Hugh Davies MD

Dr. Hugh Davies, Research Ethics Advisor to the Health Research Authority, concluded the morning with a discussion on the ethical issues around determining the true consequences of research and seeking fair consent. He subtitled his talk “Risk, trust and misunderstanding” and touched upon an issue that is crucial to the relationship between the research community and the wider public: the misunderstanding of the value of clinical research to healthcare, and the impact that this has on the willingness of patients to take part in clinical trials.

Dr. Hugh started by quoting David Wooten, who said that “effective healthcare only began when doctors learned to count”. While professionals in the field can all point to scandals relating to poorly conducted research, Hugh contended that we need to understand the denominator, and the context within that research is conducted.

There is much that RECs can do to mitigate the risks around clinical research. Relating to misconduct, the REC should look into the calibre and probity of the researchers. It is also important to recognise and address conflicts of interest, with scrutiny of data “ownership” and access, particularly around research publication policy. There are also issues around funding arrangements and particularly the choice of outcome measures: choosing “easy enpoints” that may not actually be relevant to how the medicine would be used in clinical practice. Hugh highlighted the work of the James Lind Initiative in bringing physicians and the public together to discuss which endpoints are of value.

Conversely, Hugh explained, there is also a risk to the public from unresearched healthcare. The protection of research subjects needs to be balanced with the lack of effective treatment. Worse still, Hugh mentioned the CRASH study, which demonstrated that a widely-used (but never researched) intervention was actually harming patients.

Obviously, the risks for research subjects include receiving treatment already shown to be of no value and of denying treatment that has already been proven effective. However, there are also risks of poor science and useless results, and RECs should consider these points. Data confidentiality and “distress” around research procedures should also be considered.