The Office for Research oversees all aspects of research at the RMH, with the major component of work arising from the operation of the HREC and the governance of research projects undertaken at or by the RMH.
The fees charged represent only partial recovery of the total cost of providing ethical and governance oversight. Fees have been set based on the total (human and other) resources required to review a new research project on submission and then to monitor and manage it over its lifetime.
The fee structure is competitive with those imposed by similar organisations and reflects the actual resource allocation to the process of scientific and ethical review.
New project fee schedule
- The Office for Research will charge either a governance or ethics fee for new research projects - but not both.
- Fees are payable at the time of submission
| Ethics or Governance new research project fees | Total (incl. GST) |
| Commercially sponsored study - First Time in Humans Clinical Trial | $7,700 |
| Commercially sponsored study - single site project | $6,050 |
| Commercially sponsored study - multiple site project (including governance only submissions) | $7,700 |
| Commercially sponsored sub-study or an observational study - single site project | $3,300 |
| Commercially sponsored sub-study or an observational study - multi-site project | $5,500 |
|
Investigator-initiated CTN clinical trial - commercially supported |
$3,300 |
| Investigator-initiated research project - commercially supported | $1,100 |
|
Investigator-initiated CTN clinical trial - not commercially sponsored |
$770 |
| Other projects - Non-Melbourne Health protocol | $550 |
| Other projects - Melbourne Health protocol | $220 |
| Quality Assurance project | $110 |
Definitions
Investigator-initiated CTN clinical trial - commercially supported: Funding and/or investigational product provided by pharmaceutical or device company
Investigator-initiated CTN clinical trial - not commercially supported: Funding obtained for a source other than a pharmaceutical or device company (for example, NHMRC, NIH, hospital, collaborative group)
Investigator-initiated research project - commercially supported: Funding provided by commercial entity (for example, pharmaceutical, device, biotech companies)
Amendment fee schedule
- The fees charged represent only partial recovery of the total cost of providing ethical and governance oversight. Fees have been set based on the total (human and other) resources required to review a new research project on submission and then to monitor and manage it over its lifetime.
- Fees are payable at the time of submission.
- Fees are cumulative: For example, if a submission received for a commercially sponsored project includes an updated Protocol ($880 incl. GST) and Investigator Brochure ($220 incl. GST) the total fee payable will be $1,100 (incl. GST).
| Commercially sponsored studies where the RMH is the reviewing HREC | Total (incl. GST) |
| Major Amendment | 1,100 |
| Major Amendment submitted within one month of ethics approval | 1,430 |
| Protocol Amendment only | 880 |
| Minor Amendment | 440 |
| Administrative Amendment | 220 |
| Updated Investigator Brochure (IB) | 220 |
| Addition of Site to existing clinical trials | 550 per site |
| Commercially sponsored studies for governance-only review (where the RMH was not the reviewing HREC) | |
| Major Amendment | 770 |
| Protocol Amendment only | 660 |
| New or amended Patient Information & Consent Form (PICF) and/or patient-facing documents only | 220 |
| Change to the Melbourne Health Principal Investigator | 220 |
| Administrative Amendment | 220 |
| Update IB | 220 |
| Non-commercially sponsored projects | |
| Protocol Amendment | 110 |
| PICF changes | 110 |
| Addition of sites - note this fee is per submission, not per site added | 110 |
| All other amendments including Administrative changes | No Fee |
Definition of amendment type
Major amendment:
- Protocol amendment associated with an amended or new Participant Information and Consent Form/s (PICF), or
- New PICF only (where Melbourne Health is the reviewing HREC), or
- Protocol amendment associated with patient-facing document changes, or
- Investigator Brochure associated with an amended (or new) PICF
Minor amendment:
- Amended PICF only and/or other new patient-facing docs only, or
- Change of Principal Investigator/ Coordinating Principal Investigator, or
- Removal of a site
Administrative Amendment: Minor updates to existing patient-facing documents, protocol clarification letters, advertising material, agreement amendment, single-word changes.
Addition of site to an existing commercially sponsored trial: These charges are on top of any other Amendment fees. For example, if a protocol amendment and 2 additional sites are submitted together, the ethics review fee will be $880 plus $1100 for the 2 additional sites ($550 x 2) = $1980 incl. GST