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Ethics - Ethics and regulatory

It is an expectation that with few exceptions an approval from a bona fide ethics committee is required to establish a research project at Auckland DHB. Approval from a Health and Disability Ethics Committees (HDECS; Ministry of Health) is the default expectation. However, if a research projects falls outside the scope of review of an HDEC Auckland DHB researchers may apply to the Auckland Health Research Ethics Committee. Ethical approvals from other institutional (University) ethics committees will be considered on a case by case basis.

Health and Disability Ethics Committees (HDECs)

Most clinical research and all clinical trials are reviewed by HDECs, which are operated by the Ministry of Health. There are four HDECs, Northern A, Northern B, Central and Southern. All are multi-regional and may review applications submitted from all parts of New Zealand. HDECs follow a standard operating procedure since 2012. This SOP will be reviewed and updated in 2021.

An HDEC approval is the default requirement for the acceptance of a research project by Auckland DHB. 

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

Link to HDEC online forms application process()

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 can review and approve health and disability research studies that :

1.  are not eligible for review by an HDEC (i.e. very low risk research);

2.  involve human participants from the geographic region served by the Auckland DHB or their health information;

3.  are conducted by Auckland DHB employees, University of Auckland staff, or University of Auckland students.

As Auckland DHB is a partner in the AHREC collaboration the AHREC application form can be used for Auckland DHB institutional research approval. However getting ethical approval from AHREC is not equivalent to obtaining Auckland DHB institutional approval. You must submit your fully authorised AHREC application along with the other study documents to the Research Office, which will coordinate locality resource and Maori responsiveness assessments. Ensure the section about impact on Auckland DHB is conscientiously completed and that the electronic form is authorised by the appropriate Auckland DHB head of department

Link to AHREC application process and form()

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.

The National Ethical Standards were updated in December 2019. The revised standards cover all health and disability research and quality improvement. These expand on previous guidelines issued by the NEAC in 2012 and bring together the Ethical Guidelines for Observational Studies and the Ethical Guidelines for Intervention Studies into one document, and also aims to cover gaps and new ethical issues that have become apparent since the 2012 Guidelines.

The National Ethical Standards will help all researchers including new researchers and in-training researchers, foster awareness of ethical principles and enhance more rapid translation of research into clinical practice and health services delivery.

Link to the NEAC Standards ()

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.

 

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 ()

Current ICH-GCP

ICH 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)()

Visit our Resources page for link to GCP training and certification.