Ethical and Legal Challenges in Communicating Individual Biomonitoring and Person

描述（由申请人提供）：为了了解环境污染物如何影响健康，研究人员越来越多地转向对人体血液、尿液、母乳和其他组织进行生物监测，并在个人空间取样，例如测试家中的灰尘和空气。新的测试测量了低水平的各种化学物质——最近包括邻苯二甲酸盐、双酚a、溴化阻燃剂（多溴二苯醚）和全氟化合物（PFOA）等。虽然科学研究的目的是分析人群的模式，但研究参与者往往希望了解他们自己的个人结果。这个项目的目标是，在健康影响不明确、减少接触战略的有效性不确定的情况下，为决定是否以及如何向参与者报告个人接触结果制定道德实践准则。作为提出伦理实践的基础，本项目调查了个人暴露评估研究中参与者的经验、价值观和态度，以及IRB成员、研究人员、临床医生和法律专家的观点。负责保护人类研究参与者的研究人员和机构审查委员会（irb）必须尊重研究参与者的自主权；权衡报告结果的好处，这可能有助于科学素养，并告知和授权参与者采取行动；并考虑潜在的危害，例如，来自错误的担忧、耻辱或无效的行动。他们还必须考虑在私人场所（如家中）检测到污染物时可能出现的法律或财务问题。由于生物监测和个人暴露测量迅速扩大，很少有报告实践的模型存在；2006年美国国家科学院的一份报告指出，迫切需要对个人暴露报告进行实证研究。这个项目有助于填补这一空白。具体目标是(1)对报告了对健康影响不确定的化学品的个别结果的研究进行四项案例研究，并对每项研究进行(a)分析知情同意和报告方法以及(b)对研究参与者、研究人员和内部审查委员会成员进行深入访谈；(2)开展法律研究，研究联邦和州房地产和环境法规定的披露风险的义务如何可能因家庭测量而触发，以及披露义务如何可能与参与者的隐私发生冲突；(3)开展三个焦点小组，以进一步检查多种观点，并激发研究人员、IRB官员、律师、临床医生和社区健康倡导者之间的对话；(4)根据其他具体目标的结果，制定、同行评审和传播个人暴露研究有效、道德和后勤可行的报告-反馈方案的指导方针。这四个案例研究包括政府、学术和针对成人和儿童的倡导性研究，包括加州生物监测项目的试点研究、一项队列健康研究、一项饮用水中PFOA暴露的生物监测研究，以及关于改善美国化学政策需求的倡导性生物监测研究。

DESCRIPTION (provided by applicant): In order to learn how environmental contaminants may affect health, researchers increasingly turn to biomonitoring of human blood, urine, breast milk, and other tissues, and to sampling in personal spaces, such as testing dust and air in homes. New tests measure low levels of a wide range of chemicals -- recently including phthalates, bisphenol A, brominated flame retardants (PBDEs), and perfluorinated compounds (PFOA), among many others. While the scientific aim is to analyze patterns in populations, study participants often want to learn their own individual results. The goal of this project is to develop guidelines for ethical practices in decisions about whether and how to report personal exposure results to participants when the health implications are unclear and the effectiveness of exposure reduction strategies is uncertain. As a basis for proposing ethical practices, this project investigates the experiences, values, and attitudes of participants in personal exposure assessment studies and the perspectives of IRB members, researchers, clinicians, and legal experts. Researchers and institutional review boards (IRBs) charged with protecting human research participants must respect the autonomy of study participants; weigh the benefits of reporting results, which may contribute to science literacy and inform and empower participants to take action; and consider the potential for harm, for example, from misplaced worry, stigma, or ineffective action. They also must consider legal or financial issues that may arise when contaminants are detected in a private place, such as a home. Because biomonitoring and personal exposure measurements have expanded rapidly, few models exist for reporting practices; and a 2006 National Academy of Sciences report identified a pressing need for empirical research into individual exposure report-back. This project helps to fill that gap. The specific aims are (1) to conduct four case studies of research that has reported individual results for chemicals for which health effects are uncertain, and for each study to (a) analyze informed consent and report-back methods and (b) conduct in-depth interviews with study participants, researchers, and IRB members; (2) to conduct legal research that examines how obligations to disclose hazards under federal and state real estate and environmental laws might be triggered by measurements in homes and how disclosure obligations might conflict with participants' privacy; (3) to conduct three focus groups to further examine multiple perspectives and stimulate dialogue among researchers, IRB officials, lawyers, clinicians, and community health advocates, and (4) based on results of the other specific aims, develop, peer review, and disseminate guidelines for effective, ethical, and logistically feasible report-back protocols for personal exposure research. The four case studies encompass government, academic, and advocacy research with adults and children, including the pilot study for California's Biomonitoring Program, a cohort health study, a biomonitoring study of PFOA exposure from drinking water, and advocacy biomonitoring studies of the need for better US chemical policies. PUBLIC HEALTH RELEVANCE: Environmental public health research and surveillance depends on biomonitoring and personal exposure studies that test for a wide range of chemicals for which the health effects are not yet fully understood. In these studies, researchers and human research review boards (IRBs) must weigh the potential benefits, harms, and implications for justice and autonomy of reporting individual results to participants who are tested. This project investigates the experiences, attitudes and values of study participants who received personal exposure results, and the perspectives of researchers, IRB members, clinicians, lawyers, and lay health advocates as a basis for developing and disseminating best practices guidelines.