The Office for Research oversees all aspects of research at RMH, with the major component of work arising from the operation of the Human Research Ethics Committee and the governance of research projects undertaken at or by 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 upon 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.
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
Download: Office for Research Fee Payment Form
New projects
| Ethics or Governance new research project fees | Total (inc 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 with -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, e.g. NHMRC, NIH, hospital, collaborative group. |
| Investigator-initiated research project - commercially supported | Funding provided by commercial entity, e.g. pharmaceutical, device, biotech companies. |
Amendments to existing commercially sponsored projects
| Ethics amendment fees | Total (inc GST) |
|---|---|
| Commercially Sponsored Studies | |
| Ethics Review: Protocol amendment; substantial PICF changes | $880 |
| Ethics Review: Admin changes; updated IB | $220 |
Ethics Review: Addition of sites to existing clinical trial | $550 per site |
| Governance Review: Protocol amendment; substantial PICF changes | $660 |
| Governance Review: Admin changes; updated IB; variations to CTRA/CIRA | $220 |
| Non-commercially sponsored studies | |
| Ethics Review: Protocol amendments only | $110 |
| All other amendments | No Fee |
Definitions
| Substantial PICF changes | PICF changes due to updated safety information and/or protocol amendments. Administrative changes to the PICF, such as addition of investigators or typographical amendments, are not considered substantial. |
| Admin changes | Includes updated investigator brochures and addition of investigators only. Note that administrative changes will not incur a charge if submitted in conjunction with a protocol amendment or substantial PICF changes. |
| Addition of site to an existing trial | These charges are on top of any other amendments. For example, if a protocol amendment, IB and 2 additional sites are submitted together, the ethics review fee will be $880 plus $1100 for the 2 additional sites ($550 x 2) |
Fee details
- Fees are payable in full at the time of the initial submission of a project or amendment.
- Fees are non-refundable after the Committee review has taken place.
- All payments that are submitted to the Office for Research must be completed using the appropriate fee form.
- Melbourne Health does not issue invoices for payment of fees.
- A receipt of fee will be issued only upon request.