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Research Information
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All researchers must read the information below regarding the institutional and ethical requirements for conducting research within the Waikato DHB. |
Contact:
- Denise Irvine
CTA Nurse Coordinator
021 795 063 or Ext 23255 or
- Nicola McKenzie
CTA Administration Assistant
021 241 5802 or Ext 23559
Ethical requirements
The New Zealand Health and Disability Ethics Committee website contains all the documentation and information for ethics submission, as well as administrator contact details.Please note there is a new National Application Form for Ethical Approval of a Research Project -2009-v1. The 2005 version will be accepted until 30 September 2009. Researchers may be asked to resubmit the compensation declaration form B if it is not the 2009 version and provide other documentation requested in the application form 2009-v1.
For observational studies an Expedited Ethics Review may be appropriate. Read the Expedited Ethics Review process before completing the application.
Maori consultation
When planning a study and considering the ethical requirements, it is necessary to consult with Maori.In the Waikato DHB this is done through Te Puna Oranga (Maori Health Service) and the Kaumatua Kaunihera Research Subcommittee.
Documents required include the Ethics Application form, information and consent forms, a concise description of the study and the completed HEAT (A Health Equity Assessment Tool (Equity Lens) for Tackling Inequalities in Health) tool.
Send the application and documents to Kay Berryman, Te Puna Oranga (Māori Health Service), and you will be notified of a time and date for the meeting with the Kaumātua Kaunihera.
Waikato DHB requirements
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.For externally sponsored clinical trials the Confidentiality Agreement needs to be seen by the DHB legal advisors who will approve and send to the relevant service manager for signing. However, if is termed a "Deed" of confidentiality it must be signed by the chief operating officer (COO).
The Clinical Trial Agreement (CTA) (between the sponsor and the DHB) and if applicable, the New Zealand DHB Standard Indemnity form is then sent to the sponsoring company/external researcher for their agreement and signature. This can sometimes require negotiation before agreement is reached. The COO signs all CTAs and Indemnities.
All proposed research within the Waikato DHB, including observational studies which have Expedited Ethics approval, must have the Final Authorisation Checklist/Database form signed before the study can commence. A database number needs to be assigned before final authorisation to proceed with the research is given by the COO. The database number is assigned through the office of the Chair, Board of Clinical Governance, currently the chief medical advisor on Level 9 of the Menzies building at Waikato Hospital.
Approval must be obtained from the clinical director/s of the area/s where the research is likely to impact (eg laboratory, pharmacy, nursing etc); the researcher's clinical director / service unit manager; the service manager and final approval to proceed is signed by the relevant group manager and the COO.
For studies which involve Intensive Care Unit (ICU) and High Dependancy Unit (HDU) patients it is essential that the studies have been discussed with the appropriate staff prior to the commencement of the study. Please read the Guideline for Researchers, Primary Investigators and Research Nurses for studies which involve intensive care and high dependency patients.
This is to ensure the safety and good clinical care of the patients enrolled in the study and also for the protection of the ICU and HDU staff caring for these patients.