Community Consultation as an Ethics Method

描述(由申请人提供)：在过去的十年里，研究人员、机构和研究赞助商与美国和国外的少数族裔和土著人口进行了各种形式的对话。这些“社区协商”是遗传学研究的一个日益常见的辅助工具，特别是对于旨在创建一个组织和信息库的项目，以供多个研究人员在更长的一段时间内使用，使用许多不同的方案。在磋商上花费了数百万美元。 社区协商可以实现通过个人知情同意和标准道德审查无法实现的目标，例如将研究人群中的成员身份或认同所调解的第三方伤害降至最低。会商可以让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方案。它们还旨在获得有关潜在参与者的相关价值观、偏好、关切和/或判断的反馈。尽管正在进行许多社区协商，但对于协商可以针对哪些道德和政策目标，以及哪些协商方法最适合于实现特定目标，还没有达成一致意见。对于什么应该引发磋商，或者监督机构应该根据什么标准进行评估，几乎没有达成一致意见。本项目旨在为社区协商的实践提供理论依据。一个由来自不同学科的18名学者和来自经常研究的人群的个人组成的工作组将参与一个讨论过程，包括话语、论证、反思和写作，以回答有关社区咨询的问题。该小组的审议将得到描述研究人员和参与者咨询经验的采访数据的补充。该小组将提出指导方针，IRBs和其他研究监督实体可以根据这些准则来确定议定书是否需要伴随磋商，审查员可以根据这些准则来确定拟议的磋商是否可能实现既定的伦理或政策目标。这个项目将产生几份针对专业、政策和公众(非专家)受众的手稿。

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.