Whole-genome analysis and whole-exome analysis generate many more clinically actionable findings than traditional targeted genetic analysis. These findings may be relevant to research participants themselves as well as for members of their families. Though researchers performing genomic analyses are likely to find medically significant genetic variations for nearly every research participant, what they will find for any given participant is unpredictable. The ubiquity and diversity of these findings complicate questions about disclosing individual genetic test results. We outline an approach for disclosing a select range of genetic results to the relatives of research participants who have died, developed in response to relatives’ requests during a pilot study of large-scale medical genetic sequencing. We also argue that studies that disclose individual research results to participants should, at a minimum, passively disclose individual results to deceased participants’ relatives.
Open Peer Commentaries.
- Beneficence, Clinical Urgency, and the Return of Individual Research Results to Relatives
- Disclosing Individual Genetic Research Results to Deceased Participants’ Relatives by Means of a Qualified Disclosure Policy
- Risks to Relatives in Genomic Research: A Duty to Warn?
- Disclosure/Disruption: Considering Why Not to Disclose Genetic Information After Death
- Disclosing Decedents’ Research Results to Relatives Violates the HIPAA Privacy Rule
- Clinically Significant? Depends on Whom You Ask
- Disclosing Results to Genomic Research Participants: Differences That Matter
- The Ever-Evolving Concept of Clinical Significance and the Potential for Sins of Omission in Genetic Research
- Rethinking Clinical Risk for DNA Sequencing
- Blurring Boundaries