| US, 2013 |
• A minimum list of conditions, genes and variants should be routinely evaluated and reported to the ordering clinician who can place them into the context of that patient’s medical and family history, physical examination and other laboratory testing. |
| • Any findings included by the list should be reported by laboratories without seeking consents from the patient and family. |
| • A clinician should be trained to communicate and interpret the results of incidental findings. |
| US, 2014 |
• Before performing the clinical sequencing, a written consent should be obtained from the patient, describing the interpretive uncertainty, privacy, possible impact on other family members, and the inevitable generation of data. |
| • Patients have the right to opt out of the analysis of the medically actionable gene list, so that they can choose not to receive the results of IFs. |
| • Same policies apply to children as to adults. |
| • Patients must decide whether to analyze the whole set of medically actionable genes (gene list) or none of them. It is infeasible to analyze a subset of the genes due to practical difficulties. |
| US, 2015 |
• The disclosure of IFs should occur only when the information has clear clinical utility. |
| • Informed consent should be obtained if there is a substantial likelihood of generating clinically relevant IFs. |
| • Parents should be able to decline to receive IFs of their child. |
| • In case of IFs that indicate urgent and serious implications for a child’s health, the results must be returned regardless of any preferences of the child and parents. |
| • It is ethically acceptable, but not required, to search for IFs that are not relevant to the clinical indication for sequencing. |
| US, 2017 |
• ACMG setup a new process for accepting and evaluating nominations for updates to the secondary findings list. |
| • Based on the previous secondary findings list, 4 genes have been added and one gene been removed. A new updated secondary findings minimum list includes 59 medically actionable genes recommended for return in clinical genomic sequencing. |
| Canada, 2003 |
• Clinical genetics records should be maintained indefinitely except those that have minimal importance to future interaction in genetics with the patient or other family members. |
| Canada, 2015 |
• Avoid the discovery of SFs, and focus on the primary indication of the test. |
| • Genome sequencing should only be considered when proved useful in the evaluation process and a selective filtering process is recommended. |
| • The adult patient should have the right to receive or not to receive the results. |
| • The results of the child must be returned to the parents if ACA criteria are satisfied. |
| Canada and Europe, 2015 |
• Targeted tests are recommended. |
| • If treatment or prevention is available during childhood and the variant indicates a serious problem, the IFs should be reported to parents. |
| • When carrier status information is relevant to parents for reproductive choices, they could be offered this information. |
| • Parents may also be offered information regarding unsolicited findings that are severe and clinically actionable relevant to their own health. |
| UK, 2011 |
• The possibility of incidental findings should be minimized. Targeted tests or analyses are preferred. |
| • Physicians have no obligation to provide IFs irrelevant with clinical question. |
| • Informed consent is not sufficient to deal with IFs. |
| • Where variants are of unknown significance, the responsibility to investigate might be less clear. |
| UK, 2014 |
• National Health Service (NHS) should adopt targeted tests using gene lists, which have greater clinical utility then WGS/WES. |
| • It should minimize the generation, interpretation and disclosure of IFs, because the potential harms are likely to outweigh the potential benefits. |
| • Informed consent should be obtained from patients if it is necessary for WGS/WES, which should include the possible generation of IFs. |
| • Disclosure decisions will be informed by clinical judgement, though patients should have opportunities to express views on disclosure. |
| • Patients should be given the opportunity to opt out of re-contact. |
| • Patients should be informed that the sequencing data would be stored in a secured, comprehensive, and accessible NHS database. |
| • A multidisciplinary committee and many evidence-based studies are needed on the return of IFs. |
| Denmark, 2012 |
• Patients should be given a “degree of involvement in deciding whether, and to what extent, they are to receive feedback on any incidental findings.” |
| • Genetic testing should be accompanied by “impartial and comprehensive information as well as counseling, both before and after testing.” |
| Europe, 2013 |
• Targeted genetic tests are much preferred because they can avoid incidental findings that cannot be interpreted. |
| • Known genetic variants with limited or no clinical utility should be filtered out. |
| • Patients’ claims to a right not to know about findings do not automatically override professional responsibilities. |
| • Guidelines for testing minors should be established to balance the autonomy and interests of child and the parental rights of not receiving IFs of the child. |
| Germany, 2013 |
• The council refutes the idea that the doctor has the right to inform relatives of the patient who might also be affected by the genetic condition, or to recommend them to get genetic counseling. |
| • Prenatal genetic diagnosis should only be conducted if there is an increased risk of a genetic disease. |
| • If the genetic information is irrelevant with the health of the born child, this finding should not be communicated to the pregnant woman. |
| Australia, 2014 |
• Genomic testing should have a sound evidence base before prescription. |
| • Targeted testing measures are recommended to avoid or minimize incidental findings. |
| • Clinicians should use standard practices in deciding whether to return IFs given the patient has agreed to it. |
