Ethical and Legal Challenges in Communicating Individual Biomonitoring and Person

个人生物监测和人员交流中的伦理和法律挑战

基本信息

批准号：
8368264
负责人：
Gary Adamkiewicz
金额：
$ 71.13万
依托单位：
SILENT SPRING INSTITUTE
依托单位国家：
美国
项目类别：
财政年份：
2009
资助国家：
美国
起止时间：
2009-12-15 至 2014-10-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/8368264
关键词：
Address Adult Advocacy Advocate Affect Air Attitude Back Biological Monitoring Blood Breathing California Case Study Charge Chemicals Child Clinic Clinical Communities Community Health Confidentiality Conflict (Psychology)Data Disclosure Dust Effectiveness Empirical Research Environmental Exposure Environmental Health Environmental Pollution Equilibrium Ethical Issues Ethics Flame Retardants Focus Groups Future General Population Goals Government Government Agencies Guidelines Hair Hand Health Health Policy Home environment House Dust Human Human Milk Human Subject Research Incidental Findings Individual Informed Consent Institutes Institutional Review Boards Interview Journals Justice Knowledge Laws Lawyers Learning Legal Legal Obligations Measurement Measures Methods Modeling Monitor NIH Program Announcements Participant Pattern Peer Review Personal Behavior Personal Space Persons Pilot Projects Policies Population Study Practice Guidelines Privacy Protocols documentation Public Health Published Comment Publishing Regulation Reporting Research Research Personnel Research Subjects Resources Risk Sampling Science Scientist Soil Test Result Testing Tissues Translating Translations Umbilical Cord Blood Uncertainty United States National Academy of Sciences Universities Urine Water base bisphenol A cohort drinking water empowered experience guidebooks hazard health organization literacy member phthalates pollutant programs prospective psychologic public health relevance public health research response risk perception social stigma web site

项目摘要

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.

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人类血液，尿液，母乳和其他组织的生物监测，并在个人空间中取样，例如在家庭中测试灰尘和空气。新的测试测量了低水平的广泛化学物质 - 最近包括邻苯二甲酸盐，双苯酚A，溴化阻燃剂（PBDES）和全氟化合物（PFOA）等。尽管科学目的是分析人群中的模式，但研究参与者通常想学习自己的个人结果。该项目的目的是制定道德实践指南，以确定是否以及如何向参与者报告健康含义的结果以及如何向参与者报告，而尚不确定暴露策略的有效性尚不确定。作为提出道德实践的基础，该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，并为参与者采取行动并授权并授权参与者采取行动；并考虑造成伤害的潜力，例如，忧虑，污名或无效的行动中存在危害。他们还必须考虑在私人地方（例如房屋）中发现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量测量已经迅速扩展，因此很少有用于报告实践的模型。 2006年的一份美国国家科学院报告确定了对个人暴露报道后表的经验研究的迫切需求。该项目有助于填补这一空白。具体目的是（1）进行四个研究案例研究，这些案例研究报告了对健康影响不确定的化学物质的个体结果，并且每项研究都对（a）分析知情同意和报告后卫方法，以及（b）对研究参与者，研究人员和IRB成员进行深入的访谈；（2）进行法律研究，以研究如何通过衡量房屋的测量来触发联邦和州房地产和环境法规定的危害的义务，以及披露义务如何与参与者的隐私相抵触；（3）进行三个焦点小组，以进一步研究多种观点并刺激研究人员，IRB官员，律师，临床医生和社区健康拥护者之间的对话，以及（4）基于其他特定目的的结果，发展，同行评审，并散布有效的，伦理和逻辑上可行的报告型公益方案，以实现个人敞口研究。这四个案例研究涵盖了与成人和儿童进行的政府，学术和倡导研究，包括加利福尼亚生物监测计划的试点研究，一项队列健康研究，一项对饮用水中PFOA暴露的生物监测研究以及倡导生物监测研究，以实现更好的美国化学政策。