Why is the multitude of terms a problem?

While the authors of the different regulations and guidelines listed in table 1 may intend to mean something similar, each of these terms caries different connotations and lineages (as we describe below). Users of the guideline may in turn reasonably interpret the terms differently from the intended meaning. In addition, both the intended meaning and the users’ interpretation might differ from the most ethically appropriate meaning of the term. If the authors of the guidelines do intend to refer to the same core idea, it would be preferable to use a consistent term to capture this concept. The terms are very rarely defined or differentiated (we discuss exceptions below) and are sometimes used interchangeably within one document, suggesting that they are meant to capture the same concept. For example, a report from the Institute of Medicine (USA) round table on clinical data uses the terms ‘common good’, ‘public benefit’ and ‘public good’ seemingly interchangeably.12 The Australia National Statement uses the terms ‘benefit’, ‘common good’, ‘public good’ and ‘public interest’ throughout, without a clear differentiation of the terms.13

Alternatively, it is possible the authors do in fact mean something different when they refer to common good versus public interest versus public good versus public benefit. This is problematic in a different way. If the meanings of the key terms do differ, the guidance documents do not make this clear. This ambiguity will likely lead to confusion and inconsistency. Second, if the terms differ in meaning and multiple terms are used within one document, this amounts to multiple different tests that researchers must meet. This approach is confusing, and potentially overly burdensome and an unnecessary barrier to valuable research. Third, if the terms mean different things in different documents, this indicates variable standards between jurisdictions. Health data sharing is increasingly a global pursuit and different research ethics standards between jurisdictions can increase the cost, time and energy associated with getting consent waivers for researchers working across jurisdictions, for example, on international public health data sharing. We assume for the purposes of this paper that despite the various terms employed, they are intended to capture the same central normative idea of an overarching common or public interest in research.

Consistency and speed of review are major challenges for IRBs/RECs and this is likely exacerbated by the use of multiple competing terms. The ethics review process has been widely criticised by researchers for being opaque,14 15 inconsistent,16–19 and slow and unduly burdensome.20–22 Slow, unpredictable and inconsistent processes can impede valuable science and frustrate researchers.20 23 It is plausible that the use of inconsistent terminology and a lack definitions within guidelines generates uncertainty within IRBs/RECs and can slow review and increase variable interpretations. A systematic review of empirical literature evaluating IRBs found evidence of variation in multicentre review with inconsistent or ambiguous interpretation of the federal regulations.24 Qualitative research with RECs in New Zealand found that the lack of clarity regarding terms such as public interest in the national regulations was a source of anxiety and stress for committee members: ‘We’re sort of operating in a little bit of the void’. Committee members described the process of approving consent waivers for data and tissue research as leaving ‘a bad taste in your mouth’ and causing ‘my hairs to rise up on end’.11 Empirical research in the UK found that the introduction of new regulation and specific guidance for RECs can provide clarity and authority and may facilitate the process of gaining ethical approval for tissue-based research.25 This empirical literature suggests that the inconsistent use of terminology is problematic for IRBs/RECs trying to interpret and implement guidance and is plausibly slowing review and impeding approval of valuable research.

Note first that the multitude of different terms simultaneously in use is strikingly unusual. By comparison, other core concepts in research ethics do not have multiple synonyms. Concepts such as consent, risk, incidental benefit, autonomy are referred to by a single consistent term, even where there is debate about the definition of that term. The marked plurality of terms referring to public interest in research ethics is perhaps indicative of conceptual confusion and the necessity for further work to unpack the normative role that the public interest criterion plays in justifying consent waivers. Below we explain the common normative force that underlies these related terms, and explain why this normative force can justify data research without consent.

In our view, it is preferable to move towards greater international harmonisation of data research standards where possible. By harmonisation, we do not refer to formal regulatory alignment across jurisdictions. International regulatory harmonisation may be possible in some contexts such as financial markets26 and trade,27 but it is unlikely to be achievable in the area of research regulation, given the existing international regulatory divergences.28 29 Instead, we are proposing a sort of conceptual harmonisation, where the way the relevant concept is deployed in ethical discourse as well as IRB/REC practice is made more consistent and defensible.5

Conceptual differences between different terms

To demonstrate the potential for confusion and uncertainty arising from synonymous use of the terms, we take four very similar and commonly used terms and explain their different lineages outside of research ethics. This demonstrates the various connotations and implications the different terms carry.

‘Public interest’ as the preferred term

‘Public interest’, ‘public benefit’, ‘public good’ and ‘social value’ all have different meanings, implications and emphases and should not be used interchangeably. Ongoing use of multiple terms impedes clarity, transparency and consistency—in the administration of research ethics guidelines, empirical research with the public and patients, and academic debate about the normative principles of good data sharing.

Of the above four terms, we propose ‘public interest’ be adopted more uniformly because it better captures the core normative force justifying consent waivers, while avoiding the baggage carried by some of the alternate terms. In the next section, we will elaborate on the role these norms play in justifying research without consent. Before turning to that role, we will briefly explain the relative deficiencies of alternative terms.

‘Public Good’, as noted, typically refers to the economic notion of non-rivalry and non-excludability. This may be an apt description of fully open data, where none can be excluded from access and use of the data by one party does not reduce the available supply for other researchers. But much health data research is, for good reason, controlled rather than open, and public good may be an ambiguous term to use in these contexts.

‘Social value’ is a problematic term for consent waivers because of its status as a necessary basic requirement of all human subjects’ research. Our present purpose is to explore the concept that offers normative justification for consent waivers in particular. Social value by contrast is used as a term that underpins all research, therefore using it in the context of consent waiver may lead to confusion and blurring of the line between general evaluations of a study’s contribution to social value, and the more specific question of whether data research without consent is on balance in the public interest.

One might argue that this confusion could be allayed by generating a subclass of ‘social value’ relevant to consent waivers, as CIOMS does in explicating the higher ‘important’ social value threshold for consent waivers.41 Given the lack of explanation differentiating ‘important’ from ‘ordinary’ social value, this term carries unnecessary ambiguity in relation to consent waivers. Additionally, CIOMS’ explication of social value is problematic because it distinguishes social value from other normative considerations that should be relevant when assessing the justification of a consent waiver. In particular, in Guideline 1 CIOMS explicitly differentiates promoting social value from protecting subjects’ rights. This distinction implies social value is relatively narrow in conceptual scope, not encompassing the rights of individuals. As we argue in detail below, consent waivers should take account of a broad range of considerations, including the potential for the research to breach data subjects’ or others’ rights. As rights seem to be excluded from an assessment of social value, this term is too narrow to capture the normative work necessary to justify consent waivers.8 Social value is therefore broad in its application across all clinical research; but its conceptual scope is narrower than public interest.

Similarly, ‘public benefit’ is problematic in this regard, insofar as it offers a relatively narrow account of what could justify consent waivers. Benefits relate to individuals or groups of individuals becoming better off—it is explicitly welfarist in this regard. Yet other values like distributional justice do not fall neatly into such a benefit rubric. Generating new knowledge that helps address health inequity without improving overall population-level benefit should be reasonable grounds for a consent waiver. Justice and distributive concerns seem to fall outside the scope of ‘pubic benefit’ and this term is therefore too restrictive to reflect the full range of ethical considerations relevant to consent waivers.

The role of the public interest criterion

Our view is that the public interest criterion best captures the primary normative justificatory force for granting consent waivers. In order to better explicate the public interest criterion, we need to understand the purpose and function of the criterion in the context of waivers of consent.

Data research without consent needs some positive justification for the overriding of individuals’ privacy. By granting a waiver of consent to data access, there is an intrinsic privacy violation—sensitive information about individuals’ health is accessed or shared without their knowledge or permission. This poses some material risk to individuals, by increasing the possibility of a data breach due to dissemination of information beyond its original confines. But more importantly, it limits individuals’ autonomy by taking away their ability to control who has access to their health information. Because sharing identifiable data without consent carries some individual risk and impedes the rights of patients, it must be justified.

Gelinas, Wertheimer and Miller argue that not all research without consent impedes individuals’ rights. In contexts where there are no rights violations, there would be no need for a public interest criterion to be used. That is to say, there would be no autonomy limitation in need of justification. One example they give is for quality improvement research, where institutions—not patients—presumably have a right of control.10 One difficulty with this analysis is that it implies control is mutually exclusive, and if institutions maintain control of data, patients are deemed to have no relevant interests or rights to control data. Yet insofar as patient health data are co-created by patients and institutions, both patients and institutions retain an interest in the collective governance of that data.42 Additionally, even quality improvement studies using health data will generally require a certain form of justification with reference the interests of patients served by the institution. For research studies that aim to benefit a much wider array of the public by generating generalisable knowledge, there will need to be a commensurately broad justification that appeals to the public interest.

Importantly, public interest is only one of several criteria that must typically be met in the granting of consent waivers for data research. That is to say, public interest is a necessary but not sufficient condition for granting consent waivers. Other criteria will be familiar across many jurisdictions, particularly: (1) The research must be minimal risk. (2) Obtaining consent is impracticable. (3) Identifiable data are needed to meet the study aims. But none of these criteria provide a positive reason for the research or allow for an assessment of the importance of the research relative to the risks. By contrast, the public interest criterion does the normative work of positively justifying the consent waiver. By formally requiring studies to meet this criterion, IRBs/RECs can better ensure that data research without consent is ethically justifiable.

Scope of the public interest criterion

We should conceptualise the criterion in a wide, rather than narrow manner, both in terms of its normative content as well as the sorts of populations it covers. ‘Public interest’ is broader than public goods, public benefits or social value.

Jurisdictions that have introduced a public interest criterion for consent waivers seek to ensure that IRBs/RECs consider the broad implications of allowing or preventing the research, both on the individual data subjects involved and the wider community. A broad focus is particularly important in relation to consent waivers because IRBs/RECs are assessing the acceptability and importance of the research on behalf of the public. When participants have the option to consent for themselves, they are able to make a judgement about whether the risks and benefits of the research are acceptable to them. This judgement is morally transformative, in that it makes permissible (in conjunction with other necessary criteria) what would otherwise be impermissible through the exercise of the participant’s agency.43

However, where consent is not sought, moral transformation falls exclusively on the shoulders of the IRB/REC. The transformation is no longer a reflection of the agency of the data or tissue subject, but instead reflects the judgements of a duly appointed body tasked with evaluating the public interest of a study (among other things). As such, their assessment of the interests, rights, risks and benefits involved must be broader and more substantial than what an individual participant might consider.

So, while consent and the public interest criterion may perform overlapping ethical functions of moral transformation, they are different tests. When deciding whether to provide consent, the participant may dismiss claims of social benefit, reject without explanation certain considerations as relevant and give idiosyncratic weightage to specific considerations (eg, whether needles involved). The public interest test by comparison requires consideration of more general interests. Because it takes into consideration the interests of a range of affected individuals and groups with diverse values, commitments and circumstances, evaluation of the public interest must abide by procedural norms of publicity such as reasonableness and transparency.44

Implications

We have argued that the justificatory role of the ‘public interest’ criterion in relation to consent waivers is to provide the positive normative force for granting consent waivers for data use. We have advocated for public interest as the preferable term and concept, ahead of public good, public benefit or social value. Public interest is broader than these other terms in two regards. First it does not focus simply or even primarily on health. Public interest refers the overall assessment of the potential impact of the research of common goods such as privacy, trust, justice in addition to population health. Second, public interest considers both the negative and positive impacts of the research; whereas social value, public benefit and public good aim only to quantify the positive aspects of the study. We have argued that public interest is the right test for consent waivers because sharing health data without consent has broad implications beyond the data subjects.

However there is a potential limitation of the broad approach. The arguments presented here demonstrate the complex and demanding job that IRBs/RECs are asked to perform when assessing requests for consent waivers. Members of IRBs/RECs are unlikely to have expertise or specific training to gauge many elements of the common good, for example, the privacy impact or future economic benefit of research. A broader concept will be more challenging to apply in practice and IRBs/RECs will need specific tools to help them assess public interest.52

An advantage of our approach is that we make explicit the work required of IRBs/RECs in granting consent waivers and the critical role they are now playing in the new health data ecosystem. This can highlight the evidence committees may legitimately require to make their assessment. IRBs/RECs may ask researchers to commission a privacy impact assessment for their protocol; require researchers to further engage stakeholders to assess perceptions of value and risk; require greater patient and public involvement in the design or oversight of some research; or require a commitment to specific benefit-sharing arrangements. Because of the breadth and complexity of the assessment required, IRBs/RECs may need to allocate more time to consider consent waivers.

A major challenge for governments, clinicians and the research community is how to demonstrate responsible stewardship of health and other personal data. IRBs and RECs sit at the heart of this process. Future work must focus on aligning terminology and conceptual as well as normative standards for data sharing to ensure clarity, transparency and consistency. An important next step is to operationalise the concept of public interest and develop a workable framework for IRBs/RECs and other decision-making bodies to use when identifying, measuring and weighing different elements of the public interest.