Developing pathways for community-led research with big data: a content analysis of stakeholder interviews.

BACKGROUND: Big data (BD) informs nearly every aspect of our lives and, in health research, is the foundation for basic discovery and its tailored translation into healthcare. Yet, as new data resources and citizen/patient-led science movements offer sites of innovation, segments of the population with the lowest health status are least likely to engage in BD research either as intentional data contributors or as 'citizen/community scientists'. Progress is being made to include a more diverse spectrum of research participants in datasets and to encourage inclusive and collaborative engagement in research through community-based participatory research approaches, citizen/patient-led research pilots and incremental research policy changes. However, additional evidence-based policies are needed at the organisational, community and national levels to strengthen capacity-building and widespread adoption of these approaches to ensure that the translation of research is effectively used to improve health and health equity. The aims of this study are to capture uses of BD ('use cases') from the perspectives of community leaders and to identify needs and barriers for enabling community-led BD science. METHODS: We conducted a qualitative content analysis of semi-structured key informant interviews with 16 community leaders. RESULTS: Based on our analysis findings, we developed a BD Engagement Model illustrating the pathways and various forces for and against community engagement in BD research. CONCLUSIONS: The goal of our Model is to promote concrete, transparent dialogue between communities and researchers about barriers and facilitators of authentic community-engaged BD research. Findings from this study will inform the subsequent phases of a multi-phased project with the ultimate aims of organising fundable frameworks and identifying policy options to support BD projects within community settings.

Implementing a universal informed consent process for the All of Us Research Program.

The United States' All of Us Research Program is a longitudinal research initiative with ambitious national recruitment goals, including of populations traditionally underrepresented in biomedical research, many of whom have high geographic mobility. The program has a distributed infrastructure, with key programmatic resources spread across the US. Given its planned duration and geographic reach both in terms of recruitment and programmatic resources, a diversity of state and territory laws might apply to the program over time as well as to the determination of participants' rights. Here we present a listing and discussion of state and territory guidance and regulation of specific relevance to the program, and our approach to their incorporation within the program's informed consent processes.