--- title: "Do I need HNZ Research Authorisation?" canonical: "https://research.refined.site/space/Research/141033474/Do%20I%20need%20HNZ%20Research%20Authorisation%3F" format: markdown --- You are required to obtain Health New Zealand Research Authorisation if you are applying for one of the following research designs: ### 1. Interventional research Example: a clinical trial whereby the researcher controls and studies an intervention(s) given to voluntary participants for the purpose of adding to the knowledge of its health effects. > ℹ️ Refer to NEAC Standard [Chapter 10.8](https://neac.health.govt.nz/national-ethical-standards/part-two/10-ethical-features-of-studies/) - Intervention studies. ### 2. Observational research This includes research associated surveys, interviews and focus groups whereby the researcher observes and analyses natural relationships between variables and outcomes, and records them but does not influence the assignment. > ℹ️ Refer to NEAC Standard [Chapter 10](https://neac.health.govt.nz/national-ethical-standards/part-two/10-ethical-features-of-studies/) - Observational studies. ### 3. Innovative research Innovative research is the application of known procedures in new or novel circumstances in which those procedures have not been tested. > ℹ️ Refer to NEAC Standard [Chapter 10.74](https://neac.health.govt.nz/national-ethical-standards/part-two/10-ethical-features-of-studies/) - Innovation research. ### 4. Implementation research** ** An implementation research seeks to answer questions of accessibility, acceptability, appropriateness, and feasibility in the translation of research outcomes into practice. > ℹ️ Refer to NEAC Standard [Chapter 10.46](https://neac.health.govt.nz/national-ethical-standards/part-two/10-ethical-features-of-studies/) - Implementation research. ### 5. Research registries and future use of data This refers to data being prospectively collected in a registry for the purposes of both specified or unspecified future research analysis. > ℹ️ Refer to NEAC Standard - [Chapter 7.57](https://neac.health.govt.nz/national-ethical-standards/part-two/7-informed-consent/) - Future use of data. ### 6. Quality improvement (QI) projects QI is an umbrella term for a range of activities with the goal of improving the experience, process, safety and efficiency of health care systems. Some QI activities may involve factors that increase ethical risk and require ethics committee review. It is important you discuss the proposed QI activity with your district’s QI team before proceeding or you can contact your district Research Office for advice.   > ℹ️ Refer to NEAC Standard [Chapter 18](https://neac.health.govt.nz/national-ethical-standards/part-two/18-quality-improvement/) - Quality Improvement. ### 7. Clinical audit A ***clinical audit*** investigates whether an activity meets explicit standards, as defined by national or international standards, policies, guidelines, or best practice reviews, for the purpose of checking and improving the activity audited. An audit generates knowledge for the situation in which it was undertaken, rather than generalisable knowledge. It should provide feedback primarily to the local setting or particular service involved, although it may also involve a wider dissemination by way of publication or presentation of its findings. A clinical audit will generally not require ethics review but may need approval from the service or locality where it is performed. Refer to National Ethical Standards for Health and Disability Research and Quality Improvement (the Standards) Chapter [18. Quality improvement | National Ethics Advisory Committee (health.govt.nz)](https://neac.health.govt.nz/national-ethical-standards/part-two/18-quality-improvement). Audit and related activities which attempt to create ***new generalisable knowledge*** in response to an acknowledged information gap meet the definition of ***research*** and do require an ethics committee and locality review and approval. Where this will involve the use of** identifiable data without consent**, even within your own organisation, Health and Disability Ethics Committee (HDEC) approval is required. An audit or related activity that involves the use, collection or storage of human tissue ***without consent***, other than in accordance with a statutory exception ***always*** requires HDEC review. Refer to HDEC Standard Operating Procedures Chapter 3, point 30 (page 12) [Operating procedures | Health and Disability Ethics Committees](https://ddec1-0-en-ctp.trendmicro.com:443/wis/clicktime/v1/query?url=https%3a%2f%2fethics.health.govt.nz%2foperating%2dprocedures&umid=802964f0-252e-41b1-8bb3-8792283ead47&auth=a3bd55c094d03421cab4e906146bf630b01a7779-31bc2c102a3b387a996cb32c2e44d19a19d696ea) > ℹ️ **If you are unsure where your project fits, or you require further support, please contact the team at** research@waitematadhb.govt.nz **to discuss.** --- HNZ Research Authorisation is also required for Allied Health CASP & Nursing portfolio/ PG Cert/Dip/Masters/Doctorate/PhD/ Medical Council or College registration projects that have a research component. > ℹ️ You do not typically need HNZ Research Authorisation for the following (but advice is still available): > ℹ️ > ℹ️ - Quality Assurance type audits eg. monitoring temperature of fridges, calibrating equipment etc. > ℹ️ - Information System projects unless they have a component that interacts with patients > ℹ️ - Facilities projects unless they have a component that interacts with patients (e.g. survey/interviews) > ℹ️ - Service planning projects, unless they have a research component (e.g. an evaluation, pre/post implementation measures) --- ###### Last reviewed June 2026 Author: Kathryn Tennant