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 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 OfR are waiting on responses is not counted in the 5 business days.
• 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.

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 investigator (including student researchers) to the project and there is no research agreement in place between the RMH and the investigators' organisation, complete and submit a draft Research Collaboration Agreement (MACH template) – ensure you include the other investigators' organisation.
  Note: the new agreement must not be in conflict with existing agreements for the project.
• Submit the draft agreement and all existing agreements for review.
• 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 research agreement in place between these two institutions, you will need to submit an agreement for review and signing. Please refer to the governance 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). 

• For change of sponsor – provide a letter from the sponsor stating they are now sponsor of the study
• For change of Coordinating Principal Investigator (CPI) or Principal Investigator (PI) – complete the Additional Personnel Form for the new CPI/PI, signed by both the old and new CPI/PI
• 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.
• Updated PICFs with name of new sponsor/PI
• If commercially sponsored – Updated indemnities, CTN and CTRA as required
• If not commercially sponsored – state on amendment form that no other updated documents are required.

One of the most common questions the Office receives is around the definition of "recruitment" sites versus "study" sites. We ask that you read the following before adding a new recruitment site to ensure that you are applying for the appropriate approval and to avoid delays in obtaining approval.

What is a recruitment site?

A recruitment site is where the site is only providing information via advertisements, such as a flyer or study poster, regarding a study occurring at another site.

What is a study site?

A study site is where:

• The site intends to consent or conduct any study procedure, or
• Any investigators are involved in discussing the study with potential participants – this would require the investigators to be trained in the protocol, or
• Any investigators are involved in the study in any way other than displaying advertisements such as a flyer or study poster, or
• A governance application is required at the new site

If any of the cases above apply, you are required to complete the procedure for adding a new study site.

How to add a new recruitment-only site

To add a recruitment-only site, submit the following:

• Statement of approval from Head of Department at the recruitment site
• Any recruitment materials going to participants

• 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
  • Updated Clinical Trial Research Agreement

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.

For investigator-initiated studies where you would like to have additional tests/data sent to a new collaborator – for example, blood samples to the Walter Eliza Hall Institute for extra/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
• An agreement between the RMH Principal Investigator and the collaborator. The type of agreement depends on the nature of the collaboration. Please contact the Governance team to discuss before submission.

For “non-ethics” amendments – for example, changes to an agreement, addition of a new agreement, indemnity, budget – 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