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.

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