In this section
Please use Ethics Review Manager (ERM) to submit all amendments and other post approval requirements.
Amendments should be submitted for HREC review as soon as possible. There are no submission deadlines for amendments.
It is the responsibility of the Principal Investigator to ensure HREC approval is obtained for all amendments prior to implementation. Failure to conduct research according to an ethically approved protocol risks researchers' legal indemnity, right to publication and
opportunity to seek future funding.
An amendment may include (but is not limited to) changes to the:
Please note as of the 1 July 2019 the changes to the
HREC Payment Fees. These are payable in full at the time of the initial submission of a project or amendment.
All payments that are submitted to the Research Ethics and Governance Office at RCH must be completed using this
form or the payment remittance advice provided (proof of payment).
RCH HREC Fee Payment Form
There are three options for payment Credit Card, Electric Funds Transfer and Internal Cost Centre Transfer.
If payment does not accompany the initial submission or amendment the Ethics review process will not be able to start until it has been received.
To determine whether fees are applicable to the review of your submission, please review the schedule of
Submission Fees. You do not need to submit this form if no fee applies.
Amendments should be submitted to the HREC that reviewed and approved the original application.
The following documents must be submitted when seeking ethical approval for amendments from the RCH HREC:
ERM - Amendment Form (from the HREA)
Signatures, if adding Associate Investigators or a New Site (and site PI):
If Protocol changes affect support provided by Supporting Department, please provide revised sign off:
* If the study is multi-site and the Melbourne Children’s Campus is a participating site please ensure any new or revised documents submitted are both the Master version and the Site Specific version (based on the ethically approved masters)*
If the study is multi-site and ethical approval for RCH has been obtained from another HREC, the following documents must be submitted for governance authorisation:
ERM - Site Governance Amendment (from the SSA)
Please ensure the file name reflects the name of the document, as well as the version number
The Coordinating Principal Investigator (CPI) is responsible for submitting amendments on behalf of all participating sites. Once the amendment has been approved, a copy of the approval letter and approved master documents should be forwarded to the Principal Investigator (PI) at each participating site to obtain governance authorisation.
An eCTN variation must occur if any of the details concerning the notification have changed. This includes (but is not limited to) the type of investigational product used, dose, route of administration and/or the manufacturer. An eCTN variation is also required if there have been changes to the site, sponsor or PI. Sponsors are responsible for submitting variations to the eCTN. As such, for all commercially sponsored clinical trials, this will be done by the pharmaceutical company or CRO. For all investigator initiated clinical trials where MCRI are the sponsor, please contact MCTC@mcri.edu.au for further information and instructions on submitting a variation.
All updated documents should be submitted as a amendment. All updated documents should also include a new version number and date to ensure ongoing accountability. The only exception to this is the correction of typographical errors, which can be corrected by the research team without having to update version numbers/dates or seek approval from REG. If you are unsure about whether to submit a amendment, please contact the office for advice.
Amendments are typically reviewed by the HREC Chair out of session. Where appropriate, a governance review is also undertaken concurrently by office staff. Only in exceptional circumstances will a amendment be escalated for full HREC review. This generally only occurs where the risk is considered high, or additional expertise is required. If your submission does require full HREC review, you will be notified as soon as possible.
We aim to have amendments approved within 2-4 weeks. Additional delays may occur during busy periods, however, we will ensure you are informed if it is likely your submission will be delayed for any reason.
Please submit your thank you letter, with version number and date, as an amendment to the REG office. The Plain Language Adviser will review your letter and give you feedback. This
Example Thank You Letter
gives you guidance on how to write your own letter. Once the Plain Language Adviser has approved your letter, you will get a letter from REG giving you clearance to send the letter to participants.