Sharing unexpected biomarker results with study participants.

Sharing unexpected biomarker results with study participants.
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DOI:
10.1289/ehp.1001988
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发表时间:
2011-01
影响因子:
10.4
通讯作者:
Bornschein RL
Bornschein RL
中科院分区:
环境科学与生态学1区
文献类型:
--
作者:
Hernick AD;Brown MK;Pinney SM;Biro FM;Ball KM;Bornschein RL

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乳腺癌与环境研究中心 (BCERC) 包括来自基础科学、流行病学和社区的合作者,开展研究以调查环境暴露是否与青春期时间相关。对部分研究参与者进行的一项试点研究评估了测量 6-8 岁女孩血液和尿液中选定的暴露生物标志物的可行性。在大辛辛那提研究人群中,我们发现居住在小社区的 90% 以上的年轻女孩的全氟辛酸 (PFOA) 血清浓度升高。研究小组审议了是否以及如何向我们的研究家庭报告 PFOA 研究结果。我们将解决我们的决定中考虑的问题,以及我们用来呈现调查结果的格式。当我们寻找 PFOA 水平升高的潜在来源时,结果得到了验证。作为一个研究团队,我们努力解决有关报告意外结果的问题,这些结果来自未知来源且具有未知的临床意义。最终,我们决定通过完善的沟通计划向研究家庭展示这些发现。研究团队成员来自不同的经历和背景,导致对这些发现的临床、伦理和公共卫生问题有不同的解释。道德争论的焦点是预防原则、知情权和不伤害权。鉴于环境生物标志物技术的进步和跨学科研究模式的更多使用,必须为研究参与者制定沟通计划。
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. 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. 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. 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. 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.
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