Table 4.

Major U.S. consensus recommendations on returning IFs and IRRs in genetic or genomic research.

National Bioethics Advisory Commission75	Return results only if “the findings are scientifically valid and confirmed” “the findings have significant implications for the subjects’ health concerns” and “a course of action to ameliorate or treat these concerns is readily available.”
Centers for Disease Control (CDC)127	Criteria for returning IRRs in population-based genetic research: “When the risks identified in the study are both valid and associated with a proven intervention for risk reduction, disclosure may be appropriate.”
Wolf et al.1	Researcher should disclose IFs likely to offer strong net benefit from participant’s perspective: (a) genetic information revealing significant risk of a condition likely to be life-threatening; (b) genetic information that can be used to avoid or ameliorate a condition likely to be grave; and (c) genetic information that can be used in reproductive decision-making: (1) to avoid significant risk for offspring of a condition likely to be life-threatening or grave or (2) to ameliorate a condition likely to be life-threatening or grave. Researcher may disclose IFs offering possible net benefit from participant’s perspective: (a) genetic information revealing significant risk of a condition likely to be grave or serious, when that risk cannot be modified but a research participant is likely to deem that information important; and (b) genetic information that is likely to be deemed important by a research participant and can be used in reproductive decision-making: (1) to avoid significant risk for offspring of a condition likely to be serious or (2) to ameliorate a condition likely to be serious. Researcher should not disclose IFs offering unlikely net benefit from the participant’s perspective, including information whose likely health or reproductive importance cannot be ascertained.
Caulfield et al.90	Return of IRRs and IFs “In general, the results offered should be scientifically valid, confirmed, and should have significant implications for the subject's health and well-being. Plans to return other forms of data—such as significant non-health-related data—should be built into the study design and governance structure.”
National Heart, Lung, and Blood Institute (NHLBI)86	Recommendation 1: IRRs“should be offered to study participants in a timely manner if they meet all of the following criteria: The genetic finding has important health implications for the participant and the associated risks are established and substantial. The genetic finding is actionable, that is, there are established therapeutic or preventive interventions or other available actions that have the potential to change the clinical course of the disease. The test is analytically valid and the disclosure plan complies with all applicable laws. During the informed consent process or subsequently, the study participant has opted to receive his/her individual genetic results.” Recommendation 4 “Investigators may choose to return individual genetic results to study participants if the criteria for an obligation to return results are not satisfied (see Recommendation 1) but all of the following apply: The investigator has concluded that the potential benefits of disclosure outweigh the risks from the participant’s perspective. The investigator’s Institutional Review Board (IRB) has approved the disclosure plan. The test is analytically valid and the disclosure plan complies with all applicable laws. During the informed consent process or subsequently, the study participant has opted to receive his/her individual genetic results.”