I've just returned from a 1-day conference organised by the National Research Ethics Service. I can't say I've finished the day with a wonderful sense of optimism about the future of ethical review of clinical research.
The day began with a talk that was supposed to be an update about what NRES was doing. In fact it was mainly about NRES's mission statement, the drafting of which seems to have occupied an outrageously disporportionate amount of NRES's intellectual efforts. As I wrote on my feedback form for the event, this focus on writing a mission statment shows "an alarming lack of perspective". Maybe I'm just old fashioned, but I've never really seen the point of any mission statement that doesn't begin with the words "Your mission, should you decide to accept it...". Did the Pharaohs have a mission statement when they built the pyramids? Did Nelson have a mission statement at Trafalgar? You wonder how much could have been achieved if all the effort that had clearly gone into the (as yet unfinished) mission statement had been spent on doing something useful instead.
That was depressing, if not altogether surprising. What made me really dispair for the future of research ethics, however, was that the talk was followed with some extremely lively questions from the floor about the wording of the mission statement. The number of ordinary research ethics committee members who seemed to think that the fine points of the wording of the mission statement was a sensible subject for discussion filled me with a terrible feeling that the world has gone into an inexorable decline from which it will never recover.
We then descended from this particular circle of hell to the next. This took the form of a lecture about the legitimacy of ethics review. I thought this sounded like it would be an interesting topic, but I couldn't have been more wrong. The lecture was given by a philosopher, and I do not have the faintest clue what he was actually talking about. Now, I don't have any training in philosophy, so I can't be sure whether my complete inability to discern a single coherent point from the talk was due to my lack of familiarity with philosophical concepts or was because he was talking complete bollocks. However, on talking to the delegate sitting next to me, who it turned out had an MA in philosophy and who also failed to perceive anything remotely comprehensible in the lecture, I felt I was probably starting to narrow down the options.
After an extremely welcome coffee break, we split into small workshops on various ethical topics. I went to one about a new system for "proportionate ethical review". This is a new fast-track system for research applications which present "no material ethical issues" (at least in theory). In principle, it's a good idea. Ethical review can be a slow and resource-intensive process, and for some simple, non-invasive studies, it may well be over the top. A pilot project is currently running within NRES to see how these low-risk studies can be reviewed more quickly. The only trouble is that the pilot doesn't seem to have been designed to assess what seems to me to be the most important aspect of the scheme. Some ethical issues are rather subtle, but nonetheless important. It's not uncommon that I'll be in an ethics meeting and we will almost be ready to approve a project which seems completely reasonable to me and most other committee members, when one particularly alert member might point out some subtle ethical issue that none of the rest of us had thought about, and which we are then readily agreed needs attention before the project can be approved. The risk of the fast-track system is that such subtle issues may be missed. Nothing in the pilot scheme is designed to look at whether they are, which strikes me as a pretty major omission.
The day wasn't all doom and gloom, however. I also attended an interesting workshop on the Human Tissue Act, which is an important piece of legislation in the context of clinical research. It's complicated and confusing, but at least I'm not quite as confused now as I was before I went to the workshop. We also had some interesting group discussion exercises in which we looked at some specific ethical issues, which led to some lively and constructive discussions. It reminded me that ethics committees are fortunate to have a great many members who are prepared to give careful and intelligent thought to ethical issues.