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.
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.
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
- Auckland Women’s Health Council. Submission on the Review of the Ethical Review Structure in New Zealand. 29 October 1997.
- Federation of Women’s Health Councils. Consumer Consultation Representation and Participation. October 1992.