Human Research Ethics Committee Variation Request Form

Variation For CDU-HREC Approved Protocols

Details of variations or modifications from the original approved proposal and the rationale behind the request(s) need to be advised in writing for review and approval.

For changes in regards to project personnel, the names, contact details, qualifications and reasons for joining or leaving must be provided regarding all personnel. It is the responsibility of the Principal Investigator to ensure that all members of the team are adequately informed regarding the standard conditions of approval set out in the originally approved proposal.

GUIDE TO COMPLETING THIS FORM

All relevant answers must be completed. Depending on your response to the answer given, additional information may be required. You will be unable to continue until the required answers have been completed.
Progress on this form can be saved and completed at a later stage.
When selecting 'save and continue later', a link will be generated which can be emailed to you. This will allow you to return to complete the form. This will also allow you to share the form with others to complete certain parts of the form. You can then email the link to another (e.g., Student Principal Investigator), to complete/sign and submit. ( Please note : if you are a student completing this form, please ensure to include your signature before clicking 'save and continue' and generating the link to be sent to the PI to sign and submit)
Ensure that any supporting documentation is attached. There is an option to attach documents at the end of this form.
Once you submit the form, it will automatically be sent to humanethics@cdu.edu.au in PDF format. A copy will also be emailed to the PI listed on the application form.

Researchers conducting research relevant to or involving First Nation peoples and communities must report on individual and community involvement (see Section Two of this form).

Please provide the following information:

Project Title *

CDU-HREC Reference: *

Name of Principal Investigator *

Email *

Faculty/Institution *

Contact Number

Is this project part of a CDU Course, including Higher Degree Research?

YesNo

Student name

Faculty/Institution (student)

Email (student):

Contact Number (student):

Please indicate which of the following amendments are applicable *

Extension of ethics approval requiredChange of personnel (e.g. addition/removal of investigators)Change of Principal Investigator (PI)Protocol variation (e.g. change in methods, expanded scope, participants)Variation Request for Program Approval projectOther

New Expected Completion Date (if extension requested) *

** Please note: Clearance is granted for five years in accordance with the National Statement. A new application may be required after this time. **

Change of personnel

Please indicate the following: *

Remove investigator/s from projectAdd investigator/s to projectBoth (add and remove investigator/s)

Investigator/s to be added to the project

Name *

CDU Staff/Student ID *

Faculty *

Role *

Email address *

Investigator to be removed from the project

Name *

Role in project *

Date involvement ceased *

Briefly explain reason for removal *

Details of new Principal Investigator (PI)

Title *

Full Name *

Staff ID *

Email address *

Faculty/Institute/Centre *

Phone (business) *

Qualifications *

Details of protocol variation request

Details of Original Research Design (methodology and/or methods): *

Please detail the Proposed Amendments to the above: *

Justification for the Amendments: Why do you need to make these amendments? *

Details of Variation Request for Program Approval project

Is the variation request to add a new researcher or student covered by the Program Ethics approval *

YesNo

Please provide the following, to be attached this variation request:

Coursework Program Approval Form: Application for student project approval form completed by the student
Plain Language Statement and Consent Form relevant to the project if required

Details of proposed amendment *

Justification for amendments *

Details of "other" amendment request

Details of Original Approval: *

Details of proposed amendments: *

Justification for amendments: *

Have any new ethical risks arisen since the protocol was approved? *

Yes No

If you answered YES, please provide details about the actions you have taken or propose to take to address the issues. *

Were any conditions attached to your previous ethics approval? *

YesNo

If you answered YES, please indicate how you have complied with the conditions of approval. *

Have you read and complied with the National Statement on Ethical Conduct in Research Involving Humans? The National Statement can be accessed via the link below. *

YesNo

The National Statement on Ethical Conduct in Human Research (2025)

Attachments

All relevant files have been attached (below) *

YesNoN/A

Please provide any relevant documents for this amendment request

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(e.g., updated Information Sheet for Participants, updated protocol etc.)

Principal Investigator *

Draw signature|Type signatureClear

Date signed (PI): *

Student signature (if applicable)

Draw signature|Type signatureClear

Date signed (student):

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