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 Office will close for business from 11.00 am Wednesday, 23 December 2020 and reopen on Monday, 4 January 2021. Please see deadline dates below for submissions to the Office for Research and HREC:
Urgent matters, for example issues impacting patient safety and wellbeing, will be reviewed as soon as possible – researchers are asked to contact the Office for Research via telephone on (03) 9342 8530 to ensure that urgent matters are brought to the attention of the appropriate team member so they can be reviewed and actioned 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 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.
The MH Office for Research has been receiving Participant Information and Consent Form (PICF) amendments which contain changes in addition to what the protocol has specified or PICF changes that have not been mentioned in the MH Amendment form.
This has been adding to the review timelines within the Ethics Managers and results in clarifications to the Researcher/Sponsor. E.g. addition of new language to the confidentiality, data collection/management and privacy sections.
If sponsors insist on including them, please ensure the Amendment Form clearly details this – what has been inserted and the rationale.
Deleting an approved template wording and then re-writing the same but in a different way without any rationale as to why it was done adds to the review timelines and will be queried by the Office for Research.
In addition, if the amendment has an impact on the Contract/Agreement (i.e. an ongoing agreement needs to be changed in some way as a result of the amendment, e.g. changes to sponsor name, payments made by sponsor to institution, etc.), please state this in the amendment form so the Ethics Managers are aware.
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.
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.
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.
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.
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 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).
For “non-ethics” amendments , eg changes to an agreement, addition of a new agreement, indemnity, budget etc., researchers must submit: