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 feesTotal (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 supportedFunding 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 supportedFunding 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$220
Non-commercially sponsored studies
Ethics Review: Protocol amendments only$110
All other amendmentsNo Fee

Definitions

Substantial PICF changesPICF 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 changesIncludes 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 trialThese 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.