Community Consultation as an Ethics Method

描述（由申请人提供）：在过去的十年中，研究人员，机构和研究赞助商在美国和国外与少数民族和土著居民进行了各种形式的对话。这些“社区咨询”是遗传学研究越来越常见的辅助手段，特别是对于旨在创建一个组织和信息库供多名研究人员使用的项目，有许多不同的协议，在很长一段时间内。数百万美元用于协商。 社区咨询可以实现通过个人知情同意和标准伦理审查无法实现的目标，例如最大限度地减少因研究人群成员资格或身份而引起的第三方伤害。磋商可以使潜在的研究参与者和研究人群了解人类遗传学/基因组学研究和特定的协议。它们还旨在就潜在参与者的相关价值观、偏好、关切和/或判断征求反馈意见。虽然许多社区协商正在进行中，但对于协商可以解决哪些道德和政策目标，以及哪些协商方法最适合解决特定目标，没有达成一致意见。对于什么应当引发协商，或者监督机构应当以什么标准来评价协商，几乎没有达成一致意见。本项目旨在为社区咨询的实践提供理论基础。一个由来自不同学科的18名学者和经常被研究的人群组成的工作组将参与讨论、论证、反思和写作的审议过程，以回答有关社区协商的问题。小组的讨论将辅以访谈数据，描述研究人员和参与者的磋商经验。该小组将提出指导方针，IRB和其他研究监督实体可以根据这些指导方针确定方案是否需要伴随咨询，审查人员可以根据这些指导方针确定拟议的咨询是否可能实现规定的伦理或政策目标。该项目将产生几份针对专业、政策和公众（非专家）读者的手稿。

DESCRIPTION (provided by applicant): Over the past decade researchers, institutions and research sponsors have engaged in various forms of discourse with minority and indigenous populations in the US and abroad. These "community consultations" are an increasingly common adjunct to genetics research, particularly for projects aiming to create a repository of tissues and information for use by multiple researchers, with numerous different protocols, over an extended time period. Millions of dollars are being spent on consultations. Community consultation may achieve goals not attainable through individual informed consent and standard ethics review, such as the minimization of third-party harms mediated by membership in or identification with a study population. Consultations can inform potential research participants and study populations about human genetics/genomics research and about particular protocols. They are also intended to elicit feedback regarding potential participants' relevant values, preferences, concerns and/or judgments. Although numerous community consultations are underway, there is no agreement on which ethics and policy goals consultation can address, and which methods of consultation are best for addressing particular goals. There is little agreement as to what should trigger consultations, or the standards by which oversight bodies should evaluate them. This project aims to provide theoretical grounding for the practice of community consultation. A working group of 18 scholars from diverse disciplines, and individuals from frequently studied populations, will engage in a deliberative process of discourse, argumentation, reflection and writing to answer questions regarding community consultation. The group's deliberation will be supplemented with interview data describing researchers' and participants' experiences with consultations. The group will propose guidelines by which IRBs and other research oversight entities can determine whether a protocol requires accompanying consultation, and by which reviewers can determine whether a proposed consultation is likely to achieve stated ethics or policy goals. This project wilt yield several manuscripts aimed at professional, policy and public (non-expert) audiences.