Research Ethics fees

Research Ethics fees

Early Phase Clinical Trials fees

For the SCHN HREC's fee structure for Early Phase Clinical Trials (EPCT), please refer to the EPCT Submission Guideline available on our Early Phase Clinical Trials page.

Fees apply for the review of clinical trial research ethics applications and applicable clinical trial research ethics amendments by SCHN HREC.

A completed invoicing authorisation form must be submitted for all clinical trial research ethics application submissions and applicable clinical trial research ethics amendment submissions.

Fees will apply as per the table below. Please note that the fee schedule below applies to clinical trials only, excluding EPCT. Please contact the Research Ethics Office if you are unsure whether a fee is applicable to your application.

Type of applicationSponsor/Financial supportAmount (incl. GST)
New applicationCommercial external sponsor$6,250.00
 Non-commercial external sponsor$1,000.00
Amendment – adding a sub- studyCommercial external sponsor$2,500.00
 Non-commercial external sponsor$500.00
Amendment – adding a siteCommercial external sponsor$1,500.00
 Non-commercial external sponsor$150.00
Amendment – major amendment*Commercial external sponsor$1,000.00
 Non-commercial external sponsor$250.00
Amendment – minor amendment**Commercial external sponsor$500.00
 Non-commercial external sponsor$150.00

*Major amendment

  • Protocol amendment
  • Revision of the study design due to safety issues
  • Revisions in drug dosage, participant groups and numbers of study participants
  • Investigator brochure updates, where there are associated changes required to the Participant Information Sheet/Consent Form (PISCF).
  • Request for extension of HREC approval

**Minor amendment

  • Participant Information Sheet/Consent Form amendments with changes not required to be reviewed by the Human Research Ethics Committee.
  • Investigator brochure updates where there is no change required to the Participant Information Sheet/Consent Form.
  • Change of Principal Investigator/Coordinating Principal Investigator.
  • Minor updates to existing patient-facing documents, protocol clarification letters, advertising material and single-word changes

Please note that at SCHN, an amendment that involves both major and minor changes will only incur a major amendment fee.

Clinical trial review fees are mandated by the NSW Ministry of Health Policy Directive.

Last updated Wednesday 20th December 2023