Publication Announcement - Public Expectations For Return Of Results From Large-Cohort Genetic Research

Main Category: Genetics
Article Date: 15 Dec 2008 - 1:00 PDT

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Participants in a series of focus groups felt strongly that anyone taking part in a large-cohort genetic study should have access to their research results, according to a new paper in the American Journal of Bioethics. Authors Juli Murphy, Joan Scott, David Kaufman, and Kathy Hudson of the Center, and co-authors Gail Geller of Johns Hopkins University and Lisa LeRoy of Abt Associates, also report that potential participants in a large genetic biobank held considerably varying views on what kind of information they would want to receive, and how they would want to receive it. Focus group members also repeatedly and spontaneously suggested that research participants be given ongoing choices as to which research results they received.

In recent years there has been a proliferation of small- and medium-sized genomic biobanks - databases containing genetic and various amounts of environmental and health information, sometimes collected from many people over long periods of time, which can be used to examine genetic and environmental contributors to disease. The National Institutes of Health (NIH) and other federal health agencies are considering establishing a large national biobank, which would involve recruitment of a nationwide, representative sample of at least 500,000 people. Such a biobank would support hundreds or thousands of studies of a broad range of conditions, some of which may not even be anticipated when the biobank is established. Recognizing that dialogue with the public would be critical to the success of such a biobank, the NIH's National Human Genome Research Institute turned to the Center to conduct a pilot public consultation project. The focus groups were one component of that project.

"The open-ended and evolving nature of genomic biobanks raises challenging questions about informed consent and the return of individual research results to participants," write the authors. "Currently, in the absence of a universally recognized policy, there are wide-ranging views and practices about return of individual research results to participants in genomic biobanks."

The authors introduce their results by outlining some of the key arguments in support of, and challenges raised by, returning individual research results. One key challenge is how to keep from blurring "the distinction between research and the practice of medicine" - i.e., research participants may mistakenly expect to receive clinically relevant information from a study. Moreover, some observers note the enormous financial, logistical, and time burdens that responsible return of results would incur on a research project. Arguments in favor of returning results include that "sharing results with participants further underscores that the study participant is a partner in the research endeavor, and not simply a means to an end," thus bringing greater public recognition of, enrollment in, and support of biomedical research. A third camp advocates a middle ground: that researchers only return results with "relevance to health" (although authors note that definitions of relevance are also not agreed upon).

The authors conducted 15 focus groups in five cities (Philadelphia, PA; Phoenix, AZ; Kansas City, MO; Jackson, MS; and Portland, OR), plus a pilot focus group in Hagerstown, MD. Focus group members were recruited to reflect a range of demographics, including age, education, race, ethnicity, gender, and socioeconomic status.

Focus group members were presented with scenarios representing different types of research results (including exposure to environmental risks and genetic predisposition to treatable and untreatable conditions), and asked for their views on receiving such results. Responses were highly variable, but two factors emerged as being important: Any results returned should be accurate, focus group members said, and they should be actionable. Focus group participants also "repeatedly and spontaneously suggested that cohort study participants be given ongoing choices [of what types of results they would receive], often using Internet analogies such as setting preferences or filters."

The authors note the necessity of considering public opinion before involving large groups of people in research: "Failure to garner public acceptance can halt creation of [biobanks]… and impede medical progress. The results of our focus group research underscore the need for public consultation in the planning and design phases of large population biomedical research endeavors."

Public Expectations for Return of Results from Large-Cohort Genetic Research.
Murphy, J., J. Scott, D. Kaufman, G. Geller, L. LeRoy, and K. Hudson. 2008.
American Journal of Bioethics 8: 36-43.

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