Following the release of the Cartwright Report in August 1988 major changes were made to the membership and conduct of ethics committees throughout New Zealand. The Cartwright Inquiry had found that “the lack of the systematic seeking of consent to inclusion in research or treatment (except for operative procedures) and the inadequate procedures for approval and surveillance of research and treatment, pose a serious risk to patients’ rights.” Judge Cartwright recommended that better procedures for scientific and ethical assessment be developed, and that all health research be reviewed by independent ethics committees. She also recommended that approximately half of the members of ethics committees be lay members.1
Over the next two years both the Minister of Health and the Ministry of Health set about developing standards for ethics committees and implementing the required changes. Ethics committees were established in which half the members were lay people and half were health professionals or researchers. Committees also were required to have a lay member as chairperson. Fifteen regional ethics committees were set up throughout the country but within a few years it was reported there were significant differences in their membership, scope and in how they operated.
Over the past decade both the Ministry of Health and a succession of Ministers appear to have forgotten the lessons of Cartwright Inquiry and ethics committees have become subject to political influences. Appointment processes and standards have deteriorated to the extent that in many respects they are barely recognisable from those set up in the early 1990s. Appointments to ethics committees are now political appointments rather than ethical appointments. Some of these changes mean that the public can no longer have confidence that ethics committees are acting in a manner that “safeguards the rights, health and wellbeing of consumers and research participants.”
One of the most unacceptable changes is that appointments to the seven ethics committees (in 2004 the number of ethics committees was reduced to six and a new national multi-centre ethics committee responsible for the review of all multi-centre and national research was established) are now made by the Minister of Health. This has resulted in some bizarre appointments being made that fall well outside the half lay, half health professional membership guidelines.
During the last half of 2010 a member of the AWHC attended the meetings of the Northern X ethics committee that meets once a month on the Green Lane Clinical site in Auckland. During one meeting it was revealed that one of the lay members on the committee is actually a nurse. A former member of one of the Auckland ethics committees reported that when she was on the ethics committee there was a retired cardiologist, a retired pharmacologist and a physiotherapist taking up lay positions on the committee.
It is also evident that the focus has shifted from protecting participants in research trials to smoothing the way for what researchers want to do and advancing the vested interests of the pharmaceutical companies who are the sponsors of many research proposals. At the November meeting of the Northern X ethics committee the lawyer on the committee wearily pointed out that she had been voicing her concerns about the way the drug companies were avoiding their responsibilities for compensating research participants should they suffer any unexpected or adverse or outcomes. Despite stating that they abide by the Researched Medicines Industry Association (RMI) guidelines on compensation for research participants, drug companies insist on having significant “out” clauses in the research proposals.
It was these sorts of issues that were behind the AWHC’s repeated calls for ethics committees to be included under the umbrella of the Health & Disability Commissioner’s office at the 5-yearly reviews of the HDC Act and the Code of Consumers’ Rights. Political interference along with inadequate training and ongoing education has resulted in ethics committees forgetting who they were established to protect.
1. Report of the Cervical Cancer Inquiry 1988. Page 214.