Processes and factors involved in decisions regarding return of incidental genomic findings in research

Genet Med. 2014 Apr;16(4):311-7. doi: 10.1038/gim.2013.140. Epub 2013 Sep 26.

Abstract

Purpose: 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.

Conclusion: 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.

Publication types

  • Research Support, N.I.H., Extramural

MeSH terms

  • Decision Making / ethics*
  • Disclosure / ethics
  • Ethics Committees, Research / ethics
  • Ethics Committees, Research / legislation & jurisprudence
  • Genetic Research / ethics*
  • Genetic Research / legislation & jurisprudence
  • Genome, Human
  • Genomics / ethics
  • Humans
  • Incidental Findings*
  • Research Personnel / education
  • Research Personnel / ethics*