Submit an amendment

When Melbourne Health is the reviewing HREC

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

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

When Melbourne Health is a site (Governance review)

If Melbourne Health is a site, all changes in personnel (Principal Investigators, Associate Investigators, Student Research, Research Coordinator, Contact person) need to be submitted to our office 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 PICF’s: 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 a University of Melbourne student investigator on the project and there is no research agreement in place between Melbourne Health and the University of Melbourne, please complete and submit Annexure A of the Master Collaboration Agreement 2015 between Melbourne Health and the University of Melbourne.
• Each student added to a study is also required to complete the Student Approval to Examine Records for the Purposes of Research
• GCP training – for MH researchers, we require copies of GCP certification for all members of the MH research team. Please note that MH now requires all clinical researchers to complete face to face GCP training, rather than online training. MH provides such training onsite for all of its staff with sessions held once a month. If at the time of the amendment request face to face training has not been completed, then you must provide confirmation of enrollment into the next available training session (booking can be made here). Approval with be granted on a conditional basis in this instance, providing the training is attended as booked and certification provided upon completion. GCP training remains current for 3 years. For further on GCP or other training please 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.

Note, sites outside of Victoria and Queensland do not use the ERM platform, please contact the Department of Health by telephone for assistance when creating an SSA for these sites. Department of Health telephone (03) 9096 7395.

• 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 a Notification to the Reviewing HREC for the use of Ionising Radiation in Research - Standard Care Form to be completed and signed by the Site 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 MH 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 Melbourne Health (MH) is the reviewing HREC, the private site/s being added under MH ethics approval need to confirm they accept the conditions of MH 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 MH 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 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 CTRA

For investigator-initiated studies where you would like to have additional tests/data sent to a new collaborator (eg. blood samples to the WEHI 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 MH PI and the collaborator. The type of agreement depends on the nature of the collaboration. Please contact the Governance Manager 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.
  • Memorandum of Understanding/ 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).