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).”, 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.