With new rules governing the running of Research Ethics Committees due to be introduced shortly, ours is to be closed. I am told this over a cappuccino by the regional manager before she heads home to Chester. How Northumberland came to be under the remit of a regional manager based in Chester is an enigma in itself, but outdone by the revelation that our meeting turns out to be part of the consultation process required before she can recommend what she has just told me will happen. Did I hear her right?
‘The final decision is taken by the regional health authority,’ she confirms. She gives me a nice smile to help reassure me of her good intentions. She is conducting the process as best she can: distant others take the unpleasant decisions.
What grounds might we have for objecting to her plans for closure of our committee? None it seems: the National Research Ethics Service (NRES) is predicting over-capacity and this ‘re-structuring’ will address this.
‘I am having to close three committees in Manchester,’ she reassures me. ‘This is no reflection on the committees being closed.’ Nothing personal indeed.
So what are these new rules that will cause such a sudden drop in the need for ethics committees? Well, there are two main changes that will have this effect, both still being consulted on. One is for employees of NRES to start triaging projects with only those deemed to have major flaws then seen by a committee. The other is for research involving NHS premises and staff to be deemed no longer worthy of review by a committee.
‘Ethics is such a woolly subject,’ complained yet another colleague earlier in the day. It is in the curriculum for GP registrars and yet those who need to teach it feel it as elusive a thing as an escaped sheep. Having chased a few renegade woolly subjects in my time however, ethics is nothing like so difficult to corral. You disagree? Well, let me explain.
Ethics is fundamentally about having good reasons for acting in one way rather than another. Consistency is key. And what count as good reasons are things most of us agree on: honesty, fairness, respect, and the like.
So, is it fair to treat research subjects differently because they are patients and not NHS staff? Patients are at risk from a possible abuse of power by their clinicians, staff are at risk from a possible abuse of power by their managers. Simply having a choice whether or not to be involved can be a problem if, for example, your manager is recruiting to the project. And that says nothing about how power relationships might affect the conduct of the research itself.
What, too, of triage by NRES staff? Is it right to introduce a system that uses employees subject to targets to vet applications and decide which ones committees will see? The whole point of committees is that they provide a pooling of expertise and that they are independent. Bypassing committees some of the time will create a two-tier research standard, yet patients, the research subjects themselves, come in only one version: vulnerable.
But most of all, what of consultation processes? The institutional approach to them in the NHS has now reached a point of moral bankruptcy. There is no ethical woolliness here. It is fundamentally dishonest to refer to a consultation process when the outcome is already decided and yet, in the modern NHS, this is now so commonplace that it barely garners more than a shrug or a raising of the eyebrows most of the time.
‘I'll email you a copy of my report,’ the regional manager says, stepping out into the sunshine with me and proffering her hand. ‘It'll say you have been insulted.’
Or did she say ‘consulted’? Perhaps she did, but then who is to say honesty matters?
- © British Journal of General Practice, 2008.
