Post-approval requirements for ethics
After research ethics approval, you are required to perform specific procedures to ensure that research continues to comply with ethical standards.
During the post-approval stage, researchers must use Ethical Review Manager to submit the following documents:
- Commencement form to the HREC and the Research Governance Office once they begin their research
- Please note that you must receive authorisation from Research Governance prior to the research commencing.
- Annual progress report form to the HREC on the anniversary of their Ethics approval
- Final progress report form to the HREC within six months after completing your study.
On the additional contacts page, you can contact Research Ethics and Governance.
To amend a research project, you must use Ethical Review Manager to submit the following documents for HREC review:
- a signed covering letter
- relevant, clean, and tracked versions of updated supporting documents such as participant information and consent forms or research protocols.
If the risk is low, the HREC Chair may approve amendments between meetings. Otherwise the Chair will refer the amendment to the next meeting.
Please note: Researchers must submit amendments to each relevant Research Governance Office for approval after their HREC review.
What is a serious adverse event?
An adverse event can be any unfavourable or unintended sign, symptom, or disease temporally associated with the use of a medicinal (investigational) product, irrespective of whether or not it is related to the product.
What if a serious adverse event occurs?
Researchers are required to take the following steps to report any serious adverse events:
The Office for Research Governance and Development (ORGD) also conducts research monitoring to ensure safety and transparency.