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Public interest in health data research: laying out the conceptual groundwork
  1. Angela Ballantyne,
  2. G Owen Schaefer
  1. Centre for Biomedical Ethics, Yong Loo Lin School of Medicine, National University Singapore, Singapore
  1. Correspondence to Dr G Owen Schaefer, Centre for Biomedical Ethics, Yong Loo Lin School of Medicine, National University Singapore, Singapore 117597, Singapore; owen_schaefer{at}nus.edu.sg

Abstract

The future of health research will be characterised by three continuing trends: rising demand for health data; increasing impracticability of obtaining specific consent for secondary research; and decreasing capacity to effectively anonymise data. In this context, governments, clinicians and the research community must demonstrate that they can be responsible stewards of health data. IRBs and RECs sit at heart of this process because in many jurisdictions they have the capacity to grant consent waivers when research is judged to be of particular value. However, several different terms are used to refer to this value (including public interest, public benefit, public good and social value), indicating a lack of conceptual clarity regarding the appropriate test for access to health data for research without consent. In this paper we do three things. First we describe the current confusion and instability in terminology relating to public interest in the context of consent waivers. Second we argue for harmonisation of terminology on the grounds of clarity, transparency and consistency. Third we argue that the term ‘public interest’ best reflects the normative work required to justify consent waivers because it is the broadest of the competing terms. ‘Public interest’ contains within its scope positive and negative implications of a study, as well as welfare, justice and rights considerations. In making this argument, we explain the normative basis for consent waivers, and provide a starting place for further discussion about the precise conditions in which a given study can be said to advance the public interest. Ipsos MORI study found that: … the public would be broadly happy with administrative data linking for research projects provided (1) Those projects have social value, broadly defined. (2) Data are de-identified. (3) Data are kept secure. (4) Businesses are not able to access the data for profit.

  • informed consent
  • research ethics
  • regulation
  • public policy
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Footnotes

  • Twitter @G_Owen_Schaefer

  • Contributors This paper was conceived by AB. AB conducted the background research and wrote the initial draft. GOS and AB conducted redrafts and edits after discussion and mutual agreement. GOS and AB approved the final version.

  • Funding GOS's work is supported by the Singapore National Medical Research Council's Research, Innovation and Enterprise 2020 Grant. AB has not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.

  • Competing interests None declared.

  • Patient consent for publication Not required.

  • Provenance and peer review Not commissioned; externally peer reviewed.

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