Does the ANPRM's Appeals Provision Address IRB Incompetence?

A correspondent suggests that the ANPRM fails to address the problem of incompetent IRBs, such as IRBs that lack the expertise necessary to do their work or otherwise fail to meet all the requirements of the existing Common Rule. I am inclined to disagree.

ANPRM Comment Period Extended to October 26

The Department of Health and Human Services has extended the comment period for the ANPRM to October 26. HHS has posted a preliminary announcement, and the official announcement is planned for the September 1 Federal Register.

The Years Spin By

In his presentation to the Presidential Commission for the Study of Bioethical Issues today, Ezekiel Emanuel showed some textual slides that were visible during the live webcast but do not show up--at least on my browsers--when I replay the recording.

One of these slides featured a timeline of events leading to the current system of human subjects protections. That timeline featured two common errors.

Emanuel: ANPRM Will End Reliance on Worthless Gut Reactions

I watched the webcast of this morning's appearance by Ezekiel Emanuel before the Presidential Commission for the Study of Bioethical Issues. There were no huge surprises in Emanuel's presentation; much of it repeated points he had made in the New England Journal of Medicine. But I found some of his remarks, and the Commission's response, noteworthy.

Sociologist: IRBs Have Almost Killed Fieldwork

Laurie Essig, Assistant Professor of Sociology and Women's & Gender Studies at Middlebury College and a contributor to the Chronicle of Higher Education's Brainstorm blog, complains that "IRBs have effectively shut down our ability to actually find out about people’s lived experiences. IRBs have treated speaking with someone as equivalent to experimenting on them and have almost killed fieldwork in the process."

[Laurie Essig, "The IRB and the Future of Fieldwork," Brainstorm: Ideas and Culture, 12 August 2011.]

Aristotle: History Is Not Generalizable

I stumbled across the following passage from Aristotle's Poetics:

It is not the function of the poet to relate what has happened, but what may happen--what is possible according to the law of probability or necessity. The poet and the historian differ not by writing in verse or in prose. The work of Herodotus might be put into verse, and it would still be a species of history, with meter no less than without it. The true difference is that one relates what has happened, the other what may happen. Poetry, therefore, is a more philosophical and a higher thing than history: for poetry tends to express the universal, history the particular.

So history is not subject to the Common Rule, but poetry is.

How Many Questions Must an ANPRM Ask?

Officially, the ANPRM asks 74 questions. In an effort to simplify things for scholars in the social sciences and humanities, I offered a list of just ten. The University of Rochester takes the other tack, counting 152 questions.

However many questions you care to answer, you've got 35 days left.

H/T: Human Research Protections Blog.

CITI Program as Mind-Numbing, Coercive, Counterproductive McEthics

Sanjay Srivastava of The Hardest Science kindly alerted me to a newly published critique of the mortifyingly stupid CITI Program.

[Jennifer J. Freyd, "Journal Vitality, Intellectual Integrity, and the Problems of McEthics," Journal of Trauma & Dissociation, available online: 15 July 2011, DOI:10.1080/15299732.2011.602290]

A Quick Guide to the ANPRM

The ANPRM's 74 questions may overwhelm some scholars and scholarly organizations that might wish to respond; already several organizations have called for the comment period to be extended to 120 days.

In the hope of of making things easier, I have tried to lay out some of the most pressing questions in "How should human subjects regulations change? A guide to “Human Subjects Research Protections: Enhancing Protections for Research Subjects and Reducing Burden, Delay, and Ambiguity for Investigators” for scholars in the social sciences, humanities, and journalism, and the organizations that serve them."

I welcome comments on this document.

Research Psychologist Blogs ANPRM

Sanjay Srivastava, associate professor in the Department of Psychology at the University of Oregon, has been posting some helpful observations about the ANPRM on his blog, The Hardest Science:

Chronicle of Higher Ed Reports on ANPRM

The Chronicle of Higher Education reports on the ANPRM, emphasizing historians' concerns.

[Ryan Brown, "Historians Welcome Contemplated Changes in Human-Research Guidelines," Chronicle of Higher Education, 7 August 2011.]

Your humble blogger is quoted, as is Rob Townsend of the American Historical Association. The president-elect of the Oral History Association, Horacio N. Roque Ramírez, calls for some kind of review process to ensure that historians are familiar with the ethical implications of their work. But he agrees that current procedures are "tedious and nonsensical."

Agreed. I would go just a bit further, arguing that IRB oversight is a barrier to serious consideration of the ethics of oral history, since it has done so much to discredit the idea of ethics review.

ANPRM: Organizations Seek Longer Comment Period

Public Citizen and PRIM&R have both requested that the ANPRM comment period be extended to 120 days.

The more I grasp the complexities responding to the ANPRM, the less adequate 60 days seems to me.

Wall Street Journal Blogs ANPRM

Christopher Shea, author of the landmark 2000 article, "Don't Talk to the Humans: The Crackdown on Social Science Research," notes Rob Townsend's call to action on the ANPRM.

[Christopher Shea, "Historians and Human-Subjects Research," Wall Street Journal: Ideas Market, 5 August 2011]

Shea writes,

Understandably, some social scientists want to know why historians should get a pass on paperwork and oversight that takes up lots of their own time.

So the question is: How can oral (or, more generally, contemporary) historians escape inappropriate IRB scrutiny without denigrating their own work? Or, to back up a step, should they, in fact, have to go through the same procedures as social psychologists doing lab studies?

Might I interest him in a 4,800-word answer?

ANPRM: It's Time to Redefine Research

In an earlier posting, I warned that the ANPRM's proposed "Excused" category could expand rather than diminish IRB interference with research in the social sciences and humanities.

Another option mentioned in the ANPRM--a redefinition of the scope of the Common Rule--could do more to achieve the ANPRM's goals of "better protect[ing] human subjects who are involved in research, while facilitating valuable research and reducing burden, delay, and ambiguity for investigators." It could even the regulations with the statutes they claim as their basis.

I see several options here.

Inside Higher Ed Reports on ANPRM

Inside Higher Ed reports on the ANPRM, with emphasis on concerns about the overregulation of the social sciences, humanites and journalism.

[Doug Lederman, "Updating the Common Rule," Inside Higher Ed, 3 August 2011]

The story quotes C. K. Gunsalus, Felice Levine, and your humble blogger. Mostly they are positive about the ANPRM, but Gunsalus and I express reservations. Hers concerns the proposal to extend the regulations to all research conducted at federally funded institutions:

"I have a hard time seeing how it makes sense to cover poets at universities but ignoring" surveys done by companies or research that takes place at fertility clinics or other entities that forgo federal funds. "I don't agree with this choice, and don't think it will solve the problem in the way they think it will."

ANPRM: May I Be Excused?

One of the boldest proposals in the ANPRM, and one of enormous importance to social scientists, is the idea of replacing the current category of exempt reseach with a new category of "Excused" research. This proposal could reduce IRB and IRB-office intrusion into a great deal of social research. But, depending on the details, it could instead convert an enormous amount of presently exempt research into research subject to expedited or even full-board review.

Social scientists will need to be very careful as they respond to this proposal.

Will ANPRM Limit the Use of Published Data?

Despite the ANPRM's general goal of "reducing burden, delay, and ambiguity for investigators," the proposed policy for the re-use of pre-existing data threatens to increase all of those by expanding the current definition of human subjects research.

AHA Alerts Members to ANPRM

Robert Townsend, Deputy Director of the American Historical Association, alerts AHA members to the significance of the ANPRM in a blog post: AHA Today: Getting Free of the IRB: A Call to Action for Oral History. The post points up the need for historians to think broadly as they prepare their comments on the ANPRM and not passively accept the categories devised by bioethicists.

ANPRM's Problem Statement: Helpful but Incomplete

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

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

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

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

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