Not whether but how: the ethics and Language of reporting back individual results.

backgroundThe ethical obligation of reporting back research results (RBRR) is established. Yet the ethical dimensions of how RBRR is implemented remain largely unexplored. The Environmental influences on Child Health Outcomes (ECHO) program has identified logistical challenges in RBRR, citing limited guidance resources as a key obstacle. The objective of this research was to characterize and assess ethical considerations for RBRR: (i) with or without clinical significance; (ii) within a pregnancy cohort, and; (iii) within a study population with diverse cultural and traditional contexts.

methodsExpert Panelists (n = 20), including exposure scientists, community engagement specialists, public health researchers, clinicians and ethicists convened virtually and completed short surveys to identify ethical considerations regarding how RBRR is conducted. While the original objective was to characterize ethical guidelines for RBRR across three potential outcomes, the Panel identified a need for RBRR harmonization; conflicting and inconsistently applied terminology and definitions prevented the Panel from fully discussing the original topics.

resultsEthical considerations for conducting RBRR were mapped to the principles of bioethics (respect for autonomy, beneficence, nonmaleficence, and justice), with Panelists suggesting that additional ethical frameworks could be used in parallel or as a replacement. However, when considering results with or without clinical significance, the Panel identified a clear need for standardized terminology when describing RBRR, particularly regarding the relevance of results to individual health, behavior, and knowledge. The Panel recommended the following related to RBRR: (i) develop centralized resources; (ii) develop multi-use materials; (iii) ensure clear assignment of RBRR responsibility within research projects; (iv) encourage active engagement of research participants in the RBRR process to foster and maintain trust; (v) recognize community-level harms and benefits; (vi) extend RBRR beyond study completion; and, (vii) establish standardized language. DISCUSSION: The Panel highlighted challenges such as non-standard terminology and difficulty discerning between RBRR with clear health or regulatory standards versus results without established, quantified health relationships. The Panel affirmed all research results, regardless of established health relationships, that benefit participants should be returned. While RBRR guidelines were considered universal, the Panel emphasized the need for nuanced considerations, particularly when working with culturally diverse or pregnant populations. Future work should address ethical considerations regarding RBRR’s responsibilities for depositing data in a public-use repository.