First, define your activity – quality improvement or research?
Ethical risk and quality improvement activities
Data collection and management
Publishing results of quality improvement activities
If undertaking quality improvement activities, health providers must meet the ethical requirements set out in the National Ethics Advisory Committee’s National Ethical Standards for Health and Disability Research and Quality Improvement (the Standards).
The Standards are based on bioethics principles and Te Ara Tika, a set of Māori ethical principles that draws on a foundation of tikanga (Māori protocols and practices).
The Standards apply whether an activity is reviewed by an ethics committee or not, and include transparency to consumers, whether consent is obtained or not (see Informed consent below).
‘Quality improvement activities’ include programmes, projects, interventions and processes. They involve ‘cycles of change that are linked to measurable assessment, with the goal of improving the experience, process, equity, safety and efficiency of healthcare, assessing the current situation and systematically implementing or testing evidence-based knowledge within a local organisation’. They also feature co-design, evaluation, programme evaluation and clinical audit.
To help you decide whether your activity is quality improvement or research, use the following questions. If you answer ‘yes’ to any, the activity is research and not quality improvement and you will need to follow your organisation’s research and ethics policy. If you answer ‘no’ to the questions, you will need to consider how your quality improvement activity will meet the requirement of the Standards and reflect bioethics principles and Te Ara Tika.
- Is the activity primarily intended to create new, generalisable knowledge? Yes/No
- Will the activity occur outside of the standard of clinical care? Yes/No
- Will the interventions be allocated differently among participants through randomisation, use of control groups and/or placebos? Yes/No
- Will human tissue be collected or stored outside of the standard of clinical care? Yes/No
Quality improvement activities are generally regarded as having a low or negligible ethical risk, however, there are some factors that may increase the ethical risk of harm. These include, but are not limited to, when:
- there is a potential for physical or psychological harm to consumers
- vulnerable individuals or groups are involved
- additional burdens are put onto consumers and health care professionals to take part
- the data collected is of a sensitive nature
- the use of data is secondary to what it was originally consented for
- individuals may be identifiable through the way the data is used or made available
- there is not enough evidence to determine that the proposed change in the standard of clinical care is safe or effective
- the activity is unlikely to provide direct benefits to consumers.
Quality improvement activities should aim to limit ethical risk and maximise potential benefits. Ethical risks will need to be assessed regularly and managed throughout the activity to ensure this. The benefits should justify the resources spent as well as any risks for participants.
Using the bioethics principles and Te Ara Tika, here are some questions to help you consider ethical risks and potential benefits:
- How will this activity benefit people’s health or wellbeing?
- How will this quality improvement activity avoid causing harm to individuals and communities?
Respect for people:
- How will people be able to freely decide to participate?
- How will the benefits and burdens be fairly distributed to reduce inequities?
Te Ara Tika
- How will/have Māori been engaged with the quality improvement activity?
- How will Māori participants, iwi, hāpu and whānau be engaged throughout the stages of this quality improvement activity?
- How will Māori be involved in this quality improvement activity?
- How will Māori and the community benefit from this quality improvement activity?
- How will you ensure participants are treated with cultural sensitivity?
- Who will benefit from the quality improvement activity?
- How equitable will the outcomes be for Māori?
If you identify any potential adverse consequences for participants’ privacy and confidentiality, physical, psychological, emotional, social, financial or cultural safety and wellbeing, you will need to put in place actions to manage those consequences. Examples include collecting and managing data appropriately, getting informed consent and providing information to participants about the changes or intervention the quality improvement activity will include.
There are two possible sources of data collection: new information that you collect from participants or using existing data that has already been collected through routine clinical care or standard organisational reporting. Each require a different approach.
Collecting new information
If you are collecting new information from participants, give them information about the activity before you start collecting data then obtain their informed consent. Also think about whether the data collection:
- will put an additional burden on participants beyond their routine care
- will need culturally safe and appropriate methodologies
- involves information that is sensitive in nature or application
- involves vulnerable individuals or groups
- potentially may cause distress.
Then put in place actions to manage these considerations. Examples might include involving or seeking advice from Māori, Pacific or disability advisors, use of in-person interviews and/or focus groups, or reimbursement for parking.
Using existing data
If you are using existing data:
- make a plan for ensuring the sovereignty, privacy and confidentiality of data during collection, access, storage and management, and sharing, analysis and publishing of findings
- use non-identifiable data where possible
- ensure data has been collected and will be analysed in a culturally appropriate and equitable way
- ensure people involved in the quality improvement activity are operating under professional standards and maintain confidentiality of data at all times
- consider how you will manage confidentiality among those not employed by the health care organisation involved in the activity, for example, consumers involved in co-design projects
- consider how data will be shared with participants and results disseminated to show how participants have contributed to the activity.
As above, put in place any actions needed to manage these considerations.
Remember, at all times, the potential benefits of a quality improvement activity must always outweigh any potential risks to consumers.
When collecting new data from participants you will need to get their informed consent in writing. Give participants:
- clear and understandable information about the activity
- the opportunity to ask questions
- the opportunity to reflect on their potential involvement and what it would mean for them.
There should be no undue pressure put on participants to give informed consent.
If you plan to publish any results from your quality improvement activity, review the author guidelines with the relevant journal to see the level of ethical approval and oversight needed. If your organisation has a standardised research and ethics policy which applies when planning quality improvement activities, this may be enough to meet these requirements, rather than requiring formal ethical committee review.
1. The Standards define health service providers as including health service workers, nurses, clinicians and any person involved in quality improvement. It also broadens the term researcher to include all those responsible for quality improvement activities.
2. See: https://neac.health.govt.nz/national-ethical-standards-health-and-disability-research-and-quality-improvement/part-two/2-ethical.
3. National Ethics Advisory Committee. 2019. National Ethical Standards for Health and Disability Research and Quality Improvement. Wellington: Ministry of Health. URL: https://neac.health.govt.nz/publications-and-resources/neac-publications/national-ethical-standards-health-and-disability.