Human Research Ethics2024-06-12T01:39:20+00:00

Human Research Ethics 

Amendments

For research approved by a Metro North HREC, approval is required for any amendments to the protocol, PICFs, advertisements, radio scripts, questionnaires, patient cards, etc.  At a minimum the following is required  

  • Detailed covering letter explaining the rationale for changes to the study and study documents.  
  • Ensure that all documents have document identifiers in the footers, i.e. version numbers, dates and page numbers 
  • Completed and signed fee template (if applicable) 

Changes to associate investigators that do not impact the study or transfer of data do not require HREC review; they can be managed via the study delegation log.   

 Amendments are submitted via ERM. Refer to the User Guide and FAQs documents are available to assist you with accessing and using ERM. 

 Please note that ongoing ethical approval is now contingent upon the submission of an Annual Progress Report, to be received by 30 April each year. 

Amendment Checklist

Cover letter

Cover letter detailing the rationale for the change  

  • Site amendment – state the sites and the PI for each new site. 
  • Protocol amendment – rationale and summary of the change 
  • PICF/Supporting documentation – rationale and summary of the change 
  • Amendment Cover letter template 

Site amendment

If adding a new site, the following is required: 

  • List the site(s) and the Principal Investigator for each site. 
  • Curriculum Vitae/Resume for the Principal Investigator. 
  • HREC indemnity – required for all private sites and commercially sponsored studies. 

Study documents

  • Protocol – A track change and clean version of the protocol with correct version control.  The cover letter should explain the rationale for the change.  
  • Participant Information Sheet and Consent 
    • A track change and clean version of the protocol with correct version control.   
    • The cover letter should explain the changes and clarify the amendment for example if participants need to be reconsented, or if the amendment provides additional risk or harms to the participant. 
  • Investigator’s Brochure 
    • A track change and clean version of the protocol with correct version control.   
    • The cover letter should explain any changes to the risk profile or if changes to the participant information sheet and consent is required. 
  • Other – any updates to other study documents or new documents should also be outlined in the cover letter  
  • Please complete the relevant fee template and submit with your application.   
    • Schedule of Fees
    • Fee template  -This fee template applies for all submission that are not sponsored or led by a Queensland Health Hospital and Health Service (HHS).   
    • HHS Fee template – Inter-journal transfer for Hospital and Health Services (HHS) led/sponsored studies only. 

More information on fees.

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