A voice for women's health

Major Flaws in SOPs for Ethics Committees - February 2012

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 reduction in number of ethics committees from seven to four, will significantly increase the workload of each committee. To meet that workload, the committees are expected to reduce the level of scrutiny of clinical trials, provide expedited review by the chair, and not review some research. The outcome is that many studies will not receive full ethical review, and some will not be reviewed at all. 
  • As a result of the above change, research protocols for clinical trials that will be categorised as low risk, will receive only expedited review by a committee chair. While on the surface this sounds an appropriate way of making ethical review more efficient the draft SOP shows that it is likely on occasion to prove hazardous. For example trials of probiotic use in serious illness would be categorised as not requiring full review. Yet one such trial conducted in the Netherlands and published in the Lancet 2008, reported a major excess of deaths in the probiotic group and subsequent investigation showed that the monitoring arrangements for adverse events were insufficient; hence some deaths may have been avoidable. 
  • Student research will also not receive review by HDECs (unless it is an intervention study conducted at PhD level). Hence the research carried out by a doctor into a clinical matter for the purpose of achieving a Masters degree, would not be reviewed by the HDEC (the appropriate committee for research with public hospital patients).
  • The reduction in the numbers of members of ethics committees from 12 to 8 will result in both a loss of expertise, and a reduction in lay participation. 
  • Ethics committees will not assess scientific validity, even though scientific validity is one of the standards required for research to be ethical.
  • A central clearing house for allocating protocols will impersonalise the review process and undermine co-operation between researchers and HDECs and the communities they work in.”  

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.” 


 

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