Amendments

Expedited Review (ER) pathways for RMH HREC and RMH Research Governance post-approval amendments: this is a review pathway which provides for ethics and governance post-approval amendments within 5-14 Victorian business days (stop clocks apply). 

The ER amendments pathway is available to both commercial and non-commercial studies where:

• RMH is the reviewing HREC and/or
• RMH is the sole site or the lead site; or
• RMH is a participating site for a multicentre study.

ER is available once both the Office for Research (OfR) and the relevant study team have agreed to pursue this pathway. It is subject to reviewer availability and OfR agreed capacity at the time of submission. 

All the following standard conditions apply if you are considering accessing this route.

• Study teams that are interested in this pathway must contact the Office for Research beforehand for prior clearance as well as a quote for ER fee.
  The fee for ER is variable and depends on the amendment content and complexity.
• Expedited Review Fee is additional to standard review fees. 
  The total fee applicable for ER amendments is generally quoted at twice the total standard fee.
  Proof of payment should be provided as soon as possible.
• Complete amendment submission packages only should be submitted to our Office through the RMH Post Approvals Inbox. Upon submission, applicants must confirm with the Office that the application has been received and accepted for ER (by telephone). 
• Timeframes to approval are based on ‘clock stops’ capturing for OfR review time. This means the time the OfR waits on responses from researchers is not counted in the time (business days) to review.
• Standard existing contract amendments only. No new contracts unless agreed in advance by the OfR.
• Budgets finalised and complete prior to submission
• No amendments allowed to the submission package once the review clock commences

If you are interested in exploring Expedited Review of a Post-Approval Amendment, please contact the Office for Research.

1. Download and carefully review the Amendment Guidelines
2. Complete and submit:
   • A signed Amendment Request Form
   • The RMH has Royal Melbourne Hospital has recently updated the method of payment for submission fees. All fees will now be via RMH invoice or internal journal transfer. Submit the applicable Fee form:
     • Fee Form - commercial studies - post approval
     • Fee Form - non commercial studies - post approval
   • All documents required for review specific to your circumstance – see below for Additional documentation required for specific amendment types
3. Open the email template for postapproval@mh.org.au and enter all information as requested:
   • Important to include the local project number in the subject of the email
   • Once you have all the files that you want to submit, you need to compress them into a zipped folder. If using Windows: Select the files, right-click on them, and select Send to > Compressed (zipped) Folder.

4. Submit your Amendment with the zipped folder. Ensure you receive the acknowledgment email from the Office for Research. If you do not get an acknowledgment email, it may mean that the Office has not received your email submission – contact the Office on (03) 9342 8530.

5. If your amendment review requires the Expedited Review pathway, see the information above and contact the Office for Research.

When the Royal Melbourne Hospital (RMH) is the reviewing HREC

As the reviewing HREC, RMH only need to be informed of a change in Principal Investigator or Contact Person (such as the trial coordinator) at each site in which the RMH HREC are providing ethical approval.

Other changes, such as Associate Investigators from sites other than the RMH do not need to be submitted to the RMH HREC. However, these amendments are required to be submitted directly to the local site governance office for review.

When the RMH is a site (Governance review)

If the RMH is a site, all changes in the RMH site personnel (Principal Investigators, Associate Investigators, Student Research, Research Coordinator, Contact person) need to be submitted to the Office for Research for review.

Required documentation:

• Additional Personnel Form
• Curriculum Vitae for the new researcher (if not previously submitted in the last 3 years). The Curriculum Vitae Form can be used and submitted instead. Send the CV via email to research@mh.org.au prior to submitting your amendment.
• Updated PICFs – If the new personnel will be involved in consenting patients please consider adding the new investigator to the PICF. It is acceptable to wait until other PICF changes are being initiated to save numerous version changes. Please state this on the amendment form if that is what you intend to do.
• If you are adding an external investigator (including student researchers) to the project and there is no research agreement in place between the RMH and the investigators' organisation, complete the Contract Kickstarter Form as part of your amendment submission.
• GCP training – Provide copies of GCP certificates for all members of the RMH research team. For further information about GCP requirements at the RMH visit the GCP Training web page.

Generally, this can only be done for studies that have been reviewed under the Streamlined Ethical Review Process (SERP) or the National Mutual Acceptance (NMA) system. For studies that do not fit into these categories, please contact the Office for Research for information on your options for adding a study site.

For sites that do not use Ethics Review Manager (ERM) – which are sites outside of Victoria and Queensland – contact the Coordinating Office by telephone for assistance when creating an SSA for these sites on 0408 274 054.

• If converting from a single-site to multisite project submit a new master PICF
• If commercially sponsored – Updated CTN and Indemnities as required
• If radiation involved (including pre-MRI safety screening examinations) – If standard care, submit the HREC radiation notification letter to be completed and signed by the Principal Investigator for each site. If additional to standard clinical care, an independent assessment report by a Medical Physicist (RSO report) must be included in the submission – one report for each applicable site
• If new site is Catholic institution – site-specific PICF with Catholic-approved pregnancy wording
• If addition of the new site involves a new collaboration between the RMH and another institution and there is not a contract in place, complete the Contract Kickstarter Form as part of your amendment submission. Please refer to the Contracts Office page for details on research agreements. 
• Addition of a Private Site – Where the RMH is the reviewing HREC, the private site/s being added under the RMH ethics approval need to confirm they accept the conditions of the RMH HREC review by signing an agreement to undertake ethical review of human research for an external entity. This agreement only needs to be signed once per private organisation (not per study). Please contact the Office for Research to see if there is already an agreement in place. If not, a private site agreement will be required
• Additional Personnel Form
• Curriculum Vitae Form for the new researcher (if not received in the last 3 years). 

One of the most common questions the Office receives is around the definition of various types of “sites.” Our definitions of each site type can be found on the Submit an ethics application for review page, under What is a "site" for the purpose of my clinical research project?.

If you are adding RMH as a new site and are unsure whether you need to submit an SSA application, refer to the Do I need to submit an SSA application? on the Submit a governance application for site specific assessment page. 

All site types added are standard sites for the purposes of the fee form. Some referral sites or equivalent, for some projects, may be an exception. Contact the Office for Research to discuss whether your project’s sites may qualify as “non-standard” for fee purposes. 

• Clear description of the rationale for the changes (including a summary of changes) to the protocol and whether this warrants Participant Information and Consent Forms (PICF) changes. If PICF changes are required, consider using a PICF addendum and outline if/how patients will be re-consented.
• Tracked and clean version of protocol/PICF
• If increase in number of tests/visits:
  • Updated statement of approval from relevant service departments
  • Updated budget for governance purposes
  • A completed Contract Kickstarter Form

Provide a clear description of the changes, including a summary of changes, and note whether this amendment warrants Participant Information and Consent Form (PICF) changes.

If updating the risk statement of the PICF ensure that the changes are in lay language.

Submit an Amendment Request Form and outline the details of the required changes.

The Contracts Office will provide advice on the agreements required to formalise a change of sponsor.

• Complete the Additional Personnel Form for the new CPI/PI, signed by both the old and new CPI/PI
• Submit a Curriculum Vitae for the new CPI/PI (if not previously submitted in the last 3 years). The Curriculum Vitae Form can be used and submitted instead. Send via email to research@mh.org.au prior to submitting your amendment.
• Provide updated PICFs with name of new sponsor/PI

For investigator-initiated studies where you would like to have additional tests/data sent to a new collaborator – for example, blood samples to WEHI for extra or new testing.

• Additional Personnel Form for the new collaborator
• Email a copy of the new collaborator's Curriculum Vitae fo research@mh.org.au
• Updated protocol of what new collaborator is doing. For example. how are samples/data being sent (must be de-identified), for how long, and how and when will they be destroyed
• Updated PICF informing participants that their data/samples are going offsite and, if required, include whether the data/samples are coded, how long they will be kept for and how they will be destroyed
• A completed Contract Kickstarter Form

Researchers must submit:

• The Amendment Request Form, clearly describing in detail, the nature of the change, the reason for the change and where the amendment involves a financial transaction (for example, change to budget), a calculation of the financial value of the transaction
• Amendments involving changes that may have an impact on services provided by supporting departments – for example, radiology, pharmacy, pathology – must also be accompanied by signed Statements of Approval from the relevant supporting department head

Complete the Contract Kickstarter Form. 

Refer to the Contracts Office page for more details on research agreements.