Wednesday Talk at the U. of Michigan

I will speak about my work on IRBs on Wednesday afternoon at the University of Michigan's Center for Bioethics and Social Sciences in Medicine.

Li and Brown Continue Negotiations

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

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

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

Survey: 28% of Linguists Report Inappropriate IRB Demands

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

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

SBS White Paper Calls for Drastic Reform

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

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

NIH Pledges $1 Million for Research on IRB Regulations

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

You have my attention.

h/t: Theresa Defino.

Anthropologist: IRBs Create "the Worst of Possible Worlds"

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

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

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

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

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

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

The Ethical Imperialism of Moral Science

I have posted extended comments about Moral Science as

Zachary M. Schrag, "The Ethical Imperialism of Moral Science," Bioethics Forum, 4 January 2012.

Does Moral Science Think the System is Working?

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

On page 42, we learn that

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

But on page 55, the report concedes that

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

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

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

Happy New Year, OHRP!

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

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

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