The following ethics records should be kept by the researcher after ethics approval has been given:
- The ethics application, including all approved documents
- A copy of all correspondence exchanged between the HREC and the researcher prior to approval
- The ethics approval letter
- Documents/approvals specified in any Special Conditions of Approval stipulated in your letter of approval
- Consent forms – the Ethics Office may request these for an audit
- Copies of modification forms and annual reports
- Any approvals related to changes in personnel or any other modifications during the life of your study (please note that approvals to modifications may also contain special conditions of approval. See Understanding the Letter of Approval.
These records should be stored in the locations stated in Section E of the ethics application questionnaire.
For more information refer to the data retention guidelines.