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）：此申请介绍广泛的挑战领域（01）生物伦理学和特定挑战主题，02-HG-101：知情同意和数据访问策略。我们的项目标题是“数据访问政策对生物库参与的影响”。 NIH数据访问遗传学研究的政策为遗传研究者提供了巨大的机会，但也为将参与者教育和招募参与者带入大规模的遗传研究方面带来了许多挑战。 NIH于2007年8月发布了全基因组协会研究（GWAS）的最终数据访问和共享政策。该政策要求将GWA的特定表型和遗传数据存放到政府控制的，有限的访问数据库中。这项研究的目的是研究NIH数据访问政策将如何影响大规模遗传研究的参与。与GWAS的出现同时，全球医疗中心和研究机构正在开发生物库，这些生物库容纳大量参与者的DNA样本和数据。需要大规模参与者招聘计划来维持和发展这些资源，这些资源将越来越“攻击”以支持GWAS。建立这些和类似收藏的研究人员面临的挑战包括：教育潜在研究参与者有关遗传研究和数据共享政策的最合适方式，如何向他们告知已知和潜在风险，以及如何以有效且可扩展的方式进行此操作。这些挑战使得单独同意研究参与者以及对每个未来使用的同意变得越来越困难。广泛的同意，其中参与者同意使用其生物循环系统和数据进行未指定的未来对前瞻性收集的同伙的研究，在美国，在欧洲被接受。但是，关于为参与者提供有关未来访问和使用样本和数据的使用的控制权的争议。选择退出模型，其中参与者可能表明他们不希望将剩余的临床样本或用于研究的病历数据纳入生物库中。尽管这种做法是有争议的，但由于美国研究人员寻求更有效的方法来积累GWA和其他基因组广泛的分析方法所需的大规模收集手段，因此其使用可能变得更加普遍。在遗传研究和现有数据访问政策的背景下，必须评估潜在参与者对广泛同意和退出模型的理解。迄今为止，尚未评估参与者有关数据访问政策和实践的知识及其对参与或参与偏好的潜在影响。我们将确定所需的新型教育策略，以帮助芝加哥大都会医院的患者组成的患者清楚地了解遗传研究的数据获取政策，政府作为数据持有人的作用，政策中包括的隐私保护以及已知的和潜在的隐私风险。具体而言，我们建议：（1）调查数据访问政策是否影响患者参加前瞻性医院的生物库的意愿，（2）评估遗传研究的广泛数据共享策略是否会影响参与者对两种同意模型的偏好：广泛的同意和选择退出方法，以及（3）帮助未来的患者访问Policies的建议。为了解决这些目标，我们将对西北纪念医院确定的患者的随机样本进行半结构化访谈，并附有门诊诊所。访谈将以更深入的初步数据从焦点组获得有关数据共享和遗传学研究的访问，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发提供信息，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来解决患者参与遗传研究的兴趣。调查结果将为参与研究的参与者提供教育信息和同意模型的建议提供基础。这项研究的目的是研究NIH数据访问政策如何共享遗传研究信息将影响参与大规模遗传研究。 NIH数据访问政策鼓励研究人员之间广泛分享遗传研究信息，以加快遗传研究改善人类健康的转化。该政策尚未评估其对参与遗传研究的影响，也没有研究参与者对本政策的理解和偏好。