Research Development Unit (RDU)

 

Barwon Health Research Agreements

There are a number of regulatory documents that are required as part of a research project including agreements, insurance and indemnities. 

To determine if a Research Agreement is required for your project, and links to Research Agreement templates – please click here.

 

Barwon Health Ethics & Governance Fees

RDU fees have been set based on a percentage of the total (human and other) resources required to review a new research project upon submission and then to monitor and manage it over its lifetime.

The fees charged represent only partial recovery of the total cost of providing ethical and governance oversight.

Barwon Health raises invoices for all RDU review fees. Please complete the following steps;

1. Download a RDU Invoice Request Form (click here to download - updated July 2024)
2. Enter as much information as possible into the “blue” coloured areas.
3. Upload completed form to ERM as a Microsoft Word document with your submission.

Research not covered in the below payment types is exempt from any review fees.

All queries regarding this process should be directed via email to [email protected]

Please note: Fees are cumulative. To download the Fee Schedule (updated August 2024), click here.

Commercially sponsored studies	$ Amount (ex GST)	$ Amount (inc GST)
NEW APPLICATIONS
Sponsored study: Initial HREC or Governance Review	6000	6600
POST APPROVAL AMENDMENTS FOR COMMERCIAL STUDIES
Protocol Amendment	600	660
PICF Amendments/Updates	600	660
Investigator brochure update	200	220
Minor Amendment – administrative amendment only, including but not limited to patient-facing documents such as diaries, surveys, questionnaires, advertisements, typos, memos	200	220
CTRA Amendment	200	220
Changes to Barwon Health Principal Investigator	200	220

 

Collaborative group studies & unsponsored investigator-initiated studies - includes low risk	$ Amount (ex GST)	$ Amount (inc GST)
NEW APPLICATIONS
Investigator-initiated CTN/CTA clinical trial - with commercial support	3000	3300
Investigator-initiated study (no CTN/CTA) - with commercial support	1000	1100
Investigator-initiated CTN/CTA clinical trial – no commercial support	1000	1100
Investigator-initiated study (no CTN/CTA) - no commercial support	500	550
Other projects: non-Barwon Health protocol	500	550
Barwon Health projects (with no other institution involved)	No Fee	No Fee
POST APPROVAL AMENDMENTS FOR COLLABORATIVE STUDIES
Major Amendment – includes updates to Protocol, Consent Form, IB updates	200	220
Minor Amendment – administrative amendment only, including but not limited to patient-facing documents such as diaries, surveys, questionnaires, advertisements, typos, memos	100	110
Changes to Barwon Health Principal Investigator	100	110
CTRA/RCA Amendments	100	110
Amendment for Barwon Health in-house project - no third party	No Fee	No Fee