Human Research Ethics Committee

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 National Mutual Acceptance.

PREPARING YOUR ETHICS APPLICATION

All projects must submit:
  • 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) [the VSM is also found as a sub-form in the HREA]
  • CVs (if not already submitted within the last two years): Multisite ethical review -Coordinating Principal Investigator and Principal Investigators CVs for sites included in the ethical review. Single site ethical review – Peter Mac Principal Investigator CV.
Some projects may also need to submit:
  • If project has WA site(s): Western Australian Specific Module (WASM)
  • If using unapproved therapeutic goods: Clinical Trial Notification (CTN) or Clinical Trial Exemption (CTX), listing each site under review. The CTN is an online form. Please include a PDF/screenshot 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.
  • If using radiation: Radiation reports for each site: 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 the sponsor of a clinical research project: Approval from the Clinical Research Sponsorship Committee. 
  • If First Time in Human (FTIH) review was required: FTIH reviewer report(s).
  • If Institutional Biosafety Committee (IBC) review for the Peter Mac site was required: Outcome of the IBC review.
  • If project is commercially sponsored: HREC Only Indemnity. Find Peter Mac site contact details for use in Indemnities here.
  • If project is commercially sponsored: Copy of the Standard Indemnity for all sites. Find Peter Mac site contact details for use in Indemnities here.
  • Protocol
  • 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
  • Other project documents e.g. questionnaire, diary, participant card, information brochures
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.

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.

    Low risk research is defined as research in which the only foreseeable risk is one of discomfort. Negligible risk research is defined as research in which the only foreseeable risk is no more than inconvenience.

    • Protocol (template protocol suitable for a simple Low Risk project is provided if required)
    • Low Risk Participant Information and Consent Form (suggested template suitable for projects with ongoing participation). Multisite ethical review – provide a master PICF. Single site ethical review – provide a PICF on Peter Mac letterhead.
    • Invitation/Introduction letters (suitable for single questionnaire/survey where consent is indicated by return of the single questionnaire/survey)
    • Questionnaires/surveys and/or other data collection tools
    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.

    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.

    • 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:

    Hand delivery address:
    Human Research Ethics & Governance
    Peter MacCallum Cancer Centre
    Level 4, 305 Grattan Street
    Melbourne VIC 3000

    Postal address:
    Human Research Ethics & Governance 
    Peter MacCallum Cancer Centre
    Locked Bag 1 A'Beckett St 
    Melbourne, VIC 8006

    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.