Managing incidental genomic findings in clinical trials: fulfillment of the principle of justice

doi:10.1371/journal.pmed.1001584

. 2014 Jan;11(1):e1001584.

doi: 10.1371/journal.pmed.1001584. Epub 2014 Jan 14.

Managing incidental genomic findings in clinical trials: fulfillment of the principle of justice

Rafael Dal-Ré¹, Nicholas Katsanis², Sara Katsanis³, Lisa S Parker⁴, Carmen Ayuso⁵

Affiliations

¹ Clinical Research Program, Pasqual Maragall Foundation, Barcelona, Spain.
² Center for Human Disease Modeling, Department of Cell Biology, Department of Medicine, Duke University, Durham, North Carolina, United States of America.
³ Duke Institute for Genome Sciences and Policy, Duke University, Durham, North Carolina, United States of America.
⁴ Center for Bioethics and Health Law, University of Pittsburgh, Pittsburgh, Pennsylvania, United States of America.
⁵ Department of Genetics, Health Research Institute-Jimenez Diaz Foundation University Hospital (IIS-FJD), Madrid, Spain ; CIBERER (Centro de Investigación Biomédica en Red de Enfermedades Raras), Instituto de Salud Carlos III, Madrid, Spain.

PMID: 24453945
PMCID: PMC3891615
DOI: 10.1371/journal.pmed.1001584

Managing incidental genomic findings in clinical trials: fulfillment of the principle of justice

Rafael Dal-Ré et al. PLoS Med. 2014 Jan.

. 2014 Jan;11(1):e1001584.

doi: 10.1371/journal.pmed.1001584. Epub 2014 Jan 14.

Authors

Rafael Dal-Ré¹, Nicholas Katsanis², Sara Katsanis³, Lisa S Parker⁴, Carmen Ayuso⁵

Affiliations

¹ Clinical Research Program, Pasqual Maragall Foundation, Barcelona, Spain.
² Center for Human Disease Modeling, Department of Cell Biology, Department of Medicine, Duke University, Durham, North Carolina, United States of America.
³ Duke Institute for Genome Sciences and Policy, Duke University, Durham, North Carolina, United States of America.
⁴ Center for Bioethics and Health Law, University of Pittsburgh, Pittsburgh, Pennsylvania, United States of America.
⁵ Department of Genetics, Health Research Institute-Jimenez Diaz Foundation University Hospital (IIS-FJD), Madrid, Spain ; CIBERER (Centro de Investigación Biomédica en Red de Enfermedades Raras), Instituto de Salud Carlos III, Madrid, Spain.

PMID: 24453945
PMCID: PMC3891615
DOI: 10.1371/journal.pmed.1001584

Abstract

Rafael Dal-Ré and colleagues discuss how incidental findings are likely to be viewed as potential benefits of research participation in genomics trials, and investigators should implement mechanisms to ensure provision of timely and appropriate care. Ensuring provision of such interventions in countries lacking a universal public health care system may prove challenging.

Please see later in the article for the Editors' Summary

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Conflict of interest statement

The authors have declared that no competing interests exist. The opinions expressed in this article are those of the authors and may not reflect the opinions of the organizations that they work for.

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References

1. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (1979) Belmont report: ethical principles and guidelines for the protection of human subjects of research. Fed Regist 44: 23192–23197.
1. Dresser R (2011) The role of patient advocates and public representatives in research. In: Emanuel EJ, Grady C, Crouch RA, Lie RK, Miller FG, et al. The Oxford textbook of clinical research ethics. Oxford: Oxford University Press pp. 231–241.
1. Mestan KK, Ilkhanoff L, Mouli S, Lin S (2011) Genomic sequencing in clinical trials. J Trans Med 9: 222. - PMC - PubMed
1. Wolf SM, Lawrenz FP, Nelson CA, Kahn JP, Cho MK, et al. (2008) Managing incidental findings in human subjects research: analysis and recommendations. J Law Med Ethics 36: 219–248. - PMC - PubMed
1. Green RC, Berg JS, Grody WW, Kalia SS, Korf BR, et al. (2013) ACMG recommendations for reporting of incidental findings in clinical exome and genome sequencing. Genet Med 15: 565–574. - PMC - PubMed

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[1] National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (1979) Belmont report: ethical principles and guidelines for the protection of human subjects of research. Fed Regist 44: 23192–23197.

[2] National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (1979) Belmont report: ethical principles and guidelines for the protection of human subjects of research. Fed Regist 44: 23192–23197.

[3] Dresser R (2011) The role of patient advocates and public representatives in research. In: Emanuel EJ, Grady C, Crouch RA, Lie RK, Miller FG, et al. The Oxford textbook of clinical research ethics. Oxford: Oxford University Press pp. 231–241.

[4] Dresser R (2011) The role of patient advocates and public representatives in research. In: Emanuel EJ, Grady C, Crouch RA, Lie RK, Miller FG, et al. The Oxford textbook of clinical research ethics. Oxford: Oxford University Press pp. 231–241.

[5] Mestan KK, Ilkhanoff L, Mouli S, Lin S (2011) Genomic sequencing in clinical trials. J Trans Med 9: 222. - PMC - PubMed

[6] Mestan KK, Ilkhanoff L, Mouli S, Lin S (2011) Genomic sequencing in clinical trials. J Trans Med 9: 222. - PMC - PubMed

[7] Wolf SM, Lawrenz FP, Nelson CA, Kahn JP, Cho MK, et al. (2008) Managing incidental findings in human subjects research: analysis and recommendations. J Law Med Ethics 36: 219–248. - PMC - PubMed

[8] Wolf SM, Lawrenz FP, Nelson CA, Kahn JP, Cho MK, et al. (2008) Managing incidental findings in human subjects research: analysis and recommendations. J Law Med Ethics 36: 219–248. - PMC - PubMed

[9] Green RC, Berg JS, Grody WW, Kalia SS, Korf BR, et al. (2013) ACMG recommendations for reporting of incidental findings in clinical exome and genome sequencing. Genet Med 15: 565–574. - PMC - PubMed

[10] Green RC, Berg JS, Grody WW, Kalia SS, Korf BR, et al. (2013) ACMG recommendations for reporting of incidental findings in clinical exome and genome sequencing. Genet Med 15: 565–574. - PMC - PubMed

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Managing incidental genomic findings in clinical trials: fulfillment of the principle of justice

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Managing incidental genomic findings in clinical trials: fulfillment of the principle of justice

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