Ethics committees: impediments to research or guardians of ethical standards?

Method and results

A research study focusing on the needs of and provision of care to children who might be expected to die during childhood was commissioned by the Department of Health. Parents of such children who were resident in four selected regional health authorities recruited themselves to the study through advertisements in voluntary group newsletters, and providers of statutory and voluntary care in the selected health authorities were interviewed. In this study I identified the correspondent of each of the 43 district ethics committees by telephone and sent him or her a letter. The letter was written with the guidance of an ethicist and sought advice about whether the research study required formal ethical approval, given that no children were to be interviewed and all the usual ethical safeguards would be adhered to. Letters were posted in two batches during May 1993.

The replies varied considerably. Twenty one committees required no approval to be sought and 18 required formal applications to be made; four of the committees did not reply. When these four committees were excluded, the number of days until I received a reply ranged from six to 161 days, with a mean of 60.1 days (table). The cost of the approval process in terms of paper and photocopying ranged from the cost of one letter to that of 2151 sheets of paper. The requirements of the ethics committees also differed about who was eligible to sign the application—that is, whether a doctor of consultant status working within the health authority was required to sign the application.

Comment

Although some diversity of practice between different ethics committees is inevitable, my study showed a worrying degree of variation. Substantial inconsistencies in the practice of ethics committees in the United States (institutional review boards) have also been found,4and Oakley noted how the social support and pregnancy outcome study “benefited from the irregular means deployed to pass our proposal through the ethics committee barrier.”5

Unless the practice of ethics committees is improved and made more uniform, large multicentred studies will not be possible and research budgets will be dissipated in photocopying costs and unpredictable waiting times. My results suggest that the establishment of a national ethics committee for multicentred studies needs urgent consideration.

Responsibility for the views expressed, issues of interpretation, and questions of inclusion and omission are mine and do not necessarily reflect the views of the Department of Health.