Center for Human Genetics, Marshfield Clinic Research Foundation, Marshfield, Wisconsin, USA.
Am J Med Genet A. 2011 Apr;155A(4):737-41. doi: 10.1002/ajmg.a.33896. Epub 2011 Mar 15.
The Personalized Medicine Research Project (PMRP) is a population-based biobank with more than 20,000 adult participants in central Wisconsin. A Community Advisory Group (CAG) and Ethics and Security Advisory Board (ESAB) provide ongoing feedback. In addition, the study newsletter is used as a two-way communication tool with study participants. The aim of this study was to assess and compare feedback received from these communication/consultation strategies with results from focus group discussions in relation to protocol changes. In summer 2009, enrollee focus groups were held addressing these topics: newsletter format, readability, and content of three articles written to solicit PMRP subject feedback. The CAG and ESAB jointly reviewed focus group results, discussed protocol changes to access residual blood samples, and made recommendations about the general communication approach. Nearly everyone in three focus groups stated that they wanted more information about PMRP. No focus group participant said that accessing stored samples would have changed their enrollment decision. Most said they wanted to be informed directly about changes affecting their original consent. For minimal-risk PMRP protocol changes, the community, CAG, and ESAB were comfortable with an opt-out model because of the initial broad consent. The planned duration of the biobank extends for decades; therefore regular, ongoing communication to enrollees is necessary to maintain awareness and trust, especially relating to protocol changes reflecting evolving science. The multi-faceted approach to communication including newsletters, external advisory boards, and focus group discussions has been successful for the PMRP biobank and may be a model for others to consider.
个体化医学研究项目（PMRP）是一个基于人群的生物库，在威斯康星州中部有超过 20000 名成年参与者。一个社区咨询小组（CAG）和伦理与安全咨询委员会（ESAB）提供持续的反馈。此外，研究通讯也被用作与研究参与者进行双向沟通的工具。本研究旨在评估和比较这些沟通/咨询策略收到的反馈与有关方案变更的焦点小组讨论的结果。在 2009 年夏天，对参与者进行了焦点小组讨论，讨论的主题是：通讯格式、可读性以及为征求 PMRP 主题反馈而撰写的三篇文章的内容。CAG 和 ESAB 共同审查了焦点小组的结果，讨论了访问剩余血液样本的方案变更，并就一般沟通方法提出了建议。三个焦点小组中的几乎每个人都表示，他们希望获得更多关于 PMRP 的信息。没有焦点小组参与者表示，访问存储的样本会改变他们的入组决定。大多数人表示，他们希望直接了解影响其原始同意的变更。对于风险最小的 PMRP 方案变更，由于最初的广泛同意，社区、CAG 和 ESAB 对选择退出模型感到满意。生物库的计划持续时间长达数十年；因此，需要定期向参与者进行持续沟通，以保持意识和信任，特别是在反映不断发展的科学的方案变更方面。包括通讯、外部咨询委员会和焦点小组讨论在内的多方面沟通方法对 PMRP 生物库是成功的，可能是其他机构考虑的模式。
