Post-approval: managing your project
After ethics approval has been granted for a project, the researcher has certain responsibilities to uphold to ensure continuing ethical compliance.
Requesting amendments or modifications
If you are modifying any aspect of the study, for example:
- recruitment procedures
- extension of ethics approval
- addition and removal of personnel
- new funding
- changes to Participant Information Statement/Consent Form
you need to submit a request for modification.
Some modifications may require changes to any of the public document(s) such as Participant Information Statements, Consent Forms, advertisements and questionnaires, etc. You should include amended documentation with your modification request. Please provide tracked and clean copies of any amended documentation.
Sponsors of clinical trials should include a table of documents, listing each document that they wish to amend and provide a summary of changes in an email.
All modifications should be emailed to email@example.com
If you are adding students, then you should submit the Request for Amendment Form and provide a rationale for the addition of students.
For all other modifications, please complete the Request for Amendment Form.
Requests to change personnel only or change in funding only are considered by the Ethics Secretariat and can be submitted at any time.
Amendment requests are considered by the HREC's Executive. The HREC Executive meets once a month between meetings.
Please contact the Ethics Secretariat to enquire about Executive meeting dates. Sometimes the Executive may recommend the modification be review by the HREC. You will be notified of this and any likely delay to notification of final outcome.
Reporting adverse events
An adverse event may be a harmful, unpleasant, or undesirable response, reaction, or outcome experienced by a research participant or researcher.
Such incidents may include unanticipated harm to participants – including physical harm, anxiety, pain, psychological disturbance, devaluation of personal worth and social advantage – or harm to the reputation of the researchers and the University.
Other adverse events that might have an impact on the continued ethical acceptability of the project must be reported to the HREC as soon as possible. This includes instances of privacy breaches, loss of data, damage to property and other similar occurrences.
A research participant wishing to report an incident can contact the researcher directly or contact the Ethics Secretariat on + 61 2 9850 4459 or firstname.lastname@example.org
A research participant wishing to lodge a complaint about a research project or researcher can contact the Director, Research Ethics and Integrity on +61 2 9850 7854 or email@example.com
Please complete an Adverse Event Form on the HREC's forms page and email the completed form, with any relevant documentation, to firstname.lastname@example.org.