Amendments that alter approved and authorised research taking place at Bayside Health (Peninsula) require review and approval/authorisation prior to implementation.
Amendments include:
- Changes to the approved protocol, Investigator’s Brochure (IB) or other project documentation, such as participant information and consent form (PICF), advertisements, questionnaires, patient documents.
- Changes to the Principal Investigator or other research personnel.
- Changes to the agreement +/- indemnity as a result of the above.
Single site lower risk/higher risk projects approved by Bayside Health Peninsula Human Research Ethics Committee (HREC) require an Ethics Amendment Request which is reviewed and approved by the Bayside Health Peninsula HREC.
If there is an amended agreement +/- indemnity a Site Governance Amendment Request is also required for review and authorisation by the Bayside Health Peninsula Research Governance Officer.
Single site project ethics and site governance amendment requests must be submitted at the same time.
Multi-site projects approved by an external certified reviewing HREC require a Site Governance Amendment Request reviewed and authorised by the Bayside Health Peninsula Office for Research. This includes Bayside Health (Peninsula) Research Governance Officer review of any amended agreement +/- indemnity.
A multi-site project amended agreement +/- indemnity may be submitted independently to the associated protocol related amendment submission with notification.
How do I apply for HREC Approval of a Single Site Lower Risk/Higher Risk Ethics Amendment?
- Ethics Amendment Requests are submitted via Ethical Review Manager (ERM). If you do not have an ERM account register here Login – ERM Applications .
- The Principal Investigator (PI) must also have an ERM account for electronic signature through ERM. The Applicant user guide to ERM provides comprehensive guidance on how to use ERM.
- Create a Low Risk Notification Form (LRNF)/Ethics Amendment Request VIC as a sub-form of the Low Risk VIC/HREA on ERM.
- Select Amendment as the purpose if using an LRNF.
- Complete and upload other required documents. If there is an amended agreement +/- indemnity proceed to the ‘How do I apply for Site Governance Authorisation of an Amendment?’ section below for further instruction.
- PI signs the form/request using ERM’s electronic signature process.
- Submit the LRNF-Amendment/Ethics Amendment Request VIC via ERM Applications only when all steps above are complete.
What documents do I need to submit to HREC?
Below is a list of the documents required for HREC submission. Incomplete applications will not be accepted for review.
All documents must have a version number and date (no draft documents or those with comments or tracked changes will be accepted as part of the submission).
Mandatory:
- Low Risk Notification Form or Ethics Amendment Request VIC
Project Dependent:
- Protocol
- Investigator’s Brochure
- Participant Information and Consent Forms
- Any other amended documents used in the project
- Investigator(s) CV
- Investigator(s) Good Clinical Practice certification (Clinical Trials only)
- CTN Acknowledgement (New PI)
- Change to Research Personnel Form
- Ethics/Governance Payment Form – Recipient Created Tax Invoice (RCTI)*
*Commercially Sponsored Projects only
How is my ethics amendment reviewed?
The HREC meets monthly to review new and amended projects.
The amendment is reviewed by the Committee and their decision documented in the minutes.
A change in research personnel alone(other than the Principal Investigator) will be reviewed and approved by the Bayside Health Peninsula Office for Research.
You will receive feedback via ERM within 7 days of the Committee meeting
Research ethics amendments must not be implemented until an Ethics Amendment Approval letter is received from Bayside Health Peninsula.
How do I apply for Site Governance Authorisation of an Amendment?
- Site Governance Amendment Applications are submitted via Ethical Review Manager (ERM). If you do not have an ERM account register here Login – ERM Applications .
- The Principal Investigator (PI) must also have an ERM account for electronic signature through ERM. The Applicant user guide to ERM provides comprehensive guidance on how to use ERM.
- If you have an amended agreement +/- indemnity send the unsigned documents to ResearchContracts@phcn.vic.gov.au for review as soon as possible. The budget amounts (if any) do not need to be entered, only the text will be reviewed. This can occur while you collect your costs and other documents.
- For a single site project amended agreement +/- indemnity create a Site Governance Amendment Request as a sub-form of the Low Risk VIC SSA/ Site Specific Assessment (SSA) on ERM. Complete and upload amended agreement +/- indemnity.
- For a multi-site project create a Site Governance Amendment Request as a sub-form of the Site Specific Assessment (SSA) on ERM. Complete and upload other required documents.
- PI signs the request using ERM’s electronic signature process.
- Submit the Site Governance Amendment Request via ERM Applications only when all steps above are complete.
What documents do I need to submit to Governance?
Below is a list of the documents required for submission.
Mandatory:
- Site Governance Amendment Request
- Multi-site projects only;
- HREC approval letter of amendment(s)
- HREC approved documents
Type of Amendment Dependent:
- Protocol
- Investigator’s Brochure
- Participant Information and Consent Forms
- Any other amended documents used in the project
- Investigator(s) CV
- Investigator(s) Good Clinical Practice certification (Clinical trials only)
- CTN Acknowledgement (New PI)
- Change to Research Personnel Form
- Amended Agreement
- Amended Indemnity
- Amended Contracts Checklist
- Ethics/Governance Payment Form – Recipient Created Tax Invoice (RCTI)*
*Commercially Sponsored Projects only
How is my governance amendment reviewed?
- Site Governance Amendments are not subject to fixed deadlines.
- The Office for Research assesses the amendment and liaises with the Principal Investigator or Study Coordinator.
- Feedback will be sent via ERM.
- If the Office for Research authorises the amendment you will be provided with a Site Governance Amendment Authorisation Letter via ERM.
- If the amendment is for an agreement +/- indemnity only, authorisation and the fully signed amended agreement +/- indemnity amendment will be provided in Correspondence via ERM.
Research governance amendments must not be implemented until Site Governance Amendment Authorisation is received from Bayside Health (Peninsula).