John Lilleyman and Charles Warlow disagree

Dear John, Medical research ethics committees are sometimes unethical. How can that possibly be? After all, they were set up to protect patients from over-enthusiastic researchers’ risky experiments. But nowadays, ethics committees have gone too far.
Urged on by a vocal minority who claim to represent patients, committees are inconsistent, partly because of their varying interpretations of the law and contradictory professional guidance.
Moreover, the results of approved research can be so biased that they are misleading. For example, if consent is insisted upon for every patient in a study which just involves confidential observation of medical records, and if anonymisation is neither practical nor possible, then non-consenters would be excluded. But non-consenters are different to consenters in ways which are impossible to predict (and which can’t be measured without their records anyway), so research findings from just the consenters would be biased.
Is that ethical? I think not. And 85 per cent of the population did not think that their details being automatically passed to the national cancer registry would be an invasion of their privacy.
Furthermore, despite the application process being streamlined, it remains difficult and time consuming to get low-risk research through these committees. Researchers are either disguising their research as audit, persisting at the expense of their own research output, or giving up in despair. Yours, Charles

Dear Charles, You protest too much, perhaps. Research ethics committees are not ‘urged on by a vocal minority who claim to represent patients’. Rather they struggle with the Declaration of Helsinki, Department of Health rules, the European Clinical Trials Directive and a raft of difficult legislation relating to mental capacity, data and tissue. Interpreting all this, in addition to the inherent subjectivity of ethics, means some inconsistency is inevitable. Nevertheless, all committees now work to standard operating procedures and are increasingly being subjected to quality assurance measures such as accreditation and appraisal.

Your example where you think they ‘go too far’ is arguable. I agree restricting research access to medical records to those patients consent can produce biased sampling. But the same can be said of any clinical study where patients volunteer. Sometimes bias is clinically important, sometimes not, but in the broad context you describe I would not call it unethical. Cancer registries and other exceptions notwithstanding, studying identifiable medical information without consent should not be unrestricted, surely?
As for the application process, efforts are being made to fast-track low-risk studies and to redefine what does and does not require formal ethics review. So do not despair.  Yours, John

Dear John, Researchers must protest. If we had not highlighted the lunacy of local research ethics committees requiring multiple copies of an application for multicentre observational research, already approved by a multicentre ethics committee, we might still be stuck in the 1990s. Then, we dispatched 5789 pages of A4 weighing 26.9 kg to 15 local research ethics committees, all for three trivial amendments, which delayed the research project by months (the opportunity cost brings tears to my eyes).
Biased sampling does indeed occur in clinical research, which is why it is mostly rubbish. For years, epidemiologists have urged clinicians to use a proper sampling frame. I do not advocate unrestricted access to patient data, but the obligation to consent or anonymise can ruin clinical research.
Ethics committees should embrace the permissive elements of data protection legislation and the concept of proportionality, by balancing the risk of disclosure of patient data (for which there has never been a successful prosecution in the UK) against the public benefit of unbiased research.
Autonomy has gone too far, a residue of Thatcherism exalting the individual over society, while the common good is in retreat. And what of the extraordinary double standard that allows clerks, without any ethics committee review at all, to trawl through the same patient records for auditing the clinical service? Yours in desperation, Charles

Dear Charles, There is no need to exhort researchers to protest about the bureaucracy of ethics review since they have never been slow to do so.
Why not encourage them instead to reflect on the unethical medical experimentation highlighted by Pappworth and Beecher in the 1960s? These authors pointed out that several apparently pioneering novel procedures and trials both in the UK (Pappworth) and the USA (Beecher) took advantage of participants by exposing them to risks they did not fully appreciate. The experimenters invariably and genuinely believed that what they were doing was harmless or justified. Researchers nowadays are no different, which is why they find ethics review so irritating and why it remains important.
The 1991 edict that some 200 local NHS economies should each have a research ethics committee generated many problems, including inconsistency and a lack of understanding that much research is not a local affair. This led to the bureaucratic nightmare you describe.
Tackling it has not proved easy, but England is now well on the way to the goal of a coordinated National Research Ethics Service with fewer committees that will consistently provide proportionate, timely and sensible reviews. The rest of the UK is watching with interest.
As for your thoughts on autonomy, I might agree with you that benign paternalism still has a place in medicine and possibly even in government, but social mores have moved on and so, I suppose, must we. Yours, John
Dear John, I thought you would mention Pappworth and Beecher. Their revelations of invasive experiments lead to research ethics committees, and quite right too. But they didn’t have anything to say about non-intrusive research using medical records.
If we are blind to what we are doing, as researchers were in the 1960s, where will we be in another 40 years – no medical research at all maybe? Important research is being suppressed or delayed for no good reason, and this matters to patients – including me.
Because I had cancer of the colon at a young age, my children might like to know that daily aspirin substantially reduces their increased risk. This fact nearly failed to emerge. It was based on following up several thousand patients in two vascular disease trials – all of whom had given consent to be in the trials for a few years. It took the researchers three years to get permission to track them 20 or more years later through the UK cancer registries, without their consent. They very nearly gave up, such were the delays and frustrations.
I can do nothing but protest, but through your position you could sort out the bureaucratic juggernaut of research ethics committees, for the benefit of patients. Will you? Yours, Charles

Dear Charles, So we agree research ethics committees are necessary. We also agree there are difficulties with non-intrusive research using medical records, but this is not down to ethics committees. The 2001 Health and Social Care Act effectively prohibited the use of non-consented patient data without specific approval of the Patient Information Advisory Group set up for the purpose. There was an outcry from researchers and some hastily produced exceptions to the rule, such as cancer registries, but PIAG remains the stern gatekeeper for the type of project you are worried about, rather than ethics committees.
Other bodies also regulate research, of course, including local NHS Research and Development offices, the Human Tissue Authority, the Medicines and Healthcare Regulatory Authority and several dealing with specialised areas. These are all part of your bureaucratic juggernaut. Devolution hasn’t helped much, either.
So streamlining the application process for relevant research approvals and ensuring universal proportionality of review will obviously be complicated. Happily, there is now an emerging will to achieve it being shown by all involved. For example, with ethics leading the field, progress is being made on an integrated application form where online data entered once is at one click transferred to the relevant regulators. It’s a start. Hang on in there. Yours, John

Professor Charles Warlow is at the Department of Clinical Neurosciences at the Western General Hospital, Edinburgh

Sir John Lilleyman is Medical Director at the National Patient Safety Agency