PROJECT SUMMARY This project, entitled, “Not whether but how: the ethics of reporting individual results in a pregnancy cohort,” addresses bioethics research as it relates to ethically informed reports to a culturally diverse pregnancy cohort.The ethical considerations around whether data should be returned have been carefully assessed and characterized under the bioethics framework, with the conclusion that there is an ethical obligation to return data. Consequently, how data is returned must be carefully assessed using a similar framework. The goals of this project, specific to bioethics research, are to characterize and assess ethical considerations related to howdata is returned to individuals in a pregnancy cohort, with the hypothesis that ethically informed reports increase participant knowledge and study engagement while reducing potential harms. Building on work we have conducted within the Columbia Center for Children’s Environmental Health (CCCEH) Fair Start cohort, a member of the Environmental Influences on Child Health Outcomes (ECHO) consortium, we will evaluate the hypothesis that ethically informed reports increase participant knowledge and study engagement while reducing potential harms. We will convene an Expert Panel comprised of study participants, bioethicists, researchers, experts in responsible conduct of research, and maternal health experts, as well as representatives from ECHO program components. In Specific Aim 1, we will use the Delphi methodology, a validated technique aimed at developing consensus, the Panel will identify and assess ethical considerations associated with how data is returned. The panel will co-create a survey and focus group discussion guide, which will be used in Specific Aim 2, to evaluate the ethical return of data in a pregnancy cohort that have received individual data (n=168) or have not yet received individual data (n=63). The results from the Expert Panel and the results from the pregnancy cohort will inform Specific Aim 3, developing preliminary best practices to guide how data is returned to study participants. The research will evaluate ethical considerations around the return of data in a culturally diverse pregnancy cohort, with data that lacks clinical significance. Participant preference and expectations around how data is returned will be evaluated through surveys and focus groups. Thus, we propose to evaluate how to return data within a pregnancy cohort and identify additional important variables that may influence the return of data. The anticipated impact of this work will inform best practices for returning data to pregnant individuals but is anticipated to scale to other study populations as well and can be extended to other populations from diverse cultural backgrounds representedacross the ECHO consortium.