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title: "FAQs"
canonical: "https://research.refined.site/space/Research/48333763/FAQs"
format: markdown
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### Ethics FAQs

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<summary>Does my research need ethics committee review?</summary>

- All research, audit and related activity must complete the Te Whatu Ora -Waitematā locality [approval process](https://research.refined.site/space/Research/144244737/Approval+process) and some activity will also require an ethics committee approval. Levels of ethical risk are used to determine the level of ethical oversight in health research. Table 8.3 of the NEAC Standards for Health & Disability Research and Quality Improvement (2019) describes ethical risk categories and will help decide whether your research reaches the level of risk requiring an independent ethics committee review.
  Ethics Committees available to Te Whatu Ora -Waitematā staff
  - **Health & Disability Ethics Committee (HDEC)**  
You will need to set up your login to HDEC ETHICS RM to access application platform ([Login - NZ Ethics RM Forms](https://nz.forms.ethicalreviewmanager.com/Account/Login))
    Where research is Out of Scope for HDEC but still requires or would benefit from an independent ethical review
  - **Auckland Health Research Ethics Committee (AHREC)**  
AHREC is a collaboration between the University of Auckland, and Te Whatu Ora - Te Toka Tumai Auckland, Counties and Waitematā districts and is available to the staff of these organisations. AHREC is managed by University of Auckland (UoA). You will need to [set up a UoA login](https://cdn.auckland.ac.nz/assets/HumanEthics/onboarding_for_external_users_vs_2.pdf) to access the AHREC Ethics RM application platform.
  - **Other University Ethics Committee** Waitematā staff who are also students of, or hold joint appointments with other universities may seek ethical review from that institutions ethics committee.
  If you are not sure whether or not your study requires ethics committee approval, forward your proposal to [waitemataresearch@tewhatuora.govt.nz](mailto:waitemataresearch@tewhatuora.govt.nz).
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<summary>Does Quality Improvement (QI) activity require ethics committee review?</summary>

- Refer to the [National Ethical Standards for Health & Disability Research and Quality Improvement](https://ethics.health.govt.nz/operating-procedures/) (Dec 2019).  
Section 18 discusses Quality Improvement. Also refer to Section 1 Scope (pages 29-33).
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<summary>Do I need ethics approval to present a case study?</summary>

- No formal ethics approval is required for case reports, especially where the material is de-identified. It is considered best practice when writing up a case report and the patient and/or family are available to contact, to inform them that you are wanting to write a case report, explain why and how they will not be identified; You should record details of the conversation in the patient's clinical notes. Patients/families are usually very pleased that you have taken the time to inform them and often feel good to be assisting medical knowledge. Patients/relatives may of course decline consent. You should ensure your clinical director and unit manager are aware of your intention to publish if Te Whatu Ora -Waitematā will be identifiable.
  Case Study Information Sheet (template)  
Case Study Consent Form (template)
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<summary>What are the features of a fit for purpose peer review?</summary>

- A peer review process should be commensurate with the type of proposal, the potential risk to participants and the location of the research. The type of peer review process used must be fit-for-purpose and justifiable and the peer reviewer must be independent of the study.  
Refer to
- [Scientific peer review submissions ](https://ethics.health.govt.nz/guides-templates-and-forms/scientific-peer-review-submissions-guidance/)- guidance on HDEC website
- [National Ethical Standards for Health & Disability Research and Quality Improvement](https://ethics.health.govt.nz/operating-procedures/) (Dec 2019). Peer Review Section 9.25 - 9.31 (pages 113-114)
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<summary>When is non-consented use of health information ethically justifiable?</summary>

Health & Disability Ethics Committees (HDEC) can only approve use of health information without consent if the researcher clearly details how it is ethically justified. HDEC will expect to see the following justifications in an ethics application:

1. The process for obtaining consent is likely to cause undue anxiety for those whose consent is sought; **OR** the requirement for consent would prejudice the scientific value of the study; **OR **it is impossible in practice to obtain consent due to the quantity or age of the records; **AND**
2. There would be no disadvantage to the participants or their relatives or to anyone involved in collecting the data; **AND**
3. The public interest in the study outweighs the public interest in privacy.
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### Privacy

Please see [Privacy NZ legislation](https://research.refined.site/space/Research/124551195/Privacy+NZ+legislation).

### External researchers

For full instructions for external researchers [click here](https://research.refined.site/space/Research/48333813/External+Researchers).

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###### **<span style="color: #97a0af">Last reviewed November 2023 </span>**  
**<span style="color: #97a0af">Page Co-ordinator: Judy Williamson</span>**