 1 (2012): 16–24, DOI: 10.1080/00330124.2011.596783.]

Monday, July 16, 2012

IRB Sought to Monitor Interviews with Elected Officials

The first article in the Professional Geographer special issue argues that the IRB system assumes that the researcher is a "powerful, knowing agent who assembles a scientific methodology that is always of potential harm to the researched," while subjects are always "less knowing" and vulnerable. As a result, scholars "face the presumption of guilt while seeking to prove innocence in the IRB process of application, negotiation, and usually, but not painlessly, final approval to conduct research."

[Deborah G. Martin and Joshua Inwood. “Subjectivity, Power, and the IRB,” Professional Geographer 64, no. 1 (2012): 7–15, DOI:10.1080/00330124.2011.596781.]

Friday, July 13, 2012

IRB Chair: "Human Subjects Oversight Is Here to Stay"

Back in September 2011, I noted that the Professional Geographer had posted a focus section on IRBs (it appeared in print in February 2012). At the time I was too busy reading and writing ANPRM responses to comment on the six items in the focus section, but with the luxury of summer I can now do so. Today, I start with the introduction.

Ironically, given its appearance at that moment of regulatory upheaval, the introduction to the focus section dismisses the possibility of regulatory reform.

[Patricia L. Price, "Introduction: Protecting Human Subjects Across the Geographic Research Process," Professional Geographer 64:1 (2012), 1-6, DOI: 10.1080/00330124.2011.596780.]

Thursday, July 12, 2012

SAGE Insight Posts "The Case Against Ethics Review"

My Research Ethics article, "The Case Against Ethics Review in the Social Sciences," has been posted on the SAGE Insight blog. This means you can read it free. Thanks, SAGE!

Wednesday, July 11, 2012

First Circuit Rejects Belfast Project Historians' Appeal

On Friday, July 6, the First Circuit Court of Appeals rejected the effort by two oral historians to block the release of interviews of participants in Northern Ireland's Troubles, archived as the Belfast Project at Boston College's Burns Library.

Citing precedent, especially Branzburg v. Hayes, 408 U.S. 665 (1972), the court majority found that "the choice to investigate criminal activity belongs to the government and is not subject to veto by academic researchers."

[In re Request from United Kingdom, Nos. 11-2511, 12-1159, --- F.3d ----, 2012 WL 2628046 (1st Cir. July 06, 2012)]

In a concurrence, Judge Juan Torruella is more sympathetic to the researchers, arguing that academic researchers are entitled to "a degree of protection" and possess "a cognizable interest under the First Amendment." However, he continues, "any such interest has been weighed and measured by the Supreme Court and found insufficient to overcome the government's paramount concerns in the present context."

Tuesday, July 10, 2012

Harvard Law Today Reports on ANPRM Conference

Harvard Law Today, published by Harvard Law School, reports on May's conference on the ANPRM, held at the school's Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics.

["The Future of Human Subjects Research Regulation," Harvard Law Today, July 2012.]

The article highlights the plenary address by Greg Koski, former director of OHRP.

Koski said regulation has been dominated by human-subject protectionism and an ethical-review system that has “devolved to regulatory compliance oversight.” The result, he said, is a system that is “inefficient and burdensome.” His recommendation, he said, was to replace the current system with one modeled after medical training and certification.

He said: “If we were able to develop a paradigm of professionalism in human research, it would likely be every bit as effective, less costly, less burdensome and more efficient than the protectionist, compliance-focused system that we are now seeking to reform. I would argue that reform of our current system is perhaps not the most appropriate or even adequate approach to try to achieve the goals that we seek.”

Monday, July 9, 2012

Sociologists of Sexuality Voice IRB Complaints

Sociologist Janice Irvine finds that IRBs "play a significant but largely unnoticed role in the marginalization of sexuality research," and that "the IRB closet obstructs a broad production of sexual knowledge—not simply about identities and communities, but also about a range of sexual acts, desires, and attitudes."

[Janice M. Irvine, "Can't Ask, Can't Tell : How Insitutional Review Boards Keep Sex In The Closet," Contexts 2012 11: 28, DOI: 10.1177/1536504212446457. The story has been picked up by the Chronicle of Higher Education: Dan Berrett, "Review Boards Force Sex Research Into the Closet, Survey Suggests," Chronicle of Higher Education, 28 June 2012.]

Wednesday, July 4, 2012

Emmerich Reviews Behind Closed Doors and Ethical Imperialism

Nathan Emmerich of Queen's University, Belfast, finds that Laura Stark's book and my own "together . . . illustrate the nature of ethics as an aspect of research governance fundamentally contributing to our understanding of the phenomena in a manner that goes beyond the relatively limited or restricted consideration offered by applied ethical analysis."

[Nathan Emmerich, Review of Behind Closed Doors: IRBs and the Making of Ethical Research and Ethical Imperialism: Institutional Review Boards and the Social Sciences, 1965-2009, Sociological Research Online 17, Issue 2 (May 2012).]

Thursday, June 14, 2012

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?

Wednesday, June 13, 2012

Limited-Time Offer! Act Now!

SAGE has kindly made my article, "The Case against Ethics Review in the Social Sciences," free to access for a month. Download it while you can!

[Zachary M. Schrag, "The Case against Ethics Review in the Social Sciences," Research Ethics 7 (December 2011): 120-131, doi:10.1177/174701611100700402]

Saturday, June 9, 2012

"Community Members" Play Murky Roles

Robert Klitzman continues to publish findings from his 2007-2009 series of interviews with 46 IRB chairs, directors, administrators, and members. In an Academic Medicine article, he finds that IRBs' "community members" struggle because their "roles can be murky."

Robert Klitzman, "Institutional Review Board Community Members," Academic Medicine 87 (July 2012), doi: 10.1097/ACM.0b013e3182578b54, post author corrections version, 22 May 2012.]

Friday, June 8, 2012

Study Finds IRBs Often Fail to Discuss Common Rule Criteria

The Common Rule [45 CFR 46.111(a)] requires IRBs to determine that each protocol they approve satisfies seven requirements: risks are minimized, risks are reasonable, selection of subject is equitable, informed consent is sought, informed consent is documented, safety is monitored when appropriate, and privacy and confidentiality are protected when appropriate. A team of researchers has found that "the IRB made clear determinations on all relevant criteria for 20 of the 104 (19%) protocols" they examined.

[Charles W. Lidz, Paul S. Appelbaum, Robert Arnold, Philip Candilis, William Gardner, Suzanne Myers, and Lorna Simon. "How Closely Do Institutional Review Boards Follow the Common Rule?" Academic Medicine 87 (July 2012), doi: 10.1097/ACM.0b013e3182575e2e, post author corrections version, 22 May 2012]

Thursday, June 7, 2012

Sex and Trauma Surveys No Riskier Than Cognitive Tests

A team of psychologists has found that responding to survey questions about trauma and sex is no more stressful than completing "well-established cognitive tests."

[Elizabeth Yeater, Geoffrey Miller, Jenny Rinehart, and Erica Nason. "Trauma and Sex Surveys Meet Minimal Risk Standards Implications for Institutional Review Boards." Psychological Science (Published online before print May 22, 2012), doi: 10.1177/0956797611435131. h/t Michelle Meyer.]

Wednesday, June 6, 2012

Ethics Committees as Foucauldian Shepherds

Three Norwegian researchers using a "Foucault-inspired analysis" charge that "ethics monitoring bodies can be conceived as executing a type of paternalistic power over vulnerable and marginalized groups, a practice which is virtually identical to the exercise of power that, according to their mandate, they should be protecting these groups against."

[Truls I Juritzen, Harald Grimen, and Kristin Heggen. “Protecting Vulnerable Research Participants: A Foucault-Inspired Analysis of Ethics Committees.” Nursing Ethics 18, no. 5 (September 2011): 640–650, doi: 10.1177/0969733011403807]

Wednesday, May 30, 2012

Minimal Risk Approval: 27 months, $170,000

A team of health services researchers found that getting approval for a minimal risk study took 27 months and consumed $170,000 in staff time.

[Laura A. Petersen, Kate Simpson, Richard SoRelle, Tracy Urech, and Supicha Sookanan Chitwood, "How Variability in the Institutional Review Board Review Process Affects Minimal-Risk Multisite Health Services Research," Annals of Internal Medicine 156, no. 10 (May 15, 2012): 728–735. h/t Human Subject News.]

Thursday, May 24, 2012

AAHRPP Claims IRBs Rarely Disapprove Research

The Association for the Accreditation of Human Research Protection Programs (AAHRPP) notes that of the organizations it surveyed (it doesn't report how many or how they were selected) 63 percent "did not disapprove any protocols in the past year" and only "13.2 percent disapproved two or more percent." The AAHRPP uses these figures to argue that the "perception that IRBs disapprove a significant portion of research protocols submitted is not true."

I wonder whom they are accusing of holding this perception. Serious observers of IRBs know that a board need not formally reject a proposal to make it impossible for the researcher to proceed. Look at what happened at Linda Thornton. Look at what happened to Kathryn Edgerton-Tarpley's student. Or the anonymous researcher who wanted to study how parents discipline their children. In these cases, researchers abandoned projects in the face of IRB intransigence, allowing the IRB to claim it had not disapproved the project.

I am therefore unsurprised by AAHRPP's figures. I am surprised that AAHRPP thinks that formal disapproval is a meaningful measure of the IRB suppression of research, and by its stooping to this straw man argument.

Monday, May 21, 2012

Against Armchair Ethics: Some Reflections from Petrie-Flom

As followers of my Twitter feed will know, I spent Friday and the first half of the Saturday at The Future of Human Subjects Research Regulation, a conference sponsored by the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School.

The conference organizers, led by Professor Glenn Cohen, did a magnifent job bringing together participants with varied views and backgrounds, and as a group we discussed ideas ranging from treating research subjects as workers to including adolescents on IRBs. Those who want the full story should be able to watch videos of the presentations before too long.

I was struck, however, by one recurring theme: the distinction between evidence-based approaches and armchair ethics.

Thursday, May 17, 2012

The Case against Ethics Review in the Social Sciences

Research Ethics has published my article, "The Case against Ethics Review in the Social Sciences." The article appeared in print in December 2011, but it has only recently appeared online.

[Zachary M. Schrag, "The Case against Ethics Review in the Social Sciences," Research Ethics 7 (December 2011): 120-131, doi:10.1177/174701611100700402]

(As of 17 May 2012, the DOI is working, but one can find the article at

The article gathers many of the arguments made in the first five years of this blog.

Wednesday, May 16, 2012

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).]

Monday, May 14, 2012

Research Participants Find REB Assumptions "Stereotypical, Simplistic, and Discriminatory"

While I'm catching up on my JERHRE reading, here's an important article from the December 2011 issue. An anthropologist and a public health researcher at the University of British Columbia have found that women who use drugs resent assumptions that they are unable to consent to participating in research, and they consider participation in such research to be an absolute right.

[Kirsten Bell and Amy Salmon, "What Women Who Use Drugs Have to Say About Ethical Research: Findings of an Exploratory Qualitative Study." Journal of Empirical Research on Human Research Ethics 6, no. 4 (December 1, 2011): 84-98, DOI: 10.1525/jer.2011.6.4.84.]

Saturday, May 12, 2012

Sieber and Tolich Lament "Medical Model"

The editors of the Journal of Empirical Research on Human Research Ethics call for researchers to stand up to their IRBs.

[Joan E. Sieber and Martin Tolich. "Research Ethics and Research Governance." Journal of Empirical Research on Human Research Ethics 7, no. 2 (April 2012): 1-2, DOI: 10.1525/jer.2012.7.2.1].

Friday, May 11, 2012

Community Researchers Flee the CITI

An article in the latest issue of the Journal of Empirical Research on Human Research Ethics finds that standard research ethics training programs--specifically the mortifyingly stupid CITI Program--are inappropriate for Community-Engaged Research (CEnR).

[Anderson, E., S. Solomon, E. Heitman, J. Dubois, C. Fisher, R. Kost, M. Lawless, et al. "Research Ethics Education for Community-Engaged Research: A Review and Research Agenda." Journal of Empirical Research on Human Research Ethics 7, no. 2 (April 2012): 3, DOI: 10.1525/jer.2012.7.2.3]

Thursday, May 10, 2012

Philosopher and IRB Chair Call for Repeal of IRB Exemptions

Writing in IRB: Ethics & Human Research, Mahesh Ananth and Michael Scheessele, both of Indiana University South Bend, argue against exempting all minimal-risk research from IRB review. They do so in terms that would require the repeal of the 45 CFR 46.101 exemptions, though it is not clear they understand the implications of their own argument.

[Mahesh Ananth and Michael R. Scheessele, "Exempting All Minimal-Risk Research from IRB Review: Pruning or Poisoning the Regulatory Tree?" IRB: Ethics & Human Research 34, no. 2 (April 2012): 9–14.]

Tuesday, May 8, 2012

Dingwall: UK May Enact Research Integrity Rules With Little Scholarly Input

Writing on social science space, Robert Dingwall warns that the United Kingdom's Economic and Social Research Council seems to be crafting burdensome regulations on research integrity without defining the problem to be solved, considering the costs of regulation, or consulting scholarly associations:

Thursday, May 3, 2012

Friday, April 27, 2012

Li Abandons Suit, But Brown University Still Ponders IRB Reform

Though it no longer faces a faculty lawsuit, Brown University is considering an outside review of its troubled IRB.

As readers of this blog may remember, Brown faculty have been complaining about the IRB since 2007, if not before.

In 2011, a Brown professor, Jin Li, took the highly unusual step of suing the university because of IRB interference in her work. In March, Li abandoned that effort, her attorneys agreeing to a dismissal with prejudice.

According to the Daily Herald, Brown faculty and administrators are discussing possible reforms, including an external review, broader disciplinary representation on the IRB, the creation of an additional IRB for non-biomedical human subject research, and "changing the charge of the IRB to make it not only a monitory board but also one that provides a more supportive and guiding role to research teams."

[Aparaajit Sriram, "IRB Likely to Undergo Review," Brown Daily Herald, 26 April 2012.]

The article does not mention the possibility of an appeals process, the lack of which was one of Li's complaints.

Thursday, April 26, 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.]

Tuesday, April 24, 2012

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,]

Thursday, April 12, 2012

An End to IRBs?

Ethics review is a big industry. As Will van den Hoonaard has noted,

In Canada alone, the business of academic ethics is a $35 million industry; when you include three other countries (United States, United Kingdom, and Australia), the industry amounts to some $500 million, with an inordinate amount of costs borne by cash-strapped universities. The reciprocal obligations, contradictions, and inherent permutations of such a large industry are nearly impossible to escape.

It may be hard to imagine such an industry disappearing overnight.

AAHRPP Organizations Check Fewer Boxes

The AAHRPP has reported that only 29 percent of its accredited organizations (not counting VA facilities, which don't have the option to uncheck boxes) pledged to apply all parts of the Common Rule to research not directly sponsored by the federal government. However, 72 percent of organizations that left at least one box unchecked still "applied the DHHS regulations to all research regardless of funding source." Thus, for a great many organizations, unchecking a box or two remains a way to escape federal oversight without offering researchers any additional freedom.

Friday, April 6, 2012

Could Retrospective Review End Nitpicking?

Robert Klitzman and Paul Appelbaum, both of Columbia University, suggest that shifting research oversight to the retrospective review of a subset of projects, rather than prospective review of proposals, could reduce the "variability and subjectivity across IRBs" that now characterizes ethics review.

[Robert Klitzman and Paul S. Appelbaum, "To Protect Human Subjects, Review What Was Done, Not Proposed," Science 335 no. 6076 (30 March 2012): 1576-1577,
DOI: 10.1126/science.1217225.]

Wednesday, March 21, 2012

Ball State Student Finds IRB Instructions "Impersonal, Dry, and Long"

Stephanie Hedge, a PhD Candidate at Ball State University in Rhetoric and Composition, describes how IRB requirements aggravated her difficulties in "persuading students to be my guinea pigs for a semester."

[Stephanie Hedge, "Successfully Recruiting Research Participants," Inside Higher Ed, 20 March 2012.]

Friday, March 16, 2012

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.]

Petrie-Flom Center Posts ANPRM Conference Program

The Petrie-Flom Center for Health Law Policy, Biotechnology and Bioethics at Harvard Law School has circulated the following announcement, concerning a conference at which I will speak. I am happy to post the announcement in full.

Wednesday, March 14, 2012

REC Forbids Dissertations on Lap Dancing

Robert Dingwall fears that "research ethics is co-opted to infantilize students who are legally adults but treated as if they should never be allowed to risk a bad experience."

[Robert Dingwall, "Better Drowned than Duffers…?," social science space, 19 February 2012.]

Friday, March 2, 2012

Video of my Michigan Talk Now Online

The University of Michigan Center for Bioethics and Social Sciences has kindly posted a video recording of my February 1 talk:

Zachary Schrag talk, February 1, 2012 from CBSSM Developers on Vimeo.

and the subsequent panel discussion, featuring Cleo Caldwell, Carl Schneider, and Alford Young, Jr.:

Ethical Imperialism: The Case Against IRB Review of the Social Sciences, 2/1/12 Panel Discussion from CBSSM Developers on Vimeo.

Tuesday, February 28, 2012

IRBs Misunderstand Researchers' Complaints

A study of IRB chairs, members, and staff finds that they understand that researchers regard them as powerful actors, "Yet IRBs may misperceive PI complaints."

[Robert Klitzman, "The Ethics Police?: IRBs’ Views Concerning Their Power," PLoS ONE 6 (2011): e28773. doi:10.1371/journal.pone.0028773. h/t Roberto Veloso]

Friday, February 17, 2012

Moskos Plugs Ethical Imperialism

Peter Moskos gives a a kind mention to Ethical Imperialism on his blog.

Moskos has nicer things to say about flogging than about IRB review.

Monday, February 13, 2012

Talk at NIH

On March 5 I will speak to the Bioethics Interest Group at the National Institutes of Health on the topic "Blunder at Belmont: The 1970s Origins of IRB Mission Creep."

Those familiar with my first book may appreciate the irony of my speaking in the William H. Natcher Building.

Friday, February 10, 2012

VA IRB is "Kafkaesque and Dickensian"

Writing in Bioethics Forum, a team of interview researchers describe the Veterans Administration IRB process as "Kafkaesque and Dickensian."

[Jenny E. Ostergren, Marguerite E. Robinson, Molly J. Dingel, Bradley Partridge, Barbara A. Koenig, "Kafkaesque and Dickensian: The Human Subjects Protection Maze," Bioethics Forum, 9 February 2012.]

Wednesday, February 8, 2012

Inside Higher Ed Interviews Stark

Laura Stark speaks about her new book, Behind Closed Doors, with Inside Higher Ed.

[Mitch Smith, "Behind Closed Doors," Inside Higher Ed, 8 February 2012.]

Stark explains, "It would seem that fairness is not the only criteria used in IRB evaluations."

"Informed Consent Is 20 Pages of Nothing"

Nature reporter Daniel Cressy writes that

Informing clinical-trial participants of the risks they face is a cornerstone of modern medical research, and it is enshrined as a human right in international codes of ethics. But an influential group of ethicists and medical researchers warned at a meeting in Brussels last week that the process has become a box-ticking exercise focused more on offering legal protection to a trial’s organizer than actually protecting patients.

[Daniel Cressey, "Informed Consent on Trial," Nature 482, 16 (2 February 2012) doi:10.1038/482016a]

Ethicists are particularly alarmed by the steady growth in the length of consent forms.

In many cases “the informed consent is 20 pages of nothing,” says Harry Bleiberg, an oncologist formerly at the Jules Bordet Institute in Brussels who is now a medical consultant for the pharmaceutical industry.

While consent forms have grown longer, it is not clear that they were ever anything other than "a box-ticking exercise focused more on offering legal protection to a trial’s organizer than actually protecting patients." Perhaps Cressey wrote "has become a box-ticking exercise" when he meant "remains a box-ticking exercise."

Monday, February 6, 2012

Biographer Decries IRB Assumptions

Craig Howes, professor of English and director of the Center for Biographical Research at the University of Hawai‘i, Manoa, acknowledges the ethical challenges of biographical writing but seems to doubt that IRB review is the appropriate tool for handling them.

[Craig Howes, "Asking Permission to Write: Human Subject Research," Profession (2011): 98-106, DOI: 10.1632/prof.2011.2011.1.98. h/t Steve Burt.]

Wednesday, February 1, 2012

Educator: Ethics Requirements Do Not Respect Ethnographic Participants

Kristen H. Perry, assistant professor of elementary literacy at the University of Kentucky College of Education, draws on her experience with refugees to argue that "Existing ethical guidelines may be inappropriate for the research designs qualitative researchers use and the communities they study, in part because they are based on positivistic, biomedical research paradigms."

[Kristen H. Perry, "Ethics,Vulnerability, and Speakers of Other Languages: How University IRBs (Do Not) Speak to Research Involving Refugee Participants," Qualitative Inquiry 17 (2011): 899–912, DOI: 10.1177/1077800411425006]

Sunday, January 29, 2012

Monday, January 23, 2012

Li and Brown Continue Negotiations

A correspondent asks for an update in the case of Jin Li, the Brown professor who sued her university after its IRB restricted her research.

I checked Public Access to Court Electronic Records (PACER) and found that on January 13, the parties jointly asked for an extension of the discovery deadline, telling the court "that they continue to negotiate a settlement of the claims. Due to the efforts made negotiating a settlement, only minimal discovery has been propounded so far. As such, if the parties are unable to settle, then the parties will need time to complete formal discovery."

I have posted the motion and other key documents on my IRB Documents page.

Wednesday, January 18, 2012

Survey: 28% of Linguists Report Inappropriate IRB Demands

The response to the ANPRM from the Linguistic Society of America led me to an interesting article describing the result of an international survey of linguists about their encounters with ethics review. Though the author of the article claims that "in general, ethics regulation appears to be working," her data suggest that IRB review exacts a heavy cost in time and knowledge with little clear benefit.

[Claire Bowern, "Fieldwork and the IRB: A Snapshot," Language 86 (December 2010): 897-905 | DOI: 10.1353/lan.2010.0048]

Monday, January 16, 2012

SBS White Paper Calls for Drastic Reform

Weighing in at 72 pages, the "Social and Behavioral Science White Paper" is the most detailed response to the ANPRM from scholars in the social sciences. The paper presents a grim picture of the state of IRB review and is generally supportive of the ANPRM's goal of reform. But it offers detailed, helpful warnings about the potential effects of the proposed "excused" category and the adoption of HIPAA as a model for confidentiality requirements. Though it shies away from the toughest questions about the IRB system, it is a good expression of the frustrations felt by so many researchers in the social sciences and humanities.

[American Educational Research Association et al., "Social and Behavioral Science White Paper on Advanced Notice for Proposed Rulemaking (ANPRM), Federal Register 44512-531 (July 26, 2011); ID Docket HHS-OPHS-2011-0005," 26 October 2011.]

Thursday, January 12, 2012

NIH Pledges $1 Million for Research on IRB Regulations

A January 10 HHS press release notes that "the National Institutes of Health is committing $1 million to support research that will be used to evaluate the impact of the revisions to the HHS regulations governing human subject research that are currently being considered. Assessing the impact of the revisions that are ultimately implemented will be critical to the development of an evidence-based approach to ensuring the effectiveness of human research subject protections."

You have my attention.

h/t: Theresa Defino.

Wednesday, January 11, 2012

Anthropologist: IRBs Create "the Worst of Possible Worlds"

Jonathan Stillo, a PhD candidate in medical anthropology at the CUNY Graduate Center, writes with great sensitivity of the ethical challenges he faced while studying mortally ill patients at a tuberculosis sanatorium in Romania. He suggests that IRB review was at best an irrelevance and at worst a hindrance to his efforts at ethical research.

[Jonathan Stillo, "The Trobriand Islanders Never Friended Malinowski on Facebook," 30 November 2011, CAC.OPHONY, and "Research Ethics in Impossibly Unethical Situations," CAC.OPHONY, 21 December 2011. Another hat tip to the indefatigable Roberto Veloso. I realize the IRB angle on this may be the least interesting part of Stillo's story, but this is the blog I have.]

Monday, January 9, 2012

Washington Post Confuses "Research," "Experiment," and "Medical Experiment"

On January 1, the Washington Post ran an editorial, "Medical Experiments on Humans," claiming that "in 2010, the federal government funded 55,000 experiments worldwide on human subjects" and citing "Moral Science."

But "Moral Science" does not make that claim. Rather, it states that "The federal government supported more than 55,000 human subjects research projects around the globe in fiscal year 2010, mostly in medical and health-related research, but also in other fields such as education and engineering." It does not break the 55,000 figure into experimental and non-experimental approaches.

The editorial shows some awareness of the complexity of human subjects research, noting that many people "take part in projects fueled by federal dollars that focus on social science and education research." But the editorial's headline, "Medical Experiments," does not match the data in the body of the editorial. As we proceed with regulatory reform, I hope editorial boards will learn to read and write more carefully.

Wednesday, January 4, 2012

Monday, January 2, 2012

Does Moral Science Think the System is Working?

I am struggling to understand an apparent contradiction in the Presidential Commission's report, Moral Science.

On page 42, we learn that

The current U.S. system provides substantial protections for the health, rights, and welfare of research subjects and, in general, serves to "protect people from harm or unethical treatment" when they volunteer to participate as subjects in scientific studies supported by the federal government.

But on page 55, the report concedes that

There remains a dearth of knowledge about the actual efficacy of human subjects protections. Given this, the Commission recommends that the federal government support an expanded operational research agenda to study the effectiveness of human subjects protections.

If there is a dearth of knowledge about the actual efficacy of human subjects protections, how could the Commission conclude that the current system serves to protect people from harm or unethical treatment?

And if there is a dearth of knowledge about the actual efficacy of human subjects protections, why does the Commission recommend that the federal government "require that all federal agencies conducting human subjects research adopt human subjects regulations that are consistent with the ethical requirements of the Common Rule"?

Sunday, January 1, 2012

Happy New Year, OHRP!

I started 2009, 2010, and 2011 with complaints that OHRP had failed to act on two reform initiatives it had undertaken in 2007.

In February 2007, Bernard Schwetz promised that by the end of 2007, OHRP would issue new guidelines that would give a lot of examples and will give more guidance on how to make the decision on what is research and what is not." And in October 2007, OHRP formally requested "written comments on a proposed amendment to item 5 of the categories of research that may be reviewed by the institutional review board (IRB) through an expedited review procedure, last published in the Federal Register on November 9, 1998 (63 FR 60364)."

OHRP has yet to issue Schwetz's promised examples and guidance, or to amend the expedited review list. But July's ANPRM goes so far toward honoring both of these promises that I can say with full voice, Happy New Year, OHRP! I look forward to a cooperative and productive 2012.