The Department process for applying for ethics approval is outlined below:
Ethical review process
The ethical review process in the Department follows the scientific peer review process.
The key elements of this process are outlined below:
1. All ethics applications must be submitted to the departmental ethics committee for review and approval. The only exception to this is applications to the Health and Disability Ethics Committees (HDEC), which you submit your application to directly.
2. Scientific peer review must be completed prior to submitting an ethics application to the departmental ethics committee.
3. Please visit the University’s ethics webpage for guidance on which University ethics committee to apply to and to download the latest application form for that committee. These forms do change reasonably regularly, so always download the latest version from the site whenever you are submitting an application.
4. Send your application to firstname.lastname@example.org. Include in your application:
a. The completed ethics application with your signature as the applicant.
b. Any information and consent sheets, as well as recruitment posters.
c. Evidence of successful scientific peer review, along with reviewers’ comments and your responses.
d. Ethics applications for the University of Otago Human Ethics Committee (Health) require a copy of the study protocol. Study protocol templates.
e. Evidence of Māori consultation (if available).
f. A locality assessment (if required).
g. Any other documentation (e.g. previous ethics reviews or supporting letters from organisations) which may be relevant.
5. Allow ten working days for the review to be completed. Your application will be reviewed by two reviewers from the Department, who will provide comments and potentially request changes. All ethics applications, regardless of category, are fully reviewed.
6. Once the reviewers are satisfied that any issues have been addressed, the application is signed off by the chair of the departmental ethics committee on behalf of the head of department.
7. Your application, along with the review and decision, will be forwarded to the relevant University ethics committee on your behalf. For applications that require department-level approval only, you will be notified by the University ethics committee of approval within five working days. You may not commence with the research until you have received this notification.
8. Deadlines for the submission of full applications to the University ethics committees, and the dates for those meetings. Please factor in the time required to perform scientific peer review and ethical review when planning to submit an application for one of these meetings.
If you have any questions about this process, please email the departmental ethics committee via email@example.com.
Essential elements of ethical review
When assessing your application, the ethics committee reviewers will be assessing the following points:
- Does the study team have the qualifications and expertise required to complete the study?
- Does the study team have adequate resources to complete the study?
- Does anyone on the study team have a conflict of interest?
- Has adequate scientific review been completed?
- Will the study be conducted outside New Zealand, and if yes, has local review approval been submitted?
- Will any vulnerable populations (children, prisoners, pregnant women, cognitively impaired, educationally or economically deprived, etc) be included in the study? If yes, what additional protections have been put in place to protect them?
- Is participant selection equitable, i.e., the research does not exclude unnecessarily groups who might benefit from the study (for example, Māori), and does not unnecessarily burden one group over others?
- Are protections in place to protect participants against coercion or undue influence in the recruitment and informed consent processes?
- Are recruitment materials (Advertisements, Information Sheets etc) appropriate?
- Is payment to the participants appropriate?
- Are the risks to participants well explained and minimised to the extent possible?
- Are potential benefits, both direct personal benefits and societal benefits, clear?
- Are the risks reasonable when balanced against the potential benefits of the study?
- If the study involves more than minimal risk, is the safety monitoring plan provided adequate? Is it clear who will monitor the reports of adverse events and consider stopping rules, if appropriate?
- Are all risks to personal privacy described and minimised?