About trials in New Zealand
Why run a clinical trial in New Zealand?
New Zealand has a well-established clinical trial infrastructure supported by a collaborative health system and an active industry body, the New Zealand Association of Clinical Research (NZACRes). Researchers have access to first class clinical trial facilities and work alongside world leaders in medical research.
What are the guidelines for clinical trials in New Zealand?
Ethical approval is required for all clinical trials in New Zealand and researchers must ensure that their health and disability research is conducted lawfully. The Health and Disability Ethics Committees (HDEC) are responsible for decisions that may have legal and ethical consequences.
What is the ethics approval process and how do I apply?
Health & Disability Ethics Committee (HDEC) approval is required for all research involving humans. Only one ethics committee review is required per study in New Zealand and this covers all sites. It takes 4-6 weeks from submission to full approval. The process is not difficult, but it's important to know the documents to prepare, the groups to be contacted and the processes to follow.
What are the regulations for conducting a clinical trial in New Zealand?
Medsafe’s Health Research Council (HRC) maintains two standing committees to consider clinical trial applications and make recommendations to the Ministry of Health's Director-General. ‘The HRC is committed to ensuring that all research involving human participants is based on good science, meets ethical standards, and complies with international best practice.’
What does a good trial look like?
All clinical trials in New Zealand are expected to be conducted in accordance with the internationally accepted standards of Good Clinical Practice (GCP). Its spirit should permeate all clinical research and It is essential that doctors, nurses and other health professionals involved in a clinical trial are familiar with GCP requirements.
How do I talk to potential participants?
Researchers have a duty to make sure that potential clinical trial participants fully understand the trial and what their involvement means. It is likely that potential participants who have a greater knowledge of the clinical trial process will feel more comfortable taking part.
Are there standard Indemnity and Clinical Trial Agreements?
Yes. Whether you are a researcher involved in a collaborative clinical trial project, a researcher involved in a commercially sponsored trial, or a contract research organisation, you will need to develop an agreement between the parties involved in the research. You may also need to arrange for indemnity for your research institution, ethics committee or research premises.