Abstract

In 1979 the National Commission for the Protection of Human Subjects of Biomedical and Behavioural Research in the US delivered a set of guidelines for the ethical conduct of research on human research subjects.1 In developing these guidelines, subsequently known as The Belmont Report, the Commission was “...directed to consider: the boundaries between biomedical and behavioural research and the accepted and routine practice of medicine”; and outline a set of ethical principles which would specifically govern research activities. The Report notes that maintaining this distinction is important to ensure that all research activities are subjected to ethical review and, while it acknowledges that distinguishing research and clinical care is less easy in some cases, it suggests that this is a relatively simple and straightforward task. Forty years later, biomedical activities appear more complex: clinical activities are hybridised, trial design is no longer solely aimed at improving the evidence base, but at fostering closer integration with clinical activities and learning health systems reuse individuals’ health data to generate real-time improvements in patient care.2 In short, the conceptual boundaries between research and clinical care do not appear to be as distinct as the Belmont Report implies. Two papers in this issue and Ballantyne and Schaefer ) address some of the ethical challenges generated by merging of research and clinical care. The UK’s 100 000 Genomes Project is an example of a biomedical development in which research and clinical care are no longer understood as distinct activities. Patients in the 100kGP are offered clinical genomic sequencing on the understanding that their health data will be used for research purposes. Dheensa et al note that the 100kGP was designed with the dual purpose of providing patients with …