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.

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:
• Proposed changes in the research protocol or conduct;
• Unforseen events that might affect the continued ethical acceptability of the project;
• Serious or unexpected adverse events;
• The study is abandoned for any reason. 

AMENDMENTS

Any proposed amendment to the study protocol must be notified to the HREC prior to the change being implemented.
Please supply one electronic and one paper copy of:
• The Amendment Summary Form
• 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: The revised Investigator’s Brochure
 

ADVERSE EVENTS IN CLINICAL TRIALS

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:
For SAEs or SUSARs occurring at a site under the CRGH HREC’s approval, the adverse event must be reported to the HREC within 72 hours. The report must be accompanied by a comment from the Principal Investigator on whether the event impacts on the continued ethical acceptability of the trial, or warrants changes to the protocol or informed consent documents.
[Such an event should be reported to the Sponsor of the trial within 24 hours for expedited reporting to the TGA. In the case of an investigator-initiated study, the investigator is responsible for reporting to the TGA].

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.

Annual Safety Reports or updated Investigator Brochures should be submitted at least annually to the HREC (preferably with the annual project report).

PROTOCOL VIOLATIONS/DEVIATIONS

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.
Protocol deviations (i.e. minor departures from the HREC-approved protocol which do not impact on the safety of the participants, do not affect the participant’s willingness to continue in the study or the integrity of the study data) need not be reported to the HREC.