Clarifying how to deploy the public interest criterion in consent waivers for health data and tissue research

Owen Schaefer, Graeme Laurie, Sumytra Menon, Alastair Campbell, Teck Chuan Voo

Research output: Contribution to journalArticlepeer-review

Abstract / Description of output

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 (IRBs) 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.

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.
Original languageEnglish
Article number23 (2020)
Number of pages10
JournalBMC Medical Ethics
Issue number23
Publication statusPublished - 20 Mar 2020

Keywords / Materials (for Non-textual outputs)

  • health
  • ethics
  • public interest
  • consent
  • regulation
  • waiver
  • public good
  • consent waivers
  • ethics review
  • research ethics


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