Post Ethics Approval
When the HREC is satisfied with the ethical aspects of a research proposal it will issue a written approval to the (Co-ordinating) Principal Investigator.
HREC ANNUAL REPORTS
Ethics approval is for a period of five years subject to the receipt of satisfactory annual reports. The Research Office will send a reminder.
The Annual Report Form can be found here.
If the study continues beyond five years then a resubmission request will need to be made and you may need to submit a new ethics application form.
5-yearly resubmission form can be found here.
RESPONSIBILITIES OF INVESTIGATORS
The HREC requires, as a condition of approval, that Investigators immediately report anything which might warrant a review of the ethical approval of a study. For example:
Any proposed amendment to the study protocol must be notified to the HREC prior to the change being implemented.
SERIOUS ADVERSE EVENT (SAE): An event (i) resulting in hospitalization (or prolongation of hospitalization); OR (ii) resulting in death or congenital abnormality; OR (iii) which is life threatening or medically important OR (iv) which results in a persistent disability.
SUSPECTED UNEXPECTED SERIOUS ADVERSE REACTION (SUSAR): a serious adverse event for which there is some degree of probability that the event is an adverse reaction to the administered drug, and the adverse reaction is unexpected.
IT IS A CONDITION OF THE HREC’S APPROVAL THAT THE PRINCIPAL INVESTIGATOR MEETS THE FOLLOWING REPORTING REQUIREMENTS FOR ADVERSE EVENTS:
The adverse event reporting form is available here.
For SAEs or SUSARs occurring at sites other than those under the CRGH HREC’s approval, the event should be reported within 72 hours only if it affects the ethical acceptability of the research and action is planned to change the protocol or informed consent documents.
Quarterly or 6 monthly summary SUSAR reports (Australian and international) should be submitted to the Lead HREC as they become available. These should be accompanied by a comment from the investigator as to whether action is planned for the trial on the basis of these reports.
Protocol Violations (ie serious departures from the protocol which potentially affect the welfare or rights of the participant and affect the scientific soundness of the research plan) must be reported to the HREC in a timely manner. Examples of protocol violations include failure to obtain consent, enrolment of a participant who did not meet all inclusion/exclusion criteria; performing a study procedure not approved by the HREC; medication dispensing or dosing error etc.