Bay of Plenty DHB Research Approval Application Form. Version 10.0. May 2016

Bay of Plenty DHB Research Approval Application Form

Part One: General

To be completed by Applicant

Does this Study Require Health and Disability Ethics Committee approval?

Yes / No

If Yes – Has this been obtained?

Pending / Yes / No

Does your project need to be registered on the Australia New Zealand Clinical Trials Registry (ANZCTR)? Click on the link to find out http://www.anzctr.org.au/

Is this project for Master of Nursing? Please notify Director of Nursing Julie Robinson and copy in Rana Reuther

(Online Ethics Form to be forwarded to for Locality approval)

Project title:
Outline of study/Study Synopsis:
Financial and other Benefits to BOPDHB:
Principal investigator (for this locality):
Contact details:
Other local investigators:
Contact details:

Part Two: Maori Approval

To be completed by Applicant

Which Level of Maori Consultation is required for this Study? (Assess using the Maori Consultation Guidelines below)
(circle one) Level 1 Level 2 Level 3 Level 4
Copy of Maori notification/approval email sent to Research Manager
Yes / No
Please answer the following questions in your email for Maori Consultation
1.  How do you plan to recruit Maori participants?
2.  What is the benefit to Maori?
3.  How will the results be disseminated?
LEVELS OF MAORI CONSULTATION FOR RESEARCH PROJECTS WITHIN BOPDHB
Level 1 / No Maori participants will be involved in the research project – Maori subjects are excluded
No consultation will take place as no Maori participants will be involved in the research project. An example of this would be a project researching mental health issues in Asians.
Level 2 / Possibility that Maori participants will be involved in the research project – Maori subjects will be occasionally involved.
Regional Maori Health Services will be notified of this research project. Notification will involve an email to providing a plain English summary of the project. An example of this would be a Multi-Centre Multi-National Clinical Trial of Testicular Cancer which would involve less than 5% Maori participants. Please also copy the Research Proposal Coordinator into this email –
Level 3 / Probability Maori participants will be involved with the research project – The disease process being studied is highly prevalent in Maori
Consultation will need to occur with Regional Maori Health Services regarding this research project. This will involve an email providing a plain English summary of the project and a copy of the Patient Information Sheet and Consent Form. Marama, or a representative, will contact the Clinical Trials Unit with any comments or questions. If Rana Reuther (Research Proposal Coordinator) has not been contacted within three weeks of the initial email it will be assumed that Regional Maori Health Services have no concerns with the research project. An example of this type of research project would be a Multi-Centre Multi-National Clinical Trial of Rheumatic Fever which would potentially involve significant numbers of Maori participants. Please also copy the Research Proposal Coordinator into this email –
Level 4 / Definite involvement of Maori participants with the research project – The project is a study aimed at Maori participants
Full consultation with the Maori Research Committee will take place. This will involve Amohaere Tangitu, Marama Tauranga, their choice of a local Iwi representative and the lead researcher or representative. This is a monthly meeting. Documents to be discussed will be the Patient Information Sheet and Consent Form, Protocol and plain English overview of the project. An example of this type of research project would be a project that researched Oral Health in Maori Mental Health Patients.

Part Three: DHB Resources and Clinical Study Costing Template

(To be filled out by the Researcher with input from a Business Analyst and Service Manager if applicable)
( PRINCIPAL INVESTIGATOR TO FILL IN SHADED CELLS ONLY - ADD EXTRA ROWS IF NECESSARY)
Title of Research
Principal Investigator / Phone No.
Research Nurse / Phone No.
Location for research
Date to commence / finish / Signed:
Number of patients / Researcher:
Funding per patient / total / Manager:
(Less 15% GST if applicable)
Total funding / $ -
Costings
Staff / No Hours / Hourly rate / Number of patients / Total Cost
Paperwork preparation (ethics etc. Recommend $2500)
Research Nurse set up per patient / 0 / -
Research Nurse per patient / 0 / -
Consultant (Beyond Clinical Treatment) / 0 / -
0 / -
Sub Total / $ -
Consumables per patient (eg Pharmaceuticals)
Additional to standard care / Cost / Number of patients / Total Cost
0 / -
0 / -
0 / -
0 / -
Sub Total / $ -
Procedures per patient (eg CXR, ECG, Lab Tests) additional to standard care / Cost / Number of patients / Total Cost
0 / -
0 / -
0 / -
0 / -
Sub Total / $ -
Facility costs (eg Fax / Phone / Copying) / Cost per patient / Number of patients / Total Cost
-
-
-
-
Sub Total / $ -
Total Cost
-
-
Sub Total / $ -
Total cost for research / $ -
Cost per patient / $ -
Comments (Benefits etc.)

NOTE:

If your study does not have funding, please confirm that no BOPDHB resources will be utilised for the purposes of this project (resources include BOPDHB staff time)

Confirm


DHB Resources:

You must obtain written approval for your research to proceed from both Clinical AND Service Managers in the area that your research is predominantly taking place

1.  Pharmacy

Does your study involve any medications? (including medications

Yes / No

that are standard of care)

If YES, please contact Tauranga Hospital DHB Pharmacy to discuss further ()

Please provide evidence of approval from Tauranga Hospital DHB Pharmacy

2.  Laboratory

Does your study involve any laboratory samples (local tests / storage

Yes / No

of samples / retrieval of samples?

If YES, please contact Specimens Manager at Pathlab to discuss further

Please include any costs in the budget.

3.  Radiology

Does your study involve any Radiological tests?

Yes / No

If YES, please contact the Regional Radiology Manager.

Please include any costs in the budget.

Please provide evidence of approval from Radiology Services

4.  Other Resources – eg Allied Health

Does your study involve any other resources? (including medications

Yes / No

that are standard of care)

If YES, please provide details and include any costs in the budget.


Applicant Checklist:

1. Have you completed: (X when completed)

Part One

Yes

Part Two

Yes

Part Three

Yes

2.  Attach the following documents to your application:

Protocol Synopsis/Study Design

Yes

Clinical Study Costing Template/Trial Budget

Yes / No
Yes / N/A

3.  If Study requires Health and Disability Ethics Committee

(HDEC) Approval – online Ethics Form to be forwarded to for Locality Approval

4.  Appropriate departmental approval (Clinical and service manager) to undertake research obtained – proof of this forwarded to

I declare that all staff involved in this research will respect the confidentiality of the information obtained for research purposes.

Signature: / Date:
Name: / Position:
Contact details:

Email your application along with the attached documents to the Research Proposal Coordinator –

Part Four: Clinical Trials Unit Approval

To be completed by the BOP Clinical School Research Proposal Coordinator

Does this study require Scientific Review?

Yes / No

If Yes:

Is this study Scientifically Valid?

Yes / No
Yes / No

Is this study Statistically Valid?

Does this study require input from the Clinical Trials Unit, BOP Clinical School?

Yes / No

If Yes:

Yes / No

1.  Does the CTU have capacity to take on the study? (equipment/personnel/ability)

Yes / No

2.  Is this study suitable for the CTU to participate in?

(including all financial aspects)

Yes / No

Are the facilities adequate/appropriate to conduct the study?

Yes / No

Are there adequate personnel to conduct the study?

Yes / No

Do the departments involved have capacity to conduct the study?

Signature: / Date:
Name: / Rana Reuther / Position: / Research Proposal Coordinator
Contact details: / – PH: 07) 577 5513

Part Five: Provider Arm Approval (DHB patients)

To be completed by the Bay of Plenty DHB Chief Operating Officer

Comments:

Signature: / Date:
Name: / Pete Chandler / Position: / Chief Operating Officer
Contact details: / – Ph: (07) 579 8943

Part Five: BOPDHB Head of School Approval

To be completed by the BOPDHB Head of School

Comments:

Signature: / Date:
Name: / Peter Gilling / Position: / Approved CEO Delegate
Contact details: /

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