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In defence of a broad approach to public interest in health data research
  1. Angela Ballantyne,
  2. G Owen Schaefer
  1. Centre for Biomedical Ethics, Yong Loo Lin School of Medicine, National University of Singapore, Singapore
  1. Correspondence to Dr G Owen Schaefer, Centre for Biomedical Ethics, National University of Singapore, Yong Loo Lin School of Medicine, Singapore 119077, Singapore; owen_schaefer{at}nus.edu.sg

Abstract

In their response to ‘Public interest in health data research: laying out the conceptual groundwork’, Grewal and Newson critique us for inattention to the law and putting forward an impracticably broad conceptual understanding of public interest. While we agree more work is needed to generate a workable framework for Institutional Review Boards/Research Ethics Committees (IRBs/RECs), we would contend that this should be grounded on a broad conception of public interest. This broadness facilitates regulatory agility, and is already reflected by some current frameworks such as that found in the guidelines approved under Australia’s Privacy Act. It remains unclear which elements of our broad account Grewal and Newson would reject, or indeed where the substantive disagreement with our position lies.

  • research ethics
  • ethics committees/consultation
  • policy guidelines
  • legal aspects

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We had three aims in writing ‘Public interest in health data research: laying out the conceptual groundwork’: to demonstrate a problem with the ‘public interest test’ for consent waivers for secondary research as currently framed (lack of clarity and inconsistent terminology); to advocate for harmonisation of terminology; and to argue for public interest as the preferred concept. In particular, we argued that public interest is the appropriate test for consent waivers because it is broad enough to encapsulate the necessary normative considerations that should be taken into account by Institutional Review Boards/Research Ethics Committees (IRBs/RECs) when allowing research to progress without consent.1

Grewal and Newson have responded with a critique of this broad understanding of public interest.2 They endorse the need for a public interest test for consent waivers, but favour a narrower account of public interest because they hold this will be more workable for IRBs/RECs and within the confines of the law. Grewal and Newson do not themselves provide an account of where such limits should be placed or explain which normative considerations should be excluded from the public interest test.

In this response we focus on two of Grewal and Newson’s arguments: that public interest should be analysed ‘in its legal, rather than ethical, sense’; and that a broad conceptual understanding of public interest undermines (or at worst—rules out) the possibility of developing a practical public interest test for IRBs/RECs.

Legal analysis of public interest

Grewal and Newson argue that we ‘underestimate what is as stake’ concerning the legal ramifications of a broad concept of public interest.

While we motivated our paper, in part, based on inconsistency and vagueness in current regulations and guidelines, legal analysis was not our focus—rather, we hold that in this context, the normative justification for granting a consent waiver should ground interpretations of the public interest. Adopting a narrow concept of public interest in order to minimise risk of violating the law would have an analogous effect to ‘defensive medicine’, where doctors may withhold beneficial treatment for fear of liability. Here, narrowing the concept in order to minimise the risk of legal violation could lead to preventing valuable research where waivers are ethically justifiable.

Indeed, in the context of legal scholarship, we find support for a broad interpretation of public interest. The primary point of public interest, in a legal sense, is to provide for legislative flexibility. Economist Gerhard Colm has argued that ‘In political debate, judicial practice, and economic-policy, discussion of the term public interest plays a dominant role. The term lends itself to convenient use—partly because it resists, by its nature, precise definition.’3 Indeed the Australian Law Reform Commission expressly argued that ‘Public interest should not be defined’.4 Public interest is employed as a regulatory tool precisely when there is a need to allow for regulatory agility and for a wide ranging consideration of relevant interests.

A broad account of public interest can ground a workable approach

Grewal and Newson further critique our account for being impractical, in part for our failure to draw on qualitative research, stakeholder perspectives or an understanding of the realities of IRB/REC review. We dispute that such qualitative research is a pre-requisite for conceptual analysis, but in this case one of us has undertaken extensive qualitative research in New Zealand involving all national level RECs, as well asresearchers and other stakeholders, looking at their experiences of the regulatory processes for granting consent waivers to share health information for secondary research.5 6 This qualitative research shows that RECs in New Zealand find the process of determining consent waivers stressful and this is exacerbated by the lack of a clear workable schema for interpreting public interest. We agree with Grewal and Newson that IRBs/RECs need an operational framework for assessing public interest, not merely a conceptual definition.

But Grewal and Newson also hold that our account is so broad as to be essentially unworkable for IRBs/RECs: ‘We suggest that getting to a framework will be difficult where the concept is as broad as the one they put forward’. They argue that by advocating for a broad account of public interest we have actually moved even further away from operationalising the concept of public interest for IRBs/RECs, and that a narrow account of public interest would be more practical. However, it is difficult to see what the differences between the broad and narrow approaches amount to because Grewal and Newson do not provide a definition of narrow public interest.

Grewal and Newson do point favourably to an example of a workable schema based on a presumably narrow account of public interests in the guidelines approved under Section 95A of Australia’s Privacy Act.7 Section D5 of these guidelines instructs Health Research Ethics Committees (HRECs) on how to assess public interest. But to us this is an example of a broad, not narrow, understanding of public interest. The list of considerations is extensive and we have pulled out just a few examples. In assessing public interest in relation to consent waivers, IRBs/RECs should consider:

  • The degree to which the research… is relevant to public health or public safety.

  • Any likely benefits to individuals… or the wider community.

  • The cost of not undertaking the research (to government, the public, the healthcare system and so on).

  • The public importance of the proposed research.

  • The risk of harm.

  • The degree to which the research is likely to contribute to:

    • the identification, prevention or treatment of illness, injury or disease;

    • scientific understanding relating to public health or safety; or

    • the protection of the health of individuals and/or communities; or

    • the improved delivery of health services; or

    • enhanced scientific understanding or knowledge; or

    • enhanced knowledge of issues within the fields of social science and the humanities relating to public health or public safety.

Rather than being a ‘narrow’ framework, this seems to address many of the criteria we argued were relevant to public interest and which Grewal and Newson rejected as unworkably broad. This schema includes assessment of benefits, harms and opportunity costs; not just to the people whose data will be used but to the wider community, government and public, and in the case of advancing scientific knowledge—arguably to humanity at large. To us this example aligns well with our broader account of public interest. It remains unclear which elements of our proposed account of public interest Grewal and Newson would eliminate.

We can look at one consideration as an example: should ‘enhanced scientific understanding or knowledge’ be interpreted broadly or narrowly? A narrow interpretation might consider the benefit only to the specific patient group whose data will be used in the research (e.g. patients with breast cancer); whereas a broad interpretation would consider the potential benefit to a larger group of patient (e.g. to all patients with cancer). We support a broad interpretation given that progress in science is rarely linear and technology within health is often transferable between different patient populations. Equally ‘enhanced scientific knowledge’ could be interpreted narrowly in terms of geography (e.g. of benefit to the scientific community in Australia) or broadly (e.g. of benefit to health researchers globally). Perhaps research into a rare genetic condition would only affects only a hand patients of in Australia. But knowledge generated from the research could potentially fill a gap in the medical literature and significantly contribute to the interests of this patient group globally. A narrow interpretation of public interest that looked only at the value of the knowledge to Australia might rule out such research because it fails to meet the public interest threshold for a consent waiver. And this, in our view, would be a failure of such an account. Health research is a global endeavour requiring international cooperation, sharing of knowledge and an acknowledgement of common interests.

To be sure, the Australian guidelines endorsed by Grewal And Newson are more specific than the conceptual analysis we provided. We agree with Grewal and Newson that the requirement of public interest for consent waivers in secondary biomedical research should be guided by well-defined criteria for systematic evaluation,8 and that our paper did not provide such an operational schema. Instead it provides the conceptual platform to ground the future work of developing a public interest framework for IRBs/RECs.

Ethics statements

References

Footnotes

  • Twitter @G_Owen_Schaefer

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

  • Funding Ministry of Education – Singapore: Social Science Research Thematic Grant MOE2017-SS.

  • Competing interests None declared.

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

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