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

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

SUBMITTER: Klitzman R

PROVIDER: S-EPMC3966970 | biostudies-literature | 2014 Apr

REPOSITORIES: biostudies-literature

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

Klitzman Robert R Buquez Brigitte B Appelbaum Paul S PS Fyer Abby A Chung Wendy K WK

Genetics in medicine : official journal of the American College of Medical Genetics 20130926 4

<h4>Purpose</h4>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.<h4>Methods</h4>We interviewed 28 genomics researchers in-depth about their experiences and views concerning the return of incidental findings.<h4>Results</h4>Researchers often struggle with questions concerning which inci ...[more]

PMID: 24071801

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Project description:BackgroundThe application of advanced imaging in pediatric research trials introduces the challenge of how to effectively handle and communicate incidental and reportable findings. This challenge is amplified in underserved populations that experience disparities in access to healthcare as recommendations for follow-up care may be difficult to coordinate. Therefore, the purpose of the present report is to describe the process for identifying and communicating findings from a research MRI to low-income Latino children and families.MethodsLatino adolescents (n = 86) aged 12-16 years old with obesity and prediabetes underwent a research MRI (3 Tesla Philips Ingenia®) as part of a randomized controlled diabetes prevention trial. The research MRIs were performed at baseline and 6 months to assess changes in whole-abdominal fat distribution and organ fat in response to the intervention. An institutional pathway was developed for identifying and reporting findings to participants and families. The pathway was developed through a collaborative process with hospital administration, research compliance, radiology, and the research team. All research images were reviewed by a board-certified pediatric radiologist who conveyed findings to the study pediatrician for determination of clinical actionability and reportability to children and families. Pediatric sub-specialists were consulted as necessary and a primary care practitioner (PCP) from a free community health clinic agreed to receive referrals for uninsured participants.ResultsA total of 139 images (86 pre- and 53 post-intervention) were reviewed with 31 findings identified and 23 deemed clinically actionable and reportable. The only reportable finding was severely elevated liver fat (> 10%, n = 14) with the most common and concerning incidental findings being horseshoe kidney (n = 1) and lung lesion (n = 1). The remainder (n = 7) were less serious. Of youth with a reportable or incidental finding, 18 had a PCP but only 7 scheduled a follow-up appointment. Seven participants without a PCP were referred to a safety-net clinic for follow-up.ConclusionsWith the increased utilization of high-resolution imaging in pediatric research, additional standardization is needed on what, when, and how to return incidental and reportable findings to participants, particularly among historically underrepresented populations that may be underserved in the community.Trial registrationPreventing Diabetes in Latino Youth, NCT02615353.

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

Publications

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

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