Submit an amendment

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 (i.e. trial coordinator) at each site in which RMH HREC are providing ethical approval.

Other changes, such as Associate Investigators from sites other than 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 RMH is a site (Governance review)

If RMH is a site, all changes in 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 Form for the new researcher (if not received in the last 3 years). This should be sent via email to CVsFolder@mh.org.au.
• 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 RMH and the investigators' organisation, please complete and submit a research collaboration agreement (MACH template) between Melbourne Health (Legal entity name for RMH) and the investigators' organisation.
  Note: the new agreement must not be in conflict with existing agreements for the project.
  Submit the new draft and all existing agreements for review.
• GCP training – Provide copies of GCP certificates for all members of the RMH research team. GCP training remains current for 3 years. For more details and requirements refer to the Education and Training webpage.

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 +614 0827 4054.

• 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 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 RMH is the reviewing HREC, the private site/s being added under RMH ethics approval need to confirm they accept the conditions of 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). This should be sent via email to CVsFolder@mh.org.au.

• 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 sign off by Management Accountant - Research
  • Updated Clinical Trial Research Agreement

For investigator-initiated studies where you would like to have additional tests/data sent to a new collaborator - e.g. blood samples to the Walter Eliza Hall Institute for extra/new testing.

• Additional Personnel Form for the new collaborator
• Curriculum Vitae for new collaborator to be emailed to CVsFolder@mh.org.au.
• Updated protocol of what new collaborator is doing. eg how are samples/data being sent (must be de-identified), for how long and how/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. As a rough guide:
  • Material Transfer Agreement - if you are giving the samples to a third party and have no further involvement.
  • Research Collaboration Agreement - if you are giving the samples to a third party and obtaining results back from them (eg. the research is now jointly badged).