Prior-Approval-Application-Form-Version-1-dated-7.1.2015.docx (54.8 KB)

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Tasmanian Health and Medical Human Research Ethics
Committee
Application Form:
Prior Approval from an NHMRC registered HREC
New applications for projects that have been approved by another HREC will be considered for
expedited approval in accordance with the ‘National Statement on Ethical Conduct in Human
Research 2007’ – Chapter 5.3 – Minimising Duplication of Ethical Review’
An electronic version of this Prior Approval form and attachments must be emailed to
Human.ethics@utas.edu.au
If you have any questions please call Lauren Black, Executive Officer on 03 6226 2764
Project Details
Project title
Name of HREC that previously approved project
Date of approval
Please provide proposed dates of UTAS/DHHS
involvement in the project
Start:
End:
Applicant Details
Chief Investigator/Supervisor:
Faculty/School/Section
Postal address
Phone
Email address
Please name all other local
investigator’s involved in the
project
1.
2.
3.
Student Investigators
(include contact details,
student ID, DOB, Course)
1.
2.
3.
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Health and Medical HREC Prior Approval Application Form version 4 dated January 2016
Project Specific Details
Please briefly describe UTAS/DHHS involvement in this project in the box below.
Include details as to;

Who are the Tasmanian participants and how many? How will they be recruited?

What aspects of the study will be conducted in Tasmania and by whom;

who will be responsible for the conduct of the research in Tasmania?
Collection, use or disclosure of personal information
Does the proposed research involve the collection, use or disclosure of personal information
(including medical records) held by a Commonwealth or State agency, or an organisation in the
private sector?
☐ Yes
If yes, please complete & submit the Privacy Form along with your application,
available here
☐ No
Organisational Arrangements
1. Is the UTAS/DHHS component of this project discussed in the application?
☐ Yes ☐ No
If NO, provide details of UTAS/DHHS additional role(s) in the box below.
2. Has an agreement been reached in regards to the ownership and storage of the data?
☐ Yes ☐ No
Provide details of the arrangements, or explain why no arrangements have been made in the box below.
3. Has an agreement been reached in regards to who can publish/report on the results of the
research, as well as an agreement in regards to authorship?
☐ Yes ☐ No
Declarations
The Head of School or the Head of Department is required to certify that:
•
He or she is familiar with this project and endorses its undertaking;
•
The resources required to undertake this project are available;
•
The researchers have the skill and expertise to undertake this project appropriately or will
undergo appropriate training as specified in this application. If the Head of School/Department is one
of the investigators, this statement must be signed by an appropriate person. This will normally be
the Head of School/Department in a related area or by the Dean.
Name
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Health and Medical HREC Prior Approval Application Form version 4 dated January 2016
Position
Signature
&
Date
Conformity with NHMRC Guidelines
The Chief Investigator is required to sign the following statement:
I have read and understood the National Statement on Ethical Conduct in Human Research 2007
and the Australian Code of Conduct for Responsible Research 2007. I accept that I, as Chief
Investigator, am responsible for ensuring that the investigation proposed in this form is conducted
fully within the conditions laid down in the National Statement and any other conditions specified by
the HREC.
Name of Chief
Investigator
Signature
&
Date
Supervision of students
The Chief Investigator is required to sign the following statement:
The student(s) involved with this application are fully aware of the ethical requirements as set out in
the National Statement, and of the requirements for confidentiality and security in relation to data and
information to which they have access.
I agree to provide the student(s) with an appropriate level of training to enable their involvement to
be undertaken skilfully and ethically.
I agree to provide the student(s) with an appropriate level of supervision and be responsible for their
conduct while under my supervision.
Where it is proposed that the student(s) has access to patient medical records, I am satisfied that
they understand and respect patient confidentiality and the issues surrounding research privacy.
Name of Chief
Investigator
Signature
&
Date
Signatures of Other Investigators
The other investigators should sign to acknowledge their involvement in the project and to accept the
role of the Chief Investigator.
(Name)
(Signature)
(Date)
(Name)
(Signature)
(Date)
(Name)
(Signature)
(Date)
Atttachments
PLEASE ENSURE THAT THE FOLLOWING DOCUMENTS ARE INCLUDED WITH THIS FORM:
a.
b.
c.
d.
e.
f.
Finance and Administration Form (available here)
Copy of the ethics application submitted to the other ethics committee
Copy of the final approval letter
Copy of all approved documentation (consent forms, surveys etc)
Documentation of any relevant variations to the project since its original approval
Online CTN draft submission (if applicable)
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Health and Medical HREC Prior Approval Application Form version 4 dated January 2016
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