Saturday 5 April 2014

Never mind the research, feel the governance

In the past 5 days, I have received and responded to:
  • 16 emails from people in the university, the REC and the hospital about one NHS ethics application that required a two-word change to one information sheet after it had already been approved by both the university and the REC - but the hospital spotted a minor problem and now it has to go around the whole cycle again, which is likely to take several weeks at least.
  • 6 emails about who exactly should sign one of the forms in a second ethics application (someone in the university or the hospital).
  • 12 emails about the set of documents (I lost count of what's needed past 20 items) needed for a third application.
I dread to think what the invisible costs of all these communications and actions are, when scaled up to all the people involved in the process (and my part is a small one because I delegate most of the work to others), and to all the ethics applications that are going on in parallel.

I thought I was getting to grips with the ethics system for the NHS; I had even thought that it was getting simpler, clearer and more rational over time. But recent experiences show otherwise. This is partly because we're working with a wider range of hospitals than previously, and every one seems to have its own local procedures and requirements. Some people are wonderful and really helpful; others seem to consider it to be their job to find every possible weakness and block progress. I have wondered at times whether this is because we are not NHS employees (or indeed even trained clinicians). But it seems not: clinical colleagues report similar problems; in fact, they've put a cost on the delays that they have experienced through the ethical clearance process. Those costs run into hundreds of thousands of pounds. We don't do research to waste money like this, but to improve the quality and safety of patient care.

Today, there's an article in the Guardian about the under-resourcing of the health service and the impact this is having on patient care. Maybe I'm naive, but if the inefficiencies that we find in the process of gaining permission to conduct a research study in the NHS are replicated in all other aspects of health service delivery, it's no wonder they feel under-resourced.

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