Ethical Considerations for the Return of Incidental Findings in Ophthalmic Genomic Research.

"The Importance of Implementing a Disclosure Plan In the context of a lack of clear policies, researchers need to implement a plan for managing genomic data.30,31,33,34,65 The plan should describe the type of results that could be disclosed, the modalities of communication (who would disclose results, to whom, when, how), and what should be discussed during the consent process. Different frameworks for the return of results have been proposed in the literature: policy of no disclosure, disclosure of IF of clinical utility and actionability only, disclosure of all IF, return of all genomic data without interpretation, and participant decides which IF would be returned.8,13,16,32,37 Obviously, the frameworks providing more autonomy to participants also put additional burden on the research infrastructure. Another suggested approach has been to apply filters during the analysis stage to hide unwanted results to minimize the potential for IF.27,86 This strategy has the benefit of limiting IF of potential clinical utility and minimizing the burden on the research infrastructure. Ultimately, the feasibility, cost, and consequences of each approach need to be balanced. Finally, IRBs oversee research involving human subjects. They are in a unique position to provide valuable insight in reviewing the disclosure plan to research participants and participate in the development of policies and guidelines.8,30,87"