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. 2015 Fall;43(3):486-501.
doi: 10.1111/jlme.12291.

Mapping the Ethics of Translational Genomics: Situating Return of Results and Navigating the Research-Clinical Divide

Susan M Wolf  1 , Wylie Burke  2 , Barbara A Koenig  3
Affiliations

Mapping the Ethics of Translational Genomics: Situating Return of Results and Navigating the Research-Clinical Divide

Susan M Wolf et al. J Law Med Ethics. 2015 Fall.

Abstract

Both bioethics and law have governed human genomics by distinguishing research from clinical practice. Yet the rise of translational genomics now makes this traditional dichotomy inadequate. This paper pioneers a new approach to the ethics of translational genomics. It maps the full range of ethical approaches needed, proposes a "layered" approach to determining the ethics framework for projects combining research and clinical care, and clarifies the key role that return of results can play in advancing translation.

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Figures

Figure 1
Figure 1. The translational research process, framed by the ethical domains most relevant to each stage
Figure 2
Figure 2. “Layering” ethical approaches to deal with T2 genomics projects combining human subjects research (HSR) with clinical care
This method asks whether the person is undergoing genomic analysis as a participant in human subjects research (HSR) and as a patient (2nd column). This method then “layers” ethics by applying the ethics and standards of HSR to genomic analysis that is part of the research protocol, while applying the ethics and standards of clinical care to the aspects of the genomic analysis that involve clinical use (3rd column). If both ethics apply to some aspect of the genomic analysis and conflict, this method uses a decision rule, applying to that aspect the ethics and standards that are more protective of the person undergoing genomic analysis (4th column).
See this image and copyright information in PMC

References

    1. See Wolf SM, et al. Managing Incidental Findings in Human Subjects Research: Analysis and Recommendations. Journal of Law, Medicine & Ethics. 2008;36(2):219–248.

    1. Green RC, et al. ACMG Recommendations for Reporting of Incidental Findings in Clinical Exome and Genome Sequencing. Genetics in Medicine. 2013;15(7):565–574. - PMC - PubMed
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    1. See, e.g., Burke W, et al. Recommendations for Returning Genomic Incidental Findings? We Need to Talk! Genetics in Medicine. 2013;15(11):854–859. McGuire AL, et al. Ethics and Genomic Incidental Findings. Science. 2013;340(6136):1047–1048. Wolf SM, Annas GJ, Elias S. Patient Autonomy and Incidental Findings in Clinical Genomics. Science. 2013;340(6136):1049–1050.

    1. ACMG Board of Directors. ACMG Policy Statement: Updated Recommendations Regarding Analysis and Reporting of Secondary Findings in Clinical Genome-Scale Sequencing. Genetics in Medicine. 2015;17(1):68–69. - PubMed
    1. Anticipate and Communicate: Ethical Management of Incidental and Secondary Findings in the Clinical, Research, and Direct-to-Consumer Contexts. Washington, D.C.: Presidential Commission for the Study of Bioethical Issues; 2013. [last visited January 13, 2015]. Presidential Commission for the Study of Bioethical Issues. at < http://bioethics.gov/node/3169>. - PubMed

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