Research in the New Zealand context
The Treaty of Waitangi and the standards
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):
- rangatiratanga: researchers, iwi, hapū, whānau and Māori communities working together to ensure Māori individual and collective rights are respected and protected
- whai wahi: involving Māori in the design, governance, management, implementation and analysis of research, especially research involving Māori
- kaitiakitanga: actively protecting Māori individual and collective rights, Māori data, Māori culture, cultural concepts, values, norms, practices and language in the research process.
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:
- set a priority for Māori health research: to seize opportunities for addressing the challenges to Māori health and wellbeing
- harness the innovation potential of Māori health knowledge, systems and processes
- translate relevant findings into gains in health and social wellbeing for Māori
- promote rangatiratanga; for example, with respect to data sovereignty
- enable whānau, hapū, iwi and individual Māori to exercise control over their own health and wellbeing and the direction and shape of their own institutions.
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 (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.
New Zealand ethics landscape
When do we need ethical review?
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 (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.
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:
- to provide coverage of participants in a clinical trial who sustain injury, under the Accident Compensation Act 2001, chapter 17 on Compensation
- to allow use and disclosure of health information for research purposes where it is either not desirable or not practicable to obtain authorisation from the individual concerned under the Health Information Privacy Code 1994
- to allow the use of human tissue for research where it is either not desirable or not practicable to obtain authorisation from the individual concerned under the Human Tissue Act 2008
- for every application approved for funding by the Health Research Council (the HRC), under sections 25 and 31 of the Health Research Council Act 1990.
Ethical review of quality improvement activities
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:
- Participants in quality improvement are afforded appropriate protections and respect
- Quality Improvement is undertaken to generate outcomes that are used to assess and/or improve service provision
- Those who undertake quality improvement adhere to relevant ethical principles, law and regulation
- Organisations provide guidance and oversight to ensure activities are conducted ethically including a pathway or process to identify and address concerns.
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.
Research that uses human embryos and gametes
All applications for research using human embryos and gametes should be submitted to the Ethics Committee on Assisted Reproductive Technology (ECART).
Approved ethics committees
The Health Research Council Ethics Committee (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:
- Auckland Health Research Ethics Committee
- Auckland University of Technology Ethics Committee
- Lincoln University Human Ethics Committee
- Massey University Human Ethics Committee: Northern
- Massey University Human Ethics Committee: Southern A
- Massey University Human Ethics Committee: Southern B
- University of Auckland Human Participants Ethics Committee
- University of Otago Human Ethics Committee
- University of Otago Human Ethics Committee (Health)
- University of Waikato Human Research Ethics Committee (Health)
- Unitec Research Ethics Committee
- Victoria University of Wellington Human Ethics Committee
- Wintec Human Ethics in Research Group.
For a current list of approved ethics committees, please check http://www.hrc.govt.nz/ethics-committee-approval-and-annual-reporting
Complying with New Zealand legislation and international conventions
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:
- Human Rights Act 1993
- Universal Declaration of Human Rights
- Code of Health and Disability Services Consumers’ Rights 1996
- Privacy Act 1993
- Health Information Privacy Code 1994
- New Zealand Bill of Rights Act 1990
- Human Tissue Act 2008 (particularly sections 9, 14, 19, 21, 22, 24 and 31)
- Care of Children Act 2004
- Family Violence Act 2018
- Health and Disability Commissioner Act 1994
- Health Practitioners Competence Assurance Act 2003
- Protection of Personal and Property Rights Act 1988
- Health and Disability Services (Safety) Act 2001
- Hazardous Substances and New Organisms Act 1996
- New Zealand Public Health and Disability Act 2000
- Accident Compensation Act 2001
- Treaty of Waitangi Act 1975
- Human Assisted Reproductive Technology Act 2004
- Medicines Act 1981
- United Nations Convention on the Rights of Persons with Disabilities 2006
- United Nations Declaration on the Rights of Indigenous Peoples
- Declaration of Helsinki (WMA 2017)
- International Ethical Guidelines for Health-related Research Involving Humans (Council for International Organizations of Medical Sciences (CIOMS) and WHO 2016)
- Universal Declaration on Bioethics and Human Rights 2005.
 Information on Vision Mātauranga is available on the Ministry of Business, Innovation and Employment website.
 Ethical considerations in quality assurance and evaluation activities 2014 https://www.nhmrc.gov.au/about-us/resources/ethical-considerations-quality-assurance-and-evaluation-activities
 This is a regulation issued under section 74 of the Health and Disability Commissioner Act 1994. 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. 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. 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.