Southern Health Human Research Ethics Committee (SH HREC)

1. Southern Health Human Research Ethics Committee (SH HREC) & Monash University Human Research Ethics Committee (MU HREC) Mutual Acceptance Program: Review Process Operating Procedures Investigator prepares submission for the SH HREC & identifies involvement of both Southern Health and Monash University in application Application Submitted to HREC Legal documents for Monash University and Southern Health are reviewed separately by each site SH HREC decides to approve or reject project Application Reviewed by HREC (Written feedback provided to researchers within 7 working days of meeting by Southern Health Research Directorate) Researcher responds to written feedback If application was approved subject to conditions: Responses reviewed by HREC Secretariat (Response provided to researchers within 10 working days of receipt) If application was deferred pending a response to issues raised by a SH HREC Committee: Responses included in meeting papers and must be submitted according HREC application deadlines for submissions • Any: • Protocol Amendments • Serious Adverse Events • Annual Reports • are to be forwarded to the • SH Research Directorate • and copies of these will be • forwarded to MU HREC • at the discretion of the SH HREC A copy of the Certificate of Approval is sent by SH Research Directorate to MU SCERH. Upon meeting Conditions of Approval – Certificate of Approval Issued for 3 years by SH Research Directorate Annual Report Submitted to SH HREC (Template and Reminder sent by SH Research Directorate) The researcher submits a copy of the final approved application to MU SCERH