Research Agreements and Fees
Note
The Barwon Health Research, Ethics, Governance & Integrity (REGI) Unit is changing its name to the Research Development Unit (RDU).
The change better reflects the Unit's role in developing and supporting researchers across all elements of their research including guidance on design and conduct.
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.
Attention please: The RDU Invoice Request form was updated on 20 February 2023. Please only use new version.
Barwon Health raises invoices for all RDU review fees. Please complete the following steps;
- Download a RDU Invoice Request Form (click here to download - updated 20 February 2023)
- Enter as much information as possible into the “blue” coloured areas.
- 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.
|
COMMERCIALLY SPONSORED STUDIES |
$ Amount (ex GST) |
$ Amount (inc GST) |
|
NEW APPLICATION |
||
|
Sponsored study: multi-site project (includes governance only submissions) |
6000 |
6600 |
|
Sponsored study: single-site project |
5500 |
6050 |
|
Sponsored sub-study or a non-interventional study – multi-site |
5000 |
5500 |
|
Sponsored sub-study or a non-interventional study – single-site |
3000 |
3300 |
|
POST APPROVAL AMENDMENTS |
||
|
Protocol Amendment with or without new or amended PICF/patient facing documents |
600 |
660 |
| New PICF (including PICF Addendums) | 600 | 660 |
|
Investigator brochure |
200 |
220 |
|
Administrative amendment, e.g. updates to existing PICFs or patient facing documents only i.e. diaries, surveys, questionnaires and advertisements; typos; includes CTRA Amendments |
200 |
220 |
|
Changes to Barwon Health Principal Investigator |
200 |
220 |
|
Addition of sites through Barwon Health HREC (not governance) – per site |
500 |
550 |
|
COLLABORATIVE GROUP STUDIES / UNSPONSORED INVESTIGATOR INITIATED STUDIES – Includes Low Risk |
$ Amount (ex GST) |
$ Amount (inc GST) |
|
NEW APPLICATION |
||
|
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 |
||
|
Major Amendment – includes updates to Protocol, Consent Form, IB update |
200 |
220 |
|
Minor Amendment – PI Change, administrative updates (including updates to patient facing documents e.g. diaries, surveys, questionnaires and advertisements; also including CTRA/RCA Amendments) |
100 |
110 |
|
Amendment for Barwon Health in-house project - no third party |
No Fee |
No Fee |
Last Modified: Tuesday, 13 June 2023