Ethical and Legal Challenges in Communicating Individual Biomonitoring and Person

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人体血液，尿液，母乳和其他组织的生物监测，以及个人空间的采样，例如测试家中的灰尘和空气。新的测试方法可以测量各种化学物质的低水平-最近包括邻苯二甲酸酯，双酚A，溴化阻燃剂（PBDEs）和全氟化合物（PFOA）等。虽然科学的目的是分析人群中的模式，但研究参与者往往希望了解自己的个人结果。该项目的目标是制定道德实践准则，在健康影响不明确和减少接触战略的有效性不确定的情况下，决定是否和如何向参与者报告个人接触结果。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、临床医生和法律的专家的观点。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，这可能有助于提高科学素养，并告知参与者并赋予参与者采取行动的权力;并考虑伤害的可能性，例如，错位的担忧，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的或财务问题。由于生物监测和个人接触测量迅速扩大，报告做法的模型很少; 2006年国家科学院的一份报告指出，迫切需要对个人接触报告进行实证研究。该项目有助于填补这一空白。具体目标是：（1）进行四项研究案例研究，这些研究报告了对健康影响不确定的化学品的个体结果，并且对于每项研究，（a）分析知情同意和报告方法，（B）与研究参与者、研究人员和IRB成员进行深入访谈;（二）进行法律的研究，研究如何根据联邦和州真实的房地产和环境法披露危害的义务可能会由家庭测量触发，以及披露义务如何可能与参与者的利益冲突。隐私;（3）开展三个焦点小组，进一步检查多个观点，并促进研究人员、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、同行评审和传播关于个人暴露研究的有效、道德和后勤可行的报告反馈协议的指南。这四个案例研究涵盖了政府、学术和成人和儿童的倡导性研究，包括加州生物监测计划的试点研究、队列健康研究、饮用水中全氟辛酸接触的生物监测研究，以及关于改善美国化学品政策必要性的倡导性生物监测研究。 公共卫生相关性：环境公共卫生研究和监测依赖于生物监测和个人接触研究，这些研究对尚未充分了解其健康影响的各种化学品进行测试。在这些研究中，研究人员和人类研究审查委员会（IRB）必须权衡潜在的好处，危害，以及向受试者报告个人结果的公正性和自主性的影响。该项目调查了接受个人暴露结果的研究参与者的经验、态度和价值观，以及研究人员、IRB成员、临床医生、律师和非专业健康倡导者的观点，作为制定和传播最佳实践指南的基础。

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.