BMC Medical Ethics 21 (1):1-10 (2020)

Authors
G. Owen Schaefer
National University of Singapore
Abstract
Background Several jurisdictions, including Singapore, Australia, New Zealand and most recently Ireland, have a public interest or public good criterion for granting waivers of consent in biomedical research using secondary health data or tissue. However, the concept of the public interest is not well defined in this context, which creates difficulties for institutions, institutional review boards and regulators trying to implement the criterion. Main text This paper clarifies how the public interest criterion can be defensibly deployed. We first explain the ethical basis for requiring waivers to only be granted to studies meeting the public interest criterion, then explore how further criteria may be set to determine the extent to which a given study can legitimately claim to be in the public interest. We propose an approach that does not attempt to measure magnitude of benefit directly, but rather takes into account metrics that are more straightforward to apply. To ensure consistent and justifiable interpretation, research institutions and IRBs should also incorporate procedural features such as transparency and public engagement in determining which studies satisfy the public interest requirement. Conclusion The requirement of public interest for consent waivers in secondary biomedical research should be guided by well-defined criteria for systematic evaluation. Such a criteria and its application need to be periodically subject to intra-committee and intra-institution review, reflection, deliberation and amendment.
Keywords Consent waivers  Research ethics  Public interest
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DOI 10.1186/s12910-020-00467-5
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References found in this work BETA

The Theory and Practice of Autonomy.Gerald Dworkin - 1988 - Philosophy 64 (250):571-572.
Can Broad Consent Be Informed Consent?M. Sheehan - 2011 - Public Health Ethics 4 (3):226-235.
In Defense of Broad Consent.Gert Helgesson - 2012 - Cambridge Quarterly of Healthcare Ethics 21 (1):40-50.
A Framework for Risk-Benefit Evaluations in Biomedical Research.Wendler Annette Rid David - 2011 - Kennedy Institute of Ethics Journal 21 (2):141-179.

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