Monday, February 1, 2010

AAHRPP Urges Extra Care When Talking to Pregnant Women

As I mentioned in October, Marjorie Speers, president of the Association for the Accreditation of Human Research Protection Programs (AAHRPP), has stated that her organization permits institutions it accredits to submit Federalwide Assurances (FWAs) that do not pledge to impose federal regulations on all research not directly funded by the federal government. In otherwords, institutions may "uncheck the box" without losing accreditation.

At the same time, Speers insisted that "if the boxes are unchecked, we hold the organization to have equivalent protections in place for all research." In my earlier post, I asked what an equivalent exemption might look like.

AAHRPP takes a stab at answering this in the Winter 2010 issue of AAHRPP Advance.

"To Check or Uncheck the FWA Boxes" (p. 6) notes that "The regulations that come into play when the FWA boxes are checked were written primarily with clinical research in mind. Thus, if an organization checks Subpart B of the FWA, for example, it will not be allowed to conduct SBER studies that involve pregnant women, because any study involving pregnant women is required to advance biomedical knowledge."

To give institutions more flexibility, the article claims,

AAHRPP has designed its standards to apply as much to protecting participants in SBER as they apply to protecting those in biomedical research. When organizations have unchecked the boxes, AAHRPP allows them to provide protections that are appropriate to the level and nature of the risk involved in the study and meaningful to the type of research. Under the accreditation standards, an organization could require that the results of a SBER study that includes pregnant women, for example, must contribute to general knowledge or knowledge that is beneficial to society, rather than to biomedical knowledge.

While any concession is welcome, this one is unimpressive. The regulation in question, 45 CFR 46.204 states that "pregnant women or fetuses may be involved in research" only if the research holds out the prospect of direct benefit to the pregnant women or fetus or if "risk to the fetus is not greater than minimal and the purpose of the research is the development of important biomedical knowledge that cannot be obtained by any other means."

Changing "biomedical" to "general" here yields a requirement that researchers meet a higher standard if they want to interview, survey, or observe pregnant women than if they want to interview, survey, or observe non-pregnant women, prospective fathers, or other autonomous adults. Such a requirement violates the rights of both researchers and women.

While I appreciate AAHRPP's understanding that much of the Common Rule is inappropriate when applied to non-biomedical research, the example it has chosen suggests that as an organization, AAHRPP still lacks a basic grasp of some of the issues surrounding IRB review of social science research. What is needed is not mere tinkering with the Common Rule, but wholesale reconsideration of the rights and responsibilities of social scientists.

I thank Rob Townsend for bringing this to my attention.


Catherine said...

So if I upset a potential interviewee who happens to be pregnant by telling her that I'm not allowed to do interviews with pregnant women, and she complains to my institution, that's more ethical than doing the interview?

Zachary M. Schrag said...

Don't ask me. I might be pregnant.