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.

Health New Zealand | Te Whatu Ora Waikato does not have its own ethics committee. We rely on the Health and Disability Ethics Committee (HDEC) or Institutional Ethics Committee (IEC).

The research approval process is the locality authorisation process.

Preparation

Discuss your concept or proposal with the clinical lead of the relevant service prior to registering it. For maternity services, the clinical midwife director must arrange review by the maternity services clinical governance committee. We can advise who the relevant clinical lead is.

Determine whether your proposed project is research or clinical audit. Contact the research office if you are unsure.

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.

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, click ‘Proceed’ at the end of that form to generate an ‘Out of HDEC scope’ letter. Forward this to the research office.

If you have any questions:

Research approval processes

Ethics approval

Proceed with the relevant Health and 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.

Māori consultation

Finance and resource

If your project will involve costs to the hospital 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. 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 or device

If your study involves the use of a product or device or 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 (such as biomedical, infection prevention and control, health and safety) prior to use. Full instructions will be forwarded to you by the research office.

Registry or 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.

Register your research online

To request a registration form:

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 time frames.

Email all relevant documentation to the research office. Documents may include:

  • ethics approval letter
  • protocol
  • patient information
  • consent sheets.

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.

Ongoing requirements

It is a requirement of locality authorisation that for all HDEC reviewed research, Health New Zealand | Te Whatu Ora Waikato 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).

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.

Privacy Act 1993 — New Zealand Legislation (external link)

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.

Health Information Privacy Code 2020 — Privacy Commissioner (external link)

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.