External Ethics Approval & Ratification

UNSW has adopted the recommendation of the National Statement to minimise the duplication of ethical review and therefore recognises approvals issued by other NHMRC-registered HRECs and their delegated negligible and low-risk review bodies. This means that UNSW staff and research students do not need to seek ethical review by UNSW HRECs or HREAPs.

Before this type of research can commence, the ethics approval must be registered by the Research Ethics Compliance Support (RECS) Office in the Human Ethics Research Governance process. 

Prior to the commencement of the research or participation in an external project UNSW via RECS reserves the right to place conditions on involvement or refuse involvement should approved proposals not conform to the requirements of the National Statement, other relevant legislation or potentially expose the university to undue risk.

Submission Requirements

If you have established ethics approval with an NHMRC-registered Australian HREC the submission of a separate application to the UNSW HREC for further approval is not required. However, UNSW staff and research students are required to notify the Research Ethics Compliance Support Human Ethics Team by providing the following documents that were issued or reviewed by the approving HREC.

1) HREC approval letter

2) HREC application form

3) Copies of all approved recruitment materials

4) Copies of all approved study tools 

5) Copy of the approve clinical trial protocol (if applicable)

6) Insurance , Clinical Trials Agreements or Funding Agreements.

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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.

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Personnel Modifications

Any changes to the study personnel must be submitted to the approving HREC via its submission process using their submission forms. Upon approval the research team must submit to the UNSW Human Ethics Team the following documentation:

  1. HREC approval letter or correspondence from the approving HREC noting the changes to the study personnel;
  2. 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.
  3. 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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Amendments and Modifications

 Any changes to the approved study must be submitted to the approving HREC via its submission process using their submission forms. Upon approval the research team must submit to the UNSW Human Ethics Team the following documentation:

  1. HREC modification or amendment approval letter;
  2. Any documents listed on the HREC modification or amendment approval letter.
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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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Annual Monitoring Report Forms

The annual monitoring report forms must be submitted to the approving HREC via its submission process using their submission forms. A and must include  summary of any safety monitoring report forms and any protocol deviations. Once this has been approved or noted by the approving HREC, the research team must submit to the UNSW Human Ethics Team the following documentation:

  1. HREC approval letter, or correspondence from the approving HREC, noting  the annual monitoring report form and any safety monitoring reports or protocol deviations.
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Safety Reporting Requirements

Safety monitoring reports must be submitted to the approving HREC via its submission process using their submission forms. If the approving HREC requires a sponsor to review safety monitoring report forms before submission, the forms must be submitted to the Human Ethics Team using the UNSW adverse event report forms.

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Ethics Approval Approved by an Overseas Ethics Committee

A formal application to the relevant UNSW HREAP (negligible and low risk) or HREC (more than low risk) must be made.  Any UNSW researcher undertaking research at UNSW as part of their employment is covered by UNSW insurance policies.

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