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: New Submission Fee Payment Form

New projects

Ethics or Governance new research project feesTotal (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 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.

Amendment Fee Schedule (effective 1 September 2020)

Download Amendment Fee Payment Form

Amendment Fee structure

  • 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.
  • 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).

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, etc.

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

Commercially sponsored studies where Melbourne Health is the reviewing HREC

Total (incl. GST)

Major Amendment1100
Major Amendment submitted within one month of ethics approval1430
Protocol Amendment only880
Minor Amendment440
Administrative Amendment220
Updated Investigator Brochure (IB)220
Addition of Site to existing clinical trials550 per site

Commercially sponsored studies for Governance Only Review (where Melbourne Health is not the reviewing HREC)

Major Amendment770
Protocol Amendment only660
New or amended Patient Information & Consent Form (PICF) and/or patient-facing documents only220
Change to the Melbourne Health Principal Investigator220
Administrative Amendment220
Update IB220

Non-commercially sponsored projects

Protocol Amendment110
PICF changes110
Addition of sites - note this fee is per submission, not per site added110
All other amendments including Administrative changesNo Fee

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.