Sharing Unexpected Biomarker Results with Study Participants (commentary)
Ann D Hernick (1), M K Brown (2), SM Pinney (2), FM Biro (3), KM Ball (1), RL Bornschein (2).
(1) Breast Cancer Alliance of Greater Cincinnati, (2) Department of Environmental Health, University of Cincinnati College of Medicine, (3) Cincinnati Children’s Hospital Medical Center
Environmental Health Perspectives, 119(1)
Published online Sept 29, 2010. DOI:10.1289/ehp.1001988
Background: This commentary discusses the experiences that a research team had with explaining unexpected results with the participants of a research study. The research team was part of the Breast Cancer and the Environment Research Centers (BCERC) and included researchers from laboratory and human studies and members of the community. The BCERC study sites were University of California at San Francisco, Fox Chase Cancer Center and Michigan State University. The Centers conduct studies to investigate whether environmental exposures are associated with the timing of puberty. Early puberty is linked to an increased risk of breast cancer later in life. Blood and urine samples were collected from girls ages 6-7 years old as part of a pilot study to determine if biomarkers could be measured. Environmental biomarkers are substances measured in body fluids or tissues that indicate exposure to environmental chemical. In the Greater Cincinnati study population, we found a higher level of perfluorooctanoate (PFOA) among over ninety percent of the study girls living in a small community.
Objectives: The Cincinnati research team had questions about whether and how to report the PFOA findings to our study families. This commentary discusses the issues considered in our decision, as well as the formats we used to present the findings.
Methods: PFOA (perfluorooctanoic acid) is a type of perfluoro chemical (PFC) which is used in the manufacture of teflon, flame resistant and waterproof clothing; it is also a breakdown product of certain chemicals found in stain-resistant fabrics and grease-resistant coatings. The research team had questions with issues regarding the reporting of unexpected results, that came from unknown sources and with unknown health effects. Ultimately, we did decide to present these findings to the study families through a well developed communication plan.
Discussion: Research team members came from a variety of experiences and backgrounds which led to different opinions about the many issues surrounding these findings. We debated topics such as the Precautionary Principle, the Right to Know and Do No Harm.
Conclusions: Given advances in biomarker technologies and a greater use of research teams that involve people from different backgrounds, a communication plan must be developed for those involved as study participants.