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National Ethics Advisory Committee
Kāhui Matatika o te Motu
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Ethics of Intervention Studies: Discussion Document and draft Ethical Guidelines for Intervention Studies
Date of publication: June 2008
The National Ethics Advisory Committee – Kāhui Matatika o te Motu (NEAC) has developed draft guidelines for intervention studies. The document gives guidance about conducting intervention studies in an ethical manner, and aims to facilitate high quality studies, protect the interests of participants, and foster public assurance of good study conduct. NEAC is seeking feedback on its Discussion Document and draft Ethical Guidelines for Intervention Studies (the Guidelines), available below, to make the proposed Guidelines as useful as possible.
Health professionals offer ‘interventions’ to prevent, diagnose or treat illness or disease. They need to know which interventions are safe and effective for the people who seek their help. Intervention studies are their main source of reliable information on this subject. In these studies, the investigator intervenes and then studies the effects of the intervention. A clinical trial of a new blood pressure medicine is an example of an intervention study.
Intervention studies are important because they allow clinician-investigators to exercise the sort of critical thinking, innovation and evidence-based development of practice that improves patient care. Facilitating high quality intervention studies can also help health care providers to attract and retain good staff. In short, high quality intervention studies are good for patient care.
NEAC’s Discussion Document and draft Guidelines on intervention studies aim to contribute to better health outcomes and reduced health inequalities for New Zealanders by assisting researchers to perform sound intervention studies.
The Discussion Document and the draft Guidelines pursue these aims by:
identifying ethical issues for intervention studies in New Zealand
considering how these issues are currently addressed
identifying which issues need to be addressed more effectively
proposing options for addressing these issues more effectively.
This publication is divided into two parts:
Part A (Discussion Document) identifies central ethical issues in intervention studies, and core ethical ideals that are important in addressing those issues.
Part B (draft Ethical Guidelines for Intervention Studies) seeks to achieve the aims outlined in the Discussion Document.
NEAC invites feedback on any aspect of the Discussion Document and/or draft Guidelines from a wide range of people with an interest in health and disability research ethics, including researchers, health professionals, planners, policy makers and members of the public.
Your feedback is invited by Wednesday 23 July 2008.
Information on how to respond is in the consultation document.
Please email
neac@moh.govt.nz
if you would like a copy of this publication
or download this document below:
Ethics of Intervention Studies: Discussion Document and draft Ethical Guidelines for Intervention Studies (PDF, 1 MB)
Related information
Bibliography - Ethics of Intervention Studies Discussion Document and draft Ethical Guidelines for Intervention Studies (PDF, 160 KB)
This bibliography contains a full list of all works consulted in the preparation of the publication above: Ethics of Intervention Studies. Hyperlinks to relevant websites and documents have been provided where possible.
Media Release
Media release from the Chair of NEAC, Andrew Moore.
Related NEAC guidelines
Ethical Guidelines for Observational Studies: Observational Research, Audits and Related Activities (NEAC 2006)
Useful links
New Zealand
Ministry of Health
http://www.moh.govt.nz
Operational Standard for Ethics Committees: Updated Edition (PDF)
Health Research Council, New Zealand
http://www.hrc.govt.nz
Guidelines on Ethics in Health Research
Medsafe (New Zealand Medicines and Medical Devices Safety Authority)
http://www.medsafe.govt.nz
New Zealand Regulatory Guidelines for Medicines: Volume 3: Interim Good Clinical Practice Research Guideline (Word)
International
Council for International Organisations of Medical Sciences (CIOMS)
http://www.cioms.ch
International Ethical Guidelines for Biomedical Research Involving Human Subjects
World Medical Association
http://www.wma.net
World Medical Association Declaration of Helsinki: Ethical Principles for Medical Research Involving Human Subjects (PDF)
International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use Expert Working Group
http://www.ich.org
ICH Harmonised Tripartite Guideline: Guideline for Good Clinical Practice
(PDF)
Page last updated: 11 Jun 2008
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