Applications for Research Approval should be submitted via DocMan: Online Research Locality Application. This paper form may be submitted by external researchers without access to DocMan. Please contact research@bopdhb.govt.nz if you have any questions.

Part One: Application (To be completed by Applicant)

Project title:
Principal Investigator (for this locality):
Contact details:
Other investigators:
Contact details:

Main Contact Person if not the Principal Investigator
Contact details:

Service Area

Please indicate which Service your research falls within:

☐ Allied Health, Scientific and Technical ☐ Medical	☐ Te Aka Whai Ora Toi Ora
☐ Mental Health and Addiction Services	☐ Surgical
☐ Nursing & Midwifery	☐ Women Child and Family
☐ Regional Community Services	☐ Other (provide detail)

Student Lead Projects

Is this a student lead research project?	☐ Yes	☐ No

If yes, please provide name and contact details of your clinical supervisor below.

Clinical Supervisor:
Contact details:

Master of Nursing Project

Is this project being conducted in conjunction for a
Master of Nursing qualification?	☐ Yes	☐ No

If yes, please notify the Chief Nursing Officer and provide a copy of the correspondence with this application.

Site

Tauranga	☐

Whakatane	☐

Both	☐

Other	☐ __________________________________________

Details of Research

Please indicate below the type of research / trial design that applies for your research (please tick all that apply):

☐ Observational study	☐ Interventional study
☐ Clinical drug trial	☐ Medical device trial
☐ Other (provide detail)

Please note: audits or audit related activities are approved under a different pathway with the Te Whatu Ora Hauora a Toi Bay of Plenty. Please contact the Clinical Audit Lead for details and support.

Overview of Proposed Research

Please attach a copy of your final research protocol or a brief outline of the research project

Please outline the potential benefits of your research to the Te Whatu Ora Hauora a Toi Bay of Plenty below

Please indicate how you intend to handle health data / information collected (if details are not included in your research protocol)

Research Timelines and Participants

Please provide details of planned project timelines:

Planned start date:
Planned end date:
Planned date for final study report:
Planned number of participants (or health records to be accessed):

Scientific Review

Has this study proposal been independently peer reviewed for
Scientific Validity?	☐ Yes	☐ No

If yes, please attach evidence of review.

Ethics Review Status

Please indicate the ethical review status for your research (only studies with ethics approval or those not requiring approval (with valid reason can be processed).

☐ Approved (Please attach evidence of ethical approval)	☐ Ethics review not required (Please attach letter from ethics confirming ethics review is not required or detail reason for exemption below)

Maori Consultation

Has your study been endorsed by Te Aka Whai Ora Toi Ora?	☐ Yes	☐ No

Please attach evidence of Maori Consultation.

Te Whatu Ora Hauora a Toi Bay of Plenty Head of Department and Service Business Leader Approvals

Head of Department

Your research project must be reviewed and supported by appropriate Head of Department.

Has your study been endorsed by the appropriate Head of Department?	☐ Yes	☐ No

Please provide evidence of support (i.e. email or letter from the Head of department confirming their support).

Service Business Leader Approval

Your research project must be reviewed and approved by the appropriate Service Business Leaders.

The Service Leaders assess the Te Whatu Ora Hauora a Toi Bay of Plenty resources and capacity required to conduct the research and also approve the financial aspects of the study the study budget. You will need to provide them with the following information:

The study protocol and an outline of what will be required from the Te Whatu Ora Hauora a Toi Bay of Plenty (i.e. specific details such as access to medical records, access to clinical or other equivalent systems)

Te Whatu Ora resources required to undertake research

Costs associated with conducting the research

Details of funding sources to support your research

Has your study been endorsed by the appropriate Service Business Leader?	☐ Yes	☐ No

Please provide evidence of support (i.e. email or letter from the Service Business Leader confirming their approval).

Review by Suporting Departments

Are any resources required from the following departments? (Please tick all that apply)

Researchers are required to discuss what support they require from the applicable departments and obtain agreement from the head of the applicable department. Note all projects that involve the use of medicines in the inpatient setting must dicuss their project with Pharmacy.

☐ Pharmacy
☐ Radiology
☐ Pathology (PathLab)
☐ Other (provide detail) ____________________________________

Please provide evidence of support from applicable Service (i.e. email or letter confirming agreement for provision of services).

Supporting Documents

Please ensure the following are included (as applicable) with your research application

☐ Study Protocol	☐ Evidence of peer / scientific review
☐ Patient information sheet and consent form	☐ Evidence of ethics approval
☐ Evidence of Head of Department approval	☐ Budget and study contract
☐ Evidence of Service Business Leader approval	☐ Any other relevant paperwork (i.e. questionnaires, surveys etc
☐ Evidence of Maori Consultation