Do you know if your research involves the CDHB?
If you are:
- Recruiting CDHB patients?
- Collaborating with CDHB staff?
- Using CDHB clinics or staff?
- Accessing data held by the CDHB or patient records?
- Using facilities, buildings or space of the CDHB?
How to get Locality Authorisation (LA)
- You must complete the correct LA form
- The correct LA form will be sent to you based on information you provided with the New Project Registration form
- You must provide all supporting documentation and signatures when you submit the LA form that was provided by the Research Office
- If you use the incorrect form you will be provided the correct form to complete and submit. Incorrect forms will not be processed.
Locality Authorisation requests are usually processed within 5 working days from when you've submitted the correct documentation. This will vary pending workload. If there is a genuine urgency, explain this once you have registered the project.
Requirements for approval
Ethics is required:
- HDEC approval or HDEC accredited ethics committee approval
- Out of scope projects may require additional approvals
Privacy of health information and research data must be considered.
- Privacy Impact Report may be required.
Pharmaceuticals must be registered with SCOTT for Clinical Trials
- Insurance - commercial work requires NZ$10m
- Indemnities - professional indemnity, personal indemnity and compensation
- Contracts - the CDHB has set delegations of authority as to whom can sign on behalf of the institution
The CDHB is a crown entity and thus has specific laws it must follow under the crown entities act 2004.
The CDHB culture
The CDHB has a process for institutional approval for all research.
This requires approval from all:
- Local Clinical Director(s), Service Manager(s) and/or Department Managers
- Legal, Finance, Safety
There is then the agreement required of the General Managers.
Maori consultation is expected for all research.
- TKW (Te Komiti Whakarite) is required for consultation or notification.
- TKW is also the link to the Māori Health Workers.
Transparency of costs and benefits.
The advisors can advise in the area as the following things can be covered:
- Costs – consumables, salaries, opportunity
- Benefits – knowledge, drugs
- Staffing costs, time only staffing
- Overhead requirements
Project tracker info (correct as of 6 July 2018)
This PDF show the status of projects currently in the Approval process.
Check the PDF to see:
- Whether you have provided all the necessary documentation
- What stage of the process your application is
- New Project Registration Form
- TKW Māori Submission Form (Word)
- Appointment with CDHB Biostatistician From (Word)
Expedited Māori review
The following studies will be considered for expedited review. Those that:
- Are commercially sponsored and for which the CDHB is NOT the lead site.
- Have sought and received Māori consultation from the University of Otago Christchurch.
- Have sought and received Māori consultation from the University of Otago Dunedin.
- Have sought and received Māori consultation from the University of Canterbury.
- Have sought and received Māori consultation from another NZ District Health Board.
The above form is still required to be completed but, if considered for expedited review, the study will not have to be heard at a full Hui. You should expect to hear back from your application for expedited review within two weeks.
- Standarised Clinical Trial Agreement for Contract Research Organisations (sCTRA for CRO's)
- sCTRA Standard Addendum Template
- sCTRA 2.0 Guidance Document
- Standard Indemnity & Compensation Agreement for Clinical Trials in NZ DHBs (sICA)
- Clinical Trials Costing Template