Abstract

In 2002, I wrote an editorial in this Journal arguing that it was time to review the structure and function of ethics committees in the USA, Australia and the UK.1 This followed the deaths of Ellen Roche and Jesse Gelsinger, which were at least in significant part due to the poor functioning of research ethics committees in the USA.2 In the case of Ellen Roche, it was the failure to require a systematic review of the existing literature which led to her death. Iain Chalmers and I had previously documented in 1996 the failure of ethics committees to require systematic review.3 In 1998, at the time of revising the previous guidelines and forming the first Australian National Statement on Research Ethics, I made a public submission to the Australian Health Ethics Committee arguing that the new guidelines for RECs should include a person with skills in conducting systematic reviews of the literature and that the requirement to have a religious representative on the committee be replaced with the requirement to have an ethicist. Neither of these changes was made. I argued, ‘It is time to ask whether institutional RECs should be abandoned in favour of expert committees that cover many institutions—suprainstitutional specialist committees. Supraregional specialist ethics committees could specialise—for example, in genetic research, cancer clinical trials, dermatology, respiratory physiology and each of the specialist areas of medical research. An example of such a committee is provided by the Thoracic Society of Australia and New Zealand research ethics committee, which reviews multicentre trials of respiratory drugs’.4 Around that time, I was involved ‘at the coal face’ as Chair of the Department of Human Services Ethics Committee in Victoria. In a public presentation, I arguedThere are two philosophical views of what ethics review is. On the …