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Incidental Findings in Study Participants: What Is the Researcher’s Obligation?

Background: As technology advances and genomic testing becomes commonplace, incidental findings, or the discovery of unrelated results, have increased. The American College of Genetics and Genomics (ACMG) established recommendations for the return of pathologic variants in 78 genes in the clinical s...

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Autores principales: Schaare, Donna, Ward, Linda D., Boccuto, Luigi
Formato: Online Artículo Texto
Lenguaje:English
Publicado: MDPI 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9601588/
https://www.ncbi.nlm.nih.gov/pubmed/36292587
http://dx.doi.org/10.3390/genes13101702
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author Schaare, Donna
Ward, Linda D.
Boccuto, Luigi
author_facet Schaare, Donna
Ward, Linda D.
Boccuto, Luigi
author_sort Schaare, Donna
collection PubMed
description Background: As technology advances and genomic testing becomes commonplace, incidental findings, or the discovery of unrelated results, have increased. The American College of Genetics and Genomics (ACMG) established recommendations for the return of pathologic variants in 78 genes in the clinical setting based on medically actionable conditions from genes linked with preventable or treatable diseases. However, the lack of policy in the research setting poses a serious ethical dilemma for researchers, potentially threatening the participant’s trust and willingness to contribute to a process with more significant risk than benefit. Purpose: Our goal was to determine the preferred ethical approach to handling incidental research findings and suggest a new standard for investigators and participants. Methods: By employing Wueste’s IAJD Framework of ethical evaluation, the current research policy, as well as a proposed policy, were analyzed, and then a policy analysis was employed to ascertain feasibility. Results and Discussion: The current policy of leaving the decision of returning incidental findings up to the researcher’s discretion is an ethical failure from the consequential, deontological, and intellectual freedom perspectives. However, the proposed policy of implementing the ACMG guidance for researchers to satisfy ethical demands reinforces its moral fortitude. In a period of increasing public awareness, the community, which is the prospective research pool, has increased demands for autonomy and less paternalistic behavior from medicine and science. This paper synthesizes recommendations by numerous organizations to establish a mutually beneficial policy that will ensure the U.S. Department of Health and Human Services (HHS) goal, stated in the 2014 Joint Rule, of making participants “partners” in research a reality.
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spelling pubmed-96015882022-10-27 Incidental Findings in Study Participants: What Is the Researcher’s Obligation? Schaare, Donna Ward, Linda D. Boccuto, Luigi Genes (Basel) Article Background: As technology advances and genomic testing becomes commonplace, incidental findings, or the discovery of unrelated results, have increased. The American College of Genetics and Genomics (ACMG) established recommendations for the return of pathologic variants in 78 genes in the clinical setting based on medically actionable conditions from genes linked with preventable or treatable diseases. However, the lack of policy in the research setting poses a serious ethical dilemma for researchers, potentially threatening the participant’s trust and willingness to contribute to a process with more significant risk than benefit. Purpose: Our goal was to determine the preferred ethical approach to handling incidental research findings and suggest a new standard for investigators and participants. Methods: By employing Wueste’s IAJD Framework of ethical evaluation, the current research policy, as well as a proposed policy, were analyzed, and then a policy analysis was employed to ascertain feasibility. Results and Discussion: The current policy of leaving the decision of returning incidental findings up to the researcher’s discretion is an ethical failure from the consequential, deontological, and intellectual freedom perspectives. However, the proposed policy of implementing the ACMG guidance for researchers to satisfy ethical demands reinforces its moral fortitude. In a period of increasing public awareness, the community, which is the prospective research pool, has increased demands for autonomy and less paternalistic behavior from medicine and science. This paper synthesizes recommendations by numerous organizations to establish a mutually beneficial policy that will ensure the U.S. Department of Health and Human Services (HHS) goal, stated in the 2014 Joint Rule, of making participants “partners” in research a reality. MDPI 2022-09-22 /pmc/articles/PMC9601588/ /pubmed/36292587 http://dx.doi.org/10.3390/genes13101702 Text en © 2022 by the authors. https://creativecommons.org/licenses/by/4.0/Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (https://creativecommons.org/licenses/by/4.0/).
spellingShingle Article
Schaare, Donna
Ward, Linda D.
Boccuto, Luigi
Incidental Findings in Study Participants: What Is the Researcher’s Obligation?
title Incidental Findings in Study Participants: What Is the Researcher’s Obligation?
title_full Incidental Findings in Study Participants: What Is the Researcher’s Obligation?
title_fullStr Incidental Findings in Study Participants: What Is the Researcher’s Obligation?
title_full_unstemmed Incidental Findings in Study Participants: What Is the Researcher’s Obligation?
title_short Incidental Findings in Study Participants: What Is the Researcher’s Obligation?
title_sort incidental findings in study participants: what is the researcher’s obligation?
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9601588/
https://www.ncbi.nlm.nih.gov/pubmed/36292587
http://dx.doi.org/10.3390/genes13101702
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