Section 5 is mandatory and must be completed for all ethics submissions.
Projects must be submitted both by email and via ERM by 11am on the deadline day.
5a. Submit all documentation via email
Open the email template for firstname.lastname@example.org and attach all the application documents.
If you do not receive email confirmation that the Office for Research has received your ethics submission, contact the Office directly on (03) 9342 8530 to confirm receipt.
Projects submitted that do not comply with the following items may be returned and risk not being considered for the meeting:
- PICFs and all other participant-facing documents must be submitted in MS Word format and not in PDF
- Submission must include CPI/PI authorisation using any one of the following three options:
- Scanned copies of the original wet ink signatures, or
- HREA digital authorisation function via ERM, or
- An email from the CPI or PI that references the Local HREC project number in the email authorising the submission
- Submissions must use the file name convention outlined below for each document – this will allow HREC members to identify documents more easily
File name convention
As shown in the below examples, include the following details:
[Local HREC Project Number] [EMR number] [Document Type] Version [Version Number] [Date]
- 2020.999 RMH11111 Protocol Version 1 29082020
- 2020.999 RMH11111 PICF Version 3 30092020
- 2020.999 RMH11111 HREA Version 1 22102020
5b. Submit documentation via ERM
Upload all the application documents into your Human Research Ethics Application (HREA) in Ethical Review Manager (ERM).
Please ensure you click the 'submit' button.
Criteria for review at the next HREC meeting
Submission of a new research project must be received by the 11am deadline – however, this does not guarantee that a project will be accepted for review by the HREC at its next meeting.
After the submission deadline each month, all projects received will be carefully checked to ensure that projects meet the criteria required to allow a thorough review of the project.
Projects not meeting these criteria in full will not be accepted for review and will be returned to the principal researcher for attention.
CPI, PI and Sponsor Guidance
The responsibilities of the Coordinating Principal Investigator (CPI), Principal Investigator (PI) and sponsor are summarised in the document Roles and Responsibilities in a Research Project.
- Roles in single-site research project – For a single-site project, the PI has overall responsibility for the ethics application and conduct of the research project.
- Roles in multi-site research project – For a multi-site project, the CPI has overall responsibility for the ethics application and conduct of the research project. Each site has its own PI who is responsible for the site’s SSA application and conduct of the research project at that site.
In all instances, the principal investigator at the RMH must be a paid employee of the RMH.