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Research approval (Locality Authorisation) process

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Learning and research

Research approval (Locality Authorisation) process

It is important to be familiar with the Waikato Research policy and Informed Consent policy and the National Ethics Advisory Committee (NEAC) standards. Any study that includes the administration of medicines to patients must adhere to the Waikato Clinical Trial Medicines Management protocol.

Waikato does not have its own Ethics Committee. We rely on Health & Disability Ethics Committees (HDEC) or Institutional Ethics Committees (IEC). The research approval process is the locality authorisation process.

In order to obtain locality authorisation, researchers must complete the steps below.

Note: Several of these items can be done concurrently (registration, ethics application, Māori consultation).

Service approval: Discuss your concept or proposal with the clinical lead of the relevant service prior to registering it.  For Maternity Services this includes the clinical midwife director to arrange review by Maternity Services Clinical Governance Committee.  We can advise who the relevant clinical lead is.

Determine whether your proposed project is Research or Clinical Audit.  Please contact the research office if you are unsure.

Please note if you state your study is audit on the online HDEC application form (EthicsRM), the system will automatically respond that it does not require ethics. You need to be certain it is an audit before ticking that box.

Please complete the screening questions at the start of an HDEC/EthicsRM form to determine whether your study requires ethics approval, and if so, whether it will go through the expedited pathway or the full pathway.  If you are advised it is out of scope, please click ‘Proceed’ at the end of that form, to generate an ‘Out of HDEC scope’ letter and forward that to the research office.

If in doubt, please contact research@waikatodhb.health.nz.

  • Ethics approval: Proceed with the relevant Health & Disability Ethics Committee (HDEC) or Institutional Ethics Committee (IEC) approval process, where required. 

  • Peer review: It is the researcher’s responsibility to ensure the scientific validity of the project through peer review, prior to submission to HDEC. This review may be documented using the HDEC template on their website, outlining the evidence HDEC needs to see before approval. 

    Other acceptable processes include peer review given when applying for a funding grant such as the Health Research Council, SCOTT review of new medicines, university research grants or other established robust peer review processes. For more information on HDEC, peer review requirements see Section 9 of the NEAC Standards.

  • Māori consultation: Eliminating health inequities for Māori is a key priority for Waikato.  Therefore, you must consider how your study will improve equity or knowledge, especially for our Māori population.  As part of this Waikato requires that you undertake Māori consultation. (Use this link to get information and forms).  Word versions of the forms can be emailed to you by the Research Office.

  • Finance/Resource: If your project will involve costs to the hospital and/or you have received a grant or funding for the study, you will need to provide a budget.  The Research Office will provide further information on these requirements.  Please consider all resource requirements – extra clinic appointments, extended appointments, staff time, consumables, and extra diagnostic tests (above the normal standard of care).

  • Legal: If your study will require the Waikato to sign an agreement, these will need to be reviewed by our legal team.  It is preferred that the NZACRes template agreements are used for research, especially for clinical trials.

  • Product/device: If your study involves the use of a product or device/machine (that is not already used at the hospital), you will be asked for further information to ensure that the items have the appropriate checks (e.g. biomedical, infection prevention and control, health and safety) prior to use.  Full instructions will be forwarded to you by the research office.

  • Registry/Database: If your study involves adding data to a registry or database held outside of Waikato, you may also be required to complete a Cloud Risk Assessment.  The Research Office will offer guidance on this, if it is required.
  • Email research@waikatodhb.health.nz and request the registration form. This will be emailed to you.
  • In response to your registration, the Waikato Approval of Research Form and requirements for Māori consultation will be emailed to the primary contact for the project, along with an outline of the next steps and timeframes.
  • Send all relevant documentation (such as Ethics approval letter, protocol, patient information and consent sheets) to the Research Office (via email). 
  • Please feel free to contact us for advice on ethics requirements, finance requirements or other queries.
  • Legal templates for trial agreements and indemnities are also available from the research office.

It is a requirement of Locality Authorisation that for all HDEC reviewed research, Waikato (research@waikatodhb.health.nz) is authorised to receive email notifications from the HDEC online application system (EthicsRM). 

Once all relevant approvals and documentation have been received by the Research Office an email indicating approval to commence research activities will be sent to the primary contact, and Locality Approval will be signed off online at HDEC/EthicsRM (if applicable).

Please do not submit the locality sign-off request when you are preparing your application to HDEC.  If you do this, the system will not let you submit until locality authorisation is received – and we cannot authorise until you have ethics!  You may request locality approval after your project has received HDEC approval. 

Privacy Act 1993

Principal Investigators should familiarise themselves with the Privacy Act 2020 and the Health Information Privacy Code 1994. Refer to the New Zealand Legislation website.

The Privacy Act sets out 12 Principles that govern the collection, use, storage, retention and disclosure of personal information.

The Privacy Act also permits the Privacy Commissioner to issue codes of practice governing particular types of personal information. In 1994 the Commissioner issued the Health Information Privacy Code.

This Code contains 12 Health Information Privacy Rules. The Rules are very similar to the 12 Principles in the Privacy Act but are modified specifically for the health sector.