Queensland Government
Human Research Ethics2024-07-10T05:08:03+00:00
Home > Research > Post-approval submissions > Human Research Ethics

HREC Amendments

Sometimes changes to a research project are required after HREC approval has been granted. Changes may include things like adding a new study site, updates to the Participant Information and Consent Form (PICF) or changes to the approved research protocol or study documents. These changes must be submitted to the reviewing HREC and approved as an amendment. 

For research approved by a Metro North HREC, amendments must be submitted to the Metro North HREC for approval. Amendments include addition of a new study site, or changes to the Principal Investigator at an approved site, changes to the approved protocol or approved study documentation such as PICFs, advertisements, radio scripts, questionnaires, patient cards etc. Changes to associate investigators that do not impact the study or transfer of data do not require HREC review and are instead managed via the study delegation log.  

Submit a HREC amendment

All HREC amendments must include: 

Amendments are submitted via ERM. Refer to the ERM User Guide and FAQs documents for assistance with ERM.

Submit HREC amendment via ERM

Cover letter

A cover letter detailing the type(s) of amendment and the rationale for change is a mandatory requirement for all HREC amendments. Depending on the type of amendment requested, the cover letter must outline the following: 

Site amendment – amendments that include the addition of new sites or changes to existing sites must: 

  • List the site(s) and the respective Principal Investigator on the cover letter 

Protocol amendment – amendments that include changes to the approved protocol must: 

  • Provide the rationale for change to the protocol on the cover letter 
  • Include the protocol version and date in the list of documents for review 

PICF/supporting documentation – amendments that include changes to the PICF/supporting documentation must: 

  • Provide the rationale for change and a summary of the changes 
  • Explain the amendment and clarify the consequences of the changes. For example, changes to the protocol and/or PICF may require participants to be reconsented, or change the risk profile of the research and present additional risk or harms to the participant. 

Amendment cover letter template  

Study documents

All study documents must have version control identifiers in the footer, i.e. version numbers, dates and page numbers. These version control elements must match the study document list on the cover letter.  

Site amendment – amendments that include the addition of a new site or changes to approved sites must include: 

  • Curriculum Vitae/Resume for the new/changed Principal Investigator. 
  • HREC indemnity – required for all private sites and commercially sponsored studies. 

Protocol amendment – amendments that involve changes to the approved protocol must include:  

  • Track changed version of the protocol 
  • Clean version of the protocol 

PICF/Supporting documentation – amendments that involve changes to the PICF or any of the approved study documentation must include the following for each document the HREC is required to review: 

  • Track changed version of the document 
  • Clean version of the document 
  • Any new documents 

Fee template

The relevant fee template must be completed and submitted with the application. The inclusion of the fee template, or justification as to no requirement for a fee template, must be included in the cover letter.  

Site amendments 

Any HREC amendments that impact site activities, or changes to the protocol or PICF must also be submitted to the research governance office via ERM as a post-authorisation notification.  

Annual report 

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

Reporting adverse events

The reporting of adverse events is an important mandatory safety and monitoring requirement of clinical trials.

Back to top