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 tohuman.ethics@utas.edu.au

If you have any questions please phone the Research Integrity and Ethics Office on 03 6226 6254

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.

1/3Health and Medical HREC Prior Approval Application Form version 4.1 dated October 2017

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                                                                                                        Position                                                                                                        

2/3Health and Medical HREC Prior Approval Application Form version 4.1 dated October 2017

Signature & DateConformity 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 studentsThe 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)                               

Attachments

PLEASE ENSURE THAT THE FOLLOWING DOCUMENTS ARE INCLUDED WITH THIS FORM:

a. Finance and Administration Form (available here)b. Copy of the ethics application submitted to the other ethics committeec. Copy of the final approval letter d. Copy of all approved documentation (consent forms, surveys etc)e. Documentation of any relevant variations to the project since its original approvalf. Online CTN draft submission (if applicable)

3/3Health and Medical HREC Prior Approval Application Form version 4.1 dated October 2017