McCarty Catherine A, Chapman-Stone Donna, Derfus Teresa, Giampietro Philip F, Fost Norman
Marshfield Clinic Research Foundation, Center for Human Genetics, Marshfield, Wisconsin 54449, USA.
Am J Med Genet A. 2008 Dec 1;146A(23):3026-33. doi: 10.1002/ajmg.a.32559.
The purpose of this article is to describe community consultation and communication efforts for the Personalized Medicine Research Project (PMRP), a population-based biobank. A series of focus group discussions was held in the year preceding initial recruitment efforts with potentially eligible community residents and slightly less than a year after initial recruitment with eligible residents who had declined participation in PMRP. A Community Advisory Group, with 19 members reflecting the demographics of the eligible community, was formed and meets twice yearly to provide advice and feedback to the PMRP Principal Investigator and the local IRB. Ongoing communication with study subjects, who consent on the condition that personal genetic results will not be disclosed, takes place through a newsletter that is distributed twice yearly, community talks and media coverage. Most focus group participants were concerned about the confidentiality of both their medical and genetic data. Focus group discussions with eligible residents who elected not to participate in PMRP revealed that many knew very little about the project, but thought that too much information had been provided, leading them to believe that it would take too long for them to understand and enroll in the study. In conclusion, an engaged community advisory group can provide a sounding board to study investigators for many study issues and can provide guidance for broader communication activities. Researchers need to balance the provision of information for potential subjects to make informed decisions about study participation, with respect for individuals' time to read and interpret study materials.
本文旨在描述针对个性化医学研究项目（PMRP）开展的社区咨询与沟通工作，该项目是一个基于人群的生物样本库。在首次招募工作开始前一年，与潜在符合条件的社区居民进行了一系列焦点小组讨论；在首次招募后不到一年，与拒绝参与PMRP的符合条件居民进行了讨论。成立了一个社区咨询小组，由19名成员组成，反映了符合条件社区的人口特征，该小组每年召开两次会议，向PMRP首席研究员和当地机构审查委员会提供建议和反馈。与研究对象保持持续沟通，这些研究对象同意参与的条件是个人基因结果不会被披露，沟通方式包括每年分发两次的时事通讯、社区讲座和媒体报道。大多数焦点小组参与者担心其医疗和基因数据的保密性。与选择不参与PMRP的符合条件居民进行的焦点小组讨论显示，许多人对该项目了解甚少，但认为提供的信息过多，导致他们认为需要太长时间才能理解并参与该研究。总之，一个积极参与的社区咨询小组可以为研究调查人员提供一个探讨许多研究问题的平台，并可为更广泛的沟通活动提供指导。研究人员需要在为潜在研究对象提供信息以使其能够就是否参与研究做出明智决定，与尊重个人阅读和理解研究材料的时间之间取得平衡。
