In order to obtain approval for health research to commence, the following areas must be addressed.
This process is customised for individual research projects, so you will need to discuss the requirements for your research project with us.
Contact Health Research South for assistance:
All health research studies must be registered with the Health Research South office
- Locality authorisation application form (DOCX)
Updated January 2023
- Minimal risk locality authorisation application form (DOCX)
Updated July 2022
- Checklist of requirements (DOCX)
Updated January 2023
- Locality authorisation summary leaflet (PDF)
Updated December 2022
- Health and Disabilities Ethics Committee (HDEC)
- University of Otago Human Ethics (Health)
- Localising participant information sheets and consent forms (PDF)
Updated July 2022
- HDEC locality authorisation for University of Otago non-DHB research
- Research finance page
- Costs and budgets
- Quotes including Pharmacy and Southern Community Labs
- Managing Southern DHB CF accounts (DOCX)
- New Zealand Association of Clinical Research (NZACRes) standard contracts and indemnity
- Remote Monitoring Guidelines for Clinical Trials (PDF)
Updated February 2022
- For all projects, Health Research South will advise on which staff need to be informed.
All health research requires a study protocol. The size of the project determines the level of detail and formality required. Two examples of standard protocols are linked below.
Scientific Peer Review
Read details of the peer review process
All health research in the Te Whatu Ora – Southern and DSM requires ethical review.
Ethical review will be carried out by either the Health and Disabilities Ethics Committees (HDEC) or University of Otago Human Ethics (Health). The choice of committee will depend on the nature of your research.
Locality authorisation in EthicsRM
Locality authorisation is a standard condition of HDEC approval. Health Research South will sign locality authorisation requests in HDEC’s EthicsRM system after ethics approval has been granted and all other conditions for locality have been met.
You should not request locality authorisation from Health Research South on the main EthicsRM form as this will prevent you submitting your application for ethics review. Instead, you should answer the locality question on the main EthicsRM form with “No, my study requires locality authorisation at a later date”, and request a locality authorisation from email@example.com using the Additional Locality subform. Please ensure you grant Health Research South access to the whole project using the Roles button.
Contracts between the University of Otago or Te Whatu Ora – Southern and sponsors for grants and commercial trials must be handles by the Health Research South office (Te Whatu Ora – Southern contracts) or your Research and Enterprise Research Adviser (University of Otago contracts).
Alerts for patients participating in clinical trials
For patient safety and clinician information, all interventional clinical research projects approved within the Te Whatu Ora – Southern are required to have a paper alert sheet giving information on trial treatment in the patient’s file.
Remote monitoring guidelines
Remote monitoring has now increasingly become a necessity for the required source data verification (SDV). While CRO and sponsors have different expectations and recommended pathways to conduct remote SDV, there are guidelines that the site should be aware of in order to comply with the GCP guidelines and the Privacy Act 2020. Please see guidelines in the file below.
Consultation with Māori
This is required by the University of Otago and Te Whatu Ora – Southern for all health research.
An agreement between the two organisations enables Te Whatu Ora – Southern to access the University’s consultation process.
Details of the process are at the link below.
Consultation with Te Whatu Ora – Southern and DSM
Te Whatu Ora – Southern and OMS senior staff need to know and agree to research taking place in their area. Some key staff are signatories to the Locality Authorisation process, whereas others need to be informed of projects in order to accommodate for resources required.
HDEC Locality Authorisation for University of Otago Research
All University of Otago research which requires Health and Disabilities Ethics Committees (HDEC) approval and is not carried out in Te Whatu Ora – Southern should use this process.