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属于参与者潜在兴趣的连续体。一些结果，如血压，具有明显的临床实用性，血压升高可通过服用降压药物来控制。在连续体的另一端，复杂疾病的遗传学研究结果为未来的临床管理带来了巨大的希望;然而，这些结果并不能立即付诸行动，可能只具有科学意义。进行社区基础的前瞻性研究（CBPR）的研究科学家有义务在不暗示比实际存在的更多益处的情况下传达研究结果，并有独特的机会阐明如何在产生遗传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的阿拉斯加土著健康研究中心（CANHR）进行的既定CBPR项目中传达从传统临床措施到遗传和基因组规模研究结果的研究结果。CANHR研究是一个CBPR项目，与阿拉斯加西南部育空地区Kuskokwim健康公司（YKHC）的1,300多名Yup'ik爱斯基摩人及其医疗保健提供者合作。CANHR研究的重点是识别导致Yup'ik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及其相互作用。 与华盛顿大学基因组学和医疗平等中心的研究人员合作，我们提出了一个跨学科的伙伴关系，将建立一个社区规划小组（CPG）的Yup'ik爱斯基摩代表共同定义一个文化上有意义的框架，分类CANHR结果，以及确定一个沟通计划，传播活动与研究结果类别相匹配。该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的医疗保健提供者和医疗保健促进项目领导人进行一系列反复磋商来完善。然后，我们将测试的可移植性的框架和相关的通信策略在HMO的研究设置。此外，所有研究合作伙伴将在研究开始和结束时与一组具有CBPR，教育和遗传学研究专业知识的利益相关者会面，以根据他们自己独特的研究背景和经验提供输入和反馈。最后，我们将根据我们的合作研究结果制定一个指南，以帮助其他研究人员和社区合作伙伴确定一个适当的研究成果交流计划。 公共卫生相关性：遗传和基因组规模的研究有助于提供卫生保健和预防疾病的长期潜力很高，但目前大多数结果的临床实用性有限。虽然研究参与者普遍表示有兴趣获得研究结果，但他们对复杂的遗传研究、研究过程和它试图解决的问题或实际研究结果的有意义的交流知之甚少。这项研究将使用基于社区的参与性研究方法，制定一个框架，以界定不同类别的研究成果和适当的传播计划，评估框架的普遍性，并制定一个指南，可供其他研究人员使用，以制定适当的战略，将复杂的研究结果返回给参与者。

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.