Ethics of Dissemination: Communicating with Participants about Genetics Research

描述(由申请人提供)：涉及人类的生物医学研究产生的结果符合参与者潜在兴趣的连续体。一些结果，如血压，有明显的临床实用价值，血压升高是可以通过服用降压药来操作的。在连续体的另一端，复杂疾病遗传学研究的结果为未来的临床管理带来了巨大的希望；然而，这些结果不能立即付诸实施，可能只有科学意义。开展基于社区的参与性研究(CBPR)的研究科学家有义务在不暗示比实际存在的更多好处的情况下传达研究结果，并有一个独特的机会来阐明如何在产生基因研究结果的研究中履行这一义务。这项拟议的研究旨在确定如何在阿拉斯加大学费尔班克斯大学阿拉斯加原住民健康研究中心(CANHR)实施的CBPR项目中传达从传统临床措施到基因和基因组规模的研究结果。CANHR的研究是一个CBPR项目，与1300名爱斯基摩人和他们在阿拉斯加西南部的育空库斯科维姆健康公司(YKHC)的医疗保健提供者合作。CANHR的研究重点是确定导致尤普伊克爱斯基摩人肥胖、糖尿病和心血管疾病的遗传、行为和营养风险因素，以及它们之间的相互作用。与华盛顿大学基因组学和医疗保健平等中心的研究人员合作，我们提议建立一个跨学科的合作伙伴关系，建立一个由尤普伊克·爱斯基摩人代表组成的社区规划小组(CPG)，共同定义一个对CANHR结果进行分类的具有文化意义的框架，并确定一个将传播活动与研究结果类别相匹配的沟通计划。框架和沟通计划将通过与CPG、具有研究专长的Yup‘ik领导人以及YKHC的卫生保健提供者和卫生保健促进计划负责人的一系列迭代磋商来完善。然后，我们将在HMO研究环境中测试该框架和相关通信策略的可移植性。此外，所有研究伙伴将在研究开始和结束时与在CBPR、教育和遗传学研究方面具有专业知识的选定利益攸关方会面，根据他们自己独特的研究背景和经验提供投入和反馈。最后，我们将根据我们的合作研究结果制定一份指南，以帮助其他研究人员和社区合作伙伴确定适当的计划来传达研究结果。 公共卫生相关性：基因和基因组规模的研究为卫生保健提供和疾病预防做出贡献的长期潜力很高，但目前大多数结果的临床实用价值有限。尽管研究参与者通常表示有兴趣收到研究结果，但对于他们认为关于复杂基因研究的有意义的沟通、研究过程和寻求解决的问题，或实际的研究结果，人们知之甚少。这项研究将使用基于社区的参与性研究方法来制定一个框架，以确定不同类别的研究结果和适当的沟通计划，评估框架的概括性，并制定一个指南，供其他寻求制定向参与者反馈复杂研究成果的适当战略的研究人员使用。

DESCRIPTION (provided by applicant): Biomedical research involving humans generates results that fall on a continuum of potential interest to participants. Some results, such as blood pressure, have obvious clinical utility, and elevated blood pressure is actionable by taking blood pressure medication. At the other end of the continuum, results from research on the genetics of complex diseases holds great promise for future clinical management; however the results are not immediately actionable and may only be of scientific interest. Research scientists conducting Community-Based Participatory Research (CBPR) have an obligation to communicate research outcomes without implying more benefit than is actually present, and a unique opportunity to elucidate how this obligation can be met in studies that generate genetic research results. The proposed study seeks to determine how to communicate research results ranging from conventional clinical measures to genetic and genome-scale research findings within an established CBPR project conducted by the Center for Alaska Native Health Research (CANHR) at the University of Alaska Fairbanks. The CANHR study is a CBPR project partnering with >1,300 Yup'ik Eskimos and their health care providers at the Yukon Kuskokwim Health Corporation (YKHC) in Southwest Alaska. The CANHR study is focused on the identification of, and interaction among, genetic, behavioral, and nutritional risk factors that lead to obesity, diabetes and cardiovascular disease in Yup'ik Eskimos. In collaboration with investigators at the Center for Genomics and Healthcare Equality at the University of Washington, we propose an interdisciplinary partnership that will establish a Community Planning Group (CPG) of Yup'ik Eskimo representatives to collectively define a culturally meaningful framework that categorizes CANHR results, as well as to determine a communication plan that matches dissemination activities with research result categories. The framework and communication plan will be refined through an iterative series of consultations with the CPG, Yup'ik leaders with research expertise, and health care providers and health care promotion program leaders at the YKHC. We will then test the portability of the framework and associated communication strategies in an HMO research setting. In addition, all research partners will meet with a select group of stakeholders having expertise in CBPR, education, and genetics research at the beginning and end of the study to provide input and feedback based on their own unique research contexts and experiences. Finally, we will develop a guide that is based on the results of our collaborative studies, to assist other researchers and community partners in determining an appropriate plan for communicating research results. Public Health Relevance: The long-term potential for genetic and genome-scale research to contribute to health care delivery and disease prevention is high, but most current results have limited clinical utility. Although research participants generally express interest in receiving research results, little is known about what they would consider meaningful communication about complex genetic research, the research process and questions it seeks to address, or actual research findings. This study will use community-based participatory research methods to develop a framework for defining different categories of research results and appropriate communication plans, assess the generalizability of the framework, and develop a guide that can be used by other researchers seeking to develop appropriate strategies for returning complex research findings to participants.