"Vulnerable" participants may have the most to gain from talking

Seven qualitative researchers forcefully argue that IRBs mislead research participants when they demand consent forms stating that interview research has “no known benefits.” In fact, people labeled “vulnerable” by IRBs often gain a great deal by participating in projects the IRBs deem “risky.”

[Tara Opsal, Jennifer Wolgemuth, Jennifer Cross, Tanya Kaanta, Ellyn Dickmann, Soria Colomer, and Zeynep Erdil-Moody, “‘There Are No Known Benefits …’ Considering the Risk/Benefit Ratio of Qualitative Research,” Qualitative Health Research 26, no. 8 (July 2016): 1137–50, doi:10.1177/1049732315580109.]

Can community partners replace IRBs for field experiments?

In her contribution to the PS symposium, Melissa Michelson argues that “real-world practitioners” will often know more about relevant ethics and law than will the members of an IRB.

[Melissa R. Michelson, “The Risk of Over-Reliance on the Institutional Review Board: An Approved Project Is Not Always an Ethical Project,” PS: Political Science & Politics 49, no. 02 (April 2016): 299–303, doi:10.1017/S104909651600024X.]

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

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

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

PRIM&R and SACHRP Attack Social Science Exclusion

In their comments on the NPRM, SACHRP and PRIM&R oppose the proposed exclusion of “Research, not including interventions, that involves the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior (including visual or auditory recording) uninfluenced by the investigators” (§ ll.101(b)(2)(i)); they want such research to be moved from the excluded to the exempt category. But they differ in what they think the consequences of such a move would be; SACHRP thinks that researchers would face low barriers, while PRIM&R sees a chance for its members to continue to exert more control than is authorized by regulations. Both groups fail to represent the researchers most likely to conduct these kinds of studies.

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.

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]

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.]

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.]

AAA Draft Code: "Easily Remembered" or Overly Simplistic?

The American Anthropological Association (AAA) has released a draft code of ethics, the latest step in a revision process that began in late 2008, as well as a Final Report of The Task Force for Comprehensive Ethics Review. An Executive Board subcommittee is taking comments until January 30, 2012, at ethicsfeedback@aaanet.org.

As a non-anthropologist who respects disciplinary differences, I don't mean to tell anthropologists what to do, and I do not plan to submit a comment to the subcommittee. But I can point out that while the two documents represent an impressive effort, the draft code does not reflect all the concerns of some anthropologists who have thought seriously about ethical obligations.

Circuit Court Affirms Right to Record Videos in Public

As noted by the New York Times, a recent First Circuit decision in Glik v. Cunniffe affirms the First Amendment right to make video recordings in public places.

ANPRM's Problem Statement: Helpful but Incomplete

One of the many remarkable sections of the July 26 advance notice of proposed rulemaking (ANPRM) is its admission that the Common Rule is flawed.

(Note: I have added a link to the ANPRM at the top of the link list in the sidebar.)

Since the 1970s, IRB apologists have claimed that federal regulations are flexible enough, and that local IRBs are to blame for any problems. In 2007, for example, Jerry Menikoff quoted with approval Jeffrey Cohen's 2006 claim that "the regulations provide sufficient flexibility for the efficient and appropriate review of minimal risk research. IRB review of such research does not have to be burdensome or unreasonable if IRBs appropriately utilize the flexibility in the regulations." Menikoff reiterated his claim of "flexibility within the system" in his 2009 speech, “The Legal Assault on the Common Rule."

After thirty years of such claims, it is wonderfully refreshing that the ANPRM takes so seriously many of the critiques leveled at the federal regulations themselves. And the ANPRM helpfully organizes those critiques into seven general categories.

On the other hand, ANPRM's problem statement (pages 44513-44514 in the Federal Register version) overlooks some major critiques. Fortunately, some of those critiques are implicitly recognized by some of the ANPRM's proposals.

Dreger on Naming Names

Alice Dreger explains why historians are reluctant to promise either anonymity or nonmaleficence:

Real accountability requires real names.

Australian Political Scientist: "Causing Harm . . . May Be the Whole Point"

Anthony Langlois, Associate Professor in the Department of International Relations at Flinders University, Adelaide, Australia, and a former member and chair of that university's Social and Behavioural Research Ethics Committee, finds that Australia's 2007 National Statement on Ethical Conduct in Human Research is an improvement over earlier policies, but that it still leaves an "ill fit between the requirements of [the medical] model of research ethics review and the nature of humanities and social sciences research."

[Anthony J. Langlois, "Political  Research  and  Human  Research  Ethics  Committees," Australian Journal of Political Science 46 (2011): 139-154, DOI: 10.1080/10361146.2010.544287. Also available as a preliminary preprint. Thanks to Professor Langlois for mentioning the essay on socialsciencepsace.com.]

First, Do Some Harm, Part III: Loosies in San Francisco

The third recent document illustrating the problem of applying the Hippocratic maxim to non-medical research is Leslie E. Wolf, "The Research Ethics Committee Is Not the Enemy: Oversight of Community-Based Participatory Research," Journal of Empirical Research on Human Research Ethics 5, no. 4 (December 2010): 77–86. It offers a clear example of the kind of valuable research that is impeded by simplistic medical ethics.
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First, Do Some Harm, Part II: The AAA Ethics Task Force

In mid-October, the Ethics Task-Force of the American Anthropological Association solicited comments on the following text, a section of a draft Code of Ethics now being written:

Do No Harm

Anthropologists share a primary ethical obligation to avoid doing harm to the lives, communities or environments they study or that may be impacted by their work. This includes not only the avoidance of direct and immediate harm but implies an obligation to weigh carefully the future consequences and impacts of an anthropologist’s work on others. This primary obligation can supersede the goal of seeking new knowledge and can lead to decisions not to undertake or to discontinue a project. Avoidance of harm is a primary ethical obligation, but determining harms and their avoidance in any given situation may be complex.

While anthropologists welcome work benefiting others or increasing the well-being of individuals or communities, determinations regarding what is in the best interests of others or what kinds of efforts are appropriate to increase well-being are complex and value-laden and should reflect sustained discussion with those concerned. Such work should reflect deliberate and thoughtful consideration of both potential unintended consequences and long-term impacts on individuals, communities, identities, tangible and intangible heritage and environments.

As of December 13, 33 people (presumably all anthropologists, but I'm not sure) had posted comments. The comments are often nuanced, making it hard to say whether they endorse the language or not. But they broke down roughly as follows:

Do No Harm

Significantly, the most wholehearted supporters of the "do no harm" proposal are those who uncritically embrace the Belmont Report and the Common Rule. "'Do no harm' is an IRB principle, and so it should be in our code," writes Bethe Hagens. Four other responses, from Chip Colwell-Chanthaphonh, mkline, Robert T Trotter II, and Simon Craddock Lee, all seem to suggest that the AAA code should conform to those documents, without asking much about their origins or their fit to the practices and beliefs of anthropologists.

Four other responses--from Barbara Rose Johnston, Seamus Decker, socect, and Vicki Ina F. Gloer--endorse Hagens's idea that anthropologist should "intend no harm." Despite the Belmont Report's description of "the Hippocratic maxim ”do no harm” [as] a fundamental principle of medical ethics," this form is more faithful to the Belmont's overall section on beneficence.

Do Some Harm

Eight responses--almost as many--appear to reject the "do no harm" idea on the grounds that neutrality is impossible, and anthropologists should not hesitate to harm those who deserve it. "A blanket edict to 'Do No Harm' could easily lead to a professional paralysis when one considers that a few steps away from the person giving you this interview is someone who will not like, will want or need to fight, or will suffer consequences for what is said much further down the line," writes Benjamin Wintersteen. Murray Leaf concurs. "Do no harm is fine as principle of medical practice," he writes, "where you are working with a single individual. It is nearly meaningless when you (we) work with human communities, in which what is good and what is harm is usually in contention. As some of these posts suggests, what we do is often a matter of helping some while undermining the position of others. No harm at all, in such a context, would almost always be also no help at all–and no effect at all."

Bryan Bruns offers an example. "I work, in conjunction with communities and a government agency, to design and support a process in which communities are likely to, in a reasonably democratic way, act to restrain the behavior and thereby (harm) reduce the benefits of a few people (upstream irrigators, large landowners) who currently take advantage of others, it’s not clear how a principle of 'do no harm' would allow any practical engagement."

I would say that the responses by Dimitra Doukas, Joan P Mencher, Moish, Noelle Sullivan, and Ray Scupin all fall in this general category of respecting critical inquiry. Margaret Trawick's comment is harder to categorize. "I have been teaching 'Do no harm' to my students as the first ethical principle for anthropological fieldwork, for many years," she writes. "It is a difficult principle to follow, precisely because you never know what might cause harm, and therefore you have to THINK about what you are doing in the field more carefully than you might in everyday life. Good intentions are not enough. Additionally, 'harm to whom' is a good question . . . Sometimes to protect and advocate for one party (.e.g. Untouchables in India) is to, at the least, offend some other party – e.g. high caste Hindus." Given her understanding of this problem, I'm not sure why she teaches "do no harm" rather than something like "think about whom you are harming."

It's the Wrong Question

An even greater number of responses suggest that, in the words of Carl Kendall, "This principle is way too vague and self-directed to be practically useful." Kendall hints, perhaps cynically, that anthropologists need one set of principles these ethical principles to "pass IRB muster" and a second set "to protect communities and fieldworkers." Carolyn Fluehr-Lobban argues that "'Harm' should be problematized—are there agreed upon universal standards of harm, and where is there discussion of reasonable disagreement."

James Dow rejects the medical language of IRBs: "'Do no harm' is an good ethical principle to be applied to individual social relationships, which we hope that we understand; however, there is a problem when applying it to larger societies and cultures." Likewise, David Samuels writes that "The place where you need to get informed consent is at the point at which you have turned people into characters in your story. The medicalized pre-framing of the IRB process doesn’t cover that at all."

Taken as a whole, the responses suggest that only a minority of those commenting embrace the Belmont Report and the IRB process as enthusiastically as the AAA did in its 2004 statement that presents the active involvement of IRBs as a positive good. I hope the Task Force recognizes this, and takes the opportunity to reconsider the AAA's overall position in regard to IRB review.

[Hat tip to Alice Dreger. For a historical perspective on another discipline's efforts to craft a research ethics code, see Laura Stark, "The Science of Ethics: Deception, the Resilient Self, and the APA Code of Ethics, 1966–1973," Journal of the History of the Behavioral Sciences 46 (Fall 2010): 337–370.]

First, Do Some Harm, Part I: Denzin's Qualitative Manifesto

Three recent documents demonstrate the confusion that arises when people try to apply medical ethics to non-medical fields. I will describe them in individual entries.

In June 2010, Norman Denzin, Research Professor of Communications at the University of Illinois at Urbana-Champaign, published The Qualitative Manifesto: A Call to Arms (Left Coast Press). Chapter five seeks

to outline a code of ethics, a set of ethical principles for the global community of qualitative researchers. I want a large tent, one that extends across disciplines and professions, from anthropologists to archeologists, sociologists to social workers, health care to education, communications to history, performance studies to queer and disability studies.

Part of the impetus for this effort is Denzin's recognition that IRB guidelines may not match "guidelines grounded in human rights, social justice considerations" or disciplinary codes. He is familiar with the debate concerning IRBs, having read the Illinois White Paper, the AAUP reports, and "even a humanities and IRB blog where complaints are aired."

Denzin is also familiar with oral historians' concerns that IRBs impose inappropriate requirements, as well as statements of ethics from other qualititative researchers. He seeks to synthesize what he has learned in a footnoted dialogue, part of a "one-act play" entitled "Ethical Practices":

SCENE FOUR: Oral Historians

. . .

Speaker Two:: We do not want IRBs constraining critical inquiry, or our ethical conduct. Our commitment to professional integrity requires awareness of one's own biases and a readiness to follow a story, wherever it may lead. We are committed to telling the truth, even when it may harm people (Shopes, 2007a, p.4).

Speaker One:: When publishing about other people, my ethics require that I subject my writing to a fine-mesh filter: do no harm (Richardson, 2007, p. 170).

Speaker Two:: So there we have it. A set of methodological guidelines. (83)

No. What we have is a debate between Linda Shopes, a historian, and Laurel Richardson, a sociologist, about the ethical responsibility of an interviewer to a narrator. Their perspectives reflect important differences between their professions. They also refelct the particulars of the book in which Richardson's statement appears, an account of the last months of a dying friend--hardly the typical oral history or sociological study.

Denzin turns a blind eye to this debate, instead seeming to endorse both sides. In the play, Speaker Two states that "Beneficience, do no harm, is challenged in the oral history interview, for interviews may discuss painful topics, and they [sic] have the right to walk away at any time." That seems to endorse Shopes's position. But they book closes with a proposed ethical code that leans toward Richardson, calling on all qualitative researchers to "strive to never do harm." (122)

How can Denzin read and reprint historians' arguments, then reject them without even realizing he is doing so? Is the historians' position so hard to understand? Or is the lure of innocuity so powerful?