Informed Consent and Data Access Issues in State-based Biobanks

描述（由申请人提供）：本申请涉及广泛的挑战领域（02）生物伦理学和特定的挑战主题，02- hg -101：知情同意和数据访问政策。国家资助的出生队列研究及其伴随的生物库的发展和实施背后的伦理、法律和社会问题（ELSI）是复杂和潜在的不稳定因素。密歇根州和其他州，如康涅狄格州和加利福尼亚州，正在调查和审议如何建立生物银行，迫切需要实用的ELSI研究和这些历史性举措的指导方针。因此，为了促进国家资助的人口出生队列数据库的发展，用于包括遗传学在内的广泛研究，迫切需要研究如何解决招募、知情同意和数据访问问题受到社区成员对新生儿血斑研究使用的希望、期望和焦虑的影响。我们的申请特别针对挑战区02-HG- 101*知情同意和数据访问政策。我们提出以下具体目标，以调查通过新的卫生信息技术改善这些问题的方法是否充分满足社区成员的需求。目标1：开发和测试多层次的以参与者为中心的知情同意、隐私和数据访问教育系统和协议，该系统和协议利用现有的在线健康信息技术系统，称为“私人访问”。目标2：评估参与者驱动的知情同意水平和数据访问对潜在研究招募（例如，密歇根新生儿生物库）的影响，使用面对面的“市政厅”会议和在线测试，在密歇根五个地理位置的15个不同社区进行。具体来说，我们将研究人口统计、研究类型、研究人员类型（政府、学术、私人公司）、同意选项、隐私控制类型和数据访问选项如何影响社区领导人和参与者的知识、态度，以及参与密歇根州大型出生队列和生物银行工作的同意。我们提议的项目将评估消费者驱动的知情同意和数据访问对参与密歇根州正在开发的大型出生队列和生物银行工作的影响。

DESCRIPTION (provided by applicant): This application addresses broad Challenge Area (02) Bioethics and specific Challenge Topic, 02-HG-101: Informed consent and data access policies. The ethical, legal, and social issues (ELSI) underlying the development and implementation of state-sponsored birth cohort studies and their accompanying biobanks are complex and potentially volatile. Michigan and other states, such as Connecticut and California, are in the midst of investigating and deliberating on how to set up biobanks, and there is a pressing need for practical ELSI research and guidelines for these historic initiatives. Consequently, to facilitate the development of state-sponsored population birth cohort databases for a wide range of studies, including genetics, research is urgently needed to address how recruitment, informed consent, and data access issues are affected by community members' hopes, expectations, and anxieties about research use of newborn blood spots. Our application specifically addresses the Challenge Area 02-HG- 101* Informed consent and data access policies. We propose the following specific aims to investigate whether a method of ameliorating these concerns through a new health information technology adequately addresses community member's needs. Aim 1: To develop and test a multi-level participant-centric informed consent, privacy, and data access educational system and protocol that utilize an already existing on-line health information technology system called Private Access. Aim 2: To evaluate the impact of participant-driven levels of informed consent and data access on potential recruitment into studies (e.g., the Michigan Neonatal Biobank) using both in-person "Town Hall" meetings and on-line testing in 15 diverse Michigan communities in five geographical locations. Specifically, we will examine how demographics, types of research, and types of researcher (government, academic, private company), consent options, types of privacy control, and data access options affected community leaders and participants' knowledge, attitudes, and consent to participate in a large birth cohort and biobanking effort in the state of Michigan. Our proposed project will evaluate the impact of consumer-driven informed consent and data access on participation in a large birth cohort and biobanking effort being developed in the state of Michigan.