Will the new rules for research ethics committees lead to better decisions?
Authors: N. W Goodman
Journal: Journal of the Royal Society of Medicine (2004)

Researchers can view research ethics committees as an intolerable burden on their pushing back of the medical frontiers. The truth is both more serious and more prosaic. There are enough examples of poor research ethics easily to justify the need for ethical overview of research; and most research is trivial.

The past few years have seen two upheavals in the organization of research ethics committees. They were driven partly by the pharmaceutical industry, and the industry had a point. Projects had to be reviewed by every research ethics committee in whose geographic patch individuals might be approached to take part, each committee having its own timetable and its own requirements, which might be incompatible with those of others. The differentiation between local research ethics committees (LRECs) and regionally based multicentre committees (MRECs) was an excellent idea, which worked. At first, some LRECs were uneasy at having to accept another committee's ethical review, but most were simply grateful at having less to do.

Another stimulus to change came from certain widely publicized studies in which the research ethics came under question. The blame did not lie with RECs, but regulation of ethics review was a necessary part of the research governance set up to prevent similar episodes in the future. More recently, European Union directives have demanded further changes and medical research ethics is awash with the acronyms of accountability, transparency and regulation—GAfREC, COREC, OREC. We now have SOPs—standard operating procedures.

At first, the SOPs seem unnecessarily fussy, with numbered standard letters for every purpose, and stipulation about exactly how e-mails are formatted with their appropriate disclaimers. But in the age of the computer, standard letters are a sensible approach, and in ethical matters there is no harm in being seen to treat every researcher in the same way, without favour. Many of the stipulations in the new regulations, which have the force of law from 1 May 2004, are indeed welcome. Committees used to differ greatly in their time to approve or reject applications; now there is a strict 60-day limit (though the clock stops while investigators' replies are awaited). Committees have to meet monthly; the number of applications they can consider per meeting is defined; there are rules for how subcommittees deal with issues that need not come back to full committee. The overall remit of RECs is made clear. The need for proper support, financial and educational, is recognized and there are budgets. But it is difficult to avoid the impression that the emphasis is on process, not on ethics. Whenever chairs of research ethics committees get together, this is the undercurrent to all conversation. Process, and changes in process, and implications of changes in process dominate training events. Until now, RECs have simply existed; from 1 May they will have to be accredited. The draft accreditation document is concerned almost entirely with process. Does uniform process ensure good ethical decisions?

One of the standards for accreditation is that committees (which have a maximum membership of 18) ‘must have’ balanced membership as regards age and sex, ethnic minorities, and disabilities. There are parallel standards to define who are appropriate expert and lay members. For some committees it was difficult enough finding people willing to sit even in the old days when committees pretty well ran their own affairs. Now they may have to go looking for a black female statistician. What is the correct balance of committee members with disabilities? What, anyway, is a disability? Committees can, of course, do their best to recruit a diverse range of members, and it would be wrong to reject an applicant because they are ‘too old’ or partially sighted. But ‘must’ is must.

Within the regulations, committees at least have full control over their own actions. They have only limited control over the researchers who send them applications. With more pandering to the political-correctness lobby, RECs are asked to ‘take into consideration the principle of justice [which] requires that the benefits and burdens of research be distributed fairly among all groups and classes in society, taking into account in particular age, gender, economic status, culture and ethnic considerations’. While investigators should be challenged on artificial age limits and should take care not to exclude certain groups by imposing conditions that might offend them, there are too many possibilities here for committees to be unnecessarily obstructive by, for example, demanding interpreters and translated information sheets for all projects. Some projects will necessarily exclude or include certain groups. Committees can consider projects only in isolation; they cannot take actions to ensure that research projects as a whole are distributed fairly. In the end, investigators investigate what they want to investigate, because that is what interests them.

The clearest evidence that process is more important than ethics is the stipulation that ethics committees can have only ‘one bite at the cherry’. Committees can ask investigators for as much clarification and ask for as many modifications as they want, but they can do this only once. They cannot later raise any further ethical issues. It is easy to see what underlies this. Committees could delay projects for months by raising issues one at a time—such as yet more modifications of the patient information sheet—which is clearly unsatisfactory and probably, in itself, unethical. But there is not even an ‘under exceptional circumstances’ rider. What if a committee member realizes at a late stage that there is an ethical issue so far overlooked? What is the committee to do, if to reject the research is then illegal? There is no official advice about this. One bite at the cherry is all we are allowed.

And what are the issues that exercise research ethics committees? Yes, every now and then a really thorny issue surfaces, but most of the effort goes into trivial projects that will do no harm but are unlikely to do any good. And information sheets. Much of the actual time that committee members spend on project applications goes to reading, correcting and rewriting the patient information sheets. Great store is set, quite rightly, on informed consent. It pervades all other ethical issues in research. If investigators cannot make clear to us what they are doing, how will they explain it to participants? There is no rule saying that ethics committees should rewrite information sheets; they do it because they have to.

It is uncomfortably true that, however much research ethics committees do to help investigators perform studies ethically, the only way we will know if investigators are behaving ethically is to watch them. Voluntary ethics committees simply cannot do that, and I suspect they do not wish to. Volunteers flourish free. Now that strict regulation is deemed necessary, it is only a matter of time before research ethics committees become just another part of the professional accountability business. Whether research participants will be any better protected remains to be seen.

Note I am chair of Southmead Local Research Ethics Committee.