Guidance and Resources

Related Committees and Organisations

Related committees operating in New Zealand. There is also a list of overseas committees and organisations.

• National Ethics Advisory Committee
• Health Research Council Ethics Committee
• Advisory Committee on Assisted Reproductive Technology
• Ethics Committee on Assisted Reproductive Technology
• Toi te Taiao: the Bioethics Council
• Institutional Ethics Committees
• Gene Technology Advisory Committee
• Standing Committee on Therapeutic Trials
• Useful Links

National Ethics Advisory Committee (NEAC)

The National Ethics Advisory Committee (NEAC) (www.neac.health.govt.nz) is an independent ministerial advisory committee established under section 16 of the New Zealand Public Health and Disability Act 2000. The National Ethics Advisory Committee's statutory functions are to:

• provide advice to the Minister of Health on ethical issues of national significance in respect of any health and disability matters (including research and health services)
• determine nationally consistent ethical standards across the health and disability sector and provide scrutiny for national health research and health services.

In undertaking its functions, the National Ethics Advisory Committee is expected to:

• provide advice on priority issues of national significance as requested by the Minister of Health
• provide advice to the Minister of Health regarding ethical issues concerning emerging areas of health research and innovative practice. The advice is to include the National Ethics Advisory Committee's rationale for its advice and any relevant evidence and/or documentation
• provide advice to the Minister of Health regarding aspects of ethical review in New Zealand, including the setting of principles and guidelines in relation to each of the different types of health research and innovative practice. The advice is to include the National Ethics Advisory Committee's rationale for its advice and any relevant evidence and/or documentation
• develop and promote national ethical guidelines for health research and health and disability support services (the guidelines should address how to conduct different types of health research [including ethical issues relating to Maori health research] and innovative practice in an ethical manner and should establish parameters for, and provide guidance on, the ethical review of such types of health research and health and disability support services)
• monitor and review the operation of the health and disability ethics committees for the purposes of providing direction, guidance and leadership to ensure the ongoing quality and consistency of ethical review in the health and disability sector
• undertake its tasks in a manner consistent with the principles of the Treaty of Waitangi;
• develop guidelines on conducting observational studies in an ethical manner and establish parameters for the ethical review of observational studies (including guidance regarding weighing up the harms and benefits of this type of research).

Health Research Council Ethics Committee (HRCEC)

The Health Research Council Ethics Committee (www.hrc.govt.nz) is an HRC statutory committee established under section 24 of the Health Research Council Act 1990.

The functions of the committee are to:

• consider and make recommendations to the Council on ethical issues in relation to health research, especially those emerging through the development of new areas of health research
• provide and review ethical guidelines for the Council
• ensure that, in respect of each application submitted to the Council for a grant for the purposes of health research, an independent ethical assessment of the proposed health research is made either by the Ethics Committee itself or by a committee approved by the Ethics Committee
• make an independent ethical assessment of the proposed health research, where an application for a grant for the purposes of health research is submitted to the Council in respect of health research that is of national importance or great complexity
• review, at the request of any person who has made an application for a grant for the purposes of health research, the independent ethical assessment made, in respect of the proposed health research, by a committee approved under paragraph (c) of this subsection
• give, in relation to ethics committees established by other bodies, advice on
• the membership of those committees
• the procedures to be adopted, and the standards to be observed, by those committees
• provide independent comment on ethical problems that may arise in any aspect of health research
• perform any other functions (whether or not related to health research) it is for the time being –
• given by or under any enactment; or
• authorised to perform by the Minister, by written notice to the Health Research Council after consultation with it.

Advisory Committee on Assisted Reproductive Technology

The Advisory Committee on Assisted Reproductive Technology (ACART) (www.acart.health.govt.nz) has been established under the Human Assisted Reproductive Technology (HART) Act 2004.

As an independent advisory committee, ACART sits between the government and the people of New Zealand and formulates advice and guidelines for the regulation of assisted human reproduction. ACART is required to undertake extensive public consultation before issuing advice or finalising guidelines.

Ethics Committe on Assisted Reproductive Technology

The Ethics Committee on Assisted Reproductive Technology (ECART) (www.ecart.health.govt.nz) is established and designated under section 27 of the Human Assisted Reproductive Technology (HART) Act 2004. ECART's Terms of Reference require it to consider and determine applications for assisted reproductive procedures or human reproductive research and keep under review approvals previously given.

In addition, ECART shall liaise with ACART and other relevant ethics committees on matters relating to assisted reproductive procedures and human reproductive research.

Toi te Taiao: the Bioethics Council

The Bioethics Council (www.bioethics.govt.nz) was established in December 2002 in response to the recommendations of the Royal Commission on Genetic Modification. The functions of Toi te Taiao: the Bioethics Council are to:

• provide independent advice to Government on biotechnological issues involving significant cultural, ethical and spiritual dimensions
• promote and participate in public dialogue on cultural, ethical and spiritual aspects of biotechnology, and enable public participation in the Council's activities
• provide information on the cultural, ethical and spiritual aspects of biotechnology.

Institutional Ethics Committees

Institutional ethics committees are run by New Zealand universities and private companies. The Health Research Council Ethics Committee has produced referral guidelines to clarify when an institutional ethics committee should refer a study to the appropriate health and disability ethics committee.

All seven ministerial health and disability ethics committees have also been approved by the Health Research Council Ethics Committee.

Auckland University of Technology Ethics Committee
Lincoln University Human Subjects Ethics Committee
Massey University Human Ethics Committee
UNITEC Research Ethics Committee
University of Auckland Human Subjects Ethics Committee
University of Otago Human Ethics Committee
Victoria University of Wellington Human Ethics Committee
Zenith Technology Corporation Human Ethics Committee
Gene Technology Advisory Committee

Gene Technology Advisory Committee (GTAC)

The Gene Technology Advisory Committee (GTAC) (www.hrc.govt.nz) advises the Health Research Council.

GTAC is to review, for the purposes of seeking an exemption under Section 30 of the Medicines Act (1981) or as required by an accredited ethics committee or the HRC or any of its committees, proposals for clinical trials:

• which include the introduction of nucleic acids (genetically manipulated or synthesised in the laboratory) or genetically manipulated microorganisms, viruses or cells into human subjects for the purpose of gene therapy or cell marking
• in which the introduction of nucleic acids (genetically manipulated or synthesised in the laboratory), or genetically manipulated microorganisms, viruses or cells is designed to stimulate an immune response against the subject's own cells, as in the treatment of certain cancers
• in which nucleic acids either from or within cells from animal species are transferred into humans for the purpose of disease treatment i.e. xenotransplantation
• in which human nucleic acids have been introduced into the genome of an animal species, including genetically manipulated microorganisms, for the purpose of developing products to be used for either disease prevention or treatment in human subjects
• involving vaccines in which nucleic acids (genetically manipulated or synthesised in the laboratory) or genetically manipulated microorganisms, viruses or cells have been introduced to stimulate an immune response to antigenic determinants of an infectious agent.

Standing Committee on Therapeutic Trials (SCOTT)

The Standing Committee on Therapeutic Trials (SCOTT) (www.hrc.govt.nz) and reviews proposed clinical trials on pre-registration medicines to:

• assess whether or not the proposed clinical trial of a medicine will provide clinically and scientifically useful information, particularly in relation to the safety and efficacy of the agent
• assess the ability of the triallists to conduct the trial
• attempt to improve trial design and the quality of clinical pharmacological research with particular respect to:
  • power analysis and the need for triallists to satisfactorily justify their choice of numbers of subjects to be recruited to a trial
  • efficacy and the need to establish criteria for clearly determining effectiveness of treatment
  • toxicity
• review the merit of clinical trials submitted to the Council for research funding when requested by the Chief Executive of the HRC.

All clinical trials involving pre-registration medicines will need the approval of SCOTT to proceed.

SCOTT is a committee of the Health Research Council. It is convened to provide recommendations to the Director-General of Health on the scientific validity of applications for clinical trials on new medicines.

Section 30 of the Medicines Act 1981 empowers the Director-General of Health, on the advice of the HRC, to permit the use of medicines that have not received marketing consent to be used in clinical trials for the purpose of obtaining clinical and scientific information.

Trials involving post-registration medicines do not need the approval of SCOTT, but will still need to undergo the ethical review process.

Useful Links

International
World Health Organisation (www.who.int)

World Medical Association (www.wma.net)

International Bioethics Committee, United Nations Educational, Scientific and Cultural Organisation (portal.unesco.org)

Council for International Organisations of Medical Sciences (www.cioms.ch)

International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (www.ich.org)

Australia
Australian Health Ethics Committee, National Health and Medical Research Council (www.nhmrc.gov.au)

Canada
National Council on Ethics in Human Research (www.ncehr.medical.org)

Canadian Institutes of Health Research (www.cihr-irsc.gc.ca)

Denmark
Danish Council of Ethics (www.etiskraad.dk)

Finland
National Advisory Board on Health Care Ethics (www.etene.org)

France
National Consultative Ethics Committee for Health and Life Sciences (www.ccne-ethique.fr)

Germany
National Ethics Council (www.nationalerethikrat.de)

Greece
National Bioethics Commission (www.bioethics.gr)

Iceland
National Bioethics Committee (www.visindasidanefnd.is)

Italy
National Bioethics Committee (www.palazzochigi.it)

Norway
National Committee for Medical Research Ethics (www.etikkom.no)

Portugal
Conselho Nacional de Ética para as Ciências da Vida (www.cnecv.gov.pt)

Sweden
National Council on Medical Ethics (www.smer.gov.se)

United Kingdom
NHS Central Office of Regional Ethics Committees (www.nres.npsa.nhs.uk)

Nuffield Council On Bioethics (www.nuffieldbioethics.org)

United States
The President's Council on Bioethics (www.bioethics.gov)
Office for Human Research Protections (www.hhs.gov)


Page last updated: 13 December 2007