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

Raymond, Megan; Cooper, Kayla; Parker, Lisa S.; Bonham, Vence L.

doi:10.1159/000516782

Cited by 8 publications

(3 citation statements)

References 38 publications

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“…In the present study, the participant consents were permissive for return of potentially useful information and considerable effort was expended to garner input from the wider community of Tribal leaders, local clinicians and others as suggested by Raymond et al 40 We are grateful for this community-grounded input and feel that our initial implementation plans would likely have failed, at least to some extent. It is also fortunate that we had the bene t of supplemental research funds to allow CLIA-certi ed con rmation of our results, so this issue was easily resolved.…”

Section: Discussionmentioning

confidence: 94%

Return of Participants' Incidental Genetic Research Findings: Experience from a Case-Control Study of Asthma in an American Indian Community

Best

O’Leary

O'Leary

et al. 2023

Preprint

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Purpose: The proper communication of clinically actionable findings to participants of genetic research entails important ethical considerations, but has been challenging for a variety of reasons. We document an instance of return of individual genetic results in the context of a very rural American Indian community, in hopes of providing insight to other investigators about potentially superior or inferior courses of action. Methods: The original study was a case/control study of asthma among 324 pediatric participants. The study utilized a genotyping microarray assessing over 2 million variants, including one conferring risk for hypertrophic cardiomyopathy for which the American College of Medical Genetics recommends return of results to participants. The study investigators engaged in extensive consultation with the IRB, the Tribal government and local clinicians to better inform our approach. Results: With some difficulty we were able to notify the 2 participants heterozygous for this variant. One participant welcomed this information and proceeded to obtain further clinical work-up; the other participant declined further follow-up. Conclusion: While demanding of considerable time and effort, the return of clinically actionable genetic results is important from both an ethical perspective and to provide an improved trust relationship with the community of research participants.

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Section: Discussionmentioning

confidence: 94%

Return of Participants' Incidental Genetic Research Findings: Experience from a Case-Control Study of Asthma in an American Indian Community

Best

O’Leary

O'Leary

et al. 2023

Preprint

View full text Add to dashboard Cite

show abstract

“…In the present study, the participant consents were permissive for the return of potentially useful information, including results related to “…other health problems” in addition to asthma, as stated in the consents. Considerable effort was also expended to garner input from the wider community of tribal leaders, local clinicians, and others as suggested by Raymond et al [ 45 ]. We are grateful for this community-grounded input and feel that our initial implementation plans would likely have failed, at least to some extent.…”

Section: Discussionmentioning

confidence: 99%

Return of Participants’ Incidental Genetic Research Findings: Experience from a Case-Control Study of Asthma in an American Indian Community

Best,

O’Leary,

O’Leary

et al. 2023

JPM

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The proper communication of clinically actionable findings to participants of genetic research entails important ethical considerations, but has been challenging for a variety of reasons. We document an instance of the return of individual genetic results in the context of a very rural American Indian community, in hopes of providing insight to other investigators about potentially superior or inferior courses of action. This was a case/control study of asthma among 324 pediatric participants. Subsequently, microarray genotype data became available, providing over 2 million variants, incidentally including some conferring risk for conditions for which the American College of Medical Genetics recommends return of results. The study investigators engaged in extensive consultation with the IRB, the tribal government, and local clinicians to better inform our approach. We were able to notify the two participants heterozygous for the one clinically actionable variant identified. One participant welcomed this information and proceeded to obtain further clinical work-up; the other participant declined further follow-up. While demanding considerable time and effort, the return of clinically actionable genetic results is important from both an ethical perspective and to provide an improved trust relationship with the community of research participants.

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“…With measured success [ 14 ], precision medicine researchers are increasingly expanding their outreach, recruitment, and retention of historically underrepresented communities, especially minoritized communities of color. This has also necessarily involved increased interaction with low-resource and medically underserved communities due to historic and ongoing systemic racism that broadly disadvantages communities of color [ 15 ]. Some researchers are, for example, expanding the infrastructure necessary to partner with and conduct PMR at low-resource clinical sites, such as federally qualified health centers [ 16 ].…”

Section: Introductionmentioning

confidence: 99%

Rethinking Benefit and Responsibility in the Context of Diversity: Perspectives from the Front Lines of Precision Medicine Research

Vásquez¹,

Foti²,

McMahon³

et al. 2023

Public Health Genomics

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Introduction: Federal agencies have instituted guidelines to prioritize the enrollment and retention of diverse participants in precision medicine research (PMR). Prior studies examining participation of minoritized communities have shown that potential benefits represent a key determinant. Human subjects research guidance, however, conceptualizes potential benefits narrowly, emphasizing generalized advances in medical knowledge. Further, few studies have provided qualitative data that critically examine how the concept of ‘benefit’ is interpreted or challenged in the context of research practice. This paper examines the experiences of PMR investigators and frontline research staff to understand how standard approaches to benefit are received, contested, and negotiated “on-the-ground.” Methods: Findings are drawn from a qualitative project conducted across five U.S.-based, federally-funded PMR studies. Data collection included 125 in-depth interviews with a purposive sample of investigators, research staff, community advisory board members, and NIH program officers associated with these PMR studies. Results: Researchers report that the standard approach to benefit—which relies on the premise of altruism and the promise of incrementally advancing scientific knowledge—is frequently contested. Researchers experience moral distress over the unmet clinical, psychosocial, and material needs within the communities they are engaging. Many believe the broader research enterprise has a responsibility to better address these needs. Discussion/Conclusion: Researchers frequently take issue with and sometimes negotiate what is owed to participants and to their communities in exchange for the data they provide. These experiences of moral distress and these improvisations warrant systematic redress, not by individual researchers but by the broader research ethics infrastructure.

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

Cited by 8 publications

References 38 publications

Return of Participants' Incidental Genetic Research Findings: Experience from a Case-Control Study of Asthma in an American Indian Community

Return of Participants' Incidental Genetic Research Findings: Experience from a Case-Control Study of Asthma in an American Indian Community

Return of Participants’ Incidental Genetic Research Findings: Experience from a Case-Control Study of Asthma in an American Indian Community

Rethinking Benefit and Responsibility in the Context of Diversity: Perspectives from the Front Lines of Precision Medicine Research

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