Personal Views: Two decades on an ethics committee
Authors: George Masterton
Journal: BMJ (2006)

Iam in my 20th year of continuous service on research ethics committees and my 15th as an office holder. It is time to take stock. I do so aware that a lot has been written about ethics committees by researchers, most of it highly critical, whereas committee members have published much less about their experiences and views.

When I began, a senior colleague cautioned that ethics committee duties were not the route to wealth, prestige, or foreign travel: these were the privileges of the researchers. Our main rewards were intangible: protecting patients from bad research and contributing to the greater good. Altruism wasn't the only motivation, however: the work promised stimulating intellectual challenges and the ability to keep abreast of medical developments as they unfolded. And so it has proved.


It is a rare pleasure to receive a submission from an investigator who knows how to design a trial


What wasn't mentioned when I started was the workload. Currently, as a vice chair, I average eight hours a week on committee activities. As well as assessing and then discussing the 10 new submissions at the monthly committee meeting, I chair a weekly subcommittee that reviews about the same number of substantial amendments. There are inquiries to handle and occasional disputes to resolve, matters to discuss with our excellent administrative team, guidelines and operating procedures to review, and advice to give to healthcare and government bodies. Finally, there is continuing professional development, with usually two sessions a year devoted to enhancing our skills.

In the 1980s the research ethics world seemed much simpler. The Declaration of Helsinki informed our discussions and decisions, and we supplemented this when the need arose from those few guidelines that existed. We weren't hamstrung by “Europe,” acts of parliament, regulations, and a clock obsessed set of standard operating procedures; nor were we working in a climate of constant criticism. I feel increasingly caught between a rock and a hard place as we try to protect patients from silly research and researchers from silly regulations.

How could the system be improved? I would start with three fundamentals.

Firstly, the application form remains alienating, despite face lifts and electronic titivation. Lord Warner's review of ethics committees in 2005 criticised it politely. I won't: it is a hybrid, chameleonic monstrosity. An ethics form should be distilled into no more than 10 questions, the content of which should be agreed by committees, researchers, and patients' representatives. Finally, the form should remain unaltered for five years rather than being continually amended: there is nothing more irritating for researchers than to be told they must resubmit because last year's version of the form is obsolete.

Secondly, there is the decision letter. It is infused with bureaucratic requirements, while its measure of performance is speed of reply rather than content. The key aim should be to ensure that communication from committees to researchers is informative and precise with regard to the rationale for rejection or for seeking changes to the design or to the consent procedures. It should not be a lesson in syntax, spelling, or punctuation, and it shouldn't be seen as an opportunity to impose a design that scientific members of the committee prefer.

Thirdly, if research ethics committees are riddled with faults, what about those who apply to them? It is a rare pleasure to receive a submission from an investigator who knows his or her subject and how to design a trial, who can convey this with care and consideration, who appreciates the importance of the ethical dimension in the work, and who can engage in constructive dialogue with the committee if a problem emerges. What we encounter far more often are researchers with ropey communication skills whose knowledge of their subject, research design, and ethical principles vary from passable to negligible.

Sometimes this problem stems from senior researchers delegating submission to their trainees, research associates, or students or to the sponsoring drug company. But also there exist experienced researchers whose hostility to the process of ethical review is expressed in a slapdash approach to submission, coupled with a confrontational attitude to dialogue.

The solution has to be more education and better training. Colleges could consider providing high standard, formal accreditation courses for doctors who wish to undertake research. Chief investigator status, and thereby the authority to submit research to an ethics committee, would be conferred on researchers who had been appropriately trained.