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Institutional Review Blog



News and commentary about Institutional Review Board oversightof the humanities and social sciences



Updated: 2018-01-19T08:58:42.243-05:00

 



Revised Common Rule Delayed at Least 6 Months

2018-01-19T08:58:42.386-05:00

The new Common Rule was supposed to go into effect today, but OHRP has declared a six month delay in the implementation of most of its parts. This apparently includes a delay in the redefinition of research and the liberation of oral history.


The official announcement is set to his the Federal Register on January 22, but an unpublished rule is online at https://federalregister.gov/d/2018–00997.


Here’s the justification for delaying the new definitions of research and the new exemptions:


The 2018 Requirements include four explicit categories of activities that have been deemed not research for the purposes of the Common Rule. In the absence of guidance, it would be difficult for institutions to fully take advantage of the exclusion of activities from the definition of research; therefore we now assume that many institutions would not have used these categories without guidance.


The 2018 Requirements also include five new exemption categories, and modify all but one exemption that exists in the pre–2018 Requirements. We have received feedback from SACHRP that many of the exemption categories will require significant guidance in order to be implemented. Areas where significant guidance is needed include: applying the categories of the new exemptions themselves, conducting limited IRB review (as required in four exemptions), developing and using broad consent (as required in two exemptions), utilizing the exemption for certain HIPAA covered activities, and understanding which federally supported or conducted nonresearch information collections qualify for exemption. Because the guidance necessary to implement these provisions has not yet been developed, we now assume that 50 percent of the regulated entities would not have taken advantage of the expansion in exemptions or the revised definition of research during the six-month delay.


OHRP essentially argues that in the six and a half years from the 2011 ANRPM through today, it has been unable to craft regulatory language or accompanying guidance clear enough that institutions can use it to oversee research.


The truth is, since the crackdown of 1998, universities have spent twenty years guessing what OHRP wants from them. As Robert Klitzman writes in The Ethics Police:


The fact that federal agencies at times communicated in limited, incomplete, or frustrating ways appeared to compound these problems. Committees may request clarifications from OHRP and the FDA, but find the answers “unhelpful.” Interviewees said that sometimes the agencies simply didn’t respond; and at other times, did so unsatisfactorily, merely reiterating the regulations without offering clarification. ”If they don t want to say much,” Liza said, “they’ll just repeat the regulations in five different ways.”


In not issuing definitive official opinions, federal agencies leave committees to wrestle alone with these vagaries. Working in this interpretive vacuum without guidance can generate stress and discrepancies. “The Feds often seem to back away from taking a stand;’ Troy, the chair, reported. "They’ll turn it back to us, and say, ‘Its up to the IRB.’ They’ll come in and criticize us later.” Stephen concurred:


Many times when you call for advice; they essentially just read back the regulations. You basically have to make your own decision, which is great, until you have an audit, and then you’re told you didn’t make the right decision.


Does anyone expect that another six months is going to fix this problem?




Schrag on Whitney, Balanced Ethics Review

2017-05-31T11:29:50.384-04:00

The Oral History Review has posted my review of Simon Whitney’s 2016 book, Balanced Ethics Review: A Guide for Institutional Review Board Members. (I think that’s three distinct uses of “review,” right?)


[Zachary M. Schrag, “Balanced Ethics Review: A Guide for Institutional Review Board Members. By Simon N. Whitney,” Oral History Review, accessed May 30, 2017, doi:10.1093/ohr/ohx030.]


I note,


Whitney’s approach is basically utilitarian, arguing that the good research creates outweighs its harms. In this vein, he values social science research as the equivalent of medical research . . but what of research that, like much humanities research and a fair amount of social science, aims only to increase human knowledge?


I conclude:


As Whitney well understands, IRB members face considerable pressure to overregulate. The universities or medical schools in which they work may ask them to review research (including oral history) beyond the scope of regulations, or to protect institutions from lawsuits. They will learn that they themselves are far more likely to be sued for letting one controversial study (like SUPPORT) proceed than for needlessly impairing dozens of less risky projects. And if they do receive training from the dominant institutions, they are likely to hear that “efficiency itself is not a moral imperative or an ethical value” (25). Whitney pushes back against this pressure. His book is well crafted to promote its stated goal: balance.


Oxford University Press asks that I not post a link to a free-access version of the review here, but it does allow me to post that link on my personal website.




Final Rule, three months later

2017-04-21T11:36:26.488-04:00

It’s been three months since the announcement of the new Common Rule. Some reactions so far:Shweder and Nisbett hope for vast deregulationOn March 12, Richard A. Shweder and Richard E. Nisbett published an essay in the Chronicle of Higher Education celebrating the new final rule:in January the federal government opened the door for universities to deregulate vast portions of research in the social sciences, law, and the humanities. This long-sought and welcome reform of the regulations requiring administrative oversight of federally funded human-subject research on college campuses limits the scope of institutional review board, or IRB, management by exempting low-risk research with human subjects from the board’s review.In particular, they wrote that “the overhauled policy … holds that exempted research activities should be excused from board review with no requirement of IRB approval of the exemption.”[Richard A. Shweder and Richard E. Nisbett, “Long-Sought Research Deregulation Is Upon Us. Don’t Squander the Moment” Chronicle of Higher Education, March 12, 2017.Meyer asks, what’s new?On March 16, Michelle N. Meyer tweeted a GIF showing that several of the provisions cheered by Shweder and Nisbett have been part of the regulations for decades. Indeed, since 2009, OHRP has grudgingly acknowledged that the Common Rule allows researchers to make exemption determinations. The problem has been persuading universities to take advantage of these longstanding provisions.On the other hand, Meyer notes that the liberation of oral history is new, and that the exemption for “benign behavioral interventions” is, in her terms, “new & awesome.”(GIF re-posted here with Meyer's permission.)Comments posted to the Chronicle website made similar points. They noted, for instance, that the final rule abandons the ANPRM’s proposal that for minimal-risk projects, “researchers would file with their institution or IRB a brief registration form (about one page long) that provides essential information about the study,” and that regulations could “discourage having each of these registration forms undergo a comprehensive administrative review prior to commencing the study or even afterward.”Shweder and Nisbett remain hopefulIn an April 19 essay, marking three months since the Federal Register publication of the proposed final rule, Shweder and Nisbett acknowledge the criticism. But they also emphasize that the proposed rule eliminates “the box” that encouraged institutions to submit all research, not just projects funded by the federal government, to federal oversight. “The Office for Human Research Protections has made it clear that it has no interest in overseeing research not funded by agencies bound by the Common Rule, the federal government regulations for human-subject research, or in applying the new regulations to such projects,” they write, and they encourage universities to take advantage of the new climate.[Richard A. Shweder and Richard E. Nisbett, “Don’t Let Your Misunderstanding of the Rules Hinder Your Research,” Chronicle of Higher Education, April 19, 2017]Dingwall DespairsWriting in Nature Human Behavior, Robert Dingwall despairs that the final rule did not adopt the bolder approaches of the National Research Council’s 2014 report, Proposed Revisions to the Common Rule for the Protection of Human Subjects in the Behavioral and Social Sciences. He writes, “The results are incoherent and unlikely to reduce the mistrust between social scientists and ethics regulators.”[Robert Dingwall, “Social Sciences Lose out Again in Common Rule Reform,” Nature Human Behaviour 1 (April 7, 2017): 83, doi:10.1038/s41562–017–0083.]Anthropologists, sociologists mostly silentThe American Sociological Association announced the biggest change to human subjects regulation in a generation in a 240-word item on page 3 of its newsletter. No analysis of how this will affect sociological research, or the failure of th[...]



Institutional Review Blog past and future

2017-02-17T10:10:38.321-05:00

This winter, the Institutional Review Blog passed two milestones. In December it turned 10 years old, and in January it reported on the largest reform in U.S. human subjects regulations since 1981. This seemed like a good time to archive another batch of postings, so I have deposited a second PDF with the the Mason Archival Repository Service. Now all postings from the start of the blog through the end of January 2017 can be found at http://hdl.handle.net/1920/8642. Many thanks to Wally Grotophorst, Associate University Librarian, George Mason University, for making this possible.


I am less sure about the future of this blog. In ten years I have posted about 445,000 words, a considerable investment of time and effort. I see no reason to formally close the blog, but I may be posting a good deal less frequently as I focus on completing my book about the Philadelphia riots of 1844.




You know, it's very strange

2017-01-19T18:02:11.977-05:00

On 19 January 2007, Inside Higher Ed reported the launch of this blog. Here is the kicker from that story:


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.”


Ten years later, to the day, the amended regulations are in the Federal Register.


You know, it’s very strange—I have been in the revenge business so long. Now that it’s over, I don’t know what to do with the rest of my life.


Should I consider piracy?




Why is Felice Levine satisfied?

2017-01-19T11:13:08.525-05:00

Inside Higher Ed reports that Felice J. Levine, executive director of the American Educational Research Association, is happy with the final rule. I’m curious about why; it doesn’t seem to give her anything she asked for in 2011.[Scott Jaschik, “U.S. Issues Final Version of ‘Common Rule’ on Research Involving Humans,” Inside Higher Ed, January 19, 2017.][Edited at 11:12AM to mention the normal educational practices in penultimate paragraph.]Here’s Scott Jaschik’s reporting on social science reactions to the final rule:Early reactions from social science groups to the changes in the common rule were positive. Various provisions suggest that institutional review boards, which must review proposals to study humans, work to understand the needs of different kinds of researchers, and that there are different levels of risk associated with taking an experimental drug and answering confidential survey questions.A statement from Felice J. Levine, executive director of the American Educational Research Association, said, “The revised regulations definitely show the care and hard work that went into this extensive effort to modernize the common rule. An open process that began in July 2011 has led in January 2017 to regulations that are more nuanced and that far better align human research protection and social and behavioral science research, taking into consideration level of risk and benefits. It is a fine outcome for research participants and for human science.”For anthropology, the reaction was more mixed. Anthropologists pushed hard for specific mention of “participant observation” (a key tool of their discipline). The hope is that mention of this methodology will make it easier for institutional review boards to approve projects involving this approach. Sometimes in the past, [Edward Liebow of the American Anthropological Association] said, IRB members or others have not understood that the relationship between an anthropologist engaged in participant observation isn’t the same as a scholar who is interviewing his or her research subjects.But he said that his association was “especially concerned” that the final version of the rule did not exempt participant observation, as his organization had urged.I can understand Liebow’s disappointment; the final rule offers little aid to frustrated ethnographers. I have more trouble understanding Levine’s satisfaction. In response to the 2011 ANPRM, she drafted the “Social and Behavioral Science White Paper,” which called for dramatic reforms to the IRB process. The final rule is largely unresponsive to the concerns expressed in that paper:The White Paper objected to the current  §46.116(a)(2) requirement that informed consent include a “description of any reasonably foreseeable risks or discomforts to the subject,” suggesting that “reasonably foreseeable harms” might better apply. The final rule does not make that change.The White Paper objected to the current rule’s “general mandate to apprise subjects as part of the informed consent process of alternatives to treatment or why it may be in their best interest not to participate. (Such requirements are sometimes appropriate, but add complexity and foster confusion where they are not.)” The final rule maintains the current rule’s language on this point.The White Paper “strongly support[ed] the requirement of an appeals process.” This was not included in the NPRM or final rule.The White Paper argued that “it should be incumbent on the reviewer to state specifically in writing what aspect of a registration document leads to doubt a project’s excused status and to refrain from review where it finds none.” The final rule [§__.115(a)(3)] takes a small step in requiring documentation of “the rationale for conducting continuing review of research that otherwise would not require continuing review,” but it does[...]



A social scientist’s guide to the Final Rule

2017-01-19T09:08:43.988-05:00

On 18 January 2017, sixteen federal agencies announced revisions to the Federal Policy for the Protection of Human Subjects. As I noted earlier, this marks a huge victory for historians, who have spent the last 20 years working to end the inappropriate interference of IRBs with oral history research.In addition, the final rule includes several provisions of note to scholars in the humanities and social sciences. Here are some of them; I don’t claim it is a complete list.No biospecimens overhaul; less controversyThe final rule “does not adopt the proposal to require that research involving nonidentified biospecimens be subject to the Common Rule, and that consent would need to be obtained in order to conduct such research.” This was the target of the greatest criticism from groups like the National Academies of Sciences, Engineering, and Medicine and SACHRP. So while this change has little direct bearing on the work of social scientists and scholars in the humanities, it will likely reduce the controversy surrounding the regulatory reform as a whole. The abandonment of the biospecimens proposal could also reduce opposition to reform by conservatives. The House Freedom Caucus opposed a new Common Rule on the grounds that it would cost $13.334 billion over 10 years. This figure seems to have been drawn from the NPRM’s quantified costs of $13.342 billion (using a 3 percent discount rate), and ignored the NPRM’s quantified benefits of $2.6 billion. If all the Freedom Caucus cares about is money, it may like the final rule a lot more. Of the $13.3 billion estimated costs, $12.2 billion came from complying with the new rules on secondary use of biospecimens (80 FR 54021). The new estimate is that changes will have benefits of $1.9 billion over 10 years and costs of only $528 million (at a 3 percent discount rate, which is where the $13.3 billion figure came from). If Republicans can consider benefits as well as costs (as the House Freedom Caucus has so far failed to do), perhaps the jettisoning of those rules will reduce hostility to the overall reform.Agencies continue to ignore statutory limitsLike previous versions of 45 CFR 46, this final rule claims as its statutory authority 42 U.S.C. 289, which applies to “biomedical and behavioral research,” yet it fails to restrict its provisions to such activities. The announcement explains:Regarding the concerns expressed that the Common Rule departments and agencies are not authorized to regulate humanities and social science research, this challenge had been asserted previously against the 1981 HHS protection of human subjects regulations, as well as the 1991 Common Rule, and in each case the regulatory agencies concluded that the regulation of humanities and social science research is justified. We continue to assert the authority to regulate humanities and social science research that falls within the scope of the final rule.Note the verb “assert.” Not find, show, explain, reason. No statutory analysis. Just raw assertion of power.The announcement cites the 1981 and 1991 Federal Register announcements, neither of which states that “the regulatory agencies concluded that the regulation of humanities and social science research is justified.” I know of no such formal finding.Similarly, the final rule abandons the NPRM’s proposal to impose review on clinical trials “regardless of the funding source of the specific clinical trial” without reference to the statute. Rather than concede that HHS lacks the statutory authority for such a requirement—something it did concede in 1981 (46 FR 8369)—it claims, “our proposal for extending the Common Rule to currently unregulated clinical trials would benefit from further deliberation.”Oral history is clear; ethnography is still regulatedAs I noted in my previous post, the new definition of research includes a provision [ §__.102(l)(1)] exp[...]



United States of America Frees Oral History!

2017-01-18T13:51:26.742-05:00

This morning sixteen federal agencies announced revisions to the Federal Policy for the Protection of Human Subjects, effective 19 January 2018. The final rule preserves and clarifies the NPRM’s deregulation of oral history. This is a great victory for freedom of speech and for historical research.The NPRM somewhat confusingly listed a number of activities “deemed not to be research” in §__.101, then presented the definition of research itself in §__.102. The final policy more logically defines research, then lists “activities … deemed not to be research.” Whereas the NPRM excluded “Oral history, journalism, biography, and historical scholarship activities that focus directly on the specific individuals about whom the information is collected,” the final rule offers a broader exclusion:For purposes of this part, the following activities are deemed not to be research:(1) Scholarly and journalistic activities (e.g., oral history, journalism, biography, literary criticism, legal research, and historical scholarship), including the collection and use of information, that focus directly on the specific individuals about whom the information is collected. [§__.102(l)(1)](Emphasis added, because I can.)So freedom depends on the activity, not the discipline, with literary critics, law professors, and others who interview individuals benefiting. Another section of the announcement notes that this provision will also apply to political scientists and others who hope “to hold specific elected or appointed officials up for public scrutiny, and not keep the information confidential.” The announcement explains the reasoning:In these activities, the ethical requirement is to provide an accurate and evidence-based portrayal of the individuals involved, and not necessarily to protect them from public scrutiny. For example, a biographer might collect and present factual information to support the biographer’s opinion about the character of an individual to show that the individual does not deserve the positive reputation he or she enjoys in society. These fields of research have their own codes of ethics, according to which, for example, consent is obtained for oral histories. We note that this consent standard should address the issue of oral histories of tribal members. For these reasons, we have determined that it is appropriate to remove these activities from the definition of research and from the scope of the Common Rule.In response to public comments, §__.102(l)(1) refers to more fields and methodological traditions than were proposed in the NPRM. The final rule also explicitly cites those fields and traditions as examples, in order to clarify that the focus is on the specific activities that collect and use information about specific individuals themselves, and not generalizing to other individuals, and that such activities occur in various fields of inquiry and methodological traditions. Literary criticism has been added as an example because while a piece of literary criticism might focus on information about the author(s), it would typically focus on the specific author(s) in view. Legal research has been added as an example because it would often focus on the circumstances of specific plaintiffs or parties involved in a case. It is not the particular field that removes the activity from the definition, but rather the particular activity’s focus on specific individuals.I will be posting more later about the potential effects of the revised rule on the humanities and social sciences more generally. For now, I salute all those who worked for so many years to liberate oral history, especially Jonathan Knight, Cliff Kuhn, Don Ritchie, Roy Rosenzweig, Linda Shopes, Rob Townsend, and everyone who took the time to comment on the ANPRM and NPRM. [...]



Common Rule reform still in suspense

2017-01-07T22:25:08.434-05:00

A proposed final rule on human subjects protections made it to the Office of Management and Budget on Wednesday, January 4.


Jeannie Baumann of Bloomberg thinks this means that we’ll see it in the Federal Register before January 20. But she also quotes Lisa Nichols, director of research and regulatory reform for Council on Governmental Relations, predicting that Congress will overturn the reform, since it appears on the House Freedom Caucus hit list.


Wake me up when it’s over.


[Jeannie Baumann, “White House Takes Final Steps to Revamp Medical Research Rule,” Bloomberg BNA, January 6, 2017.]




Reforms for “21st century science” would have been good for the 20th too

2017-01-02T12:08:07.766-05:00

A group of 11 researchers and IRB professionals, most of them affiliated with the University of California, San Diego, report on a brainstorming session from early 2015. They argue that readable consent forms, expert review, a less punitive system, and more exemptions would better serve researchers and participants. While they present their ideas as “a human research protections system that is responsive to 21st century science,” the measures they propose are equally valid for research as it has been practiced for decades.[Cinnamon Bloss et al., “Reimagining Human Research Protections for 21st Century Science,” Journal of Medical Internet Research 18, no. 12 (2016): e329, doi:10.2196/jmir.6634.] Five recommendationsThe team presents its proposals under five headings, but I see the second and fifth as similar in intent.Redesigning the Consent Form and ProcessThere’s broad consensus that written consent forms often fail to give prospective research participants the information they need to make a good decision. The UCSD team proposes consent forms based on Creative Commons licenses (like the one used by this blog). “Research studies,” they explain, “could create three consent forms: one that contains all the legalese and scientific exposition; one in plain English that presents the facts; and a third that is simplified even further and presents risks in bullet point format.”Empowering Researchers to Protect ParticipantsThough the authors call for “empowering researchers,” really they are calling for expert peer review:Researchers intending to engage in human-participant research could produce a document that lays out plans and risks of the research. They could then offer those documents, along with an outline of the proposed consent process, for review by their peers. Peers would be researchers in the field of relevance for the research. These documents could be posted on the Web in the same way clinical trials are registered; not to get approval but to create a public record of the research … Using [a] Web-based resource, within a few hours, researchers posing questions such as “How do I ensure that I won’t cause harm by asking this interview or survey question?” would receive answers from researchers who have been rated in terms of experience and expertise in human research protections. Elements of the plans could ultimately become like “protection modules” that could be swapped in and out of consent forms and research protocols, drawing attention to highly ranked modules.Reinforcement and Learning From ExperienceLike Greg Koski, the San Diego team sees the aviation safety system as a promising model. To encourage the sharing of important information, that system relies on more transparency, and less punishment for non-compliance.Pilots who have a “bad” landing or make another safety-related error who self-report their mistake are spared from punishment, but those who do not report it themselves are penalized if someone elects to report. Analogously, as an alternative to an IRB, in this system, researchers who create a protocol they believe to be safe, who then observe a harm during the research and who report that harm to their university or institution, present an opportunity for the research institution and community to learn how to prevent future harm.Increasing Efficiency of the Institutional Review BoardThe authors call for several measures to track and ultimately reduce the costs of IRB review. Of particular concern to this blog is their suggestion that IRBs “use the ‘exempt’ category to a greater degree, as it was intended. The exempt category is frequently appropriate for the vast majority of social and behavioral science studies, yet it is underused, which leads to delays in review and approval and, thus, wasted resources.[...]



Calls for Ethical Pluralism

2016-12-15T10:36:09.348-05:00

In separate essays, Nathan Emmerich and Igor Gontcharov argue for more flexible systems that would avoid imposing biomedical ethics on the social sciences. Emmerich calls for an emphasis on professional ethics, while Gontcharov seeks “a set of ethical principles that would better reflect the position of [social sciences and humanities] researchers and participants.” I am left unsure what either proposed reform would look like in practice. [Nathan Emmerich, “Reframing Research Ethics: Towards a Professional Ethics for the Social Sciences,” Sociological Research Online 21, no. 4 (2016): 7, DOI: 10.5153/sro.4127; Igor Gontcharov, “A New Wave of Positivism in the Social Sciences: Regulatory Capture and Conceptual Constraints in the Governance of Research Involving Humans,” SSRN Scholarly Paper (Rochester, NY: Social Science Research Network, October 31, 2016), DOI: 10.2139/ssrn.2861908.]Emmerich seeks professional ethicsEmmerich argues that the social sciences can lay claim to a democratic ideal as its ‘higher good’ and, therefore, its guiding ethos or end… . Given this end – democracy – social science research is persuaded not for its own sake or for the sake of knowledge in itself. Rather, its pursuit is rooted in the (admittedly diverse) socio-political needs of ‘democracy,’ understood as an ethos or normative as an end in itself. Because of the importance of this work, he argues, researchers should not be constrained by ethics committees. Instead, he proposes that social scientists be judged by the equivalent of clinical ethics committees (CECs), which Emmerich describes as forums healthcare professionals can attend in order to discuss any ethical issues they encounter. Committee members are usually healthcare professionals but may also include lawyers, theologians, (bio)ethicists, and patient representatives or lay persons. Debates are relatively informal and if a committee offers a collective opinion – which is not always the case – decisions regarding any action remain the responsibility of those professionals directly involved in the case. CECs therefore provide a forum for debate and, as such, a means to improve the quality of ethical reflection in practice.Were social scientists trusted to the same degree as these healthcare professionals, they couldjustify the ethical aspects of their proposal with reference to the specific disciplinary norms that guide their work as professionals. The subsequent discussion would, of course, offer critique or raise additional issues as necessary. Such committees could, if they saw fit or if it were considered helpful to do so, produce a written comments or recommendations but, in so far as they are justified in doing so, the individual researcher could proceed within the boundaries of their own professional ethics.I’ve long thought that making ethics review voluntary could force ethics committees to improve the quality of their recommendations. As it stands, committees can use threats to impose their will, so they need not persuade researchers of the value of their suggestions. If stripped of this power, they would need to make suggestions good and clear enough to inspire voluntary compliance. But I’m less sure that such a switch requires or merits the wholesale reframing from research ethics to professional ethics. If your profession is research, aren’t research ethics a form of professional ethics?I also wonder about Emmerich’s comparison of social science to “the true professions of law, medicine, [and] the clergy.” It strikes me that a key characteristic of these professions is the ability (in theory) of fellow professionals to disbar, debar, or defrock. Social scientists do not have such power. In my essay, “Ethical Pluralism,” in The Ethics [...]



Ten Years of Blogging

2016-12-12T16:08:10.918-05:00

The Institutional Review Blog launched ten years ago today. I would like to think that with or without a new Common Rule, it’s done some good, but I would dearly love to see oral history liberated in the next 39 days.


(image)



Big Data researchers call for IRB review, based on shaky premises

2016-12-09T16:27:46.678-05:00

Jacob Metcalf of the Data & Society Research Institute and Kate Crawford of Microsoft Research, MIT Center for Civic Media, and New York University Information Law Institute (I think those are three different things) want to subject Big Data research to IRB review, at least in universities. Their argument rests on shaky premises.[Jacob Metcalf and Kate Crawford, “Where Are Human Subjects in Big Data Research? The Emerging Ethics Divide,” Big Data & Society 3, no. 1 (January–June 2016): 1–14, doi:10.1177/2053951716650211.]Assumptions about assumptionsMetcalf and Crawford understand that the current Common Rule does not require IRB review of publicly available datasets. Claiming to be “historicizing extant research ethics norms and regulations” and drawing lessons “from the history and implementation of human-subjects research protections,” they proceed to invent a history of the relevant provisions.They write,US research regulations (both the current rules and proposed revisions) exempt projects that make use of already existing, publicly available datasets on the assumption that they pose only minimal risks to the human subjects they document. (1)AndThe Common Rule assumes that data which is already publicly available cannot cause any further harm to an individual. (3)AndThe criteria for human-subjects protections depend on an unstated assumption that we argue is fundamentally problematic: that the risk to research subjects depends on what kind of data is obtained and how it is obtained, not what is done with the data after it is obtained. This assumption is based on the idea that data which is public poses no new risks for human subjects, and this claim is threaded throughout the NPRM. While this may have once been a reasonable principle, current data science methods make this a faulty assumption. (8. Italics in original.)At no point do they cite any evidence that regulators excluded publicly available material from review out of the belief that it bore no risks.Here’s what the regulators had to say when they released the 1981 regulations, which introduced the present definition of research:Several commentators felt that the definition is too broad and should be restricted to biomedical research. These commentators felt that the definition should not encompass subjects not at risk, social science research, or historical research; and some preferred voluntary application of the regulations to behavioral research. In contrast, a few commentators suggested that the definition should encompass research which is so specific as not to yield generalizable results. One commentator argued that the definition violated the First Amendment or at least academic freedom in the area of biographic research …HHS has reinserted the term “private” to modify “information.” This modification is intended to make it clear that the regulations are only applicable to research which involves intervention or interaction with an individual, or identifiable private information. Examples of what the Department means by “private information” are: (1) Information about behavior that occurs in a context in which an individual can resonably expect that no observation or recording is taking place, and (2) information which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public. In order to constitute research involving human subjects, private information must be individually identifiable. It is expected that this definition exempts from the regulations nearly all library-based political, literary and historical research, as well as purely observational research in most public contexts, such as behavior on the stre[...]



Will Cures Act Replace Common Rule Reform?

2016-12-07T15:58:09.606-05:00

As of November 15, POLITICO thinks that Common Rule reform is dead:


HHS’s controversial revision of the Common Rule, the regulations that protect participants in clinical research, still hasn’t been sent to OMB for review. That’s not likely to get finished under Obama’s watch.


(David Pittman, “Obama’s HHS, Congress at Potential Odds over Pending Rule,” POLITICO, November 15, 2016)


On the other hand, Congress just passed the 21st Cures Act, which includes a provision for a Research Policy Board designed, as Science puts it, to “examine excessive regulation of research.”


In his September 29 testimony before the Subcommittee on Research and Technology, James Luther of Duke University suggested that the congressional effort could replace the executive one. He complained “that HHS is still trying to move forward with a final rule [for human subjects research] for which many of the proposals remain unchanged from the ANPRM despite overwhelmingly negative comments” about its provisions on biospecimens. And he suggested that a Research Policy Board might do a better job.


Perhaps such a board would attend to questions of concern to the social sciences and humanities, but I am not hopeful. Luther’s testimony cites the May 2016 analysis by the Council on Governmental Relations (COGR) and the Association of Public and Land-grant Universities (APLU) and the June report by the National Academies of Sciences, Engineering, and Medicine’s Committee on Federal Research Regulations and Reporting Requirements. Both of those documents mostly ignored the social sciences and humanities.


The sun never sets on the Ethical Empire.




Qualitative Sociologists Find Standard Randomness

2016-10-31T12:16:57.370-04:00

Sociologists Sarah Babb, Lara Birk, and Luka Carfagna surveyed qualitative sociologists about their IRB experiences and heard many of the usual horror stories, from insistence on inappropriate consent forms to the dribbling out of concerns over several rounds of comments. Few of their respondents are happy with the present system, though getting the right people in key positions can help.[Sarah Babb, Lara Birk, and Luka Carfagna, “Standard Bearers: Qualitative Sociologists’ Experiences with IRB Regulation,” American Sociologist, October 6, 2016, 1–17, doi:10.1007/s12108–016–9331-z. Note: I read a version of this article in manuscript and am so credited in the article.]Standardization and arbitrariness can coexistThe authors begin with a puzzle: Researchers … have raised concerns about two apparently contradictory problems. On the one hand many studies have observed that different local IRBs arrive at inconsistent decisions regarding the same research proposal, causing significant difficulties for biomedical researchers working across multiple institutions… . On the other hand, researchers in the social sciences and humanities, especially qualitative interview researchers, are more likely to charge IRBs with extending homogeneous, biomedical standards to different kinds of research . . . Why does standardization appear to be such a dominant theme in qualitative researchers’ experiences with their IRBs?As the following page makes clear, this is not so difficult a conundrum. What researchers colloquially call the “IRB” is more properly understood as a human research protection program (HRPP) with two parts. First, the institutional review board itself, composed (in a university setting) mostly of faculty, and second, the IRB administrative staff that conducts the initial screening and sets up forms and procedures. The staff component imposes highly standardized rules, then feeds any procedures raising concerns to the IRB itself, which abandons standards. It’s like going to the airport and making it through a list of security procedures—photo ID, boarding pass, shoes off, belt off, liquids in a clear bag, laptop out—only to board a plane whose destination will be chosen based on the pilots’ whim after they’ve taken off. Few qualitative sociologists like the IRB process as it now existsBabb et al. interviewed “26 sociologists at nine institutions of higher education in the Northeastern United States.” Though they included institutions whose sociology chairs offered “a range of reported IRB experiences—two more negative, three more positive, and three mixed,” only two of the 26 people they interviewed “believed that IRB review was both important and legitimate in its current form,” and one of those serves on an IRB. Of the remaining 24 respondents, six “felt that IRB regulation of sociological research was antithetical to professional norms and illegitimate” and 18 described “a conflicted sense of regret that a system designed to attend to an important issue was causing problems.”Rejection isn’t the problemIRB apologists occasionally point to a low rejection rate as a sign that the system works. This article reminds us that IRBs don’t need to reject a proposal formally to hinder research.Michael, at State University remarked that “there’s a lot of work to do to get the IRB to decide they’re not all that interested in what you’re up to.” Completing an IRB protocol—an extended form describing a research project–can take a significant investment of time, even where the research is very low risk. However, the most common concerns about paperwork were related not to[...]



Final Rule in 2016?

2016-10-25T12:05:36.525-04:00

Theresa Defino reports that OHRP “hopes to get ‘something’ out by year end.”


If OHRP were to liberate oral history on the 10th anniversary of this blog, that would be OK with me.




Brazil calls for "equitable representation from the Social Sciences and Humanities"

2016-10-02T11:59:25.813-04:00

Brazil is revising its research ethics standards in ways that will help tailor them to research in the social sciences and the humanities. The standards provide for greater representation by scholars in those fields when policies and decisions are made, and they decenter some of the medical assumptions that had previously governed all research. But they do not go as far as the Canadian TCPS2 in recognizing the legitimacy of critical inquiry.[Iara Coelho Zito Guerriero, “Approval of the Resolution Governing the Ethics of Research in Social Sciences, the Humanities, and Other Disciplines That Use Methodologies Characteristic of These Areas: Challenges and Achievements,” Ciência & Saúde Coletiva 21, no. 8 (August 2016): 2619–29, doi:10.1590/1413–81232015218.17212016.] In Brazil, a National Research Ethics Committee (Comissão Nacional de Ética em Pesquisa, or CONEP) oversees each local Research Ethics Committee (Comitê de Ética em Pesquisa, or CEP). As in other countries, medical researchers and health officials have dominated the crafting of policy, resulting in restrictions that make little sense for research in the social sciences and humanities (SSH). Since 2013, public health researcher Iara Guerriero and other members of a Working Group in Social Sciences and Humanities have labored to improve this situation, and in April 2016 they won National Board of Health approval for their resolution. In her article, Guerriero publishes the resolution and notes four major advances:Equitable composition of CONEP and involvement of SSH members in reviewing the protocols for these areas.Recognition that scientific merit must be assessed by competent areas.Discrimination between the process of obtaining and registering consent.Explanation of studies that do not require analysis by the REC/CONEP system, where the preliminary steps are not assessed.Since a major finding of Ethical Imperialism was that inappropriate regulations are the product of the exclusion of social scientists and humanities research from policy making, I am particularly encouraged by the first advance. Article 26 of the resolution states thatThe ethical analysis of the study projects to which this Resolution refers can only be done by Research Ethics Committees that have an equitable representation of members from the Social Sciences and Humanities area, with the reporters being selected from among those members qualified in this area of knowledge.Achievements 3 and 4 are also potentially quite significant. One of the enduring complaints of social scientists over the decades has been the poor fit between experimental models, which expect protocols to be designed in advance of any research, and the actual practices of qualitative researchers, whose projects evolve less predictably. Canada’s TCPS2 states that “REBs should be aware that it is quite common for specific questions (as well as shifts in data sources or discovery of data sources) to emerge only during the research project,” and it sounds as though Brazil is moving in that direction as well.The Brazilian resolution does not mention historical research, journalism, or any form of critical inquiry, and I am troubled by Article 3, section VIII, which presents the principle of “Researcher assurance that the information obtained as a result of the study will not be used to harm participants.” As I have repeatedly noted on this blog, journalists, historians, political scientists, sociologists, and even anthropologists have acknowledged that some research is legitimately critical of the people it concerns, and there is nothing wrong i[...]



"One more impediment to getting a worthwhile project done"

2016-10-01T12:37:07.282-04:00

A final horror story posted in response to Patricia Aufderheide’s essay, “Does This Have to Go Through the IRB?."


Brian Abel Ragen writes,


Eventually you will probably find a reasonable person to stop the nonsense. That was my experience when one of my graduate students was told that his plan to interview a writer for the New York Review of Books meant he was using “human subjects” and therefore needed to submit his thesis proposal to the IRB after filling out all the appropriate forms and applications. A student asking a professional literary critic why he had championed the reputation of a certain novelist was, quite rightly, seen as an interaction WITH a fellow human being, not research ON a human subject. But that should have been obvious from the beginning. What the whole process did for me as an English professor and my student in the humanities was to create just one more impediment to getting a worthwhile project done—this new obstacle laced with fear of getting in trouble with the Federal government if we made a mistake. It also protected a writer from hearing from someone who admired his work and wanted to explore it with him for a few weeks. So I would say that the limits of the IRB’s powers need to be more clearly drawn, so as to remove one more hazard from the already obstacle-strewn path to completing a degree or a research project. I won’t say that i can’t imagine projects in literary studies that don’t involve using people as actual “human subjects,” but I think the default assumption should be that any project that involves neither deception nor asking the interlocutor to do anything but talk about something is beyond the scope of an IRB.


An IRB need not block a project to discourage curiosity.




IRB consent form spooked respondents

2016-09-30T18:03:25.070-04:00

Commenting on Patricia Aufderheide’s essay, “Does This Have to Go Through the IRB?,” a writer with the screen name “reinking” relates:


I was investigating a routine instructional intervention in a school district serving a large hispanic population. IRB required, not just that the consent form be translated into Spanish (not unreasonable if a consent form was necessary), but also that I develop several versions in different dialects. Nonetheless, when sent to parents, remarkably few were returned, and I eventually determined why. The standard template for IRB consent (modeled on far riskier medical research) indicated that any questions or concerns should be directed to me as “principal investigator.” “Investigator” was apparently a term (in English or Spanish) that set off alarm bells among parents in this hispanic community.


So much for IRB sensitivity to local conditions.




More failures of "local precedents"

2016-09-19T18:53:30.526-04:00

Laura Stark’s 2012 book, Behind Closed Doors: IRBs and the Making of Ethical Research, devotes a chapter to what Stark calls “local precedents,” her term for “the past decisions that guide board members’ evaluations of subsequent research.” “By drawing on local precedent,” Stark claims, “board members can read new protocols as permutations of studies that they have previously debated and settled based on members’ warrants. The result is that IRBs tend to make decisions that are locally consistent over time.” (47)But I keep getting stories about IRBs that are locally inconsistent.Stark made her generalization after observing a handful of cases in which IRBs claimed to be either basing decisions on ones they had previously made, or making new decisions that would guide future rulings. But as far as I can tell, she did not systematically audit IRB files to test the degree to which IRB decisions are in fact locally consistent.I have long had my doubts about this claim of consistency, since so many stories from frustrated researchers concern identical studies presented to the same IRB with differing results. “The process that was approved in the first application was denied in the second because it was deemed coercive,” one complaint notes. “In every case in which we submitted the approved IRB application from the previous year, the IRB required additional changes,” another laments. A candid IRB chair admits that “Investigators may get quite different and inconsistent advice from the committee depending on what it feels like that day.”Two comments posted in response to Patricia Aufderheide’s essay, “Does This Have to Go Through the IRB?,” cast further doubt on claims of local consistency. Here they are, with the screen names of the authors:kgs_ssu At a university I don’t work at, I had a series of go-rounds regarding a caveat I placed in a proposal that boiled down to explaining that the participant pool I was working with is very small and there’s a chance some of the participants will talk to one another about this research. I had used identical language in two previous proposals at the same university. To appease the reviewer (who also strayed from reviewing to critique other areas of the proposal) I eventually removed the statement, even though I felt it was ethically appropriate to point this out and an unavoidable outcome of the type of research I am doing. The IRB personnel I worked with in that office helped as a go-between, but what a waste of time for her and for me, and I felt a tad compromised in the process.ergative:At one of my previous institutions, the IRB disliked the size of the font on the recruitment flyer I wanted to put up around campus, saying that the size in which I indicated the amount of compensation was too big relative to the size of the words saying “research study,” and therefore that constituted undue influence to participate. Silly, but I guess I can run with it, except that I used the exact poster template that my lab had been using for years under a different protocol. Depending on who or when the protocol was reviewed, absurd ticky-tack font-size objections would require corrections and resubmissions of the protocols, which resulted in an additional three or four weeks of waiting for approval.Such stories do not reveal the extent of IRB inconsistency, but neither do Stark’s observations. Without further investigation, I don’t think she can supp[...]



A satisfied customer at American University

2016-09-06T11:27:38.359-04:00

Patricia Aufderheide, University Professor of Communication Studies at American University, reports her satisfaction with the IRB at that institution. It’s great to hear some good news, and Aufderheide’s essay points to the importance of having the right people in positions of power. But it also raises questions about how good and how replicable AU’s experience is.[Patricia Aufderheide, “Does This Have to Go Through the IRB?,” Chronicle of Higher Education, August 17, 2016.] Aufderheide writes that the AU IRB, “which primarily deals with social-science and humanities research, has been more helpful to me than I ever expected it to be.” IRB staff review, she writes, helped her and a colleague think through reasons why the people they interviewed might hesitate to be interviewed, and the protocols they worked out gave them “a clear signal at the start of our work together that we were conscientious and considerate professionals.”Aufderheide credits the people involved. The IRB includes faculty in marketing, public opinion research, government, psychology, international relations, as well as a librarian. This is a far larger range of disciplines than most social scientists can hope to face, and AU is to be applauded for securing such intellectual diversity. Moreover, Aufderheide credits the unfailing patience of Matt Zembrzuski, the research compliance manager, who directs IRB operations.But Aufderheide’s raises some troubling issues as well, which suggest that not everything is as rosy at AU as she suggests, and that other universities may have trouble replicating the experience.Why is Aufderheide destroying records?The only research project that Aufderheide describes in any detail is an ongoing collaboration with Peter Jaszi to interview “creative colleagues on how they did their work, given their understanding of copyright.” As she describes the protocol,Our research team gave interviewees an informed-consent form that said in simple words what we were trying to find out and why, why we valued their time, what we thought the risks were, and how we would deal with those risks. We promised not to use their names in any published material, unless they wanted to be named (a surprising number did). We kept all the information in a passworded project-management site (Basecamp), and we deleted all the data after we completed our research.If respondents are willing to have their names used, why destroy all data? Why not give the participants the chance to have their interviews archived so that future generations can learn how copyright affected creative practice in the early 21st century? There’s gold in the interview outtakes. As Pat Bowne comments on the Chronicle site, “the phrase ‘delete the data afterwards’ sounds about as bad as ‘kill all the witnesses.’”Does the AU IRB understand minimal risk?Again, the essay is mostly vague about the projects reviewed by the IRB and the changes it demands, but it quotes Molly O’Rourke, a public-opinion researcher, in more detail:“Example, asking about the number of children someone has or marital status seems very standard — but not for a respondent who lost a child or is in the process of a painful divorce or separation,” said O’Rourke, the public-opinion researcher. “Appreciating that and writing research instruments that reflect that is hard but important.” She added: “I will never forget moderating a foc[...]



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

2016-08-11T11:35:07.397-04:00

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.]The researchers describe six qualitative social science projects they conducted over the past decade, in several countries. Three of the six projects secured IRB approval without seriously difficulty, but the other three were hampered by IRB constraints. Kaanta’s IRB demanded that she only interview inter-country Korean adoptees in places where she could find an on-call therapist in the event that her questions triggered “depression and emotional pain.” Nor was she allowed to interview pregnant women. Dickmann faced such a hassle getting permission to interview high school resource officers that she gave up on seeking permission to interview their spouses. And Opsal only got permission to interview women leaving prison after “many IRB challenges.”The authors appreciate that the IRBs have the participants’ best interests in mind, though perhaps this concern was mixed with “institutional risk mitigation and management.” But they argue that the IRB conditions can have the perverse effect of denying a good experience to the very people they are meant to protect.The fact is, people like being able to talk to a good listener. As they note,This was a major theme in Tanya’s study of adoptees as a number of her participants spoke of these transformational impacts. Vanessa explained,[Before participating] I did not realize how important a Korean identity was. I stifled my Asian-ness in an attempt to find acceptance from peers … I have made peace with my racial and ethnic identity. Thank you, Tanya, for an opportunity to participate in this study. Just verbalizing my experiences to you has brought about closure and healing to childhood issues I was previously unaware of. I’m happy being Asian. I’m happy having a white family. And, I’m happy I can finally say that.Unfortunately, IRBs do a poor job predicting such outcomes:These examples provide evidence that there is an important difference in the way individuals who hold more marginalized (“risky”) identities and those who do not experience the benefits across our project. The greater the IRB-defined risk of doing the research, the greater the quantity and quality of benefits expressed by the participants. There was not, however, a parallel finding in our themes centered on the risks individuals professed experiencing (or feared experiencing) by participating in the study. Specifically, we found no patterns of risk by research topic or population; in other words, not only were participants across our studies unlikely to identify experiencing risks because of their participation, but participants from vulnerable populations or sensitive topics were no more likely to identify risks.Instead, IRBs’ guesswork denies participants the right to make their own choices.IRBs tend to take a paternalistic approach to resear[...]



Will TCPS2 Improvements Reach Researchers?

2016-08-08T18:59:19.194-04:00

Canadian oral historian Nancy Janovicek applauds the ways that TCPS2 improves over TPCS’s treatment of oral history, but she warns that historians still must devote time to bureaucratic strategy that might be better spent exploring ethics and interviewing narrators.[Nancy Janovicek, ,“Oral History and Ethical Practice after TCPS2,” in The Canadian Oral History Reader, ed. Kristina R. Llewellyn, Alexander Freund, and Nolan Reilly (Montreal and Kingston: McGill-Queen’s Press, 2015), 73–97.]In 2003, Janovicek co-authored the Canadian Historical Association’s comments on TCPS, and in a 2006 article that became one of the first items mentioned on this blog, she warned that TCPS imposed anonymity on narrators who wished to be named, and that it suggested that Band Councils be allowed to censor indigenous narrators who might want to speak critically to historians. As she puts it in the new chapter,The original TCPS did not reflect historians’ ethics and professional concerns. It presented new dilemmas and criteria based on the policy’s emphasis on reducing harm, which had little to do with the moral issues that historians face in the field, REBs’ strict interpretations of the policy made it difficult to pursue projects on sensitive issues and often ignored the methods that are practised by oral historians and which are proven measures for balancing the reputations of their informants with the requirements of the discipline. (79)Canada proved more nimble than the United States in revising its guidelines, and the 2010 TCPS2 addressed Canadian historians’ concerns. The revised policy, Janovicek explains, recognizes that “in oral history, anonymity is the exception,” that “destroying evidence conflicts with what historians do,” that overprotection is a problem, and that “the interpretation of the policy must not impede research on controversial subjects in First Nations, Inuit, and Metis communities.” So far so good.But such wisdom does not instantly filter down to local REBs, which for twelve years under TCPS were trained to restrict research. As Janovicek concludes,Unfortunately, after the implementation of  the TCPS, historians were compelled to focus on bureaucracy; and since the introduction of TCPS2 this situation has not changed. Discussions among historians often turn to sharing strategies to ensure a successful application to the REB rather than examine deeper questions about balancing academic honesty with ethical considerations. Even though the revised policy incorporates many of the ethical issues that inform oral history practice, procedural questions continue to dominate historians’ conversations about ethics and research. There is reason for concern. In informal conversations at conferences some graduate students have admitted that they avoid oral history because they are concerned that ethics administrators will delay their research and make it impossible for them to complete their graduate work in a timely manner. At a workshop on oral history practice that I attended at Concordia University in 2011, which dealt with the ongoing ethical negotiations that influence relationships between scholars and research participants, graduate students spoke about difficulties with REBs. This was an international conference. The similarities among the graduate students, who were working under ethics policies in different countries, underscore the continued [...]



The Ethical Imperialism of the NAS

2016-07-01T12:42:15.236-04:00

The National Academies of Sciences, Engineering, and Medicine’s Committee on Federal Research Regulations and Reporting Requirements has released the second part of its report, Optimizing the Nation’s Investment in Academic Research: A New Regulatory Framework for the 21st Century. The new part includes a chapter on “Ethical, Legal, and Regulatory Framework for Human Subjects Research.” While presenting valid critiques of the NRPM, the chapter ignores the voices of scholars in social sciences and the humanities. Its proposals are unlikely to be adopted, and if they were they would continue the half-century history of marginalizing those disciplines. Yes, the NPRM has problemsThe report identifies four main problems with the NPRM:Several provisions of the proposed regulations have been identified as problematic. These include: (1) proposed changes relating to the definition and handling of biospecimens; (2) how determinations are made regarding whether certain types of research may be excluded from administrative or institutional review board consideration; (3) inconsistencies amongst the proposed changes; and (4) an absence of specifics for key deliverables… . The omission of specifics on key tools and guidelines like the exemption determination tool, consent templates, and list of privacy safeguards is problematic; because the items are undefined at present, it is impossible to comment on their merit or utility prior to the issuance of the final rule. Furthermore, it is not possible to provide an accurate estimation of regulatory impact without a clear understanding of what compliance will involve.All true. But the NAS counterproposal is unrealisticThe report recommendsthat Congress authorize, and the President appoint, an independent, free-standing national commission modeled on the President’s Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research. This commission was authorized by Congress under Public Law 95–622 in 1978, appointed by the President in 1979, and existed outside the structure of federal departments and agencies. The commission had a direct line-item appropriation from Congress, appointed its own staff, and set its own agenda.Congress should charge the proposed commission with examining and updating as necessary the ethical, legal, and institutional frameworks governing human subjects research. The commission should make recommendations to the President, Congress, and relevant federal agencies regarding how the basic ethical principles governing human subjects research should be applied to unresolved human research questions and novel human research contexts … The report notes that Congress ignored a 2002 proposal from the Institute of Medicine “for a standing independent, multidisciplinary, nonpartisan expert Committee on Human Research Participant Protections.” The report does not mention the half dozen failed efforts by Glenn and DeGette to pass new human subjects legislation. There is little chance that Congress is going to do anything.And even if Congress did act, that would take a couple of years, plus four or five years for the commission to run, then someone would have to translate its recommendation into a proposed rule, then the notice and comment, then the final rule. So really, the NAS is proposing a decade or more of the crappy status quo.The NAS perpetuates ethical imperialismT[...]



Linguist condemns "moral depravity of ethics protocols"

2016-06-13T15:31:09.279-04:00

George van Driem, Professor of Historical Linguistics at the University of Bern, minces no words in condemning the “moral depravity of ethics protocols.” He argues that human subjects rules primarily serve to cover the asses of Western universities while hampering linguists in the field and insulting the people they encounter. Paraphrasing couldn’t do justice to this marvelous essay, so enjoy the block quotations. Better still, read the whole thing.[George van Driem, “Endangered Language Research and the Moral Depravity of Ethics Protocols,” Language Documentation & Conservation 10 (2016): 243–252, http://hdl.handle.net/10125/24693].To illustrate the problem, Van Driem offers this horror story:One American researcher followed the dictates of the ethics protocol of the University of Oregon because the penalty for non-compliance for her would have been nothing less than to forfeit the right to earn a doctoral degree, even though, in the particular case in question, this involved just 400 Bhutanese ’ngütram, which at the time of the affair was less than US$10. The researcher was compelled to go back to a particular Bhutanese village and get a signature from a particular language informant on a receipt for this sum of money. The researcher in question did as she was told in good faith, and consequently the community ostracized her, shunning her on each subsequent visit because she had made them sign a legal document. The people of the language community later explained through intermediaries that they both felt insulted and were also genuinely afraid for having been made to sign a legal document, especially after all the assistance and hospitality which they had extended to the researcher. We are dealing with no less than a clash of cultures. Ethics protocols prescribe and require immoral, unseemly and outright rude behavior to be carried out by researchers in other societies with very different cultural norms. Yet how is it possible that these ethics protocols are so culturally insensitive?He finds the answer in the experience of another researcher, who himself “was born and raised in Bhutan with all the cultural and moral sensibilities of a morally upright Bhutanese citizen.” The Bhutanese researcher raised the issue that being compelled to sign a contract at all would be viewed by Bhutanese villagers as if they were not being treated in a civil fashion as human beings, whatever English label one might like to append to them as native speakers of their languages. The researcher objected that the feelings of the Bhutanese people should be taken into consideration. In response, one of the staff members of the Australian National University Ethics Division in a moment of candor told the Bhutanese researcher the following, as paraphrased by the researcher:“No, you don’t understand. We care deeply about the people in Bhutan. We care not only about today’s language community. We care even about the children and the grandchildren of these people, who might come to us one day and ask to see the written permission that their ancestors had granted us at Australian National University in order to be allowed to study their language.” This admission was highly revealing because it alludes quite plainly to what institutions and bureaucracies are really after.When I once asked a solicitor in Geneva specialized in U.S. law what the a[...]