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Strategies to Guide the Return of Genomic Research Findings: An Australian Perspective

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Abstract

In Australia, along with many other countries, limited guidance or other support strategies are currently available to researchers, institutional research ethics committees, and others responsible for making decisions about whether to return genomic findings with potential value to participants or their blood relatives. This lack of guidance results in onerous decision-making burdens—traversing technical, interpretative, and ethical dimensions—as well as uncertainty and inconsistencies for research participants. This article draws on a recent targeted consultation conducted by the Australian National Health and Medical Research Council to put forward strategies for supporting return of finding decision-making. In particular, we propose a pyramid of decision-making support: decision-making guidelines, technical and interpretative assistance, and ethical assistance for intractable “tough” cases. Each step of the pyramid involves an increasing level of regulatory involvement and applies to a smaller subsection of genomic research findings. Implementation of such strategies would facilitate a growing evidence base for return of finding decisions, thereby easing the financial, time, and moral burdens currently placed on researchers and other relevant decision-makers while also improving the quality of such decisions and, consequently, participant outcomes.

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Notes

  1. An explanation and justification of these three overarching criteria is set out in Eckstein, Garrett, and Berkman 2014.

  2. Despite being a well-accepted ethical rule, legal regimes differ considerably on whether there is any duty to rescue.

  3. For a broad discussion of the regulatory theory behind this proposal, see Black 1998.

  4. The eMERGE Network is a consortium of five U.S. institutions and two genotyping centers conducting GWAS using phenotypes derived from electronic medical records.

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Authors and Affiliations

  1. Faculty of Law, University of Tasmania, Private Bag 89, Hobart, Tasmania, 7001, Australia

    Lisa Eckstein & Margaret Otlowski

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  1. Lisa Eckstein
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  2. Margaret Otlowski
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Correspondence to Lisa Eckstein.

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Eckstein, L., Otlowski, M. Strategies to Guide the Return of Genomic Research Findings: An Australian Perspective. Bioethical Inquiry 15, 403–415 (2018). https://doi.org/10.1007/s11673-018-9856-7

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