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Health Research South:
Locality Authorisation

Whakamanahia ā-Wāhi

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:

Email hrs@otago.ac.nz

Registration

All health research studies must be registered with the Health Research South office

Protocol

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

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Ethical review

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 hrs@otago.ac.nz using the Additional Locality subform. Please ensure you grant Health Research South access to the whole project using the Roles button.

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Research finances

Contracts

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.

  • For all projects, Health Research South will advise on which staff need to be informed.

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.