The importance of attending the ethics committee meeting

As regular readers of this blog will know, I sit on an NHS research ethics committee. It's a fascinating experience.

I'd like to share with you something that happened at the meeting I attended yesterday evening. One of the applications had some rather odd things about it. It was really not clear to us why the applicants had designed the study in the way they had, rather than in a way that would be far more usual and ethical for the sort of study they were doing. There might have been good reasons for it, but without understanding what those reasons were, we did not feel that we could approve the project. There was no attempt to justify the odd design in the application, or even any acknowledgement that the design was odd.

Normally, such things would be discussed at the meeting when the applicant turns up. In this case, however, the applicant did not turn up. It's hard to understand why not. They were a large and well resourced team, and even if the chief investigator hadn't been available, surely someone else from the team could have come. We could then have discussed their project, and they could have explained to us why they were doing things the way they did.

But as that wasn't possible, we had to take the rather unusual step of issuing a verdict of "no opinion". This means that we felt we simply didn't have enough information to assess the project. It will now mean that it takes a lot longer for the project to be approved than it would have done. To be fair, we were never going to approve it at last night's meeting anyway, as there were a number of other problems with the study, not least that the patient information sheet read as if it had been written by lawyers and was a text-book example of how not to write a patient-friendly information sheet. But if we'd understood more about the study, we could at least have issued a provisional opinion that would have meant the study could have been approved once the patient information sheet had been edited torn up and written again from scratch. Attending the ethics committee meeting is really such an important part of the application process, often allowing areas of confusion to be cleared up quickly and without generating more paperwork, I can't understand why anyone would not take the opportunity to do so.

So, for anyone thinking of applying to an ethics committee for permission to run a clinical trial, I have 4 pieces of advice.

1. Do make sure you think carefully about your study, and design it in accordance with best professional standards
2. If there are good reasons why you need to do things in an unconventional manner, carefully explain what those reasons are in your application
3. Always make sure you attend the ethics committee meeting
4. Always make sure you attend the ethics committee meeting

The more eagle-eyed among you will have spotted that the last 2 of those are the same. It's such an important point I thought it was worth repeating.