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All health research occurring within Health NZ Southern must have locality authorisation from Health Research South

Locality authorisation is the approval process to conduct health research at a particular site and sits alongside ethics approval. Ethics approval and locality authorisation are separate and complementary processes.

Health Research South manages the locality authorisation process for Health New Zealand | Te Whatu Ora – Southern and the Dunedin School of Medicine (DSM). You must have locality authorisation from Health Research South Research before beginning any research project involving:

  • Patients or consumers of Health NZ Southern, or
  • Data or patient records held by Health NZ Southern, or
  • Staff of Health NZ Southern, or
  • The use of facilities, or any resources of Health NZ Southern.

In addition, all University of Otago research that requires Health and Disabilities Ethics Committees ( HDEC ) approval, which is not carried out within a Health NZ hospital, requires locality authorisation from the University of Otago.

Locality authorisation from the University of Otago

This page and the summary leaflet introduce the most common aspects that must be addressed to obtain locality authorisation.

The process is customised for individual research projects, so you may need to discuss the requirements for your research project with us.

For more information on what constitutes research, contact Health Research South or see When does your audit require locality authorisation and ethics committee review?

Contact Health Research South for assistance:

Email hrs@otago.ac.nz

Summary and checklist:

Research in the Health NZ Southern and DSM should be conducted in accordance with the Health Research South Code of Conduct.

Registration

All health research occurring with Health NZ Southern must be registered with the Health Research South office.

To do this, fill in the appropriate locality authorisation form and supply the appropriate documentation as listed below.

Locality Authorisation forms

If you are unsure which form you need to fill in, contact hrs@otago.ac.nz for advice.

A key aspect of locality authorisation is consultation and approval.

Consultation with Health NZ Southern and DSM

Health NZ  Southern and DSM 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.

Consultation with Māori

This is required by the University of Otago and Health NZ Southern for all health research. This is also a requirement for projects approved by HDEC .

An agreement between the two organisations enables Health NZ Southern to access the University's consultation process:

University of Otago policy and process for research consultation with Māori

Protocol

All research requires a study protocol. The nature of the project determines the level of detail and formality required. There are many templates available. Two examples are provided:

Scientific peer review

Peer review is an important step in the development of a research protocol. Locality authorisation includes a formal check that the peer review is satisfactory. Medsafe approval will be required if you are trialling a new medicine.

Read details of the peer review process

Ethical review

All health and disability research and quality improvement activities conducted in Aotearoa New Zealand must meet or exceed the ethical requirements set out in the National Ethical Standards.

Health research in Health NZ Southern and DSM requires ethical review.

Ethical review will usually be carried out by either the Health and Disabilities Ethics Committees (HDEC) or University of Otago Human Ethics Committees (Health). The choice of committee will depend on the nature of your research.

Consent to participate in research

For privacy reasons, Health Research South requires that patients are initially approached by Health NZ staff member for permission to share their details with researchers.

The ethics committee will require participation information sheet(s) and consent form(s) (PISCF). Use the templates provided by the appropriate ethics committee to develop your participant facing documents. The information sheets will need to be localised for each site.

Localising participant information sheets and consent forms for Health NZ Southern (PDF)
Updated June 2024

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.

Research finances

All research uses resources (staff time, procedures, equipment, admin supplies etc). Health NZ Southern, in particular, is not funded to carry out research and so all costs must be identified and covered.

If no or minimal cost to Health NZ Southern is identified, a clear explanation must be provided on the locality authorisation form.

See the Research finance page for further information.

Contracts and budgets

Contracts between the University of Otago or Health NZ Southern and sponsors for grants and commercial trials must be handles by the Health Research South office (Health NZ Southern contracts) or your Research and Enterprise Research Adviser (University of Otago contracts).

Contracts will require detailed budgets or costing sheets to be drawn up. Contact Health Research South for budget assistance (for Health NZ Southern contracts) or Research and Enterprise (for University of Otago contracts).

Budget guidance:

Medical Warnings for participants in clinical trials

For patient safety, all interventional clinical research projects approved within Health NZ | Te Whatu Ora - Southern must use the Medical Warning system in South Island Patient Information Care System (SI PICS) to record and notify health professionals that a patient is participating in a trial.

Please see our guidelines on how to add or modify a Medical Warning:

In addition, the Paper Alert Sheet template may be used in departments still using paper clinical records:

Privacy and data management

Data management and privacy safeguards will be considered as part of the locality process.

Research, audit and related activity must meet Health NZ Te Whatu Ora policy and ethical standards in relation to the safe storage, retention, transfer and disposal of research data.

Important: Identifiable data must not be emailed or uploaded to a USB drive even if password protected. Refer to the National Ethical Standards for Health and Disability Research and Quality Improvement Table 12.1 (page 164) for definition of identifiable data.

Remove identifiers, including NHIs, as soon as possible after data collection.

If re-identification may be needed, replace NHI with a Unique Study ID. Keep the list matching IDs and NHIs securely within the Health NZ district network (or other approved location) and separate from the de-identified dataset.

Where data is to be transferred, the use of safe transferal technology such as ShareFile is preferred. Ensure the access instructions / password are sent to the intended recipient in a separate communication (eg. text or Microsoft Teams).

Note: Health NZ staff can request access to ShareFile from the national IT service desk – Service Now Portal.

Remote monitoring guidelines

Remote monitoring has increasingly become a necessity for source data verification ( SDV ) required for clinical trials. While CROs and sponsors have different expectations and recommended pathways to conduct remote SDV , there are guidelines that the site should be aware of to comply with the GCP guidelines and the Privacy Act 2020.  Please see guidelines in the file below.

When does your audit / quality improvement (QI) activity require locality authorisation and ethics committee review?

Consideration should always be given to the ethical dimensions of audit and quality improvement.

Audit

A clinical audit, as defined by the NEAC Standards, investigates whether an activity meets explicit standards, as defined from 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:

Chapter 18. Quality improvement, National Ethics Advisory Committee (health.govt.nz)

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

Quality Improvement

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.

Also 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)

If you would like further support contact hrs@otago.ac.nz to discuss.

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 a Health NZ hospital should use this process.

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