Developing An Effective Community Ethical Review Model

说明(申请人提供)尽管联邦政策旨在保护参与科学研究的人类受试者，但在环境健康研究中继续出现严重的伦理挑战，似乎对有色人种社区和低收入社区的安全和福利产生负面影响。这个问题将由一个跨学科的研究团队解决，该团队来自西哈莱姆环境行动公司(WE ACT)、位于曼哈顿北部的NIEHS环境健康中心和哥伦比亚儿童环境健康中心(后两个组织都是哥伦比亚大学梅尔曼公共卫生学院的一部分)之间的现有合作，他们将实施一个教育和示范项目，即“开发有效的社区伦理审查模式”。该项目将教育研究人员(特别是NIEHS资助研究的首席研究人员和联合调查人员)和社区成员(特别是NIEHS或CDC资助研究的社区组织顾问和研究伙伴，以及其他致力于有色人种社区环境健康问题的人(大多数是有色人种妇女)，了解加强人类主体保护的最佳做法。这将通过开发、实施和评估一个可复制的模式来实现，以确保对基因-环境和非治疗性环境健康研究进行有效的社区审查。具体地说，该项目将侧重于关于哮喘病因和恶化[包括遗传因素]的研究以及对哮喘和铅的家庭干预的伦理问题。之所以选择这些研究研究，是因为项目团队在这些研究方面拥有广泛的经验，而且这些研究具有全国范围的利益。示范模式的基础是：1)评估社区成员、研究人员和健康资助者对环境健康危害和研究伦理的知识；2)现有社区伦理审查模式的案例研究；3)语言和文化上适当的环境健康和研究伦理教育材料和培训；4)关于研究伦理的地方和国家对话；以及5)对所有项目活动的评估。

DESCRIPTION (provided by applicant) Despite federal policies that are designed to protect human subjects involved in scientific research studies, serious ethical challenges continue to occur in environmental health research that appear to negatively impact the safety and welfare of communities of color and low-income communities. This problem will be addressed by an interdisciplinary research team drawn from an existing collaboration between West Harlem Environmental Action, Inc. (WE ACT), the NIEHS Center For Environmental Health in Northern Manhattan, and the Columbia Center for Children's Environmental Health (the latter organizations are both part of Columbia's Mailman School of Public Health) who will implement an educational and demonstration project, "Developing an Effective Community Ethical Review Model." The project will educate researchers (specifically, principal investigators and co-investigators of NIEHS-funded studies) and community members (specifically, community-based organization advisors and research partners on NIEHS- or CDC-funded studies and others who are working on environmental health issues in communities of color (most of whom are women of color) on the best practices for bolstering human subject protection. This will be accomplished through the development, implementation, and evaluation of a replicable model for ensuring effective community review of gene-environment and non-therapeutic environmental health research. Specifically, the project will focus on ethical issues regarding research on the etiology and exacerbation of asthma [including genetic factors] and home-based interventions on asthma and lead. These research studies have been chosen because the project team has broad experience with these studies and because such studies are of nationwide interest. The demonstration model will be based upon, 1) an assessment of community members', researchers', and health funders' knowledge of environmental health hazards and research ethics; 2) case studies of existing community ethical review models; 3) linguistically and culturally appropriate educational materials and trainings on environmental health and research ethics; 4) local and national dialogues regarding research ethics; and 5) evaluation of all project activities.