Friday, October 28, 2011

Is PRIM&R "Unaware" of Historians' Complaints?

PRIM&R has posted its ANPRM comments.

There are a number of interesting points, but let's start with the response to Question 25, about the possible exclusion of "certain fields of study" from the Common Rule.

Executive director Joan Rachlin writes,

Regarding the ANPRM’s question about whether the Common Rule should be revised to explicitly state that certain activities that have traditionally not been viewed as research (classics, history, languages, literature, and journalism, e.g.) are not covered (Q. 25), PRIM&R is unaware that the failure to exclude these fields from the Common Rule has ever been a problem for scholars in classics, or literature, etc., and therefore questions whether such a provision is even worth considering. That said, PRIM&R suggests that determinations regarding what is and is not subject to IRB review should be made on the basis of the specific research activity in question, and not on the basis of an investigator’s scholarly discipline. This would address some current inconsistencies regarding what type of inquiry gets reviewed.

"Classics, or literature, etc.?"

What's up with the "etc."? Has Rachlin not heard the complaints from historians, linguists, and journalists? Or has she heard the rumbling, but thinks that if she avoids writing "history," "language," or "journalism," those problems will go away?

History. It's the new bear taboo.

Blogged Down

The ANPRM comment period has now closed, with (as of this writing) 1099 public submissions at the website. A taxing number!

I imagine the bulk of these will concern biomedical research issues beyond the scope of this blog. Even so, extracting some of the most significant comments about the social sciences and humanities is going to be a lot of work, and I apologize in advance for what I expect to be some pretty scrappy blogging for the rest of the year.

Tuesday, October 25, 2011

In ANPRM Comments, American Historical Association Calls for Oral History Deregulation

As reported on AHA Today, the American Historical Association has submitted its ANPRM comments, with clear opposition to IRB oversight of oral history and the imposition of medical privacy rules to history research.

My Comments on the ANPRM

In addition to having assisted with the comments submitted by the American Association of University Professors and the American Historical Association, today I submitted the following comments on the ANPRM. The PDF version may be easier to read.

Monday, October 24, 2011

New York Times: Menikoff Promises Not to Restrict Public Information

Today's New York Times reports on historians' and social scientists' hopes and concerns about the ANPRM, especially the prospect of deregulating oral history while restricting the reuse of social science data.

[Patricia Cohen, "Questioning Privacy Protections in Research," New York Times, 24 October 2011.]

Sunday, October 23, 2011

In ANPRM Comments, Anthropologists Champion Free Inquiry

The American Anthropological Association has posted comments on the ANPRM to the website. Composed by AAA Committee on Ethics member Lise Dobrin and former Committee chair Rena Lederman, the 23-page document is stunningly eloquent and thorough in its indictment of the present IRB system and the shortcomings of the ANPRM. And it offers two bold and constructive suggestions that could point the way to a true reform.

Friday, October 21, 2011

Rohde Reviews Ethical Imperialism

Joy Rohde, assistant professor of history at Trinity University, reviews Ethical Imperialism for the Journal of American History and finds it "a valuable contribution to the history of federal science policy and a useful critique of a system ill-suited to the uses to which it is being put."

[Joy Rohde, Review of Ethical Imperialism: Institutional Review Boards and the Social Sciences, 1965–2009, by Zachary M. Schrag, Journal of American History 98 (2011): 600, doi: 10.1093/jahist/jar274.]

Wednesday, October 19, 2011

OHA Endorses AHA ANPRM Talking Points

The Oral History Association Council has endorsed the talking points on the ANRPM posted earlier by the American Historical Association, and it is encouraging its members to submit an abbreviated version of them as a formal comment to HHS.

h/t: Rob Townsend.

Tuesday, October 18, 2011

AHA Posts ANPRM Talking Points

The American Historical Association (AHA) has issued a set of "talking points" to "invite comments and concerns from members as we craft our response, and as a guide to historians and related specialists looking to craft their own response to the federal proposal."

Robert B. Townsend, "Oral History and Information Risk: A Response to the Federal Proposal," AHA Today, 17 October 2011.

Thursday, October 13, 2011

AAUP Posts ANPRM Comments

The American Association of University Professors has posted a reply to the ANPRM. I am proud to have contributed to this document.

Monday, October 10, 2011

Compliance Administrator Wants ANPRM to Address Subparts

Writing for PRIM&R's blog, amp&rsand, Wendy Tate, assistant director of process improvement and compliance at the University of Arizona, complains that the ANPRM fails to address the subparts of 45 CFR 46.

[Wendy Tate, "What's Missing in the ANPRM?," amp&rsand, 5 October 2011.]

Wednesday, October 5, 2011

What is Behavioral Research?

An anonymous comment on an earlier post asks, "Could you clarify the difference between behavioral science and social science?"

Robert Veatch stated the basic problem in his 1973 testimony to the House Subcommittee on Public Health and Environment:

If the proposal before us is an act for the protection of human subjects of biomedical and behavioral research, it is crucial to have a clear understanding of what constitutes "behavioral research." I note that in the definitions (sec. 1213) the term is nowhere defined. It may have two meanings. To many social scientists it will have a rather limited meaning--research in behaviorist psychology--while to the layman it may mean more broadly any research to study human behavior including all social scientific investigation. It is my hope that the intent of the bill is to use the latter meaning. If not, the act may be considerably less inclusive in application than the present HEW guidelines, which clearly are meant to apply to all social scientific research (in which subjects are 'at risk). To leave such ambiguity is a tragedy.

[U.S. House of Representatives, Biomedical Research Ethics and the Protection of Human Research Subjects: Hearings before the Subcommittee on Public Health and Environment of the House Committee on Interstate and Foreign Commerce (93d Cong., 1st sess., 1973), 240]

Veatch was right about the tragic ambiguity of the statute. But I do not think he was right about the laymen's understanding of behavioral research, at least if laymen are to include congressmen and senators. As the secretary of HEW noted in 1976, "The types of risk situations against which the regulations were designed to protect are suggested by the areas of concern which were addressed in the legislative hearings held in conjunction with the enactment of section 474 of the Public Health Service Act, 42 U.S.C. 289l-3 (added by Pub. L. No. 93-343) . . ."

Congress took almost no testimony about social science (e.g., it did not invite Laud Humphreys to testify), and nothing resembling testimony about the humanities. It did take testimony about behavioral control, and available evidence suggests that it was to oversee that kind of research that the word "behavioral" was included in the statute.

(Much more on this in Ethical Imperialism.)

If we are to align the regulations to the wording and intent of the statute, we have two choices. 1. Define behavioral by method (e.g., intervention, not interaction.) 2. Define behavioral by subject matter (designed to study mental and physical health, not social conditions.) Either could lead to improvements.

Monday, October 3, 2011

AHA Warns of ANPRM's HIPAA Proposals

Rob Townsend of the American Historical Association warns of the ANPRM's idea of subjecting a broad range of data to protections bassed on the provisions of the Health Insurance Portability and Accountability Act (HIPAA). If this proposal is implemented carelessly, historians could find themselves barred from some archival research.

"Could History Become an Information Risk'?," AHA Today, 28 September 2011.