Māori, as the indigenous people of New Zealand, and the Crown are signatories to Te Tiriti o Waitangi/The Treaty of Waitangi, which sets the foundation for the enduring relationship between Māori and the Crown as equal partners. The Government – representing the Crown – continues to respond to its obligations to honour the Treaty relationship. Māori seek to seek to overcome the particular challenges they still face in the postcolonial context, and participate equally in the partnership defined by the Treaty’.
Three principles derived from the Treaty of Waitangi, rangatiratanga (partnership), whai wahi (participation) and kaitiakitanga (protection) should inform the interface between Māori and research (Royal Commission on Social Policy 1988):
The Treaty partnership provides an opportunity to design together an advanced national health and disability research ethics platform that encompasses two world ethical views: that of western ethics and that of tikanga Māori (Māori ethics).
These Standards extend the work of previous committees, in that they now incorporate tikanga Māori, and make more logical links between Māori research theory and practice. In so doing, they are consistent with the strategic priorities of the New Zealand Health Research Strategy (Ministry of Business, Innovation and Employment and
Ministry of Health 2017). That strategy contains four guiding principles: research excellence, transparency, partnership with Māori and collaboration for impact.
These Standards also recognise He Korowai Oranga – the Māori Health Strategy (Ministry of Health 2014b), ’Ala Mo’ui: Pathways to Pacific Health and Wellbeing (Ministry of Health 2014a) and the principles of Vision Mātauranga to:
Research excellence entails embracing and valuing a range of research approaches and methodologies that are fit-for-purpose and rigorous. Those approaches and methodologies must also meet the underlying need to conduct ethical research that keeps research participants safe, protects the privacy of individuals and respects the mana (status and authority) of families and whānau and acceptable to communities.
New Zealand is a culturally diverse country. Researchers must take into account cultural viewpoints to ensure their research reflects the context and perspective of the society in which it occurs, to respect participants and to ensure that evidence generated from health research is effectively implemented.
A world-leading health and disability research and innovation system builds on existing knowledge, generates new knowledge and responds to the needs of the populations it serves. Consumers have a right to high-quality health care. These Standards recognise the vital importance and value of health and disability research, health services research and quality improvement activities to inform clinical management and public health, social and disability policy.
To meet the needs of New Zealand populations in the future, our health and disability research will need to address the pressures that we anticipate will fall on our health system. The New Zealand Health Research Strategy(external link) (Ministry of Business, Innovation and Employment and Ministry of Health 2017) and He Korowai Oranga – the Māori Health Strategy (Ministry of Health 2014b) provide health and disability research in New Zealand with clear direction for doing so.
Addressing the health and disability needs of New Zealanders often involves discussion of inequity and inequality. Previously, these terms were used interchangeably; now, there is a clear distinction between the two. The World Health Organization (WHO) defines ‘health inequalities’ as differences in health status, or in the distribution of health determinants between different population groups. For example, differences in mobility between elderly people and younger populations, or differences in mortality rates between people from different social classes (WHO 2019b). It defines equity as ‘the absence of avoidable, unfair, or remediable differences among groups of people, whether those groups are defined socially, economically, demographically or geographically or by other means of stratification’ (WHO 2019a). ‘Health equity’ or ‘equity in health’ describes the ideal state, in which everyone has a fair opportunity to attain their full health potential and no one is disadvantaged from achieving it. Equity should be a priority focus of health research activities.
In New Zealand, ethics committees determine their own scope of review, based on the level of risk posed to participants in individual situations. As a general principle, research originating in a tertiary educational institution will normally be reviewed by an institutional ethics committee (IEC) within that institution. However, particular types of research proposals an IEC receives may also come into the scope of a Health and Disability Ethics Committee(external link) (HDEC), under section 11 of the New Zealand Public Health and Disability Act 2000. The Ministry of Health administers HDECs.
The function of an HDEC is to secure the benefits of health and disability research by checking that it meets or exceeds established ethical standards. An HDEC’s scope of review is set out in its standard operating procedures (Health and Disability Ethics Committees 2018).
A research proposal that involves both human and animal subjects requires separate approvals from both human and animal ethics committees. The framework for animal ethics is set out in the Animal Welfare Act 1999(external link).
Researchers must meet relevant ethical standards when they undertake health and disability research in New Zealand, irrespective of whether their work requires ethical review.
Ethical approval from an approved ethics committee (see ‘Approved ethics committee’ below) is required:
While some level of ethical oversight is necessary, Health and Disability Research Ethics Committee review processes are often not the optimal pathway for review of these activities. Review of activities should ensure that:
The guidance provided in Chapter 18 Quality Improvement is designed to assist organisations in deciding the appropriate level of oversight for quality improvement. Organisations should consider this guidance when developing policies/advice on quality improvement activities.
All applications for research using human embryos and gametes should be submitted to the Ethics Committee on Assisted Reproductive Technology(external link) (ECART).
The Health Research Council Ethics Committee(external link) (the HRCEC) approves ethics committees to carry out ethical review. To ensure that appropriate standards are met, the HRCEC uses a formal approval process to review and monitor ethics committees (HRC (nd)).
The HRCEC currently approves four HDECs: Northern A, Northern B, Central and Southern. It currently approves 13 IECs:
For a current list of approved ethics committees, please check the Health Research Council website(external link).
These Standards are subject to legal constraints. While they may require researchers to conduct research to a higher standard than the law sets, they do not suggest that researchers may conduct research ethically or in compliance with these Standards while failing to comply with the law.
Researchers may face situations in which they experience a tension between the requirements of the law and the guidance of these Standards. In such a situation, researchers should consult with their colleagues or relevant professional body and, if necessary, seek independent legal advice. If researchers are advised that there is a conflict between the law and these standards, researchers should comply with New Zealand law.
Legislation and conventions that may be relevant to researchers include (but are not limited to) the:
 Information on Vision Mātauranga is available on the Ministry of Business, Innovation and Employment website(external link).
 See Equity of Health Care for Māori: A framework(external link) for more information
 This is a regulation issued under section 74 of the Health and Disability Commissioner Act 1994(external link). It sets out 10 rights applicable to all health and disability services consumers, including those involved in research. Investigators conducting research should be familiar with their responsibilities under the Code, and should consider their study in light of the rights of (proposed) participants. The Code is available on the Health and Disability Commissioner’s website(external link). Specific rights from the Code are noted at relevant points in these Standards. (Note also that some provisions give legal effect to ethical standards. For example, Right 4(2) states: ‘Every consumer has the right to have services provided that comply with legal, professional, ethical, and other relevant standards’.)
 This is issued under section 46 of the Privacy Act 1993(external link). It is legally binding and has the status of a regulation. The Code specifies 12 information privacy rules in relation to health agencies and health information, so is applicable to observational studies. It is available on the Privacy Commissioner’s website(external link).