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On the Justifiability of ACMG Recommendations for Reporting of Incidental Findings in Clinical Exome and Genome Sequencing

Published online by Cambridge University Press:  01 January 2021

Thomas May
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Extract

In spring 2013 the American College of Medical Genetics and Genomics (ACMG) Working Group on Incidental Findings in Clinical Exome and Genome Sequencing (hereafter “Working Group”) released a report of “Recommendations for Reporting of Incidental Findings in Clinical Exome and Genome Sequencing,” the culmination of a three-year long consensus project. The Working Group recommended that a number of incidental findings, which they define as “the results of a deliberate search for pathogenic or likely pathogenic alterations in genes that are not apparently relevant to a diagnostic indication for which the sequencing test was ordered,” be returned to clinicians (and patients) independent of patient preferences. The Working Group recognized that their recommendations may violate existing ethical norms, but believe this is justified by a fiduciary duty on the part of clinicians and laboratory personnel to prevent harm by warning patients about certain findings, a duty they claim “supersedes concerns about autonomy.”

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Independent
Information
Journal of Law, Medicine & Ethics , Volume 43 , Issue 1 , Spring 2015 , pp. 134 - 142
Copyright
Copyright © American Society of Law, Medicine and Ethics 2015

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References

American College of Medical Genetics and Genomics, ACMG Recommendations for Reporting of Incidental Findings in Clinical Exome and Genome Sequencing, available at <http://www.acmg.net/docs/ACMG_Releases_Highly-Anticipated_Recommendations_on_Incidental_Findings_in_Clinical_Exome_and_Genome_Sequencing.pdf> (last visited February 23, 2015) (hereinafter cited as ACMG).+(last+visited+February+23,+2015)+(hereinafter+cited+as+ACMG).>Google Scholar
Id., at 11.Google Scholar
Couzin-Frankel, J., “Return of Unexpected DNA Results Urged,” Science 339, no6127 (March 29, 2013): 1507–1508.Google Scholar
See ACMG, supra note 1, at 7–8.Google Scholar
Johnson, C. Y., “Controversial Guidelines Suggest Patients Should Be Informed What Risks Lurk in Their DNA,” Boston Globe, March 21, 2013, available at <http://www.boston.com/news/science/blogs/science-in-mind/2013/03/21/controversial-guidelines-suggest-patients-should-informed-what-risks-lurk-their-dna/Z50TUl6zW8k2KlXA1UG5yN/blog.html> (last visited February 23, 2015).+(last+visited+February+23,+2015).>Google Scholar
American College of Medical Genetics and Genomics, ACMG Updates Recommendation on “Opt Out” for Genome Sequencing Return of Results, Press Release, April 1, 2014, available at <https://www.acmg.net/docs/Release_ACMGUpdatesRecommendations_fnal.pdf> (last visited February 23, 2015).+(last+visited+February+23,+2015).>Google Scholar
Id.Google Scholar
See Couzin-Frankel, , supra note 2.Google Scholar
Strong, K. A. Zusevics, K. Bick, D. Veith, R., “Views of Primary Care Providers Regarding the Return of Genomic Sequencing Incidental Findings,” Clinical Genetics 86, no5(2014): 461–468;.Google Scholar
Strong, K. A. Zusevics, K. Bick, D. Veith, R., “Views of Nonmedical, Health System Professionals Regarding the Return of Whole Genome Sequencing Incidental Findings,” Wisconsin Medical Journal 113, no5 (2014): 179–184.Google Scholar
Mill, J. S., On Liberty (New York: Liberal Arts Press, 1956).Google Scholar
See ACMG, supra note 1, at 7.Google Scholar
Id.Google Scholar
Id., at 7–9.Google Scholar
Id., at 11.Google Scholar
May, T. Spellecy, R., “Autonomy, Full Information, and Genetic Ignorance in Reproductive Medicine,” Monist 89, no4 (2006): 466–481;.Google Scholar
May, T. Aulisio, M., “Personal Morality and Professional Obligations: Rights of Conscience and Informed Consent,” Perspectives in Biology and Medicine 52, no1 (2009): 30–38.Google Scholar
See Mill, , supra note 10.Google Scholar
May, T., Bioethics in a Liberal Society (Baltimore: Johns Hopkins University Press, 2002).Google Scholar
Dworkin, R., Taking Rights Seriously (Cambridge: Harvard University Press, 1978).Google Scholar
See ACMG, supra note 1, at 18.Google Scholar
May, T., “Re-Thinking Clinical Risk for DNA Sequencing,” American Journal of Bioethics 12, no10 (2012): 24–26.CrossRefGoogle Scholar
See Mill, , supra note 10;.Google Scholar
Feinberg, J., Harm to Others (New York: Oxford University Press, 1984).Google Scholar
Id. (Feinberg).Google Scholar
Green, R. C. Lupski, J. R. Biesecker, L. G., “Reporting Genomic Sequencing Results to Ordering Clinicians: Incidental, Not Exceptional,” JAMA 310, no4 (2013): 365–356.CrossRefGoogle Scholar
Id.Google Scholar
Id., at 365.Google Scholar
McGuire, A. Joffee, S. Koenig, B.et al, “Ethics and Genomic Incidental Findings,” Science 340, no6136 (May 31, 2013): 1047–1048.Google Scholar
Id., at 1047.Google Scholar
See Green, et al, supra note 23, at 365.Google Scholar
See ACMG, supra note 1, at 11.Google Scholar
Id.Google Scholar
May, T., “An Adoptive Parental Perspective on Personal Genomic Screening,” Pediatrics (forthcoming 2015).Google Scholar