Guide to writing participant information and consent forms
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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 are no longer possible.
If there are any changes required to the project a new QA project will need to be submitted to RMH-QAreview@mh.org.au.
For faster review and approval of your amendment request, we ask that you provide details of all the requested changes on the Amendment Request form. For example:
By complying with the above you will ensure that the Ethics and Governance team will be able to review your submission quickly and reduce the time to approval.
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.
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.
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.
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.
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.
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.
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.
A study site is where:
If any of the cases above apply, you are required to complete the procedure for adding a new study site.
To add a recruitment only site, submit the following:
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 - e.g. blood samples to the Walter Eliza Hall Institute for extra/new testing.
For “non-ethics” amendments , eg changes to an agreement, addition of a new agreement, indemnity, budget etc., researchers must submit: