Table 3.
Policy and normative approaches for the return of results
| Must return | |
| CIOMS/WHO | Life-saving information and data of immediate clinical utility involving a significant health problem [8] |
| COE | Significant results that concern the subject’s future health or quality of life [12,13] |
| ICH Topic E6(R2) | Information concerning adverse events, including clinically significant laboratory values related to the trial [9] |
| US MRCT | Urgent actionable results. Assess genomic results on a case-by-case basis [42] |
| Italy | Results with factual, direct benefits for treatment, prevention or reproductive choices [22] |
| Spain | Results of health relevance. Return overrides consent if it would avoid serious damage to health to participants or their families [25] |
| Canada | Material incidental findings that convey significant welfare implications [32] |
| France | Severe genetic disorders and warn family members if participant refuses to do so [20] |
| India | Actionable and have potential health benefits [36] |
| Germany | Relevant genetic risks for disease for which an effective therapy or preventative measure exists [35] |
| Australia | Findings that are of proven validity and of health significance [29] |
| Denmark | Important health information [33] |
| India | Results that are actionable and leading to potential health outcomes [36] |
| Costa Rica | Results relevant to the health of the participant or about discovered diseases not part of the research process [16] |
| Should return | |
| ICH Topic E6(R2) | Inform subject when medical care is needed for intercurrent illnesses [9] |
| US NASEM | Individual research results of high potential value to participants where feasible [41] |
| Denmark | Genetic variants with a high penetration predisposing to a severe and treatable/curable/preventable disorder [33] |
| Singapore | Clinically significant results from genetic research [38] |
| UK | Health-related findings where benefits of return outweigh harms [40] |
| May return | |
| OECD | Validated results [4] |
| ICH E-18 | Results of potential clinical significance and actionability [10] |
| US Common Rule | Consent guidance only [28] |
| UK Human Tissue Act | Related guidance documents explore the conditions of responsible return or not [39] |
| Australia | Incidental findings [29]; results if the relevance of genetic information to participants’ health is not clear until after interim analysis [30] |
| Germany | Results that show a relevant risk for a disease that cannot be treated at the time of diagnosis [35] |
| Do not return | |
| CIOMS/WHO | Prohibits return of results not scientifically valid and/or clinically significant [8] |
| Taiwan (law applies to national biobank) | Prohibits return of individual results [27] |
| Germany | Prohibits return of genetic characteristics that only slightly increase disease risk, cannot be treated or prevented, or carrier status [34] |
| Denmark | Recommends only highly penetrant variants for severe and actionable disorders be returned [33] |
| US NASEM | Recommends only results from a laboratory with clinical accreditation or an appropriate quality management system be returned [41] |
| NHLBIWG | Recommends not obliging researchers to return results beyond study funding [45] |
Note: the return policy is subordinate to the consent of the individual to receive results (or not) unless otherwise indicated