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.
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
- 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 to RMH-QAreview@mh.org.au.
Amendments to HREC and/or Governance projects
How to submit an amendment for review
- Submit all amendments by email to Office for Research, Amendments. An automatic reply will be sent to you to confirm receipt of the amendment by the Office for Research.
- Ensure that documents in the amendment are appropriately named with document type, version no, version date (eg. protocol version 3_1 Jan 2015) and that documents are not locked.
- Ensure the subject of the email includes the project number and an outline of the amendment (eg. 2015.001_Protocol amendment 3).
- Compress the files before attaching it to an email. If the file is too large please attach over a series of emails making it clear in the subject that this is what you are doing (eg. 2015.001_Protocol amendment 3_email 1 of 3).
- Attach each document seperately to the one email (eg a seperate file for the amendment form, protocol, PICF etc.)
- If the amendment includes documents that require an original signature such as CTNs, indemnities and/or contracts, please submit these in hard copy to the Office for Research with a copy of the amendment form.
- We will accept scanned signatures of the PI on amendment forms.
Guidelines for preparing general amendments
The below information are guidelines on what documents need to be submitted for commonly submitted amendments. Each amendment will contain different changes and will therefore have different requirements. Differences will also occur if the project is commercially sponsored, multisite and/or contains ionising radiation.
Consider whether the documents listed in the guide are appropriate for your particular amendment. Once you have confirmed a particular document is not required, please put this information in the amendment form (eg. “PICF update not required as project is closed to accrual”) to avoid a query further down the track.
- All amendments (including attached documents) must be submitted via email to Amendment Submissions.
- If there are changes to any of the study document(s), tracked and clean copies of these documents must be submitted as part of the amendment.
- If a study document is new (ie has not been submitted to the HREC before) this should be stated on the amendment form.
- A study protocol should contain up to date information regarding all study processes including recruitment, consent and study procedures. Therefore, if an amendment will change any of these study processes, an updated protocol (tracked and clean) must be submitted. This is to ensure that any new investigators can pick up the latest protocol and be able to conduct the study as per the approved protocol.
- To make sure your approval letters are correct, please take the time to carefully and accurately list the documents submitted on the amendment form. We will use this form to generate your approval letter.
- If a Participant Information and Consent Form (PICF) update occurs, please ensure any new wording is in lay language.
Tips for Participant Information and Consent Forms (PICFs)
Lay language is defined as language that could be understood by someone with a reading age of 12 years old. Note PICF requirements below to ensure that the approval is not delayed in the review process:
If a patient is likely to know certain medical terminology because of their condition, state this in the amendment form or as a comment on the tracked PICF so that we do not request alterations.
- The wording of ‘subject’ is not permissible so please change this to ‘participant’ where applicable within the new wording.
- Often a study Sponsor will insert the new wording from the global or AUS PICF template so please take the time to check that the wording in the Master/Site Specific PICF is acceptable to that of the HREC.
Guidelines for specific amendments
In addition to the recommended requirement for commonly submitted amendments, all amendments must also be accompanied by:
- 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 Melbourne University 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.
- For change of sponsor - provide a letter from the sponsor stating they are now sponsor of the study
- For change of principal investigator (PI) - complete the Additional Personnel Form for the new PI, signed by both the old and new PI
- Curriculum Vitae Form of the new 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.
This can only be done for studies that have been reviewed under the Streamlined Ethical Review (SER) or the National Mutual Acceptance (NMA) systems.
If the study is currently a single site clinical trial, but you wish to make it a multi-site clinical trial under the SER/NMA process, contact the Department of Health by telephone on 03 9096 7395.
If the study is currently a single site health and medical research project within Victoria, but you wish to make it a multi-site project (with additional sites in Victoria only), contact the Department of Health by telephone on 03 9096 7395.
For studies that do not fit the above categories, please contact the Office for Research for information on your options for adding a study site.
- 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 - Radiation Safety Officer (RSO) report from site, Section 4 of the Victorian Site Module (if site in Victoria), site specific PICF with RSO wording.
- 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.
- 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.
This for investigator-initiated study and 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: