BACKGROUND:As biobanks play an increasing role in the genomic research that will lead to precision medicine, input from diverse and large populations of patients in a variety of health care settings will be important in order to successfully carry out such studies. One important topic is participants' views towards consent and data sharing, especially since the 2011 Advanced Notice of Proposed Rulemaking (ANPRM), and subsequently the 2015 Notice of Proposed Rulemaking (NPRM) were issued by the Department of Health and Human Services (HHS) and Office of Science and Technology Policy (OSTP). These notices required that participants consent to research uses of their de-identified tissue samples and most clinical data, and allowing such consent be obtained in a one-time, open-ended or "broad" fashion. Conducting a survey across multiple sites provides clear advantages to either a single site survey or using a large online database, and is a potentially powerful way of understanding the views of diverse populations on this topic. METHODS:A workgroup of the Electronic Medical Records and Genomics (eMERGE) Network, a national consortium of 9 sites (13 separate institutions, 11 clinical centers) supported by the National Human Genome Research Institute (NHGRI) that combines DNA biorepositories with electronic medical record (EMR) systems for large-scale genetic research, conducted a survey to understand patients' views on consent, sample and data sharing for future research, biobank governance, data protection, and return of research results. RESULTS:Working across 9 sites to design and conduct a national survey presented challenges in organization, meeting human subjects guidelines at each institution, and survey development and implementation. The challenges were met through a committee structure to address each aspect of the project with representatives from all sites. Each committee's output was integrated into the overall survey plan. A number of site-specific issues were successfully managed allowing the survey to be developed and implemented uniformly across 11 clinical centers. CONCLUSIONS:Conducting a survey across a number of institutions with different cultures and practices is a methodological and logistical challenge. With a clear infrastructure, collaborative attitudes, excellent lines of communication, and the right expertise, this can be accomplished successfully.

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背景:随着生物库在基因组研究中将发挥越来越重要的作用,这将导致精准医学的发展,为成功开展此类研究,来自各种医疗机构的大量不同患者群体的投入将非常重要。一个重要的主题是参与者对同意和数据共享的看法,特别是自2011年卫生与公共服务部(HHS)发布了《规则制定的预先通知》(ANPRM)和随后的2015年《规则制定的预先通知》(NPRM)以来。和科学技术政策办公室(OSTP)。这些通知要求参加者同意其去识别的组织样本和大多数临床数据的研究用途,并允许以一次性,开放式或“广泛”方式获得此类同意。跨多个站点进行调查相对于单个站点调查或使用大型在线数据库都具有明显的优势,并且是了解不同人群对此主题的观点的潜在强大方式。
方法:电子病历和基因组学(eMERGE)网络的工作组,由国家人类基因组研究所(NHGRI)支持的9个站点(13个独立机构,11个临床中心)的国家联盟,将DNA生物存储库与电子病历相结合大型基因研究(EMR)系统进行了一项调查,以了解患者对同意,样本和数据共享以进行未来研究,生物库治理,数据保护和返回研究结果的看法。
结果:在9个站点之间进行设计和进行全国调查的工作提出了组织方面的挑战,在每个机构中满足人类受试者准则以及调查的制定和实施的挑战。通过委员会结构应对挑战,并与来自所有地点的代表讨论了项目的各个方面。每个委员会的产出均已纳入总体调查计划。成功解决了许多特定地点的问题,从而使调查可以在11个临床中心中统一制定和实施。
结论:在具有不同文化和实践的许多机构中进行调查是方法和后勤方面的挑战。有了清晰的基础架构,协作态度,出色的沟通渠道以及适当的专业知识,就可以成功实现这一目标。

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