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BMJ. Apr 29, 2000; 320(7243): 1217.
PMCID: PMC1127608
Personal views

The ethics of research ethics committees

Jon Nicholl, director

Our health service research unit has been carrying out primary evaluative studies for over 30 years. Much of what we do is designed to help improve health care and health services and inform NHS decisions. It may not be fundamental science but it feels worthwhile, sometimes has an important impact, and we know that it is valued, particularly if the studies are done in a timely and nationally representative manner.

But as well as our ever shortening deadlines and increasing workloads we now find that we cannot do our jobs because of research ethics committees. I do not mean that our studies are unethical. Far from it, our studies are nearly always approved—eventually—but the time taken to get approval from several local research ethics committees (LRECs) and in overcoming bureaucratic and practical obstacles, rather than ethical problems, has become a barrier to our research.

For ethics committees to have become barriers to ethical research . . . is certainly immoral

The difficulties of obtaining ethical approval for multicentre research have been widely recognised. For example, we once finally received ethical approval from one hospital research ethics committee out of more than 20 that we had approached two years after our first application and only a few months before completion of the whole study. On another occasion, after several LRECs had approved a study, one refused. This refusal came after I had attended an evening LREC meeting 150 miles away when all the members present were happy to approve the project. One member, who was absent, later objected.

These difficulties were supposed to have been put behind us with the formation of multicentre research ethics committees (MRECs). The problems have continued and the MREC is now often the problem.

We had to make several submissions and there was a nine month delay in getting approval for a purely methodological study involving no intervention and anonymised data.

After written approval from an MREC and several LRECs a study was started, but the MREC wrote four months later withdrawing its approval.

One of three LRECs was unable to approve a population survey at the right time because the committee had moved offices and the original letter had gone astray. Despite the fact that the same LREC had approved our two identical, earlier, surveys, and the fact that the MREC had approved the study involving the third survey, the LREC did not think that this could be speeded up by taking chairperson's action.

The problem is not usually to do with any single ethics committee. It is more to do with the fact that any national study inevitably involves several LRECs from each of whom approval must be sought even with MREC approval. As each committee has its own distinct application form, its own idiosyncratic timetable, and there are often requests to appear 200 miles away, it is impossible to obtain permission from more than three committees in three months.

There is always one committee secretary on leave, or a chairperson who has resigned, or a letter that is lost, and a thousand and one other delays—all of which are genuine and understandable—but which add up to the impossibility of doing practical research in the NHS to help decisions which must be made promptly. The forms (13 copies please), which must be completed, are mind boggling. For our surveys of patients we are asked to list all the known toxic effects of the questionnaire; for studies of deaths we are asked for our patient consent form; for a Medical Research Council study costing £750 000, approved after two years' consideration by several referees and involving many of the country's leading biostatisticians, we are asked for our sample size calculation.

The bureaucratic unhelpfulness of research ethics committee procedures might be bearable if the committees attended to the ethics of the studies they reviewed. In our experience they have been concentrating on scientific, legal, and confidentiality issues instead of ethical issues. Now that the Court of Appeal has made it clear that there is nothing wrong with having access to anonymised data we confidently expect other issues to begin to raise their heads—perhaps democratic issues of religious, ethnic, and cultural equality.

Of course, ethical issues are difficult. Notions of right and wrong vary; they change over time, and involve weighing the rights of individuals and society. In a rapidly changing, secular society it is sometimes hard even to identify the ethical issues. Computerised systems with formalised rules which researchers could take into account cannot be devised and would miss the essence of an ethical assessment, which is why science, the law, and confidentiality rules cannot equate to ethics. The idea of “Microsoft” ethics is neither feasible nor desirable. But for ethics committees to have become barriers to ethical research, which could help to improve health care, is certainly immoral.


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