By David Hunter

The BMJ is having it’s once yearly wrangle about the regulation of research in the UK: It’s time to change how Europe regulates research

Many of the suggestions made and complaints are to some degree valid, the present system is cumbersome (though I think moving in the right direction in many ways such as the introduction the Intergrated Research Application System (IRAS)). Efficiency could be increased without a significant loss to the quality of scrutiny.

However two counter points deserve to be made:

Firstly as per usual for these papers the evidence given in the paper that started the latest furore is actually fairly weak. (Regulation—the real threat to clinical research) No fault to the authors but two personal stories of problems they had with the regulation of their projects doesn’t necessary conduce to strong reasons to review a system of regulation. This is because this “evidence” gives us little  indication of the incidence of these problems, and of course we should recognise that no system of regulation is likely to be perfect. So this sort of evidence may indicate a problem but it is not strongly worrying.

Secondly there is a temptation to make things more complicated in trying to remedy the present problems take the suggestions described by Trish Groves in this blog post:Trish Groves on European clinical trials. There is a strong suggestion in that post the way forward would be to adopt some form of proportional ethical review, where the intensity of the review would depend on the risk posed by the research. It is an attractive idea however it faces a significant difficulty, namely as I argued in Proportional ethical review and the identification of ethical issues it is not easy to see how the ethical risks posed by a project can be determined outside of a full review by a committee. This is particularly the case given that there is legitimate controversy about the severity of particular ethical issues. Some evidence to confirm this is given by the paper in the latest issue of the Journal of Medical Ethics by J Reynolds, N Crichton, W Fisher & S Sacks entitled Determining the need for ethical review: a three-stage Delphi study . In this study the researchers asked a variety of experts to assess whether particular scenarios should be considered as audit or service evaluation or research, and to assess the level of ethical severity of the scenarios. They found:

However, the lack of consensus demonstrated on the ethical concern scale, particularly amongst the scenario questions, was more surprising. As anticipated, the limited information in the short statements resulted in more inconsistency of ratings on the audit–research scale, than for the longer scenarios. The opposite was true for the ethical concern scale; diversity of experts’ judgements of levels of ethical concern was apparent, even when more information was available. This echoed the original interview scenarios for which a wide range of ethical issues were identified by participants, with differing perceived levels of severity. This finding potentially challenges recent arguments that the audit–research distinction be replaced by judgement of level of ethical concern, to determine need for review. Although this study demonstrated a number of areas in which audit–research categorisation was not possible, or not agreed upon, it also highlighted inconsistency amongst experts in how to judge level of ethical concern.

This seems to indicate that research ethics regulation might well be best served by a relatively simple but rigorous and efficient system rather than trying to invent a complicated system to model the expected risk of research projects.