Building the Partners HealthCare Biobank at Partners Personalized Medicine: Informed Consent, Return of Research Results, Recruitment Lessons and Operational Considerations
Building the Partners HealthCare Biobank at Partners Personalized Medicine: Informed Consent, Return of Research Results, Recruitment Lessons and Operational Considerations
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DOI：
10.3390/jpm6010002
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发表时间：
2016-03-01
影响因子：
--
通讯作者：
Allen, Nicole L.
中科院分区：
文献类型：
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作者：
Karlson, Elizabeth W.;Boutin, Natalie T.;Allen, Nicole L.
合作伙伴医疗保健生物库是合作伙伴医疗保健企业范围内的一项倡议，其目标是为下一代基因型、环境、基因-环境相互作用、生物标志物和家族史与疾病表型的关联的转化研究提供基础。生物样本库自2010年启动以来，利用面对面和电子招聘的方式，截至2015年10月在Partners HealthCare的两个学术医疗中心招募了100万名受试者。通过与合作伙伴人类研究委员会的密切合作，生物银行制定了一套全面的知情同意程序，解决了患者关注的关键问题，包括隐私和研究结果的回报。吸取的经验教训包括需要仔细考虑道德问题、注意电子媒体的教育内容、在电子知情同意中对患者进行认证的重要性、需要高度安全的信息技术基础设施和通信管理，以及根据临床招聘环境采取灵活的招聘方式和流程的重要性。
The Partners HealthCare Biobank is a Partners HealthCare enterprise-wide initiative whose goal is to provide a foundation for the next generation of translational research studies of genotype, environment, gene-environment interaction, biomarker and family history associations with disease phenotypes. The Biobank has leveraged in-person and electronic recruitment methods to enroll >30,000 subjects as of October 2015 at two academic medical centers in Partners HealthCare since launching in 2010. Through a close collaboration with the Partners Human Research Committee, the Biobank has developed a comprehensive informed consent process that addresses key patient concerns, including privacy and the return of research results. Lessons learned include the need for careful consideration of ethical issues, attention to the educational content of electronic media, the importance of patient authentication in electronic informed consent, the need for highly secure IT infrastructure and management of communications and the importance of flexible recruitment modalities and processes dependent on the clinical setting for recruitment.