Informed Consent and Data Access Issues in State-based Biobanks

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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.