Office of Research Ethics and Integrity

Varying an approval (human ethics)

During an approved human research activity, you may need to update or vary how you're conducting it. Any changes have to be approved by the Office of Research Ethics and Integrity before you implement them.

If you're only proposing a minor change (e.g. additional research team members, changes to the participant information sheet, additional sites/participant group), submit a variation request using the online form below. You'll usually receive an approval email within 2 weeks. The ethics reviewer may contact you with questions before approval can be granted.

If you're proposing a major change (e.g. a new or different project) discuss this with your Research Ethics Advisor (REA) or the Office of Research Ethics and Integrity.

For projects that have received ethical approval from another HREC (admin reviews):

  • Variations must be submitted to the lead HREC for review and approval and records maintained by the research team.
  • If your project is a TGA-regulated clinical trial you must also lodge all approved documentation with OREI (email your approved documentation to humanethics@qut.edu.au).

Do not implement variations until you have formal approval from the Research Ethics Advisory Team.

Submitting a minor variation request

  1. Complete and submit the variation request form. You and the chief investigator will each receive a confirmation email.
  2. Reply to this email and attach:
    • an updated version of your approved application, with Track Changes active in Microsoft Word to highlight your updates
    • any relevant amended documentation, like a reworded Participant Information Sheet and Consent Form.
    NOTE: You should not delete anything in the application form that has already been approved and undertaken. You should just add or amend with the new information. The application form must reflect the whole history of the project.

Your variation request is then complete and will be forwarded for approval.

IMPORTANT: Please complete this variation request using Internet Explorer or Chrome. There are some noted issues with Firefox and Safari.


Fields marked * must be completed

Summary Details

8. Is this project a Clinical Trial under a CTN scheme? *

10. Have any concerns or adverse events occurred in relation to the project to date? * If YES, please provide details

Variation Request Specifics

11. Changes to research team members? * If YES, please provide details

12. Changes to research participants? * If YES, please provide details

13. Changes to data collection instruments? * If YES, please provide details

14. Changes to data collection methods? * If YES, please provide details

15. Changes to data collection sites? * If YES, please provide details

16. Changes to Participant Information & Consent processes? * If YES, please provide details

17. Changes to timeline (e.g. extension)? * If YES, please provide details

18. Other change not specified above? * If YES, please provide details

Risk Management

19. Does the proposed request alter the risks or ethical issues associated with the study? * If YES, please provide details

20. Does the proposed request alter the benefits associated with the study? * If YES, please provide details

21. Does the proposed request alter the access or use of research data as originally conveyed to participants? * If YES, please provide details

22. Does the proposed request require permissions or approvals from other authorities? * If YES, please provide details

23. Do personnel associated with this request have appropriate training & experience? * If NO, please outline what training will be provided

Documentation

Remember: you also need to submit an updated version of your application plus any amended documentation associated with this variation request, with 'tracked changes', to clearly highlight the requested changes

Submission

Note: All * form fields are required.