A voice for women's health


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 recom-mendations 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.” (1)    

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. (1)

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.”

1. Open letter to Tony Ryall

AWHC Newsletter February 2012


The Auckland Women’s Health Council (AWHC) is an umbrella organisation for individual women and women’s groups in the Auckland region who have a commitment to and an interest in women’s health issues. The focus of the Council is broad and spans many issues that are of interest to women, particularly those that impact on their health and the health of their families.

The AWHC was formed in 1988 and Council members took an active role in ensuring that the recommendations of the Cartwright Report were implemented. Since then the Council has made many submissions on matters related to research, teaching, the establishing and functioning of ethics committees, ethics committee guidelines, consumer representation on ethics committees, etc.

The AWHC begins this submission with general comments on the draft SOPs document before providing comments on specific issues raised in the document.

General Comments
Since 1995 the AWHC has consistently proposed that ethics committees should be part of the Office of the Health and Disability Commissioner with a Director of Ethics Committees taking responsibility for the administration, monitoring and reporting functions in a similar manner as the Director of Advocacy oversees the advocacy service. (1)

The Council continues to promote this recommendation as the changes introduced by the Ministry of Health over the past decade have seen the purpose of ethics committees move from that of ensuring the protection of the rights, health and welfare of research participants to becoming more focused on the agendas of researchers and the vested interests and requirements of the pharmaceutical industry. The lessons that led to the establishment of new patient-centred ethics committees in the early 1990s have been forgotten as a series of changes have been implemented that have served to undermine the main functions of ethics committees.

The “Draft standard operating procedures for health and disability ethics committees” continues this unfortunate trend and weakens the concept of independent ethics committees which focus on the rights, health and welfare of research participants. The AWHC is opposed to the reduction in the number of ethics committees from seven to four, and the reduction in the number of ethics committee members. The Council is also concerned that the current document does not state that the chairperson of each ethics committee will continue to be a lay person, in keeping with the recommendations of the Cartwright Report.

The AWHC has major concerns about medical devices that have not been approved by either international agencies such as the US Food and Drug Administration or any New Zealand agency. Recent examples of the damage and trauma done to New Zealanders by the ASR hip joints, the gynaecological mesh, and breast implants provide strong evidence of the need for serious scrutiny of all new devices that are being used in New Zealand patients. All medical devices must be required to undergo clinical trials and to obtain ethics committee approval prior to such trials going ahead.

The AWHC has similar concerns about tissue banks and we address the issue of tissue banks on pages 6 and 7 of this submission.

Section 1: Purpose and application
The AWHC does not support the emphasis and focus of standard operating procedures being on streamlining ethics committee procedures to meet the requirements of the research and pharmaceutical industries. It is essential to the purpose of ethics committees that they are independent from the Ministry of Health and safe from the relentless cost cutting exercises of various governments. Like the National Cervical Screening Programme which was also established in the wake of the Cartwright Inquiry, ethics committees have fallen victim to Ministry of Health restructurings carried out by those with little understanding of the history of and reason for these significant programmes.

It is totally inappropriate to abrogate the important roles and functions of ethics committees, to drastically reduce the types of research considered by full ethics committee review, and place an inordinate amount of power in the hands of Minister of Health appointed chairpersons. 

In a submission written in 2001 the AWHC wrote:
The AWHC is strongly opposed to the proposal listed in 133 on page 33 that the Director-General of Health should have the power to alter the number of HDECs or their corresponding designation regions of authority.” (2)

Our objections were ignored and the number of ethics committees was subsequently reduced at a considerable cost to their ability to adequately fulfill their duties. This undermining of the role, independence and authority of ethics committees by successive governments and the Ministry of Health has thus proceeded relentlessly over the past decade.    

Section 2: The role of HDECs
The list on page 4 revealing what the Ministry of Health has now decided that ethics committees will not do is further evidence of the serious erosion of the primary focus of ethics committees.

While the AWHC agrees that an ethics committee review does not constitute consultation with relevant population groups, the proposed list of what ethics committees do will not do confirms the rubber-stamping exercise that ethics committee reviews will now be limited to. 
Paragraph 5 (page 5). The AWHC does not support the restriction preventing ethics committees from requiring specific changes to research protocols on the grounds of lack of scientific validity, as it is important that research participants give their time, and bodies to well-designed studies that are going to yield trustworthy findings.

One AWHC member commented in regard to locality-specific governance issues that locality assessments need to be made consistent and transparent, especially when, as in the Auckland region, more than one DHB may be involved.

It is also essential that ethics committees are able to ensure that a research study is legal, and that such advice has been sought and the study amended as advised. The same applies to scientific advice. Council members noted that having lawyers and ethicists as well as others enrich the quality of the review, and we are concerned at the proposed changes which will diminish the value of the review process.

Section 3: Scope of HDEC review
The fact that the Minister of Health “requires updated SOPs for HDECs to clarify and reduce the scope of HDEC review” is precisely why the AWHC has argued for 17 years for the responsibility for independent ethics committees to be transferred to the Office of the Health and Disability Commissioner.

The Ministry of Health lacks sufficient independence to clarify and define what is health and disability research and what is not. It will lead to the creation of a dangerous situation if the definition of when a study requires an HDEC review is reduced to the limits described on pages 7 and 8 of the draft document. Such a change is not in the best interests of research participants.
Section 4: Applying for HDEC review
The AWHC supports the move to all applications for HDEC review being submitted electronically and that researchers be able to ask that their application be reviewed by the HDEC nearest to them.

Section 5: The full review pathway
The AWHC does not support the large amount of research that will now be reviewed by the expedited review pathway, which means by the chairperson of the ethics committee. This path risks personal bias, or the lack of specialist knowledge, leading to faulty and ill-advised decisions.

As noted already the document fails to mention that the chairperson of each ethics committee must be a lay person. This is a serious omission and the requirement for lay Chairs must be clearly stated.

The imposition of a 35-day time limit and the adoption of the 35-day review clock are indefensible in the context of limited resources being provided for the adequate and ethical functioning of ethics committees; especially with the consequent reduction in the number of ethics committees from seven to four, and the reduced membership numbers of each ethics committee.

All decisions made by an ethics committee, whether they be made by the chairperson, or the chairperson and two other committee members, or by an expedited or a full review pathway must be recorded, minuted and submitted to the next meeting of the full ethics committee. There must be a clear and concise summary of all discussions, and the rationale for the decisions that were made.

The AWHC is concerned these SOPs reflect the determined cost cutting that provides further indication that the Minister of Health underestimates the importance of independent ethics committees focused on the need to protect participants in research trials. Nor can the public have any confidence in such short-sighted measures that are tailored the needs of the research industry and on cost-savings at the expense of the safety of research participants. 

Section 6: The expedited review pathway
The AWHC is totally opposed to the vast amount of research that will now be reviewed by the Chairs of the ethics committees under the expedited review pathways outlined in this section. The expedited review process places too much power and responsibility in the hands of the four Chairs and it does not meet the need for independent, robust, transparent and accountable ethical reviews. As noted above the risks involved are considerable.

Chairs must be required to consult with at least two other members of the ethics committee, and should the chair reject their advice, the research proposal should then be required to go to a full review.

Section 7: Decisions open to HDECs
The limiting of decisions open to Ministry of Health controlled ethics committees provides further evidence as to the need for ethics committees to be placed within the protection of the office of the Health and Disability Commissioner. 

Section 8: HDECs and the Accident Compensation Act 2001
The elephant in the ethics committee room emerges in this section – the problems associated with what the document disingenuously refers to as “commercially sponsored” studies.

Paragraph 138 raises some serious issues about the nature of research that is conducted on behalf of pharmaceutical companies but fails to adequately address the lack of independence that investigators have when taking part in drug company sponsored research. Hundreds of articles and many books detail what happens when the pharmaceutical industry conducts and controls the research into the products they produce. (3)(4)(5)(6)(7)(8) Their own interests always take priority over those of researchers and research participants. It also the drug company that decides what is published and when.

The AWHC notes that concerns about compensation arrangements in drug company sponsored research have frequently been raised during meetings of the Northern X Ethics Committee, but without satisfactory resolution. It is also not always made clear to participants that they may not be covered under the current accident compensation legislation.

There is now a large body of evidence that demonstrates that the pharmaceutical industry and researchers cannot be relied on to put the safety of research participants or those who subsequently consume their drugs or use their devices above financial considerations. Research participants become vulnerable when investigators and sponsors assume responsibility for ensuring that adequate and fair compensation arrangements are in place. “Assurances from the sponsor” is not a credible or reliable guarantee.

It is also an unacceptable risk to leave localities “responsible for checking that they and relevant members of the local research team are appropriately indemnified and insured.” The issues around compensation, indemnity and insurance are those best dealt with by an independent agency – such as the Office of the Health and Disability Commissioner – which can bring important experience and expertise to these complex issues. Leaving such problems with localities is akin to burying one’s head in the sand. 

Section 9: Challenging HDEC decisions
The AWHC supports the appeal options outlined in this section with the provision that it is inappropriate for the secretariat to advise the Chair of their views (paragraph 151). The ethics committee is responsible for all decisions that are made, not the secretariat. 

Section 10: Locality review
The transfer of locality reviews to district health boards raises the issue of monitoring.

Given the ethics committees’ proposed shift of focus from protecting research participants to accommodating the desires of the pharmaceutical and research industries, it is absolutely essential that a robust system of monitoring the changes put in place to ensure that the new guidelines are followed and that the responsibilities of all localities, DHBs, investigators, and the sponsors are properly carried out. 

Section 11: Amendments to approved studies
The guidelines providing for substantial amendments and non-substantial amendments to approved studies are open to a wide and varied interpretation of the listed definitions as to what is substantial and what is not. This is risky and dangerous. Given the context in which “sponsored research” is being undertaken in New Zealand it is inadvisable to permit such discretion in regard to whether amendments submitted for HDEC review meet the vaguely defined test of substantiality.

All amendments must to be sent to the HDEC chairperson who should be required to consult with at least two other EC committee members when reaching a decision as to the status of an amendment.

Section 12: Post-approval processes
While the AWHC supports the concept that responsibility for proactively monitoring a study remains with the investigator and sponsor of that study, it is absolutely essential that HDECs keep all approvals under review.

If an annual report is not received by the ethics committee, and there is no response to the reminders sent to the investigator, the study file must remain open until the HDEC has received documented proof that the study did not actually go ahead.

This section of the document fails to address the requirement for ethics committees to ensure there is an annual report for all studies disclosing :
• whether they are completed or not.
• if a study is subsequently abandoned because it did not produce the expected results,
• or if it produced negative outcomes for research participants.

It must be made mandatory for a full report to be submitted to the ethics committee. Negative and adverse outcomes must be notified in the interests of public safety and public accountability.    

Section 13: HDEC review of tissue banks
The AWHC strongly recommends that all applications relating to the establishment and management of tissue banks must be referred to the Office of the Health and Disability Commissioner prior to a review being sought from an ethics committee. It must be made mandatory that all proposals to establish a tissue bank be reviewed by an ethics committee.

Standard policies must be developed for all tissue banks that detail the reason for and purpose of the tissue bank, how it will be governed, the processes for obtaining and storing tissue, where it will be stored, informed consent policies and forms, the process for withdrawing consent, who will have access to tissue samples, the return or disposal of tissue samples, public accountability for the use of tissue samples, etc. There must be no provision for tissues to be removed without the consent of the patient or research participant.

The importance of and need for such requirements are clearly documented in chapter 7 “A Traffic in Tissues” in Deadly Monopolies. (8) A copy of the chapter is attached to this submission.

In conclusion the AWHC has serious concerns about the health and safety of research participants in clinical trials given the changes to ethics committees that have been made and those that are being proposed in this document. We note that our concerns are shared by academics at both Auckland and Otago universities. (9)

Auckland Women’s Health Council

9 February 2012


1. Auckland Women’s Health Council. Submission on the “Review of the Ethical Review Structure in New Zealand.” 29 October 1997.
2. Auckland Women’s Health Council. Submission on “The Draft Operational Standard for Health and Disability Ethics Committees.” 15 August 2001.
3. Merrill Goozner. “The $800 Million Pill.” University of California Press. 2004.
4. Marcia Angell. “The Truth about the Drug Companies.” Random House. 2005.
5. Ray Moyhihan & Alan Cassels. “Selling Sickness: How Drug Companies are Turning Us All Into Patients” Allen & Unwin. 2005.
6. Jacky Law. “Big Pharma: How the world’s biggest drug companies control illness.” Constable. 2006.
7. Ray Moynihan & Barbara Mintzes. “Sex, Lies and Pharmaceuticals.” Grey Stone Books. 2010. 
8. Harriet Washington. “Deadly Monopolies.” Doubleday. 2011.
9. Martin Johnston. “Changes may be threat to patients, say critics.” NZ Herald. 6 February 2012.

The New Zealand Law Society has also written a submission documenting their concerns with the changes to ethics committees being pushed through by the current government and Minister of Health, Tony Ryall. Refer to: http://www.lawsociety.org.nz/home/for_the_public/for_the_media/latest_news/news/february2/standards_for_health_research_could_become_less_stringent
For a copy of the NZ Law Society's submission email the AWHC.


In September 2011 the government issued its response to the Report of the Health Committee on its Inquiry into improving New Zealand’s environment to support innovation through clinical trials.

The government’s response makes for grim reading as it outlines how they plan to reduce the number of ethics committees from seven to four and streamline the process to make the main objective of ethics committees that of supporting clinical trials rather than protecting patients.

The Health Committee’s clinical trials report was also focused on the need to take advantage of the dollars attached to “supporting innovation through clinical trials.” The Health Committee came up with a total of 54 recommendations, comprising eight key recommendations and 46 more detailed ones.

The 8 key recommendations were:
Simplify and streamline ethical review processes
Collaboration between the Ministry of Health, the Ministry of Science and Innovation, the Ministry of Economic Development, and New Zealand Trade and Enterprise
A national health research action plan that fosters innovation and commercialisation
A national framework for clinical trial research through DHBs
Build constructive and transparent relationships with the international biotechnology and pharmaceutical industries
Ensure excellent scientific infrastructure to run clinical trials
Establish a long-term objective in research and development investment
New Zealand to urgently assess Australian and UK clinical trial reports.
Growing the clinical trial industry
The Health Committee was clearly alarmed that New Zealand was missing out on the lucrative market for clinical trials. Chapter 3 of their report described the steps that need to be taken for New Zealand to create an effective clinical trials environment. The report stated “New Zealand needs to be attractive to overseas sponsors of multinational research projects. An environment conducive to pharmaceutical companies funding these trials in New Zealand is required if the clinical trial industry is to grow.”

The Committee was told that one of the important factors for a productive clinical trial environment for pharmaceuticals was “the efficiency with which the New Zealand health system can interface with the pharmaceutical companies to deliver an efficient clinical trial outcome.” (1)

One of the things obviously standing in the way is New Zealand’s ethics committees. Hence the need for the changes which “will result in a more efficient, consistent and transparent Health & Disability ethics committee review process.” (2)

While there is a token reference to “significant ethical issues” and “the protection that committees offer to participants in such research,” the government intends to alter the structure of ethics committees to ensure that they do not obstruct the pharmaceutical industry or stand in the way of delivering “efficient clinical trial outcomes.”

This is how they plan to do it.

Ethics committees prostituted
The number of ethics committees will be reduced from seven to four as of 1 July 2012 and will continue to meet monthly.  

The numbers on each committee will be reduced from twelve to eight. With another token gesture, this time to the Cartwright Inquiry, the government says it is important that lay people continue to have a strong voice and that they continue to make up approximately one half of the ethics committee membership as the Cartwright Inquiry report recommended, so “at least three members” of each committee will be lay. Since when did half of eight equal three?

The number of applications that require a full review by an ethics committee will be reduced, and the number of expedited reviews for applications for some low-risk clinical trials will be increased. Who gets to decide what is “low-risk” is not stated.

The intention seems to be that all observation studies proposals will be exempted from ethical review, so issues about privacy and protection of patient data in such studies will be exempt.

It will be the responsibility of the investigator and sponsor to obtain the peer review report on the scientific merit of the proposal – how’s that for a conflict of interest? The ethics committee won't even see a copy, its role being confined to checking that this has been done. It seems that scientific aspects of a proposal are no longer the business of ethics committees, though without that information, it is impossible for them to evaluate matters such as risks/safety for participants and scientific worth (a recognised ethical issue).

New timelines for review are to be introduced and monitored. Under the updated operating procedures for ethics committees a timeline of 35 days will be imposed for a full review and 15 days for an expedited review. Ethics committees “will be required to report regularly against these timelines, and are expected to exceed them in most cases.”

Applications online
The government is also supportive of the development of electronic (online) applications and a centrally managed system for ethics committee review – meaning centrally managed by the Ministry of Health.

The ability for researchers to make minor changes to their research after it has received ethics committee approval will also be introduced. No prizes for guessing who will decide what are “minor changes.”

Fortunately the government rejected the Health Committee’s recommendation to make research a core activity undertaken by district health boards, and fund DHBs to undertake clinical research as a front-line activity. The objectives of DHBs must remain centred on “the improvement, promotion and protection of the health of people and communities, and the reduction of health disparities,” the report states.

Importance of independence
The report of the government’s response is another nail in the coffin for the concept of independent ethics committees whose primary objective is protecting patients. Those currently in charge in government and in the Ministry of Health have forgotten the lessons learned from both the Cartwright and Gisborne inquiries.

Ethics committees were never going to be appropriately managed and safe from being amended to suit professional and commercial interests by being placed within the Ministry of Health. Consumer groups have argued for more than a decade that responsibility for ethics committees should be placed within the office of the Health & Disability Commissioner.

The November 2008 issue of the AWHC’s newsletter featured an article detailing concerns being voiced by the chairperson of the Health Research Council’s Ethics Committee (HRCEC) following the slashing of ethics committees in 2004. The article raised issues about the focus of ethics committees shifting away from the protection of patients. See the article "Ethics committees become less ethical" below. 

Women’s health groups attending the Gisborne Inquiry into Cervical Screening were also strongly opposed to the National Screening Unit being placed within the Ministry of Health and warned of the risks involved if the National Cervical Screening Programme (NCSP) was left at the mercy of the MOH. In June 2011 the “Report of the Parliamentary Review Committee regarding the NZ Cervical Screening Programme” was released. This report also makes for grim reading. Sandra Coney’s outline of the risks involved for the NCSP if it was placed within the Ministry has been proved to be dismayingly accurate. The same has proved true for New Zealand’s ethics committees.

Right 7 (10)
One of the reassurances given to women’s health groups when Right 7 (10) of the Code was amended to permit research to proceed without patient consent when tissue removed was sought to be used for research purposes was that the ethical review process would provide a strong and effective safeguard. How hollow that reassurance now sounds!

The government’s report reveals the result of the battle between the need for independent ethics committees focused on protecting patients vs the interests of the pharmaceutical/ research industries.

The score: Drug Companies 1    
                                    Patients 0


1. Health Committee. “Inquiry into improving New Zealand’s environment to support innovation through clinical trials.” June 2011.

2. “Government Response to the Report of the Health Committee on its Inquiry into improving New Zealand’s environment to support innovation through clinical trials.”

AWHC Newsletter October 2011

See also the article featured in the Otago Daily Times by Professor Charlotte Paul - 


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.

Worrying changes
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.” (2)

Ministerial appointments
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.

Compensation issues
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.
2. www.ethicscommittees.health.govt.nz/moh.nsf/indexcm/ethics-about?Open&m_id=2

December 2010

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 committees 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.

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 introduced. 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 will be making this recommendation again when preparing our submission on the review of the H&DC Act and the Code of Consumers’ Rights scheduled to take place next year.

This year there have been a number of events commemorating the 20th anniversary of the release of the Cartwright Report on 5 August 1988. None of them have 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.

· “The Report of the Cervical Cancer Inquiry 1988”
· “Ethical review of research in New Zealand” Ethics Notes October 2008

November 2008


The Ministry of Health is currently seeking candidates to be nominated to its seven new ethics committees. The seven new Ministry of Health ethics committees replace the independent ethics committees that were established in the wake of the Cartwright Report.

The AWHC received an email from the Ministry on August 5th 2004, the day of 16th anniversary of the release of the Cartwright Report. On this day Council members and others gathered as usual at the statue of peace in front of National Women’s Hospital to remember the women who died as a result of the unfortunate experiment at NWH, to reflect on what has happened to the recommendations in the Cartwright Report, and to dedicate ourselves anew to the battle to hang on to the gains that were made.

The irony of getting an email on this particular day asking the Council to “forward this information out to your networks and/or nominate suitable candidates” to one of these committees was not lost on our members. What has been happening to our independent ethics committees is an issue that has been of considerable concern to the AWHC for some time.

For a start, the Minister of Health gets to choose who will be appointed to these “independent” ethics committees. This represents an unacceptable compromise to the independence of the committees.

The seven committees the Ministry is seeking candidates for are a multi-region Ethics Committee, a Northern X and a Northern Y Regional Ethics Committee which will be based in Auckland and Hamilton, a central Regional Ethics Committee based in Wellington, an Upper South A and an Upper South B Regional Ethics Committees which will be based in Christchurch, and a Lower South Regional Ethics Committee based in Dunedin.

Each committee has 12 members half of whom must be lay people. The lay membership must include “an ethicist, a lawyer, people with consumer perspectives and people with community perspectives.” I guess this means consumer representatives need not apply! The non-lay membership must include two health researchers, two health practitioners, a biostatistician and a pharmacist or pharmacologist. Each committee will also have at least two Maori members who “should have a recognised awareness of te reo Maori and an understanding of tikanga Maori.”

Maurice Austin who is the current and soon-to-be-dispensed-with chairperson of the West Coast Ethics Committee commented recently in the Greymouth Evening Star that “consumers could be forgiven if they feel like pawns on a chess board in the midst of all this. They are caught in the endless competing struggles where the interests of policy planers, health researchers, and health practitioners variously prevail and whom assert they each know best what is good for us and how to deliver it.”

The call for ethics committees to be placed within the office of the Health and Disability Commissioner is now growing louder. It is a move that the AWHC has supported and argued for in numerous submissions made over many years. Maurice Austin believes there should be an investigation into this possibility. “This move would align with the expectations of the general public that the work of the HDC office is focused on protecting the interests of health and disability consumers and that it is seen to be independent from potential Minister-ial interference,” he said. “Such a shift would also assist considerably to retain some degree of public confidence that one of the best ethical review systems in the world is not about to be completely dismantled with barely an audible sigh.”

In the meantime hard copies of applications and CVs are due in to Gavin Koroi, Executive Assistant, Maori Health Policy & Strategic Projects, Maori Health Directorate at the Ministry of Health (fax (04) 495-4496) by 20 August 2004. The MOH email states that following receipt of the application form, the application will be endorsed by Ria Earp, Deputy Director-General of the Maori Health Directorate before being put forward to the Minister of Health.

August 2004


The Auckland Women’s Health Council (AWHC) is an umbrella organisation for individual women and women’s groups in the Auckland region who have a commitment to and an interest in women’s health issues. The focus of the Council is broad and spans many issues that are of interest to women, particularly those that impact on their health and the health of their families.

The Council was formed in 1988 and during the early years Council members took an active role in lobbying for implementation of the recommendations of the Cartwright report. This has included the Council making many submissions on matters related to research, teaching, the establishing and functioning of ethics committees, ethics committee guidelines, consumer representation on ethics committees, etc.

Despite this history of involvement in preparing submissions on matters pertaining to ethics and ethics committees, the Council is very concerned at not being included in the mailing list when “The draft operational standard for health and disability ethics committees” was sent out. The following submission has therefore been prepared in haste. It is however, consistent with the Council’s previous stance on many issues. The Council would also point out that its executive committee consists of a previous member of an ethics committee as well as a current one.

The AWHC begins its submission with some general comments on the discussion document and then provides comments on specific issues in the document.

General Comments
Since 1995 the AWHC has argued that ethics committees should be part of the Office of the Health and Disability Commissioner with the National Advisory Committee on Health and Disability Support Services Ethics taking responsibility for the administration, monitoring and reporting functions. (1) The Council continues to support this recommendation and would refer you to the copy we have enclosed of our previous submission.

The Council would also argue that the operational standard must apply to ALL health ethics committees, including those committees  which have been established and re-established within the hospitals (former HHS/CHEs) and similar committees in the private sector.

Part 1: Ethical Review
The AWHC recommends that the guiding principles (page 7) be listed with the most important ones appearing first on the list. The document states on page 6 “the goal of ethical review is to ensure the protection of the rights, health and welfare of individuals and research participants.” Therefore ‘respect for persons’ and ‘informed consent’ should be the first two on the list.

Relevant Legal Provisions
The Council believes that all the rights listed in the Code of Health and Disability Services Consumers’ Rights should be listed under this section (page 9), as there are other parts of the Code, which also apply – Right 9 for example.

The list under 27 Page 10) should also include the names of the people undertaking the research and how a research participant can contact them, a statement advising that they have the right to complain and how to go about this, and a statement advising that they have the right to withdraw from the research at any time without this affecting their treatment, future health care, etc.

Compensation for Patients and Human Participants
This section (page 15) is of concern to the AWHC, as the Council believes that it is not always made clear to participants that they may not be covered under the current accident compensation legislation. This situation is unlikely to get any better under the provisions in the bill before Parliament.

The AWHC recommends that the National Ethics Committees take responsibility for ensuring that all those people who take part in research are made aware of whether they are covered or not. This cannot be left to the regional ethics committees.

The statement under 61 is completely unacceptable.

Resource Allocation and Access Criteria
The AWHC has consistently recommended that resource allocations and access criteria be able to be ethically reviewed. We continue to support this position and the Council is therefore totally opposed to the three paragraphs listed at the top of page 28 – numbers 108, 109 and 110.

The public can have no confidence in decisions made around the allocation of resources and access criteria unless they are subject to ethical review.

Clinical Practice
Given the publicity in recent years to situations where a patient or a patient’s family do not agree with the decision made by a health practitioner as to their health care, the Council recommends that such situations be included in this section. When patients are not satisfied with the opinion(s) they have been given they or their family members should be able to apply for an ethical review of the case.

Part 4 Ethics Review System in the Health and Disability Sector
The AWHC has previously argued that a National Ethics Committee must have considerable independence from the Minister of Health. (1) The Council is strongly opposed to the National Committee being set up as an advisory committee to the Minister. Such a committee would lack credibility because of its lack of independence and its inability to undertake reviews without reference to the Minister.

The Council would refer you to the appropriate section on page 4 of our previous submission.

Given the Council’s historical and current interest and involvement in ethics committees the Council was extremely interested in the reference to a “National Health Research and Innovative Practice Review Committee” on page 32. The Council believes that information on this committee should be included in Appendix 5 “Other Committees” on page 84.

The National Ethics Committee on Assisted Human Reproduction
The AWHC believes that protection of the rights of people involved must include the child that is created as a result of assisted human reproduction. A statement is needed making it clear that this Committee has as an overriding concern the protection and promotion of the rights and welfare of the children born as a result of all forms of reproductive technologies.

As stated above all health ethics committees must be covered by the national standard.

The AWHC is strongly opposed to the proposal listed in 133 on page 33 that the Director-General of Health should have the power to alter the number of HDECs or their corresponding designation regions of authority. Nor should the Director-General be able to approve ethics committees – 138 on page 34.

Compensation and Membership
The Council supports the requirement that ethics committees must have a gender balance. Ethics committees must specifically include women with knowledge of women’s health issues.

Following the release of the Cartwright Report it became standard practice to include a health consumer advocate as part of the consumer representation on ethics committees. The AWHC recommends that this standard be reinstated as a requirement.

The Council is also concerned that there is no definition of a lay person, but there is a definition of a non-lay person. It is essential that lay persons are defined and that retired or non-practising health professionals come under the definition of non-lay persons. Over the past decade there has been a great deal written by consumer groups and women’s health organisations on consumer consultation, participation, and representation. (2) This work is an important part of the history of the establishment of ethics committees in New Zealand and must form a part of the ongoing development of standards.

Duties and Responsibilities of a Member
The AWHC would point out the typo under 1 on page 36. The commitment of all committee members is surely to the greater good of the general public, not the committee.

Conflicts of Interest
The AWHC supports the proposal that a committee member who has a research proposal before the ethics committee must leave the room when the proposal is being discussed by the committee.

Confidentiality (page 37) and Committee Meetings (page 40)
The AWHC lobbied hard in the early 1990s to ensure that regional ethics committee meetings were open to the public. The Council therefore supports the following:
• Ethics committee meetings must be held in public.
• Agendas and minutes of meetings must be made available to members of the public in the same way that agendas and minutes of District Health Boards are available. 
• Decisions made by ethics committees must be made by consensus.
• Committee members cannot be compelled to publicly support decisions made by their ethics committee or refrain from commenting publicly.
• Ethics committees must comply with both the requirements of the Privacy Act and the Official Information Act.

The standard must make it clear that only a lay person can be elected as an ethics committee chairperson as was the case when regional ethics committees were established in the wake of the release of the Cartwright Report.

Part 7  Research on participants from Special Populations

Cognitively impaired persons
Some Council members felt that there was an overemphasis on the difficulties that may be experienced by those who come under the definition of cognitively impaired. The Council recommends that there be consultation with the approp-riate consumer groups whenever research proposals are considered that involve persons from this special population.

The AWHC reiterates the point made under the previous section and recom-mends that it be stated that consultation with the appropriate community groups must be undertaken when ethics committees are considering research proposals that involve inmates.

The AWHC does not support the concept of inmates or any other participants in research being paid. Payments should only consist of reimbursement for travel expenses or childcare expenses and would therefore not apply to inmates.

Auckland Women’s Health Council

15 August 2001


1.  Auckland Women’s Health Council. Submission on the “Review of the Ethical Review Structure in New Zealand.” 29 October 1997.

2.  Federation of Women’s Health Councils. Consumer Consultation Representation and Participation. October 1992.

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