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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. |
Major changes to the Health and Disability Ethics Committees effective from July 1st 2012
The government response to the recommendations of the recent Health Committee Inquiry into improving New Zealand's environment to support innovation through clinical trials, institutes major changes to the Health and Disability Ethics Committees (HDEC) which will to take effect on July 1st 2012. These changes have important implications for researchers, research coordinators and the District Health Boards where the research is situated.
The changes encompass both structure and function of the HDECs with the number of committees reducing from 7 to 4 and the members of each committee reducing from 12 to 8.
The revision of the Ethics Committees standard operating procedures (SOPs) will see the committees focus solely on the ethics of the research and will no longer undertake scientific review. It is the responsibility of the researcher to ensure the appropriate scientific peer review has occurred. However, the committee can instruct a researcher to seek further peer review if they feel the study is poorly designed.
The HDEC application forms are being re-written and locality assessment, Maori consultation and indemnity will no longer be part of the application. The committee will only require proof of insurance by the sponsor, particularly in the case of interventional studies and that the Principal Investigator has indemnity cover.
The DHB Research Offices are currently working towards developing common processes to meet these responsibilities.
Continue with the current ethics and DHB requirements as below until July 1st 2012.
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.For observational studies an Expedited Ethics Review may be appropriate. Read the Expedited Ethics Review process before completing the application.
The locality assessment for research involving any aspect of the Waikato DHB resources must be signed by the Waikato DHB Chief Operating Officer (COO).
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.
These are the 2012 meeting dates and agenda closing dates for the Kaumatua Kaunihera Research Subcommittee.
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 New Zealand Standard Clinical Trial Agreement (CTA) (between the sponsor and the DHB) and if applicable, the New Zealand DHB Standard Indemnity is then sent to the sponsoring company/external researcher for their agreement and signature.
All documents requiring legal approval must be accompanied by a Request for Clinical Trial Research Agreement Approval form. The COO signs all CTAs and Indemnities once these have been approved by legal.
Waikato District Health Board also holds Professional Indemnity cover.
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 by the COO office, level 9 Menzies building.
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 / Nurse Manager; Director of Clinical Units and final approval to proceed is signed 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.