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:
SAFETY REPORTING FOR CLINICAL TRIALS
Safety reporting for clinical trials should be in line with the NHMRC-TGA guidance document: Safety Monitoring and Reporting in Clinical Trials Involving Therapeutic Goods (2016).
For more information on safety reporting and monitoring, see the Safety Monitoring and Reporting section.
Any proposed amendment to the study protocol must be notified to the HREC prior to the change being implemented.
Protocol deviations are minor or administrative departures from the HREC approved protocol which result in missing or unusable data. They do not affect the scientific soundness of the research plan, or the rights, safety, or welfare of research participants.
Examples include: follow up visits that occurred outside the protocol required time frame because of the participant’s schedule, or blood samples obtained at times close to but not precisely at the time points specified in the protocol.
The Sydney LHD HREC (Concord Hospital) does not require that protocol deviations are submitted for review. However, at the discretion of the (Co-ordinating) Principal Investigator or the Sponsor, a list of protocol deviations may be reported with the annual progress report.
Protocol violations are instances where the protocol requirements and/or regulatory guidelines were not followed, and are generally more serious in nature than protocol deviations. Protocol violations are considered to potentially affect the scientific soundness of the research plan and/or the rights, safety, or welfare of research participants.
Examples include: failure to obtain participant consent and participant inclusion/exclusion violations.
The HREC requires principal investigators to provide written reports of Protocol violations in a timely manner. The principal investigator will provide a copy of the report and any responses from the HREC to the Research Governance Officer.