Table 1.

Six recommendations for the optimization of the return of biomarker results

THEME	RECOMMENDATION	SUMMARY
Transparency	Ensure clarity, openness, and truthfulness in communicating about the nature, quantity, and quality of the available information, including the measurement and predictive status of the risk index. Note any limitations in the translation of results e.g., information that has little clinical relevance but is personally actionable. Clearly state the disclosure processes that were used with participants when reporting in academic and public communications about the research.	Report results based on current knowledge, interpretation, and practices.
Choice	Provide participant choice in determining (1) which information is returned, (2) the preferred method(s) of disclosure, (3) who will be involved in the process, particularly when there are implications for sharing of genetic risk with family members, and (4) when disclosure will take place, including arrangements for post-disclosure follow-up. Embed opportunities for close engagement with participants in research design. Map participant interests onto the information the research team can confidently provide.	Report on how participant choice was determined and considered.
Training	Provide instruction for research staff on how to communicate about complexity and minimize harms when sharing uncertain information. Research teams should mobilize the return of results process to collect data on the effectiveness of communication models.	Disclose who returned results and what training was provided.
Innovation	Harness novel disclosure formats for return of results such as eHealth, telehealth, chat bots, peer-to-peer support. Explore how innovative tools can facilitate personalization in terms of what results participants want returned, through which format. Ascertain which resources are needed to support participant well-being around the disclosure process. Maximize participant safety by offering participants a written summary of what has been discussed.	Consider the integration of novel tools in existing ecosystems of support, such as families and caregivers, and social media.
Harmonization	Develop, share, and harmonize evidence-based best practices around return of results for complex biomarkers to ensure a positive experience across different studies.	Report on the return of results process when communicating about the research.
Evaluation	Integrate in the return of results process a rigorous evaluation of the ethics and effectiveness (including cost-effectiveness) of the process. Evaluate the representation of the information, the form and content of communication, and its alignment with participant preferences. Assess the impact of the information. Explore evaluation approaches beyond randomized controlled trials, including small-scale and adaptive trials.	Report on the results of evaluation, including negative results.