Researcher Responsibility under Approval for Human Ethics
The guiding documentation for Human Research specifies clearly the requirement for researchers to fulfil certain reporting conditions (refer to Chapter 5.5 of the National Statement on Ethical Conduct in Human Research). The following are standard conditions of approval. Any further conditions are communicated on the letter of approval from HREC.
Standard conditions of approval:
- The Coordinating Principal Investigator will report to the SCH HREC annually in the specified format and notify HREC when the project is completed. Download the Annual report form (doc).
- The Coordinating Principal Investigator will immediately notify the SCU HREC, on the appropriate form, of any change in protocol. Download the Change of Protocol form (doc).
- The Coordinating Principal Investigator will notify the SCU HREC of any plan to extend the duration of the project past the approval period listed in their letter of approval and will submit any associated required documentation. Download the Annual Report/Renewal form (doc).
- The Coordinating Principal Investigator will notify the SCU HREC if the project is discontinued at a participating site before the expected completion date, with reasons provided.
- The Coordinating Principal Investigator will immediately report anything that might warrant review of ethical approval of the project on the Adverse Events form (doc).