From the Cell to the Street: Personalized Report-Back in Large Cohort Studies with Multi-Level Measurements

A growing consensus gives researchers the responsibility to report results back to individual participants in most studies, based on fundamental ethical principles of human research. Yet, ethical report-back of research results (RBRR) is context-specific, requiring consideration of the people and data in a particular study. New adaptations are needed, for example, to align report-back ethics with the emerging science of the exposome, defined as the totality of social and environmental factors across the life cycle. Exposome studies generate hundreds of measurements from many techniques, including geospatial assessments of neighborhood characteristics, biomonitoring for multiple classes of chemicals, and indicators of health- related effects at the cellular level. To support ethical practices in exposome-focused studies, this project will address a key challenge – report-back methods have yet to be tested for large numbers of measures across multiple domains. This project will develop innovative participant-centered methods for personalized RBRR for multi-level data in large studies and evaluate these methods in two cohorts recruited during pregnancy: Chemicals in Our Bodies (CIOB, at the University of California, San Francisco and Berkeley) and Illinois Kids Development Study (IKIDS, at the University of Illinois). It will build on the well-tested capabilities of the Digital Exposure Report-Back Interface (DERBI) to generate high-quality personalized reports for smartphone, computer, and print in studies of any size. Aim 1. Use participatory methods to develop ethical guidance for personalized RBRR for multi-level data, including large chemical biomonitoring panels, census-tract-level neighborhood metrics, and early effect biomarkers. This aim will bring together input from participants, researchers, and bioethicists, first to focus on CIOB/IKIDS and then to broaden input and discussion to other studies. Aim 2. Enhance the value of RBRR for participants by developing digital tools that support participants’ ability to take action and offer them scalable social support. Drawing on theories of health behavior, a new DERBI feature will offer opportunities for participants to identify sources of harmful chemicals that are relevant for them and commit to individual and community actions to reduce exposures. Participants will be invited to a social media group. Aim 3. Develop, deploy, and assess personalized RBRR for multiple types of data in CIOB/IKIDS. New contextual information will be developed for DERBI to help participants interpret new data types, and updated design will distill results across multiple domains. We will randomize half of participants to test the new DERBI take-action feature. Outcome assessments include follow-up surveys and in-depth interviews about experiences and environmental health literacy as well as digital analytics to assess participants’ engagement with their reports.