​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​Standard Forms Page Header 3.jpg

​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​Use of the standard forms on this page is mandatory for submissions to the Research Office. ​

Human Research Ethics and Governance S​tandard Forms

 

 

 
 

 

 

 

 

Animal Ethics S​tandard Forms

 

 

Institutional Biosafety S​tandard Fo​rms

 

 

 

 


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Human Research Ethics and Governance S​tandard Forms​

​​ ​Submission Checklists​

 

 

 

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HREC Application Forms​

Please note as of 31 August 2017 the Human Research Ethics Application (HREA) has replaced the NEAF within the Online Forms Website www.ethicsform.org/au.​                               

​All applications will be submitted on a HREA form regardless of risk level.                                       

The HREA has been designed as a smart form to accommodate all risk levels:  you only need to answer questions which relate to the type of research you are proposing.

HREA question 4.5 will ask under which review pathway you are intending to submit the application (greater than low risk, low risk, negligible risk). 

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Governance (SSA) Application Forms​

Researchers will now complete SSA applications on a NSW SSA application regardless of risk level. See the NSW Health website FAQ for additional information.

The process for submitting an SSA application for Low Risk (LNR) review will not change. However, as of 31 August 2017, all applications will be submitted on a NSW “full” SSA form regardless of project risk level.

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HREC & Governance Standard Templates

 

 

 

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Standard Participant Information Sheets and Consent Form (PISCF)

​​​Only the below (incl. NHMRC) templates will be accepted by NSLHD Human Research Ethics Committee (NSLHD HREC). Multi-centre trials must use the NHMRC standardised templates​​.    

University PISCF templates are not acceptable for studies taking place within the NSW Health system.                                                                                         

 

 

PISCF Template - Interventional/Standard

 

 

PISCF Template - Genetic Testing

 

 

PISCF Template - Tissue Banking

 

 

PISCF Template - Data Banking​

 

 

Logo Policy for study docs provided to participants (Sponsor & NSLHD)

 

 

NHMRC Forms (Multicentre Studies MUST use NHMRC forms)

 

 

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Amendments to Approved Human Research Studies Templates and Forms

 

Annual and Final Report Form for Human Research

Safety Reporting and Templates for Human Research

 

As of 3 October 2017, NSW Public Health organisations implemented new safety monitoring and reporting guidelines for all active trials.

Please find the new guidance​, definitions and reporting pathways on the NSW Health website:

 


 SUSAR Line Listings to report to HREC - Letter Template

 

 

 SUSAR Line Listings acknowledged by Lead HREC to report to Governance Officer - Letter Template

 

 

 Serious Adverse Event (SAE) and Suspected Unexpected Serious Adverse Reaction (SUSAR) Form​​

 

 

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Method of Payment Forms

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