Thursday, October 25, 2007

Pentagon Says IRB Review Not Needed for War Zone Anthropology

As reported by Inside Higher Ed, anthropologist Thomas Strong has found that the U.S. Army's Human Terrain Systems (HTS) program, which employs anthropologists to work with combat units in Iraq and Afghanistan, has decided that it need not submit projects for IRB review.

Here is the relevant passage from Strong's post:

[Col. Steve] Fondacaro . . . argues that HTS research is not subject to IRB oversight because of provision 32 CFR 219 sec. 101(b)(2), which states that research conducted through “the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior” is exempt.

Thus, the HTS is understood by the program manager to be exempt from IRB regulation within the parameters specified by the common rule. However, as I wrote in a follow up to Fondacaro, “The exemption you cite, 32 CFR 219, sec. 101(b)(2), apparently applies to HTS-type research (that is, ethnographic research) that has already been reviewed. It apparently mandates that a review board at least look at the research in order to determine whether or not continuing oversight is necessary; I don’t think this is typically understood as a determination the researcher him/herself or the research team itself makes. Further, as you know, the exemption stipulates stringent protocols regarding data recording in order to insure the anonymity of research subjects <32 CFR 219, sec. 101(b)(2)(i)>. I am therefore inclined to think the onus is on DoD to insure that those stipulations are being met through a review of the research protocol.” I am waiting to hear from Fondacaro regarding this. It is important to add that Fondacaro says that HTS program managers are waiting for “final guidance” on the matter from US Army lawyers.

Strong is, I believe, confusing the regulation itself with the interpretations of the regulations set forward by OHRP and various IRBs.

First, he assumes that the regulation "apparently mandates that a review board at least look at the research in order to determine whether or not continuing oversight is necessary." But as I noted in an earlier post, that mandate only appeared in OPRR (OHRP's predecessor) guidance of 1995, sixteen years after the exemptions were drafted by the HEW Office of the General Counsel. At the time, that office explained,

The regulations, as proposed, do not require any independent approval of a researcher's conclusion that his or her research is within one of the exceptions. In taking this approach for purposes of discussion, we have weighted the possibility of abuse against the administrative burdens that would be involved in introducing another element of review which might not be very different from the review that the exceptions are intended to eliminate.

["Applicability to Social and Educational Research," attached to Peter Hamilton, Deputy General Counsel, to Mary Berry et al., 27 March 1979, Res 3-1-B Proposed Policy Protections Human Subjects 1978-79, Record Group 443, National Archives]

As late as 1988, DHHS policy allowed institutions to choose who would decide whether an exception applied: the investigator, the IRB chair, or another official. The institutions could also decide, as a matter of institutional policy, that some or all of the exemptions were not valid.

[Robert E. Windom, Assistant Secretary for Health, to Charlotte Kitler, New Jersey Department of Health, 13 September 1988, RES-6-01 Human Subjects, OD Central Files, Office of the Director, NIH]

Thus, it is OPRR/OHRP, and not the Department of Defense, that has departed from the intention of the regulations.

Second, Strong claims that "the exemption stipulates stringent protocols regarding data recording in order to insure the anonymity of research subjects." No, the regulation simply states that IRB review is required if

(i) Information obtained is recorded in such a manner that human subjects can be identified, directly or through identifiers linked to the subjects; and

(ii) Any disclosure of the human subjects' responses outside the research could reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, or reputation.

What this means is a matter of interpretation; there is nothing about "stringent protocols."

In any event, I must doubt that Strong would be any happier had he learned that the program had been approved by a three-person quorum of a five-person Department of Defense IRB, perhaps with no anthropologists as members. The ethical validity of the program should be debated not by a local IRB but by the anthropological profession itself. And I am glad to see that is just what anthropologists are doing.

Monday, October 22, 2007

Brown U. IRB Chair: System is Broken

Ross Frazier of the Brown Daily Herald reports that Brown's "faculty are yet again pushing for change" in the human subjects review system there. ("As IRB Debate Grows, Profs Push for Reform," 16 October 2007).

Frazier reports the views of Ron Seifer, professor of psychiatry:

Seifer, the IRB chair, acknowledged the system is "fundamentally flawed and broken," adding that, "They are being asked to do something they were never intended to do."

Seifer told the class that the IRBs around the country have expanded their reach because of federal bureaucrats and a community of university research administrators who have created a culture of avoiding risk.

Those factors "all exist within very frightened university environments. They're afraid of lawsuits, and they are afraid of donors going away," Seifer said.

As reported by Frazier, senior Brown administrators seem unwilling either to defend the current system or to reform it, preferring instead to keep discussion of the issue off official agendas.

Sunday, October 7, 2007

The Dormant Right to Expertise

According to federal regulations (45 CFR 46.107), scholars should be able to expect that their research will be reviewed by someone who understands it:

each IRB shall have at least five members, with varying backgrounds to promote complete and adequate review of research activities commonly conducted by the institution. The IRB shall be sufficiently qualified through the experience and expertise of its members, and the diversity of the members, including consideration of race, gender, and cultural backgrounds and sensitivity to such issues as community attitudes, to promote respect for its advice and counsel in safeguarding the rights and welfare of human subjects.

As Jeffrey Cohen has recently noted, this means that "researchers have the right under the regulations to have their research reviewed with the appropriate expertise and it is the Institutional Official's responsibility to ensure that the review is appropriate to the research."

Unfortunately, as I have documented in this blog, researchers in the social sciences and humanities are routinely denied that right. A nice illustration of this problem appears in the recently released RAND Corporation working paper, "Ethical Principles in Social-Behavioral Research on Terrorism: Probing the Parameters," September 2007. James R. Sayer of the University of Michigan's Behavioral Sciences Institutional Review Board describes the problem of reviewing research on terrorism. Presumably this includes the research described on this blog by Scott Atran.

Here is how that case, or perhaps a similar case, appeared to Sayer, whose own expertise concerns "the effects of hydrophobic and hydrophilic glass coatings, window tinting, and defrosters/defoggers on visual performance and driving behavior."

We’ve struggled with expertise, or rather the lack of expertise. Two years ago we sought assistance from a number of academic and private institutions to get reviewers to assist us in the evaluation of one particular protocol. And we found nobody. Maybe that’s because people really don’t want to assume that risk themselves. Maybe it’s because, from an academic standard perspective, I’m sure those of you who review IRB applications don’t get many really big feathers in your cap for doing it. And you’re certainly not going to get them for reviewing somebody outside of your institution. It’s gotten to the point that at the University of Michigan we are seriously considering putting together another board. That board would deal exclusively with international research. There’s enough of it going on that we could easily keep that board busy on a monthly basis. But we will still struggle with trying to find somebody that understands what the culture is like in rural provinces of China, in the Sudan. And as hard as we try, we can’t always adhere to what is the intent of the federal regulations in having the necessary expertise.

This is a nicely humble statement, recognizing the limitations of not only Michigan's IRBs but also the entire IRB process. At the end, Sayer admits that his IRB fails to meet the very requirement Cohen identifies. Yet that humility did not stop the Michigan IRB from delaying and interfering with Atran's research.

The problem is that the right to expert review comes with no enforcement mechanism. Cohen suggests appeals should be directed to the institutional official, but in many cases that is the very person who failed to appoint appropriate experts to the IRB. One would be appealing the violation to the violator. Beyond that official lies only OHRP. And on the day OHRP reprimands an institution for constituting an IRB with insufficient expertise in the social sciences and humanities, I will buy Dr. Cohen an ice cream.

Whether Atran should have sued the university for violating the federal regulations is a question I'll leave to the lawyers.

See also, "In Search of Expertise."