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. | |
| 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. |
| Step 2: Research Approval Processes |
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| Step 3: Register your research, by completing the online Register your research form . |
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| 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 ScarletResearch 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 | Cardiology Liz LowManager 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-ArmstrongResearch Coordinator Ph: +64 7 839 8899 Fax: +64 7 838 8912 Mob: +64 (0)21 863 589 CriticalCareResearch@waikatodhb.health.nz | Diabetes Annie JohnstoneNurse 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 |
Neurology Linda Gilbertson | Respiratory, Gastro and Infectious Diseases Research Christine Tuffery | Rheumatology Denise Darlington |
Privacy Act 1993
Principal Investigators should make themselves familiar with the requirements of the Privacy Act 1993 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.
In order to obtain authorisation, researchers must have completed steps 1-3 below.
| Step 1: Register your research, by completing the online . |
|
| Step 2: Approval process |
|
| Step 3: Ongoing requirements | An email indicating approval to commence research activities will be sent once all relevant approvals and documentation has been received by the Research Office. It is a requirement of Locality Authorisation that for all HDEC reviewed research, Waikato District Health Board ( research@waikatodhb.health.nz ) is authorised to received email notifications from the HDEC online application system. |
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 ScarletResearch 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 | Cardiology Liz LowManager 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-ArmstrongResearch Coordinator Ph: +64 7 839 8899 Fax: +64 7 838 8912 Mob: +64 (0)21 863 589 CriticalCareResearch@waikatodhb.health.nz | Diabetes Annie JohnstoneNurse 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 |
Neurology Linda Gilbertson | Respiratory, Gastro and Infectious Diseases Research Christine Tuffery | Rheumatology Denise Darlington |
Privacy Act 1993
Principal Investigators should make themselves familiar with the requirements of the Privacy Act 1993 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.