NZ guidelines & ethics committees

Standard Operating Procedure for NZ Health and Disability Ethics committees (HDEC 2012)

Provides guidelines for the constitution and operation of HDECs accredited to consider proposals for research on human participants and innovative treatment.

Standard Operating Procedure for NZ Health and Disability Ethics Committees (HDEC 2012) document. [DOCX, 307 KB]

National Ethics Advisory Committee

The National Ethics Advisory Committee – Kāhui Matatika o te Motu (NEAC) is an independent advisor to the Minister of Health on ethical issues related to health and disability research and services.

NEAC published revised ethical guidelines for health and disability research in New Zealand to align with the Ministry of Health’s new procedural rules for Health and Disability Ethics Committees.

Ethical Guidelines for Intervention Studies (2012) [DOC, 186 KB] 

Ethical Guidelines for Observational Studies: Observational Research, Audits and Related Activities (2012) [DOC, 186 KB] 

Health & Disability Ethics Committees  (external link)

Medsafe guidelines for clinical trials

Medsafe - Guideline on the Regulation of Therapeutic Products in New Zealand – Part 11 – Clinical trials – regulatory approvals and good clinical practice requirements – November 2012 [DOC, 1.8 MB] 

Current ICH-GCP

Guide to current Good Clinical Practice for Research Guidelines for New Zealand – European Medicines Association – Note for Guidance on Good Clinical Practice (CPMP/ICH/135/95)  [PDF, 579 KB]