Saturday, February 13, 2010

IRBs Unfamiliar With Internet Research Ethics

Two experts in Internet research ethics find "that IRBs generally do not know what . . . protections apply strictly to online research, and such boards often ignore the complexities of such research and thereby risk harming subjects while also violating federal regulations, or, they apply such restrictive models that inhibit researchers from pursuing important online endeavors."

[Elizabeth A. Buchanan and Charles M. Ess, "Internet Research Ethics and the Institutional Review Board: Current Practices and Issues," ACM SIGCAS Computers and Society 39 (December 2009): 43-49.]

In 2006, the authors sent surveys to more than 700 US-based IRBs, of which they received responses from 334. The learned that

Few boards were aware of extant guidelines such as the Association of Internet Researchers Ethical Decision Making document, and 74% did not provide specific training around Internet research issues, and that less than half (42%) felt the Office [for] Human Research Protections or other regulatory documents were useful in Internet research reviews. These data suggest that ethics boards may not be fully informed when reviewing such research. We must consider on what bases are review boards making decisions around [Internet research ethics]? Of particular concern, our qualitative data provided indications that many boards were "unsure of who to ask," "we don't even know what questions to ask of the researcher," and, "we rely on the IT department to advise us on such IT related issues."

This is typical of an IRB system that rewards members and, especially, staffers who can recite the Common Rule from memory but imposes no real incentive to read the ethics literature of the disciplines over which they claim power.

See also: The Dormant Right to Expertise
and In Search of Expertise.

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.