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

超越同意：患者对临床数据和样本使用管理的偏好

• 批准号: 8839503
• 负责人: Sandra Soo-Jin Lee
• 金额: $ 39.94万
• 依托单位: STANFORD UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2014
• 资助国家: 美国
• 起止时间: 2014-09-26 至 2017-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8839503
• 关键词: Accounting; Address; Attitude; Benefits and Risks; Clinical; Clinical Data; Clinics and Hospitals; Computerized Medical Record; Confidentiality; Consent; Data; Electronics; Empirical Research; Ethical Issues; Ethics; Evolution; Focus Groups; Funding; Genetic; Genetic Research; Genomics; Health; Health system; Healthcare; Healthcare Systems; Image; Individual; Information Technology; Informed Consent; Institutional Review Boards; Interview; Investigation; Knowledge; Language; Learning; Light; Literature; Medical; Medical Records; Medical Research; Methods; Modeling; Notification; Patient Care; Patient Preferences; Patients; Perception; Policies; Population; Population Heterogeneity; Privacy; Procedures; Process; Public Health; Quality of Care; Relative (related person); Research; Research Personnel; Research Project Grants; Risk; Safety; Sampling; Structure; Surveys; Trust; Underrepresented Minority; United States; United States National Institutes of Health; Work; base; benefit sharing; biobank; clinical practice; clinically significant; comparative effectiveness; data sharing; digital; effectiveness research; expectation; improved; innovation; patient population; policy implication; preference; public health relevance; social norm; tool; transmission process

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.

描述（由申请人提供）：目前，关于患者对医疗记录和患者数据的使用以及与隐私，机密性，知情同意和结果返回有关的伦理问题的偏好鲜为人知，尤其是在EMR中。此外，缺乏有关特定治理策略的患者偏好的数据。认同医学研究中人数不足的患者尤其如此。为了解决这一差距，拟议的研究将评估患者在EMRS和生物群体治理中应如何访问，使用和管理样本的临床数据和样本的偏好。我们将使用一种混合的方法方法来三角调节半结构化的个人访谈，焦点小组的数据以及对来自不同人群的患者态度的定量调查。我们预计，我们的发现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有直接的影响。这项研究的具体目的是：目标1：评估和比较患者对种族和种族多元化患者人群中临床数据和样本的使用和治理的态度，重点是：a））感知和权衡风险和收益之间的权衡； b）在“边界”条件下使用，使用和共享临床数据和样本的收集，和共享样本的偏好和可接受性； c）关于信任及其与治理策略的关系的态度； d）这些偏好和态度的原因； e）导致各种偏好和态度的因素。目标2：确定与临床数据以及样本使用，共享和治理的态度和偏好相关的因素。