New Zealand Health and Disability Ethics Committees


 
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Guidance and Resources

Guidance on Ethical Research Review



Review of Research Proposals


Operational Standard for Ethics Committees

The Operational Standard for Ethics Committees (2006) provides guidance on principles that should be considered when reviewing research proposals, and sets out consistent operational and administrative procedures common to all ethics committees.

The Operational Standard replaces the 1996 National Standard for Ethics Committees.

Ethical Guidelines for Observational Studies

Guidance on undertaking Observational Studies, including when ethics committee review is required.

Guidelines on Using Cells from Established Human Embryonic Stem Cell Lines for Research

The guidelines allow New Zealand researchers to use cells from established hESC lines in research with a number of restrictions, including mandatory ethical review of hESC research applications.

Guidelines for the Use of Human Tissue for Future Unspecified Research Purposes

The guidelines allow New Zealand individuals to give consent to their tissue being used for future unspecified research, subject to having been provided with sufficient information and options for consent.

Guidelines for Researchers on Health Research Involving Māori

The Health Research Council’s Māori Health Committee has produced these Guidelines to assist researchers who intend undertaking biomedical, public health, or clinical research involving Māori participants or on issues relevant to Māori health

Health Information Privacy Code

This code sets specific rules for agencies in the health sector to better ensure the protection of individual privacy. The code addresses the health information collected, used, held and disclosed by health agencies. For the health sector the code takes the place of the information privacy principles.

The Code of Health and Disability Services Consumers' Rights

The Code of Health and Disability Services Consumers' Rights is a regulation under the Health and Disability Commissioner Act. It confers a number of rights on all consumers of health and disability services in New Zealand, and places corresponding obligations on providers of those services.
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Research in General


Ethics in Health Research

Although the Health Research Council designed these Guidelines for the former system of ethical review, they still contain useful information on a range of topics from conflicts of interest to health information privacy.

Guidelines for an Accredited Institutional Ethics Committee to Refer Studies to an Accredited Health and Disability Ethics Committee

Accredited health and disability and institutional ethics committees conduct ethics review of applications received by the Health Research Council of New Zealand. If the committee is not accredited, then the research proposal must be reviewed by another committee that is accredited by the HRCEC

Ethics Review newsletter

Ethics Review is a newsletter produced by the National Co-ordinator of Ethics Committees that provides researchers and other interested parties with regular news and updates on New Zealand's system of ethical review.

Ethics Review is not published in hard copy.
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Specific Types of Research

Guidance to assist researchers conducting specific types of research.

Ethical Considerations Relating to Research in Human Genetics

This document was produced by the Health Research Council to assist researchers in the field of human genetics.

All research involving the manipulation of human genetic material must be approved by the Gene Technology Advisory Committee, as well as by a health and disability ethics committee. Part 6 of the National Application Form for Ethical Review of a Research Project must be completed.

Consent in Child and Youth Health: Information for Practitioners

This publication provides child and youth health practitioners with information about the ethical and legal requirements of consent. It explores issues where there is lack of clarity and provides guidance which may assist in preventing difficult issues arising. It aims to build practitioner confidence and encourage positive and safe practice.

Guidelines on Pacific Health Research

The Health Research Council has produced these Guidelines to assist research with Pacific peoples living in Aotearoa, New Zealand.

Guidelines from Operational Standard for Ethics Committees

The Operation Standard for Ethics Committees (2006) contains a number of short guidelines for specific types of research as appendices. Part 7 of the National Application form must be completed for research involving participants who are unable to consent themselves (eg children, unconscious participants).

These guidelines are for research involving:
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Clinical Research

Resources relating to clinical research.

Interim Good Clinical Research Practice Guideline

This guideline aims to make those involved in the design, performance and analysis of clinical studies aware of the minimum requirements for high quality research.

Researched Medicines Industry Guidelines

The Researched Medicines Industry has produced a set of Guidelines on Clinical Trials: Compensation for Injury Resulting From Participation in an Industry Sponsored Clinical Trial.

The Guidelines are voluntary and are adapted from those of the Association of the RMI website (www.rmianz.co.nz)
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International Guidelines

Guidelines used overseas.

Declaration of Helsinki (www.wma.net)

Council for International Organizations of Medical Sciences, International Ethical Guidelines for Biomedical Research Involving Human Subjects (www.cioms.ch)

ICH Guideline for Good Clinical Practice (www.emea.europa.eu)

Operational Guidelines for Ethics Committees that Review Biomedical Research (WHO, 2000) (www.who.int)

National Statement on Ethical Conduct in Research Involving Humans (Australian Government, 1999) (www.nhmrc.gov.au)

Research Participants


Resources relating to research participants.

Information for Potential Participants in Clinical Trials

This document provides information aimed at those who are considering participating in a clinical trial of a medicine or pharmaceutical product.

The document is available here courtesy of Merck Sharp and Dohme (NZ).

Information for Potential Participants in Clinical Trials (Word, 34 KB)


Page last updated: 25 March 2008
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