External Ethics Approval

External Ethics Approval Established in Australia

UNSW Staff, Students and Researchers: If ethics approval with an NHMRC-registered Australian HREC has been established for a human research project additional UNSW human ethics approval is not required. However, UNSW staff and research students are required to register the external approval by sending the documents specified in the submission requirements to humanethics@unsw.edu.au

Non UNSW Staff, Students and Researchers conducting research on a UNSW campus or where recruitment involves staff, students or researchers must register the external approval by sending documents as specified below along with a letter of support from the faculty or head of school confirming their agreement for the reserach to proceed. 

External Ethics Approval Established Overseas

If ethics approval with an overeseas international review board/ethics committee has been established additional UNSW Human ethics approval is not required if:

  • Participants within Australia will not be recruited;
  • UNSW will not be responsible for the conduct of the research at an Australian site;
  • A UNSW researcher, staff member or student will not be responsible for fieldwork, recruitment or data collection overseas. 

However, UNSW staff and research students are required to register the external approval by sending the documents specified in the submission requirements to humanethics@unsw.edu.au

Submission Requirements
  • Letter/email of approval from the approving HREC for initial application.
  • Ethics application form submitted to the approving HREC 
  • Copies of all approved recruitment materials
  • Copies of all approved study tools 
  • Copy of the approved clinical trial protocol (if applicable)
  • Evidence of Insurance Confirmation, Clinical Trials Agreements or Funding Agreements.
  • Site specific assessment documentation
  • Site Authorisation Letters
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Post Approval Submission Requirements

The following post approval submission requirements must be made. Please note that all post approval submissions must be submitted to reviewed, approved or noted by the approving HREC copies of all documents sent to humanethics@unsw.edu.au:

Amendments and Modifications 

Upon approval the research team must submit to the UNSW Human Ethics Team the following documentation:

  • HREC modification or amendment approval letter;
  • Any documents listed on the HREC modification or amendment approval letter.

Personnel Modifications

Upon approval the research team must submit to the UNSW Human Ethics Team the following documentation:

  • HREC approval letter or correspondence from the approving HREC noting the changes to the study personnel;
  • An updated HREC application form or the approving HREC’s personnel modification form that includes the contact details of all personnel added or where the contact details of the approved personnel have changed.
  • Copies of any approved study documentation that were revised and approved by the HREC as a result of the changes to the study personnel.
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Protocol Deviations

Protocol deviations must be reported via email to the UNSW Human Ethics Team using the UNSW Protocol Deviation Report Form. The research team must provide any relevant supporting documentation along with this report.

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Safety Reporting Requirements

Safety event or incident report forms must be reported following the requirements outlined on the following webpage:

https://research.unsw.edu.au/adverse-event-and-safety-reporting-and-monitoring-human-research

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Submission Closing Dates

Submissions must be provided by 5 pm on a Tuesday and will be processed for noting by the HREC Executive on the Thursday of that week. 

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