Auckland Health Research Ethics Committee (AHREC)

AHREC is an institutional ethics committee for Auckland DHB run in partnership with the University of Auckland under the Auckland Academic Health Alliance. AHREC reviews all health and disability research studies that fulfil all the following criteria:

1.  The study is not eligible for review for ethics approval by an HDEC.

2.  The study involves recruiting human participants from the geographic region served by the Auckland DHB.

3.  The study involves health research conducted by any of the following: an Auckland DHB employee, a University of Auckland staff, a University of Auckland student.

If your study involves Auckland DHB and you are seeking AHREC ethical approval you may not have to complete separate forms for AHREC and the Auckland DHB expedited approval process. The AHREC form can be used for both processes provided the section about impact on Auckland DHB is completed and the form is authorised (signed) by the appropriate Auckland DHB head of department. Contact the Research Office if in doubt.

Link to AHREC application process and form(external link)

Clinical Ethics Advisory Group (CEAG)

CEAG is a multidisciplinary group who provide support and advice to health professionals at Auckland DHB regarding a wide range of clinical ethical issues, to help them make their own ethical decision.

The committee does not assist with ethical aspects of research studies or direct legal matters.

If you would like support and advice on an ethical issue, please do not hesitate to contact us either through the link below or the Auckland DHB intranet.

Guide and Contact for CEAG.

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]

Link to HDEC online forms application process(external link)

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

Under section 30 of the Medicines Act, approval from the Director-General of Health is required before a clinical trial using a new medicine may commence in New Zealand. The approval process for clinical trials is administered by Medsafe.  The Health and Disability Ethics Committees administer the ethics approval system, which applies to all clinical trials conducted in New Zealand.

Approvals under other legislation may be required for clinical trials using certain types of medicines.

All clinical trials in New Zealand are expected to be conducted in accordance with internationally accepted Good Clinical Practice standards, even those that do not require approval under section 30

Medsafe - Guideline on the Regulation of Therapeutic Products in New Zealand – Part 11 – Clinical trials – regulatory approvals and good clinical practice requirements. Edition 2 – November 2018 (external link)

Current ICH-GCP

Good  Clinical  Practice  (GCP)  is  an  international  ethical  and  scientific  quality  standard  for designing, conducting, recording and reporting trials that involve the participation of human subjects. Compliance with this standard provides public assurance that the rights, safety  and well-being of trial subjects are protected, consistent with the principles that have their origin in the Declaration of Helsinki, and that the clinical trial data are credible.

Guide to current Good Clinical Practice E6(R2)(external link)

Auckland DHB is committed to clinical research excellence and growing capability in the research workforce. 

Evidence of recent ICH-GCP training has been compulsory for all named investigators on new applications for research approval of interventional studies and clinical trials at Auckland DHB. Training certification should be renewed every two years. Transcelerate BioPharma Inc (free) [DOC, 626 KB](external link)