Thursday, December 31, 2015

NPRM: How to Exclude Journalism?

Few if any argue that journalists should be required to submit their work to IRB review. Some IRB apologists think journalism is too important to bear restriction, while others consider it so full of “blatant bias and even hyperbole” that it doesn’t deserve the dignity of review. But all participants in the debate, at least in United States, seem uncomfortable with the idea of subjecting journalists to prior restraint.


The question, as always, is how to draw the line between journalism and regulated forms of conversation. The NPRM’s proposed rule attempts to do so with a specific exclusion for “Oral history, journalism, biography, and historical scholarship activities that focus directly on the specific individuals about whom the information is collected.” Will that suffice?

Neither the NPRM's language nor SACHRP's proposed replacement is quite right, so let me suggest an alternative.

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.

Monday, December 28, 2015

I Agree With PRIM&R on Something

PRIM&R has posted its draft comments on the NPRM. I have found something to agree with.


PRIM&R writes:


Over the past 25 years, the difficulty of getting all of the agencies to agree on the Common Rule was cited as the grounds for concluding that changing any provisions would require a Herculean effort. It may well be that revising the entire Common Rule at once is a task that can only be undertaken once in a generation.


But if the current NPRM, issued four years after the ANPRM to revise the Common Rule (July 26, 2011), underlines how daunting a comprehensive revision can be, it also shows that the best, evidence-based revisions will not emerge from a process that tries to make all needed revisions at once. By perpetuating the view that regulations cannot be revised when needed, the current approach risks locking in place for another 25 years a number of provisions in the NPRM that even its most enthusiastic supporters admit are flawed in important ways.


Instead, we recommend that the relevant agencies pursue an issue-by-issue approach in which it is possible to “drill down” on an issue, to consider all the sections of the regulations where it arises and all the evidence that is available—and that is needed—to resolve it well. Further, the agencies should address each issue more openly, developing and relying upon evidence, and allowing consensus to emerge and revisions to be crafted that will work well for all stakeholders. This approach would not only produce better results, but would signal that, once adopted, any provision can be changed if it does not work as well as intended.


Yes, indeed.


I don’t go so far as to agree with PRIM&R that the proposed rule should be scrapped. Historians have already waited too long for their freedom. But even the best rules deserve reexamination more frequently than once every 25 or 35 years.


I would also note that PRIM&R embodies the system’s longstanding failure to consult “all stakeholders.” If PRIM&R is serious about that phrase, it should endorse the American Anthropological Association’s call for “a commission constituted specifically of social scientists (e.g., sociologists and the like), humanistic social researchers (e.g., cultural anthropologists and the like), and humanists (e.g., historians, legal scholars, and the like) … tasked with developing alternative guidance appropriate for their fields.”

In NPRM Comments, Historians Applaud Proposed Rule

In addition to the formal comments from the National Coalition for History, endorsed by other scholarly associations, individual historians have begun submitting comments on the notice of proposed rulemaking. Without exception, they endorse the proposal to free oral history from IRB review. The only opposition comes from a professor of education and psychology who seems to suggest that tribal governments should hold veto power over oral history research.


Here are some of the highlights, alphabetical by last name. I have edited some for brevity. Full comments can be found at http://www.regulations.gov/#!documentDetail;D=HHS-OPHS–2015–0008–0001

Saturday, December 12, 2015

Blog Day

The Institutional Review Blog is nine years old today. It continues its original mission of aggregating news and commentary about IRB review of research in the humanities and social sciences, such as Wednesday’s report of an article from Feminist Studies. And it has never been closer to its goal of regulatory reform.

Wednesday, December 9, 2015

Protecting He-Man Subjects

After frustrating encounters with IRBs concerning two research projects, sociologists Liberty Walther Barnes and Christin L. Munsch argue that “IRBs are gendered institutions in which members base their decisions on culturally dominant, normative images of women and men.”


[Liberty Walther Barnes and Christin L. Munsch, “The Paradoxical Privilege of Men and Masculinity in Institutional Review Boards,” Feminist Studies 41, no. 3 (2015): 594–622, doi:10.15767/feministstudies.41.3.594.]

Monday, December 7, 2015

My NPRM Response. Draft 1.

Though the deadline for commenting on the NPRM has been extended until January 6, I post here a draft of my comments in the hopes that they may help others craft theirs and send me feedback on mine.


Tuesday, November 24, 2015

NPRM Comment Deadline Extended to January 6

OHRP has extended the deadline for NPRM comments until January 6, 2016. As a teacher with papers to grade, I applaud this extension.

Sunday, November 22, 2015

NPRM: Will Political Science Interviews Require Review?

What do we know about interview research under the NPRM?


Whatever its final provisions, the new Common Rule seems bound to be much harder to follow than, say, Canada’s TCPS2. The proposed rule is full of cross references from one section to the next, and often to other documents, such as Subpart D or the Belmont Report. This makes it hard to figure out what it says about any given form of research.


Here’s what I’ve been able to figure out about one form: interview research. My sense is that the NPRM proposes to eliminate IRB review for the vast majority of conversations between consenting adults, but it may unintentionally impose review on projects that do not merit it.


Monday, November 9, 2015

Cliff Kuhn, 1952-2015

I am sorry to learn of the death of Clifford M. Kuhn, executive director of the Oral History Association. Among his many other contributions to the study of the past, Cliff was concerned with freeing oral historians from inappropriate regulation while championing ethical standards for their work. In recent weeks I had the pleasure to talk with him about our hopes for regulatory reform, and I deeply regret that those conversations cannot continue.

Thursday, November 5, 2015

Does the NPRM Exclude or Exempt Ethnography?

Though I could not attend the October 20 Public Town Hall Meeting on the Federal Policy for the Protection of Human Subjects (Common Rule) Notice of Proposed Rulemaking (NPRM), I’ve now watched the whole thing on YouTube. Much of the day was spent discussing procedures for biospecimens, which is outside the scope of this blog. But I was interested to see Julia Gorey of OHRP reply to questions that had been sent in by two anthropologists, Lise Dobrin, co-author of the American Anthropological Association’s 2011 comment on the ANPRM, and Edward Liebow, the AAA’s executive director. Gorey frankly admitted OHRP’s lack of expertise on ethnography but held out hope that ethnography may be exempt or even excluded under the NPRM’s proposals.

Wednesday, November 4, 2015

Historians Love the NPRM

Fifteen scholarly organizations, including the American Council of Learned Societies, the American Historical Association, the American Political Science Association, the Oral History Association, and the Organization of American Historians, have signed a letter endorsing the NPRM’s proposed exclusion of “oral history, journalism, biography, and historical scholarship activities that focus directly on the specific individuals about whom the information is collected."


The letter (whose authors kindly consulted me in its early stages) is unequivocal:


We concur with this recommendation of full exclusion of such activities from IRB oversight. It reflects an appreciation that these activities should not be evaluated under frameworks originally designed with the sciences in mind. It recognizes the value and attributes of these forms of scholarship. It eliminates any ambiguity about review, regulation and enforcement, and thus removes an enormous and contentious burden for both scholars and IRBs.

Don’t change a thing!

Tuesday, November 3, 2015

Scoping Out the Common Rule

Thursday I'll speak at a meeting to discuss "Revising and Expanding the Scope of the Common Rule," Evanston, IL.

Join us live or on the web.

Friday, October 30, 2015

Does PRIM&R Welcome History Exclusion?

In its response to the 2011 ANPRM, PRIM&R denied that an exclusion for “certain fields of study” was “even worth considering.”


Now, in comments on the NPRM, PRIM&R Executive Director Elisa Hurley writes, “some of the exclusions proposed in the NPRM will likely be widely welcomed, such as the explicit exclusion of journalism, oral history, biography, and historical scholarship activities.”


As Ellen Bresler Rockmore reminds us, passive constructions (“will … be widely welcomed”) can disguise meaning, and that is the case here; is Hurley among those who will welcome the change?


I hope so. But in any case, PRIM&R seems to be finally acknowledging the grievances of historians and journalists and the need for reform.

Thursday, October 22, 2015

Virginia Universities Take on Virginia Human Subjects Law

Virignia universities, including the University of Virginia, Virginia Tech, and Virginia Commonwealth University, want to reform Virginia’s human subjects laws, which in theory impose IRB requirements on all research in the state, even constitutionally protected speech like surveys conducted by news organizations and political polling firms.


[Derek Quizon, “New UVa Rector Discourages Post-Vote Dissent, Use of Email,” Richmond Times-Dispatch, August 17, 2015.]

Thursday, September 24, 2015

NPRM: Forgotten Folklore

The NPRM proposes “to explicitly exclude oral history, journalism, biography, and historical scholarship activities that focus directly on the specific individuals about whom the information or biospecimens is collected.” Not listed is another scholarly discipline that also focuses on specific individuals: folklore. Why?


TCPS Envy, Continued

Writing in the Journal of Academic Freedom, law student James Nichols presents Canada’s TCPS2 as a model of balance “that promotes intuitive and promising research without sacrificing human integrity and protection.” However, his conclusion is largely speculative, since we still lack studies of how the document is working in practice.


[James Nichols, “The Canadian Model: A Potential Solution to Institutional Review Board Overreach,” Journal of Academic Freedom 6 (2015)]

Sunday, September 20, 2015

Alarmist Claims about Public Administration Research

Two scholars from the University of South Africa claim that more than one in four articles they sampled in two journals of public administration involved “research of a more than minimal risk level.” This claim appears to be based on a misunderstanding of U.S. regulations.


[Jacobus S. Wessels and Retha G. Visagie, “The Eligibility of Public Administration Research for Ethics Review: A Case Study of Two International Peer-Reviewed Journals,” International Review of Administrative Sciences, September 3, 2015, 0020852315585949, doi:10.1177/0020852315585949.]


Friday, September 18, 2015

NPRM. Statute? What Statute?

The NPRM cites 42 U.S.C. 289 as its statutory authority, but it does not seem to care much about following the language of the statute.

Friday, September 11, 2015

NPRM: Escape for Many, Scant Relief for Those Left Behind

While the NPRM might do much to reduce the number of projects requiring IRB review, it would do little to improve the quality of review for those projects for which it is still required. This is a retreat from the more ambitious plans of the 2011 advance notice of proposed rulemaking.


[This post will be cross-posted to the Petrie-Flom Center's Bill of Health, which is conducting an online NPRM Symposium.]

Friday, September 4, 2015

NPRM: Freedom for Historians, If They Can Keep It

The notice of proposed rulemaking (NPRM) promises long-sought relief for historians, journalists, and biographers. For these groups, the goal will be to ensure that the proposed rules are enacted as currently written.

[This post has been cross-posted to the Petrie-Flom Center's Bill of Health, which is conducting an online NPRM Symposium.]

11 September 2015: See update at the bottom of this post.

Thursday, September 3, 2015

Schrag Reviews Klitzman, Ethics Police?

Just in time for the NPRM comment period, Society has published my review of Robert Klitzman’s book, The Ethics Police?: The Struggle to Make Human Research Safe (New York: Oxford University Press, 2015). I note that “By offering the subjective worldview of IRB members, Klitzman shows how good intentions combine with ethical ineptitude to produce arbitrary decisions.”


Per my agreement with Springer, what follows is the accepted manuscript of the review. The final publication is available at Springer via http://dx.doi.org/10.1007/s12115–015–9935-x.


Wednesday, September 2, 2015

NPRM Proposes Freedom for Historians!

The long awaited Notice of Proposed Rulemaking: Federal Policy for the Protection of Human Subjects, released today, suggests the complete deregulation of “oral history, journalism, biography, and historical scholarship activities that focus directly on the specific individuals about whom the information is collected.”


In the coming 90-day comment period, historians will need to insist that this remains an unqualified exclusion. Still, despite this last peril, we have much to celebrate.


"Great joy in camp we are in View of the Ocian, this great Pacific Octean which we been So long anxious to See."

Tuesday, August 25, 2015

Gentle Regulation May Be More Effective

Law professor Samuel Bagenstos argues that recent Title IX excesses follow the pattern of IRB horror stories: the feds threaten drastic action, so university administrators hyper-regulate. He offers disability rights as an example of a less punitive regulatory effort that has produced good results.


[Samuel R. Bagenstos, “What Went Wrong With Title IX?,” Washington Monthly, October 2015.]

Saturday, August 22, 2015

Goffman Blames IRB, Again

Sociologist Alice Goffman claims that “IRB guidelines” prevent her from disclosing the location where she was interrogated by police.


[Paul Campos, “Alice Goffman’s Implausible  Ethnography,” Chronicle of Higher Education, August 21, 2015. (paywall)]

Thursday, July 30, 2015

Botkin Expects NPRM by October

At the tail end of the July SACHRP meeting (5 hours, 35 minutes into the video) chair Jeffrey Botkin stated, “We’re all anticipating the NPRM will be out before October. What that means is our business in October is likely to be the NPRM.”


Clear your calendars, folks.

Wednesday, July 29, 2015

IRBs Ignore South Africans' Concerns

Leslie London and Helen Macdonald, both of the University of Cape Town, complain that funding institutions in North America and Europe solicited their advice but then showed “little regard for local ethical practices in South Africa.”


[Leslie London and Helen Macdonald, “Transnational Excursions: The Ethics of Northern Anthropological Investigations Going South," ResearchGate, 2014.]

Tuesday, July 28, 2015

Community Researchers: IRBs Reinforce Power Differentials

Practitioners of community-based participatory research (CPBR) warn that standard IRB review can reinforce the power inequalities that CPBR hopes to mitigate.


[J. Cross, K. Pickering, and M. Hickey, “Community-Based Participatory Research, Ethics, and Institutional Review Boards: Untying a Gordian Knot,” Critical Sociology, June 3, 2014, doi:10.1177/0896920513512696; Bruce Pietrykowski, “Participatory Economic Research: Benefits and Challenges of Incorporating Participatory Research into Social Economics,” Review of Social Economy, July 7, 2015, 1–21, doi:10.1080/00346764.2015.1044841.]


Monday, July 27, 2015

British Universities See Ethics Committees as "Easy and Convenient" Censors

Adam Hedgecoe reports on two cases in which British university administrators turned to their university research ethics committees (URECs) not to protect the subjects of research, but to block controversial research they feared would tarnish the universities’ reputations.


[Adam Hedgecoe, “Reputational Risk, Academic Freedom and Research Ethics Review,” Sociology, June 25, 2015, doi:10.1177/0038038515590756.]

Sunday, July 5, 2015

Exemption by the Numbers?

Two computer researchers describe a system at Microsoft Research designed to provide automatic approval for low-risk studies. Rather than follow the Common Rule’s exemption model of requiring IRB review if any of a series of conditions is met, the Microsoft system assigns numerical values to aspects of a proposal that bear some risk to participants. Proposals with a low total get immediate approval from an Excel spreadsheet.


[Bowser, Anne, and Janice Y. Tsai. “Supporting Ethical Web Research: A New Research Ethics Review.” In Proceedings of the 24th International Conference on World Wide Web, 151–61. WWW ’15. Republic and Canton of Geneva, Switzerland: International World Wide Web Conferences Steering Committee, 2015. doi:10.1145/2736277.2741654.]

Friday, June 19, 2015

Chilling Effects

Leon Neyfakh’s essay on Alice Goffman’s methods illustrates the dangers of researchers’ anticipating, rather than documenting, IRB restrictions on their work.


[Leon Neyfakh, “The Ethics of Ethnography,” Slate, June 18, 2015.]

Goffman's Tightrope

Two new articles add useful context to the debate about Alice Goffman’s On the Run. Together, they show just how narrow a path Goffman was walking between privacy and verifiability, and between scholarship and good writing. I will address the IRB issues in a separate post.


[Jesse Singal, “The Internet Accused Alice Goffman of Faking Details In Her Study of a Black Neighborhood. I Went to Philadelphia to Check,” Science of Us, June 18, 2015.; Leon Neyfakh, “The Ethics of Ethnography,” Slate, June 18, 2015.]

Monday, June 8, 2015

PRIM&R Meets with OIRA

Elisa Hurley, executive director of PRIM&R, reports that representatives of her organization met with officials from the federal Office of Information and Regulatory Affairs (OIRA) to discuss a potential notice of proposed rule making (NPRM).


[Elisa Hurley, “PRIM&R Meets with OMB to Offer Input on Proposed Changes to the ‘Common Rule,’” Ampersand, June 8, 2015.]


Recall that PRIM&R’s comments on the 2011 ANPRM were ignorant of the concerns of qualitative researchers, particularly historians, misleading about the responsibility of IRBs for bad consent forms, and contemptuous of the goal of efficiency.


I hope OIRA will hear from other parties as well.

Saturday, June 6, 2015

Klitzman Wants "Case Law." As Did Katz, 42 Years Ago

In an opinion piece drawn from his new book, The Ethics Police?, Robert Klitzman calls for IRB transparency and respect for precedent. That is a good idea, and one that should have been implemented decades ago.


[Robert Klitzman, “Who Polices the ‘Ethics Police’?,” CNN, May 26, 2015]


Why Notes Get Shredded

While Steven Lubet criticizes Alice Goffman for having “shredded all of her field notes,” Northern Ireland’s Public Prosecution Service prosecutes Ivor Bell based on an interview seized by subpoena.


How are those shield laws coming, Josh?

Thursday, June 4, 2015

Berkeley IRB: 1 + 1 = Undue Influence

In a series of four tweets, Nicholas Christakis of Yale reports a horror story out of Berkeley:


  • colleague’s experience with Berkeley IRB: including both the following sentences in an appeal for a survey may result in undo influence.

  • sayeth the IRB: so just pick one of 2 sentences “Your participation would mean a lot to me and help my research.”

  • sayeth the IRB: so just pick one: “Many of your neighbors are participating, and I’d like to hear your opinion, too.”

  • 100,000 people die from medical care yearly, none die from surveys, & our IRB’s are wordsmithing to avoid undue influence?

Earnest Member Reads the Belmont Report

My favorite portion of The Censor’s Hand is Schneider’s invention of Earnest Member, a conscientious gentleman with good intentions but no ethical training until he is appointed to the IRB and handed copies of what Schneider terms the Sacred Texts.

Wednesday, June 3, 2015

Schneider: IRB System Is A Model of How to Regulate Badly

In an interview about his new book, The Censor’s Hand: The Misregulation of Human-Subject Research, law professor Carl Schneider charges that IRB abuses are inherent to the design of the system.


[Scott Jaschik, “‘The Censor’s Hand’,” Inside Higher Ed, June 3, 2015.]


Wednesday, May 27, 2015

A/B ≠ A&B

A/B testing is the comparison of two products by providing each, simultaneously, to two randomly selected groups. As Michelle Meyer notes, the practice is less ethically suspect than a common alternative: imposing a new product on all of one’s customers without first testing it.


A&B is an abbreviation for assault and battery. Depending on the jurisdiction, the two may be a single crime or distinct crimes, but everywhere A&B is unlawful.


Law professor James Grimmelmann has confused the two:


Suppose that Professor Cranium at Stonewall University wants to find out whether people bleed when hit in the head with bricks, but doesn’t want to bother with the pesky IRB and its concern for “safety” and “ethics.” So Cranium calls up a friend at Brickbook, which actually throws the bricks at people, and the two of them write a paper together describing the results. Professor Cranium has successfully laundered his research through Brickbook, cutting his own IRB out of the loop. This, I submit, is Not Good.


IRBs for everyone, or you get hit with a brick. I suggest that this parade of horribles is missing its elephant. Blame the IACUC?


Anyway, thanks for the link.


ETA(2:18PM): I originally linked to the wrong Meyer paper. Of course, that one's worth reading too.

Elliott Still Wants to Scrap IRBs

Writing in the New York Times about a series of scandals at the University of Minnesota, bioethicist Carl Elliott calls for the IRB system to be abandoned and replaced with “a full-blown regulatory system.” This is essentially the same argument he made in the New York Times in 2011, when the ANPRM was issued.


[Carl Elliott, “The University of Minnesota’s Medical Research Mess,” New York Times, May 26, 2015.]

Sunday, May 17, 2015

Montana Political Scientist: IRB Process Is "Cumbersome, Inadequate" for Political Research

The Montana Commissioner of Political Practices (COPP), Jonathan Motl, has determined “that there are sufficient facts to show that Stanford, Dartmouth and/or its researchers violated Montana campaign practice laws requiring registration, reporting and disclosure of independent expenditures” in October 2014, when they mailed pre-election postcards to 102,780 registered voters. The postcards were part of an effort to see if certain claims about candidates’ place on an ideological spectrum would affect voting patterns.


As part of the investigation, Motl engaged Carroll College political science professor Jeremy Johnson to determine whether the Stanford and Dartmouth researchers had violated IRB requirements. Johnson finds that they did, but also that the Dartmouth IRBs could have approved the studies without addressing the most serious ethical issues they raised. “The fundamental problem with the IRB process,” he writes, “is the narrow focus on protecting the individual subject. Concerns about human subjects in the aggregate often do not even occur to researchers, faculty, and staff involved in the IRB.”


[McCulloch v. Stanford and Dartmouth, Commissioner of Political Practices of the State of Montana, No. COPP 2014-CFP–046, Decision Findind Sufficient Facts to Demonstrate a Violation of Montana’s Campaign Practice Laws, 11 May 2015. h/t Chris Lawrence.]

Wednesday, May 6, 2015

OHRP Inaction Leaves IRBs Reliant on Gut Feelings

Theresa Defino’s Report on Research Compliance describes an April 14 webcast by Robert Klitzman about his new book, The Ethics Police.


[“Books, Bioethics Panel Say OHRP Inaction Weakens Protection System, Thwarts Trials,” Report on Research Compliance, May 2015.]


Most of the excerpts from Klitzman concern the way that OHRP silence hampers IRBs:


When they reach out to OHRP for support, IRB officials reported getting nowhere. In the chapter titled, “Federal Agencies vs. Local IRBs,” Klitzman wrote that one chair told him, “Many times when you call for advice, they essentially just read back the regulations.”


One recounted waiting two years to hear from OHRP on changes it had made. When federal officials respond, “they often refrain from doing so in writing, or say that the clarification does not apply more generally,” Klitzman was told.


Without assurance that they are acting correctly, IRBs act arbitrarily:


IRB chairs and members, according to Klitzman, “relied on gut feelings, intuition, the sniff test. People wanted to feel comfortable….They wanted peace of mind” about the studies they approved. Decisions were influenced by “pet peeves” and the “prudishness” of IRB members and chairs. Some IRBs are “user-friendly” or “pro-research,” he said.


In truth, such arbitrariness serves neither researchers nor research participants. Defino quotes Alice Dreger’s new book Galileo’s Middle Finger, which argues that “in practice, protections for people who become subjects of medical research may be their weakest in decades.”


The IRB system is premised on the notion that, at times, researchers and subjects have competing interests. Thanks to OHRP, they also have a common enemy.

Tuesday, April 28, 2015

New Books on IRBs: Israel, Klitzman, Schneider

Within the past few months, Mark Israel has published a second edition of Research Ethics and Integrity for Social Scientists, and Robert Klitzman and Carl Schneider have published substantial new works on the IRB debate.

At some point I hope to find the time to review these in depth. For now, here's the bibliography:

Israel, Mark. Research Ethics and Integrity for Social Scientists: Beyond Regulatory Compliance. Second Edition edition. London; Thousand Oaks, Calif.: SAGE Publications Ltd, 2014.

Klitzman, Robert. The Ethics Police?: The Struggle to Make Human Research Safe. 1 edition. Oxford ; New York: Oxford University Press, 2015.

Schneider, Carl E. The Censor’s Hand: The Misregulation of Human-Subject Research. Cambridge, Massachusetts: The MIT Press, 2015.

Monday, March 23, 2015

NPRM Jumps White House Fence

Report on Research Compliance has spotted a notice on the Office of Information and Regulatory Affairs website suggesting that a proposed rule on "Human Subjects Research Protections: Enhancing Protections for Research Subjects and Reducing Burden, Delay, and Ambiguity for Investigators" has reached OIRA and is awaiting EO 12866 Regulatory Review.

Don't ask me what this means in terms of a timetable, but it sounds as though the process is moving forward.

Wednesday, March 11, 2015

QI Focus Groups: Ditch Generalizability Criterion

Focus groups of professionals engaged in quality improvement (QI) or comparative effectiveness research (CER) report that the Common Rule's "generalizable knowledge" standard does not provide clear guidance.

[Whicher, Danielle, Nancy Kass, Yashar Saghai, Ruth Faden, Sean Tunis, and Peter Pronovost. “The Views of Quality Improvement Professionals and Comparative Effectiveness Researchers on Ethics, IRBs, and Oversight.” Journal of Empirical Research on Human Research Ethics, Published online before print, February 23, 2015, doi:10.1177/1556264615571558.]

Monday, March 2, 2015

IRB Asked, USB or FireWire. Silly, but Is It Bullying?

Caleb Carr, assistant professor of communication at Illinois State University, argues that abusive IRBs are best thought of as bullies.

Though IRBs are a legally required element of many higher education institutions and an important ethical part of all, their overextension of unchecked power is creating a hostile work environment for many social scientists, and calling them for what they are – systemic bullies – can empower administrators and faculties to finally respond to the increasing calls for IRB reform.

[Carr, Caleb T. “Spotlight on Ethics: Institutional Review Boards as Systemic Bullies.” Journal of Higher Education Policy and Management 37 (2015): 1–16. doi:10.1080/1360080X.2014.991530.]

Sunday, March 1, 2015

University of Queensland Punishes Researchers, Won't Say Why

The University of Queensland demoted a professor and blocked him and another researcher from publishing findings, based on charges that they had not obtained necessary ethics clearances. But the university will not explain its conduct.

[Jorge Branco. “UQ Suppressed Bus Racism Study: Academics.” Brisbane Times, February 27, 2015. Thanks to Michelle Meyer for tweeting this to my attention.]

Friday, January 23, 2015

Atran: IRBs Block Understanding of Terrorism

Interviewed by Nature, anthropologist Scott Atran reminds us that human subjects rules have impeded his efforts to understand the origins of violence like the attack on Charlie Hebdo.

[Reardon, Sara. “Looking for the Roots of Terrorism.” Nature, January 15, 2015. doi: 10.1038/nature.2015.16732. h/t Donald Pollock]

Sunday, January 18, 2015

Library Administrator Mistakes FOIA Request for Human Subjects Research

Sometime human-subjects alarmist Michael Zimmer sent requests for public documents to 30 public libraries. Though most librarians welcome requests for information, in the age of the Common Rule, you can't take anything for granted.

[Zimmer, Michael. “New Project on Privacy and Cloud Computing in Public Libraries (and Some Aftermath).” MichaelZimmer.org, January 9, 2015. h/t Rebecca Tushnet]

Zimmer reports:

One library administrator seemed to take some umbrage with my project and approach. That director emailed a larger list of library directors asking if anyone else had received my records request, noting that “There is no promise of anonymizing the data or offer to opt out of the study, which is a typically included in studies these days” and expressing surprise that my IRB would approve such a methodology. (I learned of this concern due to that director’s email being forwarded to a privacy list hosted by the ALA that I’m a subscriber to.) I’ve since replied that this methodology doesn’t involve human subjects, and follows common approaches to obtaining government information (such as the Fordham Center for Law and Information Policy’s excellent research on privacy and cloud computing in public schools). I’ll reach out to this director personally, and hopefully the concerns will be put to rest.

Sunday, January 11, 2015

Research Ethics Scales and Measures

Dr. Elizabeth Yuko kindly points me to Research Ethics Scales and Measures http://researchethicsmeasures.org/, a website run by Fordham University's Center for Ethics Education.

The website features a bibliography of publications about empirical assessments of researchers' and participants' experiences with human subjects research. Many concern medical research, particularly dealing with HIV, but they may be of interest to social researchers as well.

For additional pieces on this theme, please search this blog for the tag "empirical research."