Research projects with more than a low level of risk must be reviewed by the full Ethics Committee, e.g. clinical trials, clinical research projects and laboratory research projects.
Also low risk research projects being reviewed for sites outside of Victoria must be reviewed by the full Ethics Committee.
IMPORTANT: BEFORE PREPARING YOUR ETHICS APPLICATION
Phase I Clinical Trials
New South Wales and South Australia do not accept ethical review of Phase I clinical trials under National Mutual Acceptance.
First Time in Human (FTIH) Clinical Trials
FTIH review must be completed before the project can be submitted to the HREC. To assess whether or not your project requires First Time in Human review, complete the
Peter Mac is Sponsor
Approval from the Clinical Research Sponsorship Committee must be obtained before the project can be submitted to the HREC. Contact: [email protected]
Institutional Biosafety Committee (IBC)
IBC review must be completed before the project can be approved to commence at the Peter Mac site. To assess whether or not your project requires IBC review, complete the[email protected].
NOTE: Fees will change from 1 July 2019 – please consult the new fee schedule.
See Submission Dates and Fees for current fee schedule.
Submission due dates
See Submission Dates and Fees for upcoming submission dates for ethical review meetings.
ERM (Ethics Review Manager) submission system
Useful advice on how to create, submit and manage your ethics and research governance applications in ERM can be found at: https://www2.health.vic.gov.au/about/clinical-trials-and-research/clinical-trial-research/national-mutual-acceptance
PREPARING YOUR ETHICS APPLICATION
Note that some of documents and forms or sections of forms may NOT be applicable to your particular project.
I. Ethics Application Forms/Documents
- Human Research Ethics Application (HREA). Only one signature is required; for single site submission the Principal Investigator, or for multisite submission the Coordinating Principal Investigator.
- Victorian Specific Module (VSM)- if project has VIC site(s)
- NSW Privacy Form- if project has NSW site(s)
- Western Australian Specific Module (WASM)- if project has WA site(s)
- Clinical Trial Notification (CTN) or Clinical Trial Exemption (CTX) for unapproved therapeutic goods if required, listing each site under review. The CTN is an online form. Please include a PDF of the filled in CTN for review (Peter Mac as sponsor projects please contact the Office of Cancer Research to fill out a CTN form [email protected]). Find Peter Mac contact details for use in CTNs here.
- Radiation reports for each Victorian site, if required: If radiation exposure is additional to that received as normal clinical management provide a Medical Physicist Report (contact Medical Physicist at each site). If radiation exposure is part of normal clinical management/care, the site Principal Investigator should complete a HREC Radiation Notification Letter.
- Radiation reports for each site outside Victoria, if required: If radiation exposure is additional to that received as normal clinical management provide a Medical Physicist Report (contact Medical Physicist at each site). If radiation exposure is part of normal clinical management/care, the site Principal Investigator should complete a HREC Radiation Notification Letter.
- If Peter Mac is to act as the sponsor of a clinical research project: Approval from the Clinical Research Sponsorship Committee. Please contact [email protected]
- If First Time in Human (FTIH) review was required: Provide FTIH reviewer report(s)
- If Institutional Biosafety Committee (IBC) review for the Peter Mac site was required: Outcome of the IBC review
- HREC Only Indemnity is required if the project is commercially sponsored. Find Peter Mac site contact details for use in Indemnities here.
- Copy of the Standard Indemnity for all sites is required if the project is commercially sponsored. Find Peter Mac site contact details for use in Indemnities here.
- CVs (if not already submitted within the last two years) for Coordinating Principal Investigator and Principal Investigators of sites included in the ethical review.
II. Project Documents
- Investigator’s Brochure, if applicable
- Participant Information and Consent form/s Section 5 and section 8 in this link provide the required template PICFs for different types of research and different consent situations. Multisite ethical review – provide a master PICF. Single site ethical review – provide a PICF on Peter Mac letterhead. Find Peter Mac site contact details for use in PICFs here . For access to Peter Mac letterhead contact ethics or access through the staff portal if you are a Peter Mac staff member.
- NOTE: The PICF is for the use of prospective participants and should be written using clear and plain language appropriate for a general audience. Some tips for writing a PICF:
- It is simple and straightforward.
- The language used is easy to understand and the writing is in conversational (lounge room) style.
- There is little or no technical jargon. Use of acronyms is kept to a minimum. If used they are clearly explained.
- The content is written in the second person (you/your).
- Sentences are structured with no more than 15 words, 7-10 words are even better. Mono-syllabic words are used in preference to poly-syllabic.
- Other project documents e.g. questionnaire, diary, participant card, information brochures
NOTE: Project documents must have a version/date inserted in the footer of all pages e.g. version X dated day month year. This provides for quick and accurate identification of the current approved documents to be used by the project team.
SUBMITTING YOUR ETHICS APPLICATION
- Please ensure that all required documents are completed and that the electronic files are clearly labelled.
- Submit all forms and project documents.
The HREC Only indemnity is the only document required in hard copy, please deliver or post as per the below:
RESPONDING TO COMMITTEE QUERIES
The Coordinating Principal Investigator or Principal Investigator will be advised of the outcome of the review and any further queries or requirements.
Provide a response to each point in the committee review memo e.g. provide explanation/further information; if revisions have been made in response, state what and where. Provide any revised project documents in tracked and clean format.
GOVERNANCE REVIEW AT PETER MAC
Governance review is also required for projects to be undertaken at Peter Mac. For detailed information about the requirements for a Peter Mac Governance Review application, please refer to Governance Review.