Wednesday, May 16, 2007

PRIM&R's Public Responsibilities

Jeffrey Cohen writes, "I don't understand why you continue to criticize a program designed to explain and encourage the use of the flexibility available in the regulation and to promote communication and collaboration between IRBs and investigators to facilitate research." His comment shows that I have not made clear my concern with PRIM&R's constitution and operation. Let me suggest, therefore, that PRIM&R is a semi-official body that fails to conduct itself in a manner commensurate to its power and responsibility.

We first need to understand PRIM&R's special status as a chosen instrument of the federal government. Unlike scholarly associations, whose letters to OHRP get brushed off, PRIM&R has long functioned as an arm of OHRP and its predecessor, OPRR. For example,

  • OHRP promotes and distributes PRIM&R's "Investigator 101" CD-ROM. Similarly, PRIM&R prepared the first edition of the Department of Health and Human Services' IRB Guidebook.
  • Former OPRR head Charles McCarthy serves on the PRIM&R board; Cohen, a former OHRP official, co-organized the last conference; and current OHRP officials participate as PRIM&R conference faculty.
  • OHRP exhibits at PRIM&R conferences, and OHRP officials, particularly Michael Carome, use PRIM&R conferences to offer guidance that then gets broadcast by IRB consultants, such as Dr. Cohen.

Given these connections, an IRB member or staffer could reasonably assume that following PRIM&R's guidance is a good way to avoid sanctions by OHRP. (Indeed, she would be foolish to assume otherwise.) Since it these staffers who then return to their institutions and impose conditions on research there, PRIM&R is a key link in the chain between federal power and the daily work of researchers.

PRIM&R itself recognizes this function. For example, the recent conference provided attendees with documents offering guidance on the regulatory definition of human subjects research and the proper application of the exemptions. Since providing just such guidance is one of the responsibilities of OHRP, the conference organizers must feel pretty confident that they have OHRP's blessing to take over this important role. (Note that unlike real OHRP guidance, PRIM&R's documents are not made public.)

If this is so, what must PRIM&R do to use its power wisely and justly?

1. Identify its constituents

PRIM&R's website states that "since 1974, PRIM&R has served the full array of individuals and organizations involved in biomedical and social science/behavioral/educational research." But what constitutes that full array? Is "social science/behavioral/educational research" one category or three? If the latter, what disciplines come under which category? And are there varieties of research (such as folklore, nonfiction writing, and law) that fit none of those categories, yet that face IRB review?

I would like to see PRIM&R list all the disciplines that come under review by IRBs whose members it trains. Then it could try to make some distinctions, for example, between disciplines that offer therapy or advocacy and those that do not; disciplines that study the body and those that do not, disciplines that use formal scientific protocols and those that do not; and the like. This would lead to a second task:

2. Include a range of disciplinary perspectives

As I mentioned earlier, PRIM&R's board of directors is dominated by researchers and administrators from hospitals and medical schools. They cannot be expected to be expert in the ethics and methodologies of the full range of disciplines in the behavioral sciences, social sciences, humanities, and professions, nor could any group of scholars drawn from any one field. If PRIM&R wants to offer sound guidance to researchers in all fields subject to IRB review, it should include them on every level, from conference panels to editorial boards to the board of directors itself. The goal should be that each field has the chance to shape any guidance that affects that field, so PRIM&R does not again, for example, offer a conference panel on oral history with no historians present.

Since the vast bulk of IRB review does concern biomedical research, I would not expect equal numbers for researchers in other fields. But I do think that folklorists should have as much power to shape PRIM&R's advice on folklore as physicians have to shape PRIM&R's advice on medical research. If this requires a complex committee structure, so be it.

3. Include a range of viewpoints

Prior to the recent conference, Dr. Cohen wrote me, "if you would like to participate in the conference, we'd be happy to work you in to the program (provided you have something constructive to say)." Now he writes, "I can only conclude that you have no interest in making IRB review work better for researchers, but only in eliminating IRB review for your research."

Does that mean that someone who believes in wider exemptions from review has nothing constructive to say, and therefore no place in PRIM&R? This would contradict Cohen's earlier pride in having invited Linda Shopes, who has advocated an oral-history exemption far longer and more effectively than I. And it would contradict the above-mentioned panels at the last conference, which seem to assume that the proper scope of exemptions has yet to be determined.

I suggest that PRIM&R invite participants based on their knowledge, experience, and ability to represent their discipline, not their adherence to a party line, and that it make public its criteria for choosing participants in all of its endeavors. Perhaps I am not the right person to represent my field at PRIM&R conferences, but Taylor Atkins sure as heck isn't either.

4. Ease participation in conferences

Now I get to Dr. Cohen's specific invitation for suggestions for future conferences. I have three:

a. Don't schedule the conference during exam week. Dr. Cohen informs me that many researchers declined his invitation to participate in the conference. My guess would be that a big part of their refusal resulted from the fact that the second week of May is exam week around the nation--not a problem for federal officials, administrators, and consultants, but a big one for active teaching faculty. As it is, I am surprised he got three researchers from the University of Minnesota; it was exam week there too. October and November are pretty busy with conferences as well for many scholars. I suggest February or March might be more fruitful.

b. Announce the conference. I'm not sure how I found out about the 2007 SBER conference, but I know it was only a few weeks before the conference, and that I did not hear about it through any of my usual reading as a historian, such as H-ORALHIST, the list for oral historians. An open call for participants, months in advance, sent to scholarly newsletters and e-mail lists might boost participation.

c. Pay the costs of researchers. Maybe PRIM&R already pays the travel costs of conference faculty, but if not, it should. Most university professors are lucky to get funding to travel to one or two conferences a year, and they want to use this to attend conferences within their own disciplines. With PRIM&R charging hundreds of IRB staffers up to $950 to attend, it should be able to subsidize a few dozen researchers.

These last three suggestions might bring a few more researchers to the next PRIM&R conference, but I think the real problem is far deeper than participation at conferences. If, as Cohen suggests, PRIM&R truly seeks "to promote communication and collaboration between IRBs and investigators to facilitate research," it will have to work much harder to include the many investigators it has so long neglected.

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