Return of Genetic Research Results to Participants and Families: IRB Perspectives and Roles

Beskow, Laura M.; O’Rourke, P. Pearl

doi:10.1111/jlme.12292

Cited by 27 publications

(11 citation statements)

References 41 publications

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“…Generally, members of IRBs thought that research findings should be returned, provided participants want to know their results [ 44 , 150 ]. However, while in one study 15/22 (68%) agreed that participants should ‘probably’ or ‘definitely’ be offered the choice to receive results that may be useful for participants’ or family’s health [ 151 ], another study indicated that a large majority of the 65 Chairs of US IRBs studied favoured offering the result to participants, even if there is a lack of clear utility associated with the findings [ 149 ]. One study explored views of a cohort of Canadian IRB members, coordinators, and chairs on returning IRR [ 152 ].…”

Section: Views On Return Of Study-specific Resultsmentioning

confidence: 99%

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Return of individual research results from genomic research: A systematic review of stakeholder perspectives

et al. 2021

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Despite the plethora of empirical studies conducted to date, debate continues about whether and to what extent results should be returned to participants of genomic research. We aimed to systematically review the empirical literature exploring stakeholders’ perspectives on return of individual research results (IRR) from genomic research. We examined preferences for receiving or willingness to return IRR, and experiences with either receiving or returning them. The systematic searches were conducted across five major databases in August 2018 and repeated in April 2020, and included studies reporting findings from primary research regardless of method (quantitative, qualitative, mixed). Articles that related to the clinical setting were excluded. Our search identified 221 articles that met our search criteria. This included 118 quantitative, 69 qualitative and 34 mixed methods studies. These articles included a total number of 118,874 stakeholders with research participants (85,270/72%) and members of the general public (40,967/35%) being the largest groups represented. The articles spanned at least 22 different countries with most (144/65%) being from the USA. Most (76%) discussed clinical research projects, rather than biobanks. More than half (58%) gauged views that were hypothetical. We found overwhelming evidence of high interest in return of IRR from potential and actual genomic research participants. There is also a general willingness to provide such results by researchers and health professionals, although they tend to adopt a more cautious stance. While all results are desired to some degree, those that have the potential to change clinical management are generally prioritized by all stakeholders. Professional stakeholders appear more willing to return results that are reliable and clinically relevant than those that are less reliable and lack clinical relevance. The lack of evidence for significant enduring psychological harm and the clear benefits to some research participants suggest that researchers should be returning actionable IRRs to participants.

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Section: Views On Return Of Study-specific Resultsmentioning

confidence: 99%

“…Five studies, all from North America, explored views of IRBs on the return of SSR [44,[149][150][151][152]. Generally, members of IRBs thought that research findings should be returned, provided participants want to know their results [44,150].…”

Section: Clinical Research Settingmentioning

confidence: 99%

Return of individual research results from genomic research: A systematic review of stakeholder perspectives

et al. 2021

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“…Engagement of underrepresented populations in genomic research has been studied in various settings [12][13][14]. Several studies have examined how to return results to various demographic groups, including minors, adults who lack decision-making capacity, and relatives of deceased persons [15][16][17][18][19][20]. Very few studies have examined RoR in low-resource clinical environments such as federally qualified health centers [21].…”

Section: Introductionmentioning

confidence: 99%

Practices and Attitudes toward Returning Genomic Research Results to Low-Resource Research Participants

Raymond

Cooper

Parker

et al. 2021

Public Health Genomics

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Introduction: Many research programs are challenged to accommodate low-resource research participants’ (LRRP) ancillary care needs when returning genomic research results. We define LRRP as those who are low income, uninsured, underinsured, or facing barriers to act upon the results returned. This study evaluates current policies and practices surrounding return of results (RoR) to LRRP, as well as the attitudes of investigators toward providing ancillary care to LRRP. Methods: A semi-structured interview study was conducted with representatives of 35 genomic research programs nationwide. Eligible programs were returning, or planning to return, medically actionable genomic results to participants. Results: Three content categories emerged from this study, including: (1) RoR structures, (2) barriers to RoR to LRRP, and (3) solutions to meet community and LRRP needs. Three major structures of RoR emerged: (1) RoR Embedded in Clinical Care, (2) RoR Independent of Clinical Care, and (3) Reliance on Clinical Partnerships to Facilitate RoR. Inadequacy of program resources to address the needs of LRRP was commonly considered a significant obstacle. The attitudes and views of informants regarding responsibility to provide ancillary care for LRRP receiving genomic results were highly varied. Some informants believed that genomic sequencing and testing was not a priority for LRRP because of other pressing issues in their lives, such as housing and food insecurity. Research programs differ regarding whether clinical and social support for LRRP is considered within the purview of the research team. Some programs instituted accommodations for LRRP, including social work referral and insurance enrollment assistance. Conclusion: Support to access downstream treatment is not readily available for LRRP in many genomic research programs. Development of best practices and policies for managing RoR to LRRP is needed.

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“…The preferences of research participants with regards to receiving their personal or their child’s genetic results vary, where many are interested while some are not [ 9 ]. Researchers may have the responsibility to return genetic results to participants, when these lead to changes in the participants’ healthcare [ 10 ]. There are several recommendations on the ethical obligations of researchers for RoR in the research context [ 11 , 12 ].…”

Section: Introductionmentioning

confidence: 99%

Enhancing the Impact of Genomics Research in Autism through Integration of Research Results into Routine Care Pathways—A Case Series

Peltekova

Buhaş

Stern

et al. 2021

JPM

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The return of genetic results (RoR) to participants, enrolled as children, in autism research remains a complex process. Existing recommendations offer limited guidance on the use of genetic research results for clinical care. We highlight current challenges with RoR and illustrate how the use of a guiding framework drawn from existing literature facilitates RoR and the clinical integration of genetic research results. We report a case series (n = 16) involving the return of genetic results to participants in large genomics studies in Autism Spectrum Disorders (ASD). We outline the framework that guided RoR and facilitated integration into clinical care pathways. We highlight specific cases to illustrate challenges that were, or could have been, resolved through this framework. The case series demonstrates the ethical, clinical and practical difficulties of RoR in ASD genomic studies for participants enrolled as children. Challenges were resolved using pre-established framework to guide RoR and incorporate research genetic results into clinical care. We suggest that optimal use of genetic research results relies on their integration into individualized care pathways for participants. We offer a framework that attempts to bridge the gap between research and healthcare in ASD.

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Return of Genetic Research Results to Participants and Families: IRB Perspectives and Roles

Cited by 27 publications

References 41 publications

Return of individual research results from genomic research: A systematic review of stakeholder perspectives

Return of individual research results from genomic research: A systematic review of stakeholder perspectives

Practices and Attitudes toward Returning Genomic Research Results to Low-Resource Research Participants

Enhancing the Impact of Genomics Research in Autism through Integration of Research Results into Routine Care Pathways—A Case Series

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