Saturday, July 28, 2007

Distinguishing Audit from Research

In the latest issue of Theoretical Medicine and Bioethics there is an interesting paper on the difficulties of distinguishing audit from research in a rigorous fashion by E. Cave and C. Nichols called: Clinical Audit and Reform of the UK Research Ethics Review System. The paper is worth reading just for the overview of different research ethics systems around the world, but also hones in on a difficult issue for research ethics.

This issue is that while many research ethics system make a strong distinction between research and audit, in practice it is difficult to see what justifies this difference such that 'research' requires ethical review whereas 'audit' does not. Part of the difficulty stems from the difficulty in identifying what research is, but the larger problem is that however we define these activities some instances of each will have low risks of ethical issues and other instances will have high risks. As such it seems odd to treat them differently. However submitting every audit to full REC consideration will be very time consuming and may stretch the present system beyond breaking point. They suggest instead establishing committees which look at quality issues in audit, much the same as R&D now looks at quality in research. The role in part of these committees will be to identify those audits that need full ethical review.

While I think this is a sensible compromise position, I am hesitant to support it primarily because I would be concerned whether the audit committees would be well suited to identifying audits that needed ethical review. It is difficult to see a system that would be more robust than requiring full ethical review. This may of course mean there will be less research, but that may well be a price worth paying to protect research participants.


James Wilson said...

Perhaps one way forward would be to adopt as a guiding principle one that's already implicit in what you say, namely that level of regulation and scrutiny should be proportional to the level of risk? If we adopt this strategy, then we might be able to free up REC time to look at both potentially risky research and potentially risky audit. (Though this would have the problem that we would need to find a way of appraising risk features that was both reasonably accurate and not too time consuming).

David Hunter said...

Hmm, well I am wary of the notion of proportional review, primarily because of the last difficulty you mention, and the epistemic difficulties of identify risk. I'm inclined to think as I argued here: Proportional Ethical Review and the Identification of Ethical Issues

That unfortunately properly constituted RECs looking at comprehensive forms are the best means of doing so, but this then obviates the proportionality of the review. Given that though I am in favour of a more comprehensive approach to research ethics that doesn't differentiate on the ethics of the project depending on who is doing it, or how the participants are recruited. That presently for example the same project may require review by a properly constituted NHS REC or nobody depending on how recruitment is handled is absurd. Perhaps to avoid that absurdity I ought to be willing to bite on some form of proportional review.