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.

Important Dates to Note for New Applications

Victorian and Queensland public hospitals will be transitioning to a new database for the administration of Human Research Ethics and Site Specific Authorisation applications, ERM. Researchers will still use the same online system to create applications at Online Forms https://au.ethicsform.org/SignIn.aspx  The difference is the Ethics and Governance Units will receive the applications in a new database.

In order to migrate data from the old database AuRED into ERM there are some dates, which will have an impact on researchers who are working on a new application.  These are noted below and there are some information sheets below.

29 June 2018 Final date for researchers to create a new application form (HREA, SSA or LNR) using Online Forms (available until 5.00pm).
9 July 2018 Final date for researchers to submit an application form, further information response or post-approval report using Online Forms (available until 5.00pm).
13 July 2018 Final date for research office to upload all applications into AU RED and final date to access AU RED (until 5.00pm).
16 July 2018 ERM starts! It will be used to create and submit all applications and post-approval reports.
21-22 July 2018 (weekend) No weekend access to ERM.



 

 

Document downloads

Date
Title
Type
Size
Document Submission Requirements:
 
Ethics Submissions
Please submit:
  • 1 hard copy of the application (double sided). 
  • If the study involves a drug, please provide 2 hard copies.
  • 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 clearly identify each document. Documents are to be listed under one folder and not include sub-folders.
  • Please ensure that all submitted documents are clean, untracked versions
 
Site Specific Assessment Applications
Please submit:
  • 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 clearly identify each document and includes an exact copy of all of the Lead HREC Approved documents (if the study was not reviewed by the Monash Health HREC or Low Risk Panel) as well as the site specific documents. Documents are to be listed under one folder and not include sub-folders.
  • Please ensure that all submitted documents are clean, untracked versions.