Processes and factors involved in decisions regarding return of incidental genomic findings in research.
OBJECTIVE
Studies have begun exploring whether researchers should return incidental findings in genomic studies, and if so, which findings should be returned; however, how researchers make these decisions-the processes and factors involved-has remained largely unexplored.


METHODS
We interviewed 28 genomics researchers in-depth about their experiences and views concerning the return of incidental findings.


RESULTS
Researchers often struggle with questions concerning which incidental findings to return and how to make those decisions. Multiple factors shape their views, including information about the gene variant (e.g., pathogenicity and disease characteristics), concerns about participants' well-being and researcher responsibility, and input from external entities. Researchers weigh the evidence, yet they face conflicting pressures, with relevant data frequently being unavailable. Researchers vary in who they believe should decide: participants, principal investigators, institutional review boards, and/or professional organizations. Contextual factors can influence these decisions, including policies governing return of results by institutions and biobanks and the study design. Researchers vary in desires for: guidance from institutions and professional organizations, changes to current institutional processes, and community-wide genetics education.


CONCLUSIONS
These data, the first to examine the processes by which researchers make decisions regarding the return of genetic incidental findings, highlight several complexities involved and have important implications for future genetics research, policy, and examinations of these issues.
Department of Psychiatry, Columbia University Medical Center and New York State Psychiatric Institute, New York, New York, USA.
Robert
R
Klitzman
Department of Psychiatry, Columbia University Medical Center and New York State Psychiatric Institute, New York, New York, USA.
Brigitte
B
Buquez
Department of Psychiatry, Columbia University Medical Center and New York State Psychiatric Institute, New York, New York, USA.
Paul S
PS
Appelbaum
Department of Psychiatry, Columbia University Medical Center and New York State Psychiatric Institute, New York, New York, USA.
Abby
A
Fyer
1] Department of Pediatrics, Columbia University Medical Center, New York, New York, USA [2] Department of Medicine, Columbia University Medical Center, New York, New York, USA.
Wendy K
WK
Chung
D003657:Decision Making / Q000941:ethics*; D030881:Disclosure / Q000941:ethics; D028744:Ethics Committees, Research / Q000941:ethics / Q000331:legislation & jurisprudence; D036281:Genetic Research / Q000941:ethics* / Q000331:legislation & jurisprudence; D015894:Genome, Human; D023281:Genomics / Q000941:ethics; D006801:Humans; D033162:Incidental Findings; D012108:Research Personnel / Q000193:education / Q000941:ethics*