A voice for women's health

Concerns Over NZís Ethics Committees - November 2008

November 2008

The October 2008 issue of the Health Research Council’s newsletter Ethics Notes featured a timely article that provided a critical look at some of the problems with the current system of ethical review of research in New Zealand. The article was written by Dr Tim Dare, a lawyer who is the chair of the Health Research Council’s Ethics Committee (HRCEC) and a member of the clinical ethics committees of the Auckland and Waitemata District Health boards. It confirms some of the concerns that women’s groups have had over the past decade.
 

Cartwright Report

Today’s structure and function of ethical review committees was established in the wake of the report of the Cartwright Inquiry that 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.” One of Judge Silvia Cartwright’s recommendations was that all health research should be reviewed by an independent ethics committee. She also recommended that the ethics committee at National Women’s Hospital should be disbanded because it had “failed in significant areas.”
 

Lay Membership

As part of a raft of measures introduced nationwide following the Cartwright Inquiry, hospital ethics committees were disbanded and independent ethics committees were established by the Area Health Boards with the expectation that they would abide by the national standard that had just been developed by the then Department of Health. The new ethics committees were comprised of 50% lay members and 50% health professionals/ scientific members with the chairperson having to be a lay member. 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. 

In April 1993 the Department of Health announced that ethics commit-tees would be moved out of the Area Health Boards. An Interim Ethics Taskgroup was established to review both the existing ethics committees and the 1991 standard for ethics committees. This and further changes to the health system eventually resulted in the establishment of the Health and Disability Ethics Committees.

 

NEAC

Following the passage of the New Zealand Public Health and Disability Act in 2000, the National Ethics Advisory Committee (NEAC) was established and its members were finally appointed in December 2001.

NEAC’s statutory functions are to provide advice to the Minister of Health on ethical issues of national significance regarding health and disability research and services, to determine nationally consistent ethical standards and to provide scrutiny for such research and services.

 

Gisborne Inquiry

The cervical screening scandal in Gisborne resulted in a second major Inquiry in 2000 and the release of another report in 2001 that among other things recommended changes to the system of ethical review. NEAC undertook a review of the ethics committees system and a report with the committee’s recommendations went to the Minister of Health in December 2003.
 

Ethics Committees Slashed

This resulted in the number of ethics committees being reduced to six and the addition of new national multi-centre ethics committee responsible for the review of all multi-centre and national research. Whereas under the previous system each of the 13 ethics committees had its own exclusive geographical jurisdiction, the six new ethics committees had their jurisdiction widened to four regions, with the two busiest regions having two committees each. These changes were implemented in 2004.  
 

Multi-region Ethics Committee

However, Dr Tim Dare’s article reveals that the new system has not worked entirely as planned. He reports that:

“The multi-region practice was creaky and time consuming, though it had some serendipitous advantages. One committee acted as the ‘lead committee,’ co-ordinating responses from the remaining committees. Though it was almost certainly not its goal, the system provided uniformity: no answer went back to researchers until the co-ordinating lead committee had seen the input from the contributing committee.”

Furthermore, the expectation that the new multi-region committee would drastically reduce the work of the six regional ethics committees was soon revealed to be totally unfounded. Dr Dare who was chair of the busiest regional ethics committee at the time of the restructuring, says it quickly became clear that there had been a miscalculation. Both the multi-region committee and some of the regional committees were swamped. Since then Dr Dare says that chairs have being raising concerns about the capacity of their committees to manage their workload ethically.

“There have been attempts to address these problems. In 2007 a system of expedited review of observational research was introduc-ed. The aim was both to assist researchers and reduce committee workloads. While the system may have reduced committee workload, it seems to have increased the work-load on chairs and deputy chairs who bear most of the burden of providing expedited reviews. More recently changes have been introduced to allow research to be sent ‘out of region’ to less busy committees.”
 

Lack of Consultation

As Tim Dare points out, not only are these latter changes to the terms of reference inconsistent with the assumption of regional review for local research which has underpinned the system of ethical review, they were made without consulting with the Health Research Council Ethics Committee (HRCEC).

Given that one of the HRCEC’s responsibilities is “to give in relation to ethics committees established by other bodies, advice on membership, procedures, and standards to be observed by those committees,” as well as to provide second opinions for the ethics committees, such a lack of consultation is of considerable concern.

Tim Dare concludes his article with the warning:

“Not only do excessive workloads threaten ethical review directly, they also endanger the goodwill of committee members (who, given current meeting fees, may fairly be regarded as volunteers). The HRCEC remains concerned that no long-term solution to the workload pressures on ethics committees has been found.”

The above changes have all been documented in the AWHC’s newsletters over the past decade. They were always accompanied by the call for ethics committees to be made completely independent of the Ministry of Health and to be located within the Office of the Health and Disability Commissioner. We made this recommendation again when preparing our submission on the review of the H&DC Act and the Code of Consumers’ Rights in 2009.

In 2008 there were a number of events commemorating the 20th anniversary of the release of the Cartwright Report on 5 August 1988. None of them addressed the issue of what happened to the Cartwright Report’s recommendations regarding ethics committees. The report stated: “New treatment procedures are not systematically reviewed by the Ethical Committee but will be considered if put to it.” When the Area Health Board ethics committees were first established it was expected that they would review new treatment procedures, but the workload of reviewing research proposals quickly put an end to any serious attempt to fulfil that task.
    
As stated above the Cartwright Inquiry revealed that rights of patients at National Women’s Hospital had been seriously neglected. The Cartwright Report called for a system of ethical review to be put in place that “focused on the protection of patients.” The changes that were made in the first few years after the release of the Cartwright Report went a considerable way towards addressing the issue. However, as with some of the other areas to do with the issues that were bought to light during the Cartwright Inquiry, two decades have seen a loss of ground and a resulting tendency to focus on the needs and desires of researchers, the medical profession and the health system.

The AWHC has major concerns around what has happened to our system of ethical review after the Ministry of Health took control of the ethics committees. It is time to put the spotlight on whether they are really focused on the protection of patients, and to consider placing them under the umbrella of the Office of the Health and Disability Commissioner. 

 

References

The Report of the Cervical Cancer Inquiry 1988

Ethical review of research in New Zealand, Ethics Notes October 2008

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