Addition of sites: ethical review

Participating organisations in the National Mutual Acceptance scheme may be added to the ethical approval of a project that was reviewed by the Peter Mac Ethics Committee.

See the listing of the participating organisations under the National Mutual Acceptance scheme.

Whether a site can be added to an approved project is determined by the type of research; the initial Peter Mac Ethics Committee approval date; and the location of the site to be added, as follows:

  • Interventional research:
    • Approved from November 2009: can add Victorian sites
    • Approved from November 2012: can add New South Wales and Queensland sites
    • Approved from November 2013: can add South Australia sites
    • Approved from August 2016: can add Australian Capital Territory site
    • Approved from September 2017: can add Western Australia sites
    • Approved from December 2020: can add Northern Territory sites
  • All types of human health and medical research, including low and negligible risk research:
    • Approved from February 2015: can add Victorian sites
    • Approved from January 2016: can add New South Wales, Queensland and South Australia sites
    • Approved from August 2016: can add Australian Capital Territory site
    • Approved from September 2017: can add Western Australia sites
    • Approved from December 2020: can add Northern Territory sites

If you need assistance in determining if a site can be added to the ethical approval of a project please contact Peter Mac Ethics Committee Secretariat using the contact detail at the bottom of this page.

The Coordinating Principal Investigator (CPI) is responsible for submitting the amendment for addition of site(s) on behalf of the added site(s). The Coordinating Principal Investigator will be advised of the outcome of the review and any further queries or requirements.

Submission due dates

Submit at any time.

Preparing your addition of site application

Required documents

  • If Peter Mac is the Sponsor, addition of sites must first be approved by the Clinical Research Sponsorship Committee and approval included in your submission. Please contact [email protected] if Clinical Research Sponsorship Committee approval required.
  • Completed HREC Amendment Form signed by the Coordinating Principal Investigator. The form is created and submitted in ERM as a sub form of the project HREA. If your project does not have an ERM account please complete the form found in ‘Useful resources, training and forms’.
  • If the project is converting from a single site ethical review project to a multisite ethical review project: Master versions of participant documents may be required e.g. a Master PICF(s) that can be used at any site and includes prompts to insert site details i.e. site letterhead, site name, names/contact details for Principal Investigator/project and for site complaints/governance and, if applicable, site radiation risk wording. Apart from the site specific changes a Master PICF must be identical to the currently approved PICF.
  • CTN form listing each added site, if required. Please see the TGA CTN scheme site for advice on how notify the TGA of changes to the CTN form.
  • Radiation Notification Letter or Medical Physicist Report for each added VIC site under review, if required.
  • Radiation Notification Letter or Medical Physicist Report for each added site under review outside Victoria, if required.
  • Privacy Form required for added NSW sites only.
  • Western Australian Specific Module (WASM) required for added WA sites only.
  • HREC Only Indemnity for the added site is required if the project is commercially sponsored.
  • Copy of the Standard Indemnity for the added site is required if the project is commercially sponsored.
  • CVs (if not already submitted within the last two years) of the Principal Investigator only for each added site.

IMPORTANT NOTE: Peter Mac does not require the HREA application form to be amended to list the added sites. However an added site may require the Application Form to be amended to list the site. Please consult with the Governance office of the site(s) to be added regarding their requirements.

Submitting your addition of site application

  • Please ensure that all required documents are completed and that the electronic files are clearly labelled.
  • Email your amendment submission to [email protected] including the Peter Mac Project Number and the term ‘Addition of Site’ in the subject line of the email. Electronic signatures or scanned copies of signed pages are accepted.

  • The HREC Only indemnity: Please submit e-signing request.

Contact

Phone: (03) 8559 7540

Email: [email protected]