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Foreword by NEAC Chairperson

The National Ethics Advisory Committee (NEAC) is an independent advisor to the Minister of Health. NEAC’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.

A central focus of NEAC’s role is to set the national standards for the ethical conduct of research involving human participants that apply to all health and disability research in New Zealand. In 2015 NEAC committed to review the Ethical Guidelines for Intervention Studies and Ethical Guidelines for Observational Studies: Observational Research, Audits and Related Activities. Though these two documents were updated in 2012, the present iteration represents the first major reconsideration of the Standards since their inception.

The revised Standards merge the two sets of guidelines into one cohesive document, which also aims to cover gaps and new ethical issues that have become apparent since the 2012 Guidelines.

Human participant research is the recognised basis for improved understanding of health and disability outcomes. Hence, there is a strong ethical imperative to research, and a necessity to involve human participants in research.

The Standards form part of the strengthened regulatory framework to continue to support a productive and safe clinical trials research environment in New Zealand. They aim to provide protections for those who are asked to participate in research, and those who do participate, ensuring that their rights and well-being are central.

They also aim to reassure the New Zealand public, as potential participants in and potential beneficiaries or sponsors of research that the research enterprise is trustworthy, and that it is worth their participation, confidence, investment and support.

Public trust in the ethical integrity of the research enterprise is increasingly important. The continual development of new research methods requires oversight of their ethical implications, as is the case with research using large data sets. Ethical oversight and governance of research is an important contributor to this trust.

From the outset of this revision, it has been NEAC’s intention to integrate Māori values into the fabric of the guidelines. The values used for this purpose are those originally developed for Te Ara Tika - Guidelines for Māori Research Ethics. Internationally recognised values of bioethics, which are found in similar sets of health and disability research guidelines in many parts of the world, sit alongside the Māori values.

Significant efforts have also been made to reflect the aspirations and values of the disability community, recognising the important distinction between ill-health and disability, and trying to reflect consequent ethical distinctions.

For the first time, the Standards will be available principally on line. This will we trust, make their use easier and enable them to be a living document in response to innovations in research methods and models.

NEAC commends the work of the Guidelines Working Party which produced the bulk of the Standards, and we thank all those individuals and groups who have engaged in our consultation processes, which made a significant contribution to the guidelines as they now stand. We believe they will be of national and international significance.

Dr Neil Pickering
Chair, National Ethics Advisory Committee