Emerging Challenges in Research Ethics


CASMI Fellow, Jonathan Montgomery, had an opportunity to share his thoughts on emerging challenges in research ethics with members of the Ministry of Defence Research Ethics Committee in January. He identified a series of trends that placed the traditional paradigm under pressure.

The closer integration of researchers and participants whereby projects were co-designed rather than imposed on ‘human subjects’. This goes beyond the previous shift to the language of participation into more equal partnerships. This suggested that ethics committee reviews of recruitment processes and consent forms would need to take into account that those being ‘recruited’ had been part of the design. There were particularly interesting challenges in relation to participant-led research as explored by an article in the Journal of Medical Ethics on which he and a number of CASMI Fellows were co-authors. It would also become necessary to reconsider the idea that ethics committees had to protect participants from research that was ‘too risky’. He suggested that the idea of a ‘fair offer’ as raised by the Nuffield Council on Bioethics (which Jonathan chairs) in its report Children and clinical research: ethical issues (2015).

Increasing expectations of personalisation, which Jonathan, along with CASMI Fellows John Tooke, Rob Horne and Morten Ravn have suggested will require a new social contract for medical innovation. Reflecting on this, Jonathan suggested the personalisation agenda would bring to the fore some of the intrinsic challenges of evidence–based medicine; including the way in which it tended to present inferences as if they were deductions, the mismatch between study cohorts and patients in clinics, and the uneasy relationship with ideas of autonomy whereby patients are entitled to take decisions based on non-scientific issues. Jonathan suggested that there was also an intrinsic paradox within the drive towards personalisation, in that it relied on good quality population data, from which the differentiation of individuals could be derived by analysis of variations. This linked to the next trend…

The dominance of data in analysis sits uneasily in a paradigm of research ethics that is based on addressing the risks of new pharmaceutical interventions (in the shadow of Thalidomide and other similar problems). That traditional paradigm had led to excluding various categories of data-based research from research ethics committee (REC) oversight – such as audit and service evaluation – and also inadequate governance for innovation. The governance of surveillance and the ethics of ‘big data’ would become increasingly important. Indeed, the Government had announced its intention to establish a Council for Data Science Ethics. Amongst the consequences of this was that…

There are a number of ‘new kids’ on the research block who are not familiar with the existing structures for research governance – as had been exposed by the late realisation that the collaboration between the Royal Free and Google’s Deep Mind needed regulatory approvals. This might not be as novel as it first appears; the idea that medical research is done by doctors has long been something of a myth. Clinical trials are industrialised in terms of scale, funding and production – using experts in relevant disciplines (e.g. statistics, bioinformatics) who are not subject to the regulatory sanctions that bind health professionals. Perhaps even more importantly, those newer players do not necessarily subscribe to the ethical commitments that developed through the World Medical Association and are enshrined in the Declaration of Helsinki. The multiplicity of professions and industries from which these players are drawn, together with the integration of research participants means that it may be necessary to re-establish, and possibly negotiate, the norms and regulatory authority of our research governance structures.


Research ethics has drawn a significant part of its strength from reflection on the differences between care and research, such as the conflict of interests between individual and society. However the line between care and research is under pressure. In different ways, the demise of the ‘blockbuster’ model of drug development, the needs of payers to assess value for money (as well as safety and clinical effectiveness), and the appetite of patients for accelerated access to novel treatments all bring the ‘real world’ closer to the clinic. This manifests itself in various ways; the assertion of the ‘right to try’ unproven therapies, the rebalancing of what is anticipated to be measured prior to market access being granted and what will be learnt from closer monitoring in clinical use.

Looking to the future, research ethics will need to pay closer attention to its contribution to the problem of lack of evidence. Existing structures and concepts are designed to cope with problems of wrong-doing. Norms (at least since Nuremberg) have developed in response to evil more than in pursuit of virtue. The gatekeeping functions of research ethics committees (and institutional review boards) seek to prevent ill-conceived studies being commenced. Research governance is aimed to ensure that the conduct of studies meets the necessary standards. This precautionary approach has made it difficult to research in some areas, for example medicines for children. The lack of the evidence we need to improve care and provide therapeutic options is a significant challenge that research ethics needs to address. We need a stronger ethical framework for the right innovation and research, not just a set of barriers that constrain poor practice.

These trends require a concerted effort to build a constructive research culture that addresses the widespread distrust in what many perceive as an enterprise driven by profit and competition rather than searching for sustainable medical innovation. Research needs to be more collaborative and to demonstrate more clearly why people can trust results; transparency, reproducibility, management of competing interests, and responsiveness to community needs can all be enhanced. Such concerns are inadequately integrated into our current thinking about research ethics.

– Jonathan Montgomery


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