Skip to main content
The 5th ELSI Congress - ELSIcon2022

ELSIcon2022 Panel: If we build it will they come? Navigating ELSI considerations for broad and responsible use of All of Us data by non-traditional researchers


ELSIcon2022 • Panel • June 3, 2022

Subhashini Chandrasekharan, Laura Beskow, Rosario Isasi, Stephen Sodeke 

The All of Us Research Program is in the process of collecting biospecimens and genomic, biological, environmental, and lifestyle data longitudinally from one million or more people living in the United States. The scientific resources of the program will reflect the socioeconomic and demographic diversity of the U.S. population with a focus on inclusion of individuals who have been historically underrepresented in biomedical research such as from racial, ethnic, gender identity, sexual orientation, disability status, and other groups. The program has embraced the core value that “participant privacy and security are of utmost importance”. To this end the program has implemented a tiered data access model and built a secure cloud -based platform for data access called the Researcher Workbench. The public tier provides aggregate level data that can be accessed openly by the public including citizen scientists and other unaffiliated researchers. Beyond the public tier, individual level de-identified participant data can be accessed only by authorized users through the registered and controlled tiers of the Researcher Workbench, which both provide different types of data (genomic data only available on the controlled tier) and to varying degrees of granularity depending on privacy preserving measures that have been implemented. The program has developed and implemented policies and procedures for authorizing users to access data in the registered and controlled tiers and will continue to refine/develop them as the program evolves. Another core value of the program is that “data will be broadly accessible for research.” To that end, the program’s cloud-based Researcher Workbench with built-in analytical tools can foster access and use by a wide range of researchers, extending beyond traditional academic researchers to citizen scientists, community-based researchers, and other non-traditional researchers. The program has adopted a data passport model that allows authorized users to easily access all data within a tier of the Workbench, without the need for individual projects to be approved, but with the stipulation that a meaningful description of each project will be provided for public display. Enabling and managing access to different types of research audiences at scale, while at the same time ensuring responsible use, presents competing tensions and a range of ELSI challenges, both familiar and new. Recognizing these challenges, the program deliberates in an ongoing way through its governance bodies, particularly the All of Us Committee on Access Privacy and Security (CAPS) and the Resource Access Board (which implements the programs’ data use oversight policy) on considerations for policies, and procedures related to data access and use. The User Application (UA) Subcommittee of the All of Us CAPS, is a multidisciplinary governance body tasked with developing recommendations for user requirements to access the Researcher Workbench (registered and controlled tiers). Over the last year the UA subcommittee has been deliberating on important considerations for broadening access to sensitive and granular data to non-traditional and unaffiliated researchers, citizen scientists, and community-based researchers. Topics of deliberation encompass questions such as (i) what does access for non-traditional researchers entail in terms of resources, training, and support (ii) what makes researchers trustworthy, (iii) how important is institutional affiliation for establishing trust and user accountability, (iv) whether we can set robust yet achievable requirements for data access by unaffiliated researchers (v) what are the additional considerations for the program to meet its commitments to participant privacy and security, and many others. As part of its ongoing work to develop recommendations for the program’s policies to extend access to the Workbench, the subcommittee conducted a series of consultations with subject matter experts and stakeholders including the program’s participant ambassadors, researchers and scholars studying ELSI and policy aspects of citizen and non research.traditional science, and representatives of nontraditional communities of In this panel, members of the UA subcommittee who bring a range of disciplinary perspectives (including bioethics, law, health pol icy and genetics) will provide background on the CAPS and UA subcommittee’s roles/activities and describe (1) the purpose and structure of the consultation process including key questions the subcommittee sought to answer (2) main themes of our learnings a bout needs, expectations, and approaches to broaden access while facilitating safe and responsible use (3) potential challenges and constraints for balancing tensions in broadening data access and (4) policy and design implications for large scale precision medicine/biomedical research initiatives. These panelist presentations will be followed by a moderated discussion with the audience to answer questions and solicit additional insights and perspectives on key ELSI considerations for data access and use b y non traditional researchers, that can inform recommendations from the UA subcommittee to the All of Us program, and the program’s approaches to engage and support non productive and responsible users of All of Us data.


Data and data stewardship
precision medicine

Videos in Series

Related Videos