Major Flaws in SOPs for Ethics Committees - February 2012
At the end of December 2011 the AWHC received a copy of the draft Standard Operating Procedures (SOPs) for ethics committees. The changes set out in the document are the latest step in the government’s response to the Health Committee’s clinical trials inquiry.
The NZ House of Representatives report was released in June 2011 and was entitled “Inquiry into improving New Zealand’s environment to support innovation through clinical trials.” The government responded with a document containing recommendations for change, followed by the “Draft standard operating procedures (SOPs) for health and disability ethics committees (HDECs).” The changes which are due to be implemented by the middle of the year will effectively spell the end of the purpose, role and function of ethics committees that were set up in the wake of the Cartwright Inquiry.
The New Zealand ethics committees established in the early 1990s were designed to provide extensive safeguards for research participants. The changes about to be introduced will seriously undermine these safeguards, and are “a departure from international standards.”
Women’s health groups are not the only ones alarmed by this major erosion of protection for research participants. At the beginning of February 2012, following the New Zealand Bioethics conference held at the end of January five professors published an open letter to Minister of Health Tony Ryall regarding the proposed changes. They were the head of Otago University’s bioethics centre, Professor Gareth Jones, Professors Donald Evans, John McCall and Charlotte Paul, and Auckland University’s Professor Tim Dare.
The letter stated there were major concerns about the processes around the creation and implementation of the new policy and referred to major flaws in the quality of information received by the Select Committee that led to these changes. Even more worrying was the fact that important steps were omitted, including analysis by and consultation with the government’s own ethics advisory committee, the National Ethics Advisory Committee.
Other issues raised in their letter to Tony Ryall “are as follows:
The letter also echoes the issue raised by the AWHC in previous submissions and newsletter articles in stating that these concerns “raise issues about the independence of ethics committees housed within the Ministry of Health.”