Research approval process

It is important to be familiar with the Waikato DHB Research policy and Informed Consent policy. If the patient population you are investigating are unable to give informed consent then it is necessary to use the Best Interest Guideline for research with incompetent patients. This is to be used as a guide only and in some cases the questions may not have a simple yes/no answer.

However, the checklist should assist in considering the patient's best interests. If your study involves patients who may require admission to Critical Care please read the guideline.

In order to obtain authorisation, researchers must have completed steps 1-3 below. 
Note: several of these items can be done concurrently (registration, ethics, Maori consultation).

 

Clinical Audit: is a way of finding out whether you are doing what you should be doing by asking if you are following guidelines and applying best practice.

Research: evaluates practice or compares alternative practices, with the purpose of contributing to a body of knowledge by asking what you should be doing.

Step 1:
Audit or Research

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

You can complete and submit the HDEC Scope of Review form ethics.health.govt.nz/applying(external link) if unsure. 

If in doubt, please contact research@waikatodhb.health.nz
Step 2:
Research Approval Processes
  • 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.
  • Ethics Approval:  Proceed with relevant Health & Disability Ethics Committee (HDEC)(external link) or Institutional Ethics Committee (IEC) approval process, where required. For more details read ‘Which ethics committee?’ provided by Awhina Research & Knowledge, Waitemata DHB. 
  • Peer Review: It is the researcher’s responsibility to ensure 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 which outlines the evidence HDEC needs to see before giving 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 read Appendix 1 of the Ethical Guidelines for Intervention Studies and Ethical Guidelines for Observational Studies on the HDEC website.
      
  • Maori Consultation: Eliminating health inequities for Maori is a key priority for Waikato DHB.  It is therefore important that you consider how your study will improve equity or knowledge, especially for our Maori population.  As part of this Waikato DHB requires that you undertake Maori consultation(external link).  Information and forms is provided at the link to the left.
Product/Device: If your study involves the use of a new product or device/machine, you will be asked for further information to ensure that the items have the appropriate checks (biomedical, infection prevention & control, health & safety etc) prior to use.  Full instructions will be forwarded to you by the research office.
Step 3:
Register your research, by completing the online Register your research form(external link)
  • Register your research project at concept or proposal stage
  • Email research@waikatodhb.health.nz for advice on ethics, funding, budgeting or statistics support. Access legal templates (on this page) for trial agreements and indemnities.
  • In response to your online registration, Waikato DHB Authorisation Form(s) and requirements for Māori consultation will be emailed to the primary contact for the project.
  • Return all relevant documentation to the Research Office:
Step 4:
Ongoing requirements

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

Once all relevant approvals and documentation has 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 on-line at HDEC (if applicable).

 

Pharmacy

Note that any study that includes the administration of medicines to patients must adhere to the Waikato DHB Clinical Trial Medicines Management protocol.

Research units contact information

Breast Cancer

Jenni Scarlet
Research Nurse

Breast Cancer Research Office,
Hockin Building, Waikato Hospital
PO Box 934 Hamilton 3240 NZ

Ph: +64 7 8398726 ext 97916
Mob: +64 (0) 21 1149948
Fax: +64 7 8343657

Jenni.Scarlet@waikatodhb.health.nz
www.wbct.org.nz (external link)

Cardiology

Liz Low
Manager

Cardiology Clinical Trials Unit, Waikato Hospital
14 Horne Street, Hamilton

Ph: +64 7 839 7136
Mob: + 64 (0) 274 823 205

LizL@cardiotrialswaikato.org.nz
Clinical Trials New Zealand Limited
Eileen Bisley
Managing Director
 
Ph: +64 (07) 843 0105

Critical Care

Jewel Barlow-Armstrong
Research Coordinator

Ph: +64 7 839 8899
Fax: +64 7 838 8912
Mob: +64 (0)21 863 589

CriticalCareResearch@waikatodhb.health.nz

Diabetes

Annie Johnstone
Nurse Coordinator - Diabetes Clinical Trials

Waikato Regional Diabetes Service
26 Clarence Street, Hamilton
Private Bag 3200
Hamilton 3240

Ph: +64 7 859 9180 ext. 2775
Mob: +64 (0)21 240 9087
Fax: +64 7 838 3788

annie.johnstone@waikatodhb.health.nz

Medical Oncology, Haematology, Radiation Oncology and Palliative Care

Wendy Thomas
CNM Cancer Trials Unit

Mob: + 64 (0)21 759 529 

Wendy.Thomas@waikatodhb.health.nz

Neurology

Linda Gilbertson
Research Coordinator

Neurology Dept
Waikato Hospital

Ph: +64 (0)21 549 791

Linda.Gilbertson@waikatodhb.health.nz

Respiratory, Gastro and Infectious Diseases Research

Christine Tuffery
Research Coordinator

Respiratory, Gastro and Infectious Diseases Research

Ph: +64 (0) 21 759 531 

Christine.Tuffery@waikatodhb.health.nz

Rheumatology

Denise Darlington
Research Coordinator

Rheumatology Research

Ph: +64 (0) 21 761 926

Denise.Darlington@waikatodhb.health.nz

Privacy Act 1993

Principal Investigators should make themselves familiar with the requirements of the Privacy Act 1993(external link) and the Health Information Privacy Code 1994. Refer to the Interim Website of New Zealand Legislation.

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.