1. Scope of the Standards

This chapter sets out the scope of the Standards and provides some key definitions.

These standards set out the ethical requirements that:

• researchers must meet or exceed when undertaking health and disability research and
• health service providers and disability service providers[1] must meet or exceed when conducting quality improvement activities.

The Standards apply whether or not research or quality improvement activities require review by an ethics committee.

These Standards take a risk-based approach to ethical oversight. Ethical review should be proportionate to the risk proposed by the activity. A low level of ethical scrutiny applied to a research project or quality improvement activity assessed as low or minimal risk does not imply a lower level of adherence to the core principles of these Standards. The intention of the Standards is to ensure adequate protection of participants while reducing unnecessary impediments to, and facilitating the progress of, ethical research.

Quality improvement activities are generally low risk, but nevertheless providers should conduct them according to these Standards. Research can also be low risk, but is often not, warranting higher ethical oversight. See ‘Categories of risk’ for further information.

Defining the boundaries of health and disability research

As we as New Zealanders learn more about our own people, we face constant challenges to conventional notions of ‘health’ and ‘disability’ and the inherent limitations of each of those words to adequately recognise the worldviews of all New Zealand society.

That said, this document aims to describe the boundaries of health and disability research. It is not easy to offer a simple definition of ‘research’, or to provide a clear line between activities that are research and activities that are not. Broadly speaking, health and disability research should:

• aim to answer a question or solve a problem and therefore generate new knowledge to prevent, identify and treat illness and disease
• have the ultimate purpose of maintaining and improving people’s health – in the sense of a state of physical, mental and spiritual wellbeing, rather than simply the absence of disease or infirmity
• support disabled people to be included, participate more, exercise choice and control, and be more independent
• address health and disability disparities
• contribute to whānau ora.

This description is necessarily broad; we acknowledge that people’s health is influenced by a much wider range of social factors than their health care.

Speaking more specifically, health and disability research is any social science; kaupapa Māori methodology; or biomedical, behavioural or epidemiological activity that involves systematically collecting or analysing data to generate new knowledge, in which a human being is exposed to manipulation, intervention, observation or other interaction with researchers either directly or by changing their environment, or that involves collecting, preparing or using biological material or medical or other data to generate new knowledge about health and disability.

The following activities are not defined as ‘research’ and are not covered by these Standards.

• Public health investigations: these explore possible risks to public health, are often immediate or urgent and are often required by legislation. Examples are investigations into outbreaks or clusters of disease, analyses of vaccine safety and effectiveness, and contact tracing of communicable conditions[2].
• Routine public health activities: these include the use of identifiable data to support delivery of health services, the development of live National Health Index (NHI)-linked data as clinically actionable alerts to responsible clinicians, and the regularly investigation, assessment and monitoring of the health status of our resident populations.
• Public health surveillance: this involves monitoring risks to health by methods that include systematically collecting, analysing and communicating information about disease rates.
• Pharmacovigilance (post-marketing surveillance): this involves monitoring the adverse effects of pharmaceuticals after their introduction into the general population. Its methods include spontaneously reporting adverse events, and monitoring all adverse events for a restricted group of medicines (prescription event monitoring). Pharmacovigilance is distinguished from phase IV research, whereby sponsors or researchers conduct clinical research to assess or compare treatments (New Zealand Medicines and Medical Devices Safety Authority 2015).

Quality assurance and improvement

Quality Improvement (prospective process) and Quality Assurance (retrospective process) are slightly different forms of quality initiative. Where the primary purpose of Quality Assurance activities is to assess compliance with accepted standards for an aspect of healthcare, Quality Improvement activities are focused on how an aspect of health care can either be brought up to standard or improved. Quality Improvement therefore involves rapidly repeated, small sample cycles of measurement, analysis and change which continue until the desired improvement is attained. If a Quality Assurance activity identifies a problem, a Quality Improvement initiative may be designed to address it.

[3]In New Zealand in 2003, the Ministry of Health defined five dimensions of quality. These dimensions were underpinned by the foundations of the partnership, participation and protection principles of the Treaty of Waitangi.

Quality improvement activities use a range of tools that include, but are not limited to, clinical audit, process mapping, quality improvement cycles and evaluation. Key principles of quality improvement (Jones et al 2019) include:

• making use of our understanding of our complex health care environment
• applying a systematic approach
• designing, testing and implementing changes for improvement.

Quality improvement and research in health care exist on a continuum of activities concerned with making changes and measuring their impacts with the aim of improving systems, processes and outcomes (Hirschhorn et al 2018). Research aims to develop new knowledge, while quality improvement aims to translate that knowledge into everyday practice through specific methods in a healthcare setting (The Health Foundation 2013).

Researchers, health and disability care providers and health care institutions should consider the ethical dimensions of quality improvement because:

• patients or carers may experience burdens or risks through their participation in these activities
• some patients may benefit from quality improvement activities at the expense of others
• quality improvement activities involve the use of health data
• quality improvement activities can create potential conflicts of interest, when findings indicate shortfalls in care.
• if quality improvement projects are not methodologically sound, resulting knowledge cannot be shared with other health care providers.

As a general principle, people involved in quality improvement activities that share features of ‘research’ as defined (see ‘Defining the boundaries of health and disability research’) should follow these Standards, where relevant. For example, where quality improvement projects involve accessing and using health information many of the ethical considerations of confidentiality and privacy outlined in Chapter 13, ‘Health data’, apply. As another example, when a programme evaluation involves patients providing feedback, those conducting it must respect these patients in a manner outlined in these Standards.

Differentiating research from quality improvement

These Standards acknowledge that quality improvement has a lower risk profile than most research, and that healthcare organisations have obligations to conduct quality improvement as part of providing high quality health care for consumers. Quality improvement generally involves implementation of what we already know or reasonably believe to be beneficial. Therefore, it often lacks the elements of risk and uncertainty about impact that research tends to entail, and that necessitate ethical review.[4]

The determination as to whether an activity is ‘research’ or ‘quality improvement’ can assist researchers, and organisations, in determining the appropriate ethical oversight, and has consequences for whether the use of health data is a directly related purpose (ie, clinical audit or service improvement) or a secondary purpose (ie, research). See Table 1.2 for assistance in determining what an activity is.

Some activities may start as a quality improvement activity, but then develop a research component. In such cases, those involved in the activity must consider whether further ethical oversight is warranted.

Publication or an intention to publish a quality improvement activity does not mean an activity is classified as research, does not make it a more than minimal risk activity, and does not alone trigger specific requirement for ethics committee review. Any service provider who intends to publish results of any quality improvement activity should ensure the activity has been conducted in accordance with these Standards and should inform the editor concerned whether ethics committee review is required[5].

Ethics committees in New Zealand do not offer retrospective ethics review. Those conducting quality improvement should ensure they carefully consider whether they plan to publish work in the future, and check publishing requirements before commencing.

See Chapter 18 Quality improvement for further information, including types of quality improvement activities.

While Table 1.2 provides some guidance for distinguishing between research and quality improvement activities, it must be emphasised that some projects defy classification within this binary system. Ultimately the level of ethical oversight should be appropriate to the risks of harm from each individual project.