Beyond consent: patient preferences for governance of use of clinical data and samples

描述（由申请人提供）：目前，对患者使用医疗记录和患者数据的偏好以及与隐私、保密性、知情同意和结果返回相关的伦理问题知之甚少，特别是在EMR的背景下。此外，缺乏关于患者对具体治理策略偏好的数据。这对于那些认同医学研究中代表性不足的群体的患者来说尤其如此。为了解决这一差距，拟议的研究将评估患者对如何在EMR和生物库管理中访问、使用和管理其临床数据和样本的偏好。我们将使用混合方法，从半结构化的个人访谈，焦点小组和来自不同人群的患者的态度的定量调查三角数据的方法。我们预计，我们的研究结果将对医院和诊所以及机构审查委员会和研究人员的数据使用和共享政策产生直接影响。本研究的具体目的是：目的1：评估和比较不同种族和人种患者人群中患者对临床数据和样本使用和管理的态度，重点是：a）风险和受益之间权衡的感知和权衡; B）在“边界”条件下收集、使用和共享临床数据和样本的偏好和可接受性; c）对信任的态度及其与治理战略的关系; d）这些偏好和态度的原因; e）促成各种偏好和态度的因素。目的2：确定与对临床数据和样本使用、共享和治理的态度和偏好相关的因素。

DESCRIPTION (provided by applicant): Currently, there is little known about patient preferences on the use of medical records and patient data and the ethical issues related to privacy, confidentiality, informed consent and return of results, particularly in the context of EMRs. In addition, there is a dearth of data on patient preferences for specific governance strategies. This is particularly true of patients who identify with groups underrepresented in medical research. To address this gap, the proposed study will assess patients' preferences for how their clinical data and samples should be accessed, used and managed in the governance of EMRs and biobanking. We will use a mixed methods approach in triangulating data from semi-structured individual interviews, focus groups and a quantitative survey of attitudes of patients from diverse populations. We anticipate that our findings will have direct implications fo policies on data use and sharing by hospitals and clinics, as well as for institutional review boards and researchers. The specific aims of this research are: Aim 1: To assess and compare patient attitudes towards use and governance of clinical data and samples in a racially and ethnically diverse patient population, with an emphasis on: a) perception and weighing of tradeoffs between the risks and benefits; b) preferences for and acceptability of collecting, using and sharing clinical data and samples under "boundary" conditions; c) attitudes regarding trust and its relationship to governance strategies; d) the reasons for these preferences and attitudes and; e) the factors that contribute to various preferences and attitudes. Aim 2: To identify factors associated with attitudes and preferences towards clinical data and sample use, sharing and governance.