Essential Information for All New Applications

Prior to commencing a Research Project, researchers require ethics and governance approval. A Human Research Ethics Committee (HREC) provides ethics approval, whilst an institution provides Site Specific Authorisation for a study to be conducted at a particular site.

The Monash Health HREC are able to provide HREC Review foe other institutions, however, Site Specific Authorisation to conduct the study at a site must still be obtained from each institution prior to the study commencing.

If a researcher already has obtained HREC Review from an Institution which is NHMRC Certified for multi-centre review for that category of research, Monash Health will not duplicate HREC Review and will require an application for Site Specific Authorisation Only.

In the event, that the study requires review by the Monash Health HREC and Site Specific Authorisation at Monash Health, researchers are asked to submit both a HREC application and an application for Site Specific Authorisation.  It is requested that the application be submitted simultaneously, to allow concurrent review.

 

Document Submission Requirements:
 
Low and Negligible risk projects 
 
 
Please submit:
  • 1 hard copy of the application (double sided). 
  • 1 electronic copy on Memory Stick. (This will be returned to Researchers as long as it is labelled with the Researchers full name).
  • The electronic copy must be an exact copy of all documents submitted in hard copy and must allow for PDF annotate.
  • Please ensure that all submitted documents are clean, untracked versions
Clinical Research Projects
 
 
Please submit:
  • 1 hard copy (double sided).
  • 1 electronic  copy on Memory Stick. (This will be returned to Researchers as long as it is labelled with the Researchers full name). 
  • The electronic copy must be an exact copy of all documents submitted in hard copy and must allow for PDF annotate.
  • Please ensure that all submitted documents are clean, untracked versions.
Clinical Drug/Device Projects being submitted for Single and Multi-Site Review to Monash Health.
 
Please submit:
  • 2 hard copies (double sided).
  • 1 electronic copy on Memory Stick. (This will be returned to Researchers as long as it is labelled with the Researchers full name).
  • The electronic copy must be an exact copy of all documents submitted in hard copy and must allow for PDF annotate.
  • Please ensure that all submitted documents are clean, untracked versions.