Background

The National Ethics Advisory Committee (NEAC) is an independent advisor to the Minister of Health. NEAC was established in 2001 under section 16 of the New Zealand Public Health and Disability Act 2000.

The National Ethics Advisory Committee’s statutory functions are to:

• provide advice to the Minister of Health on ethical issues of national significance in respect of any health and disability matters (including research and health services)
• determine nationally consistent ethical standards across the health and disability sector and provide scrutiny for national health research and health services.

Reviewing the ethical guidelines

In 2015 NEAC committed to review the 2012 Ethical Guidelines for Intervention Studies and Ethical Guidelines for Observational Studies: Observational Research, Audits and Related Activities. The Ministry of Health set up a working party to review the 2012 guidelines and develop new standards determined by NEAC.

This work aligns with the Health Research Strategy 2017, which addresses investment and strengthening health research in New Zealand, particularly focusing on reducing inequity and improving health outcomes. The ethical guidelines also a part of a general strengthening of the regulatory environment for health research, as the Therapeutic Products Bill recognises that ethics is an integral part of research conduct, resulting in the protection and safety of research participants.

Consulting on the draft ethical standards

The Draft National Ethics Standards for Health and Disability Research sets out the established ethical standards that apply to all health and disability research in New Zealand.

The draft standards are mostly targeted at individual researchers but are also useful to ethics committees, research sponsors and for training and educating researchers.

NEAC has reviewed the draft standards and now seeks the views and feedback of the public.

How to have your say

Consultation is open until 5 pm, 28 September 2018.

Due to a number of requests for late submissions the deadline for submission has been extended from 20 September until 28 September 2018.

To take part in the consultation, please complete the online consultation at the Health Consultation Hub.

If you cannot complete the consultation online please print out this document, write your submission and send it to:

NEAC Secretariat
Ministry of Health
PO Box 5013
Wellington 6011

There will also be public face-to-face meetings during the consultation. These will be added to this page once confirmed.

If you have any questions, please contact us by email at neac@moh.govt.nz.

NEAC is seeking feedback on the following:

• whether the Standards are fit for purpose: are the contents of the Standards helpful, clear, relevant and workable?
• whether the Standards covers all relevant ethical issues: are there matters missing which on topics where ethical guidance should be provided? Are there any conflicts with other standards, laws or current pieces of work that should be considered?
• general feedback: should any paragraphs be amended? Are there terms that are confusing or could be better defined?

NEAC is aware of the complexity of ethical issues surrounding health and disability research. Therefore the consultation document provides the opportunity to provide detailed feedback on specific areas of the draft standards. As a submitter you are welcome to provide as much or little feedback as you want.