Sharing Unanticipated Findings In Community Health Research

Main Category: Public Health
Article Date: 29 Sep 2010 - 5:00 PDT


An article published online September 29 ahead of print in the peer-reviewed journal Environmental Health Perspectives (EHP) relates how the finding of unexpected biomarker results during a pilot community health study of school-age girls led to a debate about how and when to inform the study families. Ultimately, the transdisciplinary research team, which included community breast cancer advocates, was able to draw on its diverse experience and knowledge of ethical principles to craft a comprehensive plan to communicate the findings to the families.

During the course of the pilot study, a precursor to a larger study of environmental exposures at puberty and breast cancer risk later in life, blood and urine samples were collected from girls aged 6 or 7 years in two communities in the greater Cincinnati area. Investigators analyzed samples for a variety of endocrine-disrupting compounds and other chemicals and discovered that more than 90% of girls tested in one of the communities had blood levels of perfluorooctanoate (PFOA) significantly above the national median value for young adolescents. The source of the PFOA could not be identified at that time.

The PFOA discovery was unexpected, and at the time the health implications were poorly understood. Although participants had signed a form stating, "The investigators will tell you about significant new findings developed during the course of the research and new information that may affect your health, welfare or willingness to stay in this study," there was no mechanism in place for informing participants' families of results with unknown health effects. The situation was complicated by ongoing litigation and regulatory review related to industrial PFOA pollution in the area. Moreover, the data had not yet been peer reviewed nor were there funds or support for additional testing and more staff.

However, several ethical principles-including the precautionary principle, which urges caution where proof of safety is lacking-provided guidance for informing the families as fully as possible. The communication plan comprised presentations to all stakeholders, including families, schools, health officials, and the media; fact sheets, graphs of study data, and a brief summary of findings; information on terms and frequently asked questions; a dedicated phone for families' use; and a press release.

"Our experience offers an example of communicating an unexpected research finding to the families of study participants. While we have not yet developed a comprehensive protocol for communicating individual results, we have learned a number of important lessons for the future," the authors write.

As research using environmental biomarkers expands, it is likely that other public health researchers will encounter similar situations in which exposure is known, but the consequences are not. Prior to conducting these types of studies, researchers need to plan for open and timely communication with study participants.

Authors of the article were Ann D. Hernick, M. Kathryn Brown, Susan M. Pinney, Frank M. Biro, Kathleen M. Ball, and Robert L. Bornschein. Support was provided by the National Institute of Environmental Health Sciences and the National Cancer Institute, National Institutes of Health, U.S. Department of Health and Human Services; and the Center for Environmental Genetics, University of Cincinnati.

The article, titled "Sharing Unexpected Biomarker Results with Study Participants," will be available September 29 free of charge here.

Source:
National Institute of Environmental Health Sciences (NIEHS)

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