Conditions of approval
All ethical approvals are granted subject to the following conditions, which will be stated on your letter of approval. You will be notified of any additional conditions made by the HREC and these will also be listed on your approval letter.
It is the Chief Investigator’s responsibility is to ensure that:
- The individual researcher’s protocol complies with the HREC approved protocol.
- Modifications to the protocol do not proceed until approval is obtained in writing from the HREC.
- Section 5.5.3 of the National Statement is followed. This states that:
‘Researchers have a significant responsibility in monitoring approved research as they are in the best position to observe any adverse events or unexpected outcomes. They should report such events or outcomes promptly to the relevant institution/s and ethical review body/ies and take prompt steps to deal with any unexpected risks.'
All adverse events must be reported regardless of whether or not the event, in your opinion, is a direct effect of the therapeutic goods being tested.
- All research participants must be provided with the current Participant Information Sheet and Consent Form, unless otherwise approved by the Committee.
- The Committee is notified if any investigators are added to, or cease involvement with, the project.
- The study has approval for 4 years contingent upon annual review. A Progress Report is to be provided on the anniversary date of your approval. You will be sent a courtesy reminder closer to this due date.
- A Final Report and a copy of the published material, either in full or abstract, must be provided at the end of the project.