Human Research Ethics2024-10-14T00:49:47+00:00

HREC Amendments

Submit a HREC amendment

Amendments to research approved by a Metro North HREC must be submitted via ERM for approval.

All submissions to a Metro North HREC for amendment must include:

What is an amendment?

Adherence to the HREC approved protocol and associated documentation is a condition of approval for all research. Sometimes changes to a research project are required after HREC approval has been granted. When this happens, it is important to submit these changes to the HREC for review and approval as a HREC amendment.

A HREC amendment should be submitted for:

  • addition of a new study site
  • 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

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.

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:

  • 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.
  • Amendments that include changes to the approved protocol, PICF and/or study documentation must list the document version and date of any documents that require HREC review in the cover letter study document list, provide the rationale for change to the documentation, a summary of the changes and an explanation of the implications and 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.

 

Complete the HREC 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:

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.

More information on fees.

Related Information

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.

HREC amendment cover letter template

The HREC amendment cover letter templates outlines the minimum requirements for inclusion in a HREC amendment submission.

HREC indemnity

The Form of Indemnity – HREC review only is required for all private sites and commercially sponsored studies.

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