Impact of Data Access Policies on Biobank Participation

数据访问政策对生物样本库参与的影响

• 批准号: 7935507
• 负责人: MAUREEN E SMITH
• 金额: $ 37.21万
• 依托单位: NORTHWESTERN UNIVERSITY AT CHICAGO
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-09-22 至 2012-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7935507
• 关键词: Address; Affect; Ambulatory Care Facilities; Area; Bioethics; Chicago; Clinical; Collection; Consent; Consultations; DNA; Data; Data Set; Databases; Deposition; Development; Europe; Focus Groups; Funding; Future; Genetic; Genetic Research; Genotype; Goals; Government; Health; Hospitals; Housing; Human; Informed Consent; Institution; Interview; Knowledge; Medical Records; Medical center; Modeling; Participant; Patients; Phenotype; Policies; Policy Research; Privacy; Published Comment; Qualitative Research; Recommendation; Recruitment Activity; Research; Research Methodology; Research Personnel; Resources; Risk; Role; Sampling; Speed; Structure; Surveys; Testing; Translations; United States National Institutes of Health; base; biobank; cohort; data sharing; database of Genotypes and Phenotypes; genome wide association study; genome-wide; improved; interest; metropolitan; novel; patient population; preference; prospective; research study; willingness

DESCRIPTION (provided by applicant): This application addresses broad challenge area (01) Bioethics, and specific Challenge Topic, 02-HG-101: Informed Consent and Data Access Policies. Our project title is "The Impact of Data Access Policies on Biobank Participation". The NIH data access policy for genetic research provides enormous opportunities for genetic investigators but also raises a number of challenges for educating and recruiting participants into large-scale genetic research studies. The NIH released a final data access and sharing policy for genome-wide association studies (GWAS) in August, 2007. The policy requires specific phenotypic and genetic data from GWAS be deposited into a government controlled, limited access database. The goal of this study is to examine how NIH data access policies will impact participation in large-scale genetic research. In parallel with the emergence of GWAS, medical centers and research institutions worldwide are developing biobanks that house large numbers of participant DNA samples and data. Large scale participant recruitment initiatives are required to sustain and grow these resources that will increasingly be "tapped" to support GWAS. Challenges for the investigators establishing these and similar collections include: the most appropriate manner to educate potential research participants about genetic research and the data sharing policy, how to inform them about known and potential risks, and how to do this in an efficient and scalable manner. These challenges make it increasingly difficult to individually consent research participants as well as consent for each future use. Broad consent, one in which the participants consent to uses of their biospecimen and data for unspecified future research of prospectively collected cohorts, is generally accepted in the US and more so in Europe. However, controversy exists over how much control to offer participants regarding future access to and uses of samples and data. An opt-out model, one in which participants may indicate that they do not wish for leftover de-identified clinical samples or medical record data to be used for research is being incorporated into biobanks. Although the practice is controversial, its use may become more common as US investigators seek more efficient means of amassing large scale collections necessary for GWAS and other genome wide analytic approaches. Potential participants' understanding of both broad consent and opt-out models must be assessed in the context of genetic research and existing data access policies. To date, participant knowledge about data access policies and practices and their potential impact on participation, or their participation preferences, has not been assessed. We will ascertain novel educational strategies needed to help a patient population consisting of patients from a metropolitan Chicago hospital clearly understand the data access policy for genetic research, the role of the government as the holder of the data, the privacy protections included in the policy and the known and potential risks to privacy. Specifically, we propose to: (1) Investigate whether data access policies affect the willingness of patients to participate in a prospective hospital-based biobank, (2) Assess whether wide-spread data sharing policies for genetic research impacts participants' preferences for two consent models: broad consent and opt-out approaches, and (3) Develop recommendations to help future patients to better understand GWAS and data access policies. To address these aims, we will conduct semi-structured interviews on a random sample of patients ascertained from Northwestern Memorial Hospital and affiliated outpatient clinics. The interviews will address in greater depth preliminary data obtained from focus groups on data sharing and genetic research and will be analyzed according to qualitative research methods. Interview results will inform development of a survey to test educational messages on data sharing and to address patients' interest in participating in genetic research based on a presentation of the two consent models. The results of the survey will provide a basis for recommendations of educational messages and consent models for participants involved in studies in which data will be shared. The goal of this study is to examine how the NIH data access policies for sharing genetic research information will impact participation in large-scale genetic research. The NIH data access policy encourages wide sharing of genetic research information among investigators to speed the translation of genetic research into improving human health. This policy has yet to be assessed for its impact on participation in genetic research nor the research participant's understanding and preferences around this policy.

描述（由申请人提供）：本申请解决了广泛的挑战领域 (01) 生物伦理学，以及具体的挑战主题 02-HG-101：知情同意和数据访问政策。我们的项目名称是“数据访问政策对生物样本库参与的影响”。美国国立卫生研究院的基因研究数据访问政策为基因研究人员提供了巨大的机会，但也为教育和招募大规模基因研究参与者提出了许多挑战。 NIH 于 2007 年 8 月发布了全基因组关联研究 (GWAS) 的最终数据访问和共享政策。该政策要求将 GWAS 的特定表型和遗传数据存入政府控制的、访问受限的数据库中。本研究的目的是研究 NIH 数据访问政策将如何影响大规模基因研究的参与。随着 GWAS 的出现，世界各地的医疗中心和研究机构都在开发生物库，以容纳大量参与者 DNA 样本和数据。需要大规模的参与者招募活动来维持和增长这些资源，这些资源将越来越多地被“利用”来支持 GWAS。建立这些和类似收集的研究人员面临的挑战包括：以最合适的方式对潜在研究参与者进行基因研究和数据共享政策的教育，如何告知他们已知和潜在的风险，以及如何以有效和可扩展的方式做到这一点。这些挑战使得单独同意研究参与者以及同意未来的每次使用变得越来越困难。广泛同意，即参与者同意将其生物样本和数据用于前瞻性收集的队列的未指定的未来研究，在美国被普遍接受，在欧洲更是如此。然而，对于在未来访问和使用样本和数据方面为参与者提供多少控制权，存在争议。一种选择退出模式正在被纳入生物库，在该模式中，参与者可以表明他们不希望将剩余的去识别化临床样本或医疗记录数据用于研究。尽管这种做法存在争议，但随着美国研究人员寻求更有效的方法来收集 GWAS 和其他全基因组分析方法所需的大规模样本，它的使用可能会变得更加普遍。潜在参与者对广泛同意和选择退出模式的理解必须在基因研究和现有数据访问政策的背景下进行评估。迄今为止，尚未评估参与者对数据访问政策和实践的了解及其对参与的潜在影响或他们的参与偏好。我们将确定所需的新颖教育策略，以帮助由芝加哥大都会医院的患者组成的患者群体清楚地了解基因研究的数据访问政策、政府作为数据持有者的作用、政策中包含的隐私保护以及已知和潜在的隐私风险。具体来说，我们建议：（1）调查数据访问政策是否影响患者参与未来医院生物库的意愿，（2）评估广泛的基因研究数据共享政策是否影响参与者对两次同意的偏好模型：广泛的同意和选择退出方法，以及 (3) 制定建议以帮助未来的患者更好地了解 GWAS 和数据访问政策。为了实现这些目标，我们将对西北纪念医院及其附属门诊诊所确定的随机患者样本进行半结构化访谈。访谈将更深入地讨论从数据共享和基因研究焦点小组获得的初步数据，并将根据定性研究方法进行分析。访谈结果将为一项调查的开展提供信息，以测试有关数据共享的教育信息，并根据两种同意模型的介绍满足患者参与基因研究的兴趣。调查结果将为参与共享数据的研究的参与者提供教育信息和同意模型的建议奠定基础。本研究的目的是研究 NIH 共享遗传研究信息的数据访问政策将如何影响大规模遗传研究的参与。美国国立卫生研究院的数据访问政策鼓励研究人员广泛共享基因研究信息，以加快基因研究转化为改善人类健康。该政策对参与基因研究的影响以及研究参与者对该政策的理解和偏好尚未进行评估。