Ethical Approval
Seven Ethics Committees (divided by region) operate in New Zealand utilising one National Application Form (NAF).
For clinical trials that include one or more sites within one Ethics Committee’s region, the appropriate regional Ethics Committee must be used.
For a clinical trial with sites located across more than one Ethics Committee region, only one Ethics Committee submission / approval is required (submissions are to be made to the Multi-Region Ethics Committee).
Applications are to be submitted 2-3 weeks prior to the monthly meeting dates. Applicants should allow a total of 2-3 months for final ethics approval. There are currently no submission fees.
There is a need to ensure that issues of relevance to Maori, the indigenous people of New Zealand, are addressed. Ethics Committees have an obligation consistent with section 4 of the New Zealand Public Health and Disability Act 2000 and He Korowai Oranga, to ensure research recognises and respects the principles of the Treaty of Waitangi. Ethics Committees will require evidence of appropriate consultation with the relevant groups.
Clinical trial sites and Clinical Research Organisations in New Zealand have access to the relevant groups in order to facilitate the consultation process. There is no cost associated with this process.
Ethical review in New Zealand can also be undertaken via an expedited process, however this is only appropriate for some non-interventional studies.
For more information, including meeting dates and application forms , click here
