New Operational Standard For Ethics Committees
8 April 2002
The new Operational Standard for Ethics Committees promotes the highest standards of ethical behaviour among researchers and health care agencies, says Ministry of Health Spokesperson Dr Gillian Durham.
The Ministry today released the Standard, which will be a useful resource for ethics committees considering emerging ethical issues.
"Ethics committees often have to make difficult decisions on research and new areas of practice. The Standard responds to the need for guidance when ethics committees are considering research proposals," says Dr Durham.
"In particular, new guidance is provided on ethical issues arising from research involving children, people with intellectual disabilities, unconscious participants, clinical evaluation of established therapeutic practices, people with terminal illnesses, older persons, health participants and Maori."
Dr Durham says the Standard also addresses the need for a balance between ethics and research.
"Research must be safe and ethical. The public good of research on the development of scientific knowledge and new medical treatments needs to be balanced with issues of individual safety and health-consumer rights."
Considerable changes have occurred since the 1996 National Standard for Ethics Committees came into use and the Standard has been updated accordingly.
"We know the health sector has been wanting to see the updated Standard for some time. We've been working on it since 1999, but needed to include the recommendations of the Gisborne Cervical Screening Inquiry, changes to New Zealand Health Services through the New Zealand Public Health and Disability Act 2000 and the establishment of the National Ethics Committee."
A group including representatives of health and disability ethics committees, university ethics committees, the Health Research Council and bioethicists has advised the Ministry of Health on the Standard.
"The Ministry worked closely with experts to draw up revised guidelines, which were then circulated for public discussion and comment. Following this consultation, the Standard was developed," says Dr Durham.
The Operational Standard is available on the Ministry's website (www.moh.govt.nz)
The Ministry of Health published the first Standard for Hospital and Area Health Board Ethics Committees Established to Review Research and Treatment Protocols in 1988 following the inquiry into the treatment of cervical cancer at National Women's Hospital.
Since then the Standard has undergone a series of revisions to reflect the growing experience, expertise and knowledge being accumulated by health and disability ethics committees. Each revision has aimed to facilitate the effective operation of ethics committees and promote the highest standard of ethical behaviour among researchers and providers.
In July 1999 work commenced on reviewing the 1996 National Standard for Ethics Committees (National Standard). The goal of the review was to provide a more comprehensive resource to guide ethics committees reviewing research and innovative practice. Following extensive consultation, the 2001 Operational Standard for Ethics Committees (Operational Standard) was developed.
The roles of the National Advisory Committee on Health and Disability Support Services Ethics (National Ethics Committee), the National Ethics Committee on Assisted Human Reproduction, and the Health Research Council Ethics Committee are recognised in the Operational Standard. The National Ethics Committee will be responsible for future revisions to the Standard.
Researchers and health professionals continue to challenge the boundaries of modern health care through the expansion of scientific knowledge and the resulting development of new treatments and technologies. This Operational Standard provides guidance on a number of principles that should be considered when reviewing research proposals, and sets out consistent operational and administrative procedures common to all ethics committees.
National Ethics Committee
The National Ethics Committee is a Ministerial advisory committee established under the New Zealand Public Health and Disability Act 2000. The National Ethics Committee is established by and accountable to the Minister of Health.
Twelve members have been appointed to the National Ethics Committee. Each member has a term of office of up to three years.
The National Ethics Committee's statutory functions include: providing advice to the Minister of Health on ethical issues of national significance on health and disability matters; determining nationally consistent ethical standards across the health and disability sector; and providing scrutiny for national health research and health services.
The National Ethics Committee on Assisted Human Reproduction
This is a Ministerial committee established under the New Zealand Public Health and Disability Act 2000. Its functions include: reviewing assisted human reproductive proposals; developing protocols and guidelines relating to the ethical issues involved with aspects of assisted human reproduction for providers; advising the Minister of Health on ethical issues relating to satisfied human reproduction; and considering any other matters relating to assisted human reproduction the Minister of Health from time to time determines.
Health Research Council Ethics Committee
The Health Research Council Ethics Committee is a statutory committee established under the Health Research Council Act 1990. Its functions include considering and making recommendations to the Health Research Council on ethical issues in relation to health research and providing and reviewing ethical guidelines for the Health Research Council.
Health and Disability Ethics Committees
Health and disability ethics committees are funded and indemnified by the Ministry of Health to provide independent ethical review of research and innovative practice that will be conducted in their designated region of authority.