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.
1.HREC ANNUAL REPORTS
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. Reports must include a statement that the study is being/has been undertaken according to the original application (or as amended) and that all data is securely stored.
• 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.
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.
2. 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.
An application for an amendment should be made in the form of a letter to the Ethics Review Committee’s Executive Officer. It should contain 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: The revised Investigator’s Brochure
4. 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 RPAH 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 availablehere.
For SAEs or SUSARs occurring at sites other than those under the RPAH 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).
5. 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.