Concord Hospital Concord Hospital
The Concord Research Office

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.

Ethics approval extension request 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:
• Proposed changes in the research protocol or conduct;
• Unforseen events that might affect the continued ethical acceptability of the project;
• Any safety issue which could adversely affect the safety of participants;
• The study is abandoned for any reason. 

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.

AMENDMENTS

Any proposed amendment to the study protocol must be notified to the HREC prior to the change being implemented.

Please submit any ethics amendments via REGIS. Guides on how to submit an amendment can be found on our website here. Alternatively, please access the REGIS how-to page for quick reference guides.

SERIOUS BREACHES IN CLINICAL TRIALS

Serious breaches should be reported in accordance with NHMRC Guidance document: Reporting of Serious Breaches of Good Clinical Practice (GCP) or the Protocol for Trials Involving Therapeutic Goods 2018.
A serious breach is a breach of Good Clinical Practice or the protocol that is likely to affect to a significant degree:
              •  The safety or rights of a trial participant, or
              •  The reliability and robustness of the data generated in a clinical trial.

The NHMRC guidance does not use the terms Protocol Deviation or Protocol Violation.

Serious breaches should be reported to the reviewing HREC, usually by the Sponsor, within 7 calendar days of confirming a serious breach has occurred. The HREC will review the serious breach to evaluate its impact on the continued ethical acceptability of the study and to satisfy itself that the serious breach is managed appropriately. Reports should only be made for sites under the jurisdiction of that reviewing HREC.

It is the responsibility of the Principal Investigator to:
1. Report any suspected breach to the sponsor within 72 hours of becoming aware of it and
2. Report to their institution (via the Research Governance Officer) within 72 hours any serious breach that has been confirmed by the sponsor as occurring at their site.