Katherine D. Blizinsky, PhD - National Institutes of Health
The NIH All of Us Research Program (AoURP) aims to collect genomic, biological, environmental, and lifestyle data longitudinally from one million or more people living in the United States. The AoURP is developing scientific research resources that represent the socioeconomic and demographic diversity of the U.S. population with a focus on increased participation of those historically underrepresented in biomedical research. In this session, panelists will discuss ELSI and policy challenges faced by the AoURP, and detail implementation approaches to address them, drawing upon different stakeholder experiences within the AoURP (policy, program and IRB). The session will highlight how anticipated and unforeseen ELSI challenges for designing a precision medicine research program at national scale are being addressed in a manner that respects the program’s core values while balancing considerations for preventing harm to individuals, groups, and communities. The panelists will first present perspectives on 1) ethical oversight of the research using a single IRB model, 2) challenges with and novel approaches needed for informed consent at scale, 3) balancing ethical tensions in developing and implementing data access and data use policies, and 4) integrating ELSI considerations in policies and governance of biospecimen access and use, respectively. The following moderated open discussion will focus on approaches needed to integrate ELSI research and stakeholder feedback in design and implementation of AoURP and on mechanisms to capture and meet stakeholder expectations going forward, to enable both anticipatory and translational ethics.