title: Sharing unexpected biomarker results with study participants.
abstract: BACKGROUND
  The Breast Cancer and the Environment Research Centers (BCERCs) include collaborators from basic sciences, epidemiology, and the community, conducting studies to investigate whether environmental exposures are associated with the timing of puberty. A pilot study of a subset of the study participants assessed the feasibility of measuring selected biomarkers of exposure in blood and urine in girls 6-8 years of age. In the Greater Cincinnati study population, we found an elevated serum concentration of perfluorooctanoate (PFOA) among > 90% of young girls living in a small community.
  
  
  OBJECTIVE
  The research team deliberated whether and how to report the PFOA findings to our study families. We will address the issues considered in our decision, as well as the formats we used to present the findings.
  
  
  METHODS
  The results were verified as we searched for potential sources of the elevated PFOA levels. As a research team, we grappled with issues regarding the reporting of unexpected results, derived from unknown sources and with unknown clinical significance. Ultimately, we did decide to present these findings to the study families through a well-developed communication plan.
  
  
  CONCLUSIONS
  Research team members came from a variety of experiences and backgrounds, which led to different interpretations about the clinical, ethical, and public health issues surrounding these findings. The ethical debates centered around the precautionary principle, the right to know, and do no harm.
  
  
  CONCLUSIONS
  Given advances in environmental biomarker technologies and greater use of the transdisciplinary research model, a communication plan must be developed for those involved as study participants.
authors.affiliation: Breast Cancer Alliance of Greater Cincinnati, Cincinnati, Ohio, USA. adhernick@yahoo.com
authors.forename: Ann D
authors.initials: AD
authors.lastname: Hernick
authors.forename: M Kathryn
authors.initials: MK
authors.lastname: Brown
authors.forename: Susan M
authors.initials: SM
authors.lastname: Pinney
authors.forename: Frank M
authors.initials: FM
authors.lastname: Biro
authors.forename: Kathleen M
authors.initials: KM
authors.lastname: Ball
authors.forename: Robert L
authors.initials: RL
authors.lastname: Bornschein
mesh_terms: D015415:Biomarkers / Q000097:blood / Q000652:urine; D002210:Caprylates / Q000097:blood* / Q000652:urine; D002648:Child; D030881:Disclosure / Q000941:ethics* / Q000592:standards; D004781:Environmental Exposure / Q000706:statistics & numerical data*; D004784:Environmental Monitoring / Q000941:ethics; D004785:Environmental Pollutants / Q000097:blood* / Q000652:urine; D005260:Female; D005411:Flame Retardants / Q000378:metabolism*; D005466:Fluorocarbons / Q000097:blood* / Q000652:urine; D006801:Humans; D035842:Research Subjects
chemical_list: D015415:Biomarkers; D002210:Caprylates; D004785:Environmental Pollutants; D005411:Flame Retardants; D005466:Fluorocarbons; C023036:perfluorooctanoic acid