External Ethics Approval & Ratification

In line with the requirements of the National Statement institutions must adopt a review process that eliminates any unnecessary duplication of ethical review. Consistent with this requirement UNSW therefore recognises the ethical review and approval process issued by Australian HRECs that are registered with the NHMRC and their delegated low or negligible risk review bodies. Before this type of research can commence ethical approval must be registered via the external ethics approval notification process. (National Statement 5.3.1)

Research submitted via the external ethics approval notification process will be reviewed by the HREC Executive. The application must indicate the role that UNSW will have in the research, the staff or students who will conduct the research, along with the name and location of the sites that are covered by external approval. (National Statement 5.3.4 (a))

In line with the UNSW Human Research procedure, prior to the commencement or participation in human research where external ethical approval via a NHMRC registered HREC has been established, UNSW via RECS reserves the right to place conditions on involvement or refuse involvement in circumstances where the approved proposals do not conform to the requirements of the National Statement, the UNSW human research procedures, other relevant legislation or potentially expose the university to undue risk.

As per the requirements of the UNSW Human Research Ethics Procedure where a research project involving human participants, their data or tissue, including negligible risk research, is to be conducted overseas and the personnel responsible is a UNSW researcher or employee of an affiliated centre or institute, UNSW HREC or HREAP ethical approval must first be established. In addition, approval must be obtained from overseas ethics committees or equivalent bodies where required or appropriate. International Review Board ethical approval will not be accepted without UNSW ethical approval. 

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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