From time to time, amendments to research projects are required often due to protocol changes, updated investigator brochures, personnel changes on the study, site additions, and more. Researchers and sponsors must notify the HREC of such changes.
Office for Research News Update: Reduced Services over Christmas holiday period
The Melbourne Health Office for Research (OFR) will close over the Christmas holiday period from 12pm, Thursday 20th December 2018 inclusive and reopen on Monday 7th January 2019.
Leading up to this time, the OFR will be on reduced services. The OFR will continue to accept post approval items such as amendments/safety reports/breach reports/progress and final reports. However the review of these items will be deferred until mid-to-late January 2019.
Where there is a need for urgent review of an amendment or a safety report which may impact patient wellbeing, researchers are strongly advised to telephone the office on (03) 9342 8530 to ensure that the urgency of your correspondence is clearly understood so that review can occur in a timely manner.
The majority of amendments are reviewed out of session and do not require review at the HREC meeting nor submission by a certain deadline. When deemed necessary, amendments are sent to the scientific and/or ethics spokespersons for the project, both of whom are members of the HREC. They will determine whether the amendment can be approved by spokesperson review or whether more detailed consideration is required. If detailed consideration is required, the matter will be listed for discussion at the next HREC meeting.
Amendments to QA projects
To amend a QA project, prepare the following documents:
- A cover letter outlining the nature of the amendments and the rationale behind these changes, signed by the Project Lead
- Tracked and clean copies of the protocol, QA module and any other appendices/consent form
- Any updated HIS/Pathology forms or statement of approvals
Once complete, email the documents directly to RMH-QAreview@mh.org.au.
Instructions: Submitting amendments for Ethics and/or Governance projects
- Download and carefully review the Amendment Guidelines
- Complete and submit:
- A signed Amendment Request Form; and
- A signed Fee Form; and
- All documents required for review - See below for Documentation required for specific amendment types.
- Open the email template: Amendments@mh.org.au and enter all information as requested:
- Important to include the local project number in the subject of the email
- An automatic reply will be sent to you to confirm receipt of the amendment by the Office for Research.
Documentation required for specific amendment types
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.
- 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.
- 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 Form of the new CPI/PI (if not received in the last 3 years). This should be emailed to CVsFolder@mh.org.au.
- Updated PICF’s 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.
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.
- The definition of a recruitment site is where the new site is only providing information regarding a study occurring at another site.
If the site intends to consent or conduct any study procedure then they complete the procedures for adding a study site.
- Statement of Approval from Head of Department at 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 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
Clear description of the changes, including a summary of changes, and note whether this amendment warrants 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 (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:
For “non-ethics” amendments , eg changes to an agreement, indemnity, budget etc., researchers must submit:
- A signed Amendment Request Form that clearly and describes in detail the following:
- The nature of the change
- The reason for the change; and
- If the amendment involves a financial transaction (eg change to budget), a calculation of the financial value of the transaction.
- Amendments involving changes which may impact on services provided by supporting departments, eg radiology, pharmacy, pathology, etc. must also be accompanied by signed Statements of Approval from the relevant supporting department head.