Current guidelines for return of research results in genomic studies focus on protecting the participant from harm using criteria including analytic validity, clinical validity, actionability, and severity of the outcome. 1 Historically, rules supporting or prohibiting disclosure of individual research results employed such variables. 2 However, the formulation of these rules was based on interpretive projections from the life experience of the rule-formulators and not on rigorously-collected empirical data concerning, for example, the prevalence and degree of harm, let alone data elucidating harm’s dependence on other known or unknown variables that might be practically important in refining a practical ethical rule concerning results disclosure. 3 Thus communicating genomic research results has historically been opposed, by some, based on an assumption that therapeutic misconceptions are inevitable, that harm necessarily flows from a misconception and is unpreventable and incurable, and that such harm necessarily outweighs any potential benefit, regardless of how benefit might be conceived or measured. 4

Such theorization omits a factor now widely accepted in clinical ethics: the personhood of patients and research participants, as reflected in respect for their autonomy and consideration of their own formulations of benefit, harm, and acceptable risk. 5 That one must “protect” research participants from “harm” by imposing on them the ex cathedra