Q J Med 2003; 96: 323-324
© 2003 Association of Physicians
Editorial |
The ethical bureaucracy
Hands up those who think that research ethics committees are doing a good job. Do not expect to see Drs Maskell, Jones and Davies waving. Last month in the QJM, they reported what happened while they were setting up a multicentre study of intrapleural streptokinase.1 They reckoned that the local investigators spent 62 hours photocopying to produce the 25 296 pieces of paper needed to satisfy the 51 local research ethics committees (LRECs) involved. Others have written about similar experiences.2
The present system of research ethics committees in the UK was established in 1997 by the Department of Health. Twelve multicentre research ethics committees (MRECs) were appointed to deal with applications for studies and trials involving patients recruited from within five or more LREC boundaries. The idea was that an MREC would consider the ethical aspects of the study and that, if approval was given, LRECs could only raise objections or insist on modifications to the protocol if there was a particular local issue. This was supposed to save both time for both researchers and LRECs, and by eliminating the large variations in practice among different LRECs, make it easier to carry out multicentre research. Perhaps it was inevitable that there were difficulties at first. Some LRECs saw the new system as a threat to their independence, refused to accept decisions made by MRECs, and continued to demand protocol changes for reasons that were not local.3 Problems at the MREC/LREC interface, however, seem gradually to be lessening. The development of a standard application form for both MRECs and LRECs (due later this year) seems sensible, but at 63 pages it is unlikely to reduce the paperwork much.
MRECs are managed by the Central Office for Research Ethics Committees (COREC). COREC's mission statement is available at [http://www.corec.org.uk/index.htm], where it explains that its tasks are co-ordinating the activities of MRECs and LRECs, ensuring consistency of procedures and decision-making, providing training for committee members and keeping the UK's system of ethical review in line with European directives on clinical trials and other research involving human subjects. A recent development is the establishing of Offices of Reseach Ethics Committees (ORECs) to support and oversee LRECs. All of this apparatus operates under the aegis of Governance arrangements for NHS Research Ethics Committees (GAfREC).
Doctors were slow to realise that they might not be the best judges of the ethics of their own research. In 1967, the British Medical Journal published a harrumphing editorial in response to a report by the Royal College of Physicians about setting up committees to consider the ethics of clinical research studies. ‘In the final reckoning,’ the anonymous author wrote, ‘the decision about a particular project is one for the doctor concerned, and for him alone.’ Times change and most doctors would now agree, perhaps slightly grudgingly, that independent assessment of the ethics of a research proposal is essential. What they wonder, however, is exactly what the current system is designed to achieve.
According to COREC, the purpose of research ethics committees in reviewing a study is to protect the dignity, rights, safety and well-being of all actual or potential research participants. Some idea of how this works in practice can be gained by looking at the Department of Health briefing pack sent to committee members. It provides a framework for assessing the ethical aspects of a research proposal in the form of a series of questions that need to be considered. The first set of these questions concerns the validity of the research. Is the study worthwhile, or is it an unnecessary replication of earlier work? Are the methods used likely to result in the acquisition of new knowledge? Are the investigators capable of carrying out the study successfully? Although these questions are entirely reasonable, committees as presently constituted are only marginally competent to make this judgement. Most members have no experience of research, and know very little about either the theory or the practicalities of study design. Even those that do are unlikely to be knowledgeable across the range of study types and methodologies that come before the committee. Applicants are not required to include a systematic review of published work to demonstrate that they are addressing an unanswered question and, in my experience at least, it is rare for a committee member to undertake a literature search to check the originality of the proposal.
The second set of questions concerns the welfare of those participating as subjects in the research. What will agreeing to take part involve? Are the risks to participants acceptable? And the third set is about the related issue of the rights of patients and participants. Are they given adequate information about the study to make a properly informed decision on whether or not to take part? Is the confidentiality of patients or participants assured? Answering these questions requires much less in the way of special expertise, and committees feel on surer ground on these issues. Researchers confronted with the list of protocol amendments required by a committee often conclude that most time was spent discussing the style, grammar and wording of the patient information sheet.
Providing accurate and accessible information to patients who are considering whether to participate in a study is crucial to obtaining informed consent, and is thus an important ethical issue. But, as a recent study in the US found, those responsible for monitoring the ethics of informed consent often fall short of their own standards.4 The researchers visited the web sites of institutional review boards (the North American equivalent of research ethics committees), downloaded the templates that the boards suggested using for information and consent forms, and used the Flesch-Kincaid scale to measure the readability of the text. The average text was about 10th grade level: about the same as education to GCSE level in the UK, and far too high for a document that might be given to adults with low literacy skills. Some of the examples made the point more strikingly. Trying to explain that being in a study was an altruistic act, one template read: ‘The research physician treats all subjects under a specific protocol to obtain generalizable knowledge and on the premise that you may or may not benefit from your participation in the study.’ That the same idea is capable of clearer expression is shown by this example: ‘There is no benefit to you from being in the study. Your taking part may help patients in the future.’ COREC also offers sample texts for UK researchers to use, and it seemed fair to try the same test. They scored a little better on the Flesch-Kincaid scale—just over 9th grade level—than the average achieved by the US review boards, but this still requires quite a high standard of literacy.
Systems for the independent scrutiny of the ethics of biomedical research in the UK are evolving. COREC has had a helpful influence in improving consistency, in setting standards to ensure that decisions are taken promptly, in putting an appeal system in place, and in recognizing training needs of committee members. While all this is to be welcomed, one cannot help feeling that more attention is being paid to the processes of ethical review than the quality of the decision-making.
The author of this editorial is a member of the South West multicentre research ethics committee.
References
1. Maskell NA, Jones EL, Davies RJO. Variations in experience in obtaining local ethical approval for participation in a multi-centre study. Q J Med 2003; 96:305–7.
2. Lux AL, Edwards SW, Osborne JP. Responses of local research ethics committees to a study with approval from a mulitcentre research ethic committee. Br Med J 2000; 320:1182–3.
3. Tully J, Ninis N, Booy R, Viner R. The new system of review by multicentre research ethics committees: prospective study. Br Med J 2000; 320:1179–82.
4. Paasche-Orlow MK, Taylor HA, Brancati FL. Readability standards for informed-consent forms as compared with actual readability. N Engl J Med 2003; 348:721–6.
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