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 (known as Minestones in REGIS). It is a requirement of the NHMRC that reports on the progress of all approved studies must be submitted to the Committee at least annually.  The Milestones are to be submitted via REGIS. 

• Annual progress reports on multicentre studies must include information on the status of the study at all NSW sites for which the Ethics Review Committee is providing ethical oversight. It is the responsibility of the Co-ordinating Investigator to compile this data from advice provided by the site Principal Investigators.

• For clinical trials of drugs or devices being done under the CTN Scheme with SLHD sponsorship, the Committee requires quarterly reporting.

•For all other studies (including clinical trials sponsored by commercial companies), the Committee requires annual reporting.

•For the convenience of investigators, reminder letters and standard report forms are forwarded to the Chief Investigator approximately two weeks before each report is due.

•A final report must be submitted when the study has been completed and the results known. Please note that the Committee does not consider a study complete until the data are analysed and a report of the results written and placed in the public domain.

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 submitted as an amendment request for an extension of ethics via REGIS.

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.

The form will require you to include the following:

• The study’s protocol number and title

• Information on the reason why the amendment is needed

• The nature of the amendment

• The revised Protocol in track change with a new version # and date

• If applicable: The revised Participant Information Sheet & Consent Form in track change with a new version # and date

• If applicable, for clinical trials: All updated Investigator's Brochures must be submitted via REGIS.

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.