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HREC fees & payments

Please contact the Research Office by phone only on tel: 02 8382 4960 for a Fee Payment Reference Number (FPR) before completing any payment to this office.

Fees are payable in FULL at the time of submission for the following:

  • New Research Projects for HREC Review
  • Research Projects for Site Specific Assessment (SSA) Review
  • Amendments to Approved Research Projects

Credit Card payments are the preferred method of payment

The Research Office no longer accepts payment by cheque

Please Note: Invoice requests for payment by EFT can take up to three weeks to process and the Research Office cannot guarantee review until payment is received in full.

Our submission/review fees are in accordance with NSW Health Fee Policy Guidelines.

HREC REVIEW FEES 2015

Inc GST

Submissions to the Full HREC

Investigator-initiated research projects within St Vincent’s Hospital or The Mater Hospital, Sydney

No fee

Cooperative/collaborative group research project without commercial sponsorship

$150

External research projects without commercial sponsorship (eg. university and external entities)

$150

Commercially sponsored research project

$3300

Any collaborative-type study with commercial sponsorship

$3300

Phase 1 External Review $1100

Low/Negligible Risk (LNR) Projects

Investigator-initiated research projects within St Vincent’s Hospital or The Mater Hospital, Sydney

No fee

Cooperative/collaborative group research project without commercial sponsorship

Please Note: For studies with commercial support (eg. unrestricted educational grants) this fee only applies when the commercial body has no ownership of the study data.

$100

External research projects without commercial sponsorship (eg. university and external entities)

 

Please Note: For studies with commercial support (eg. unrestricted educational grants) this fee only applies when the commercial body has no ownership of the study data.

$100

Commercially sponsored research project

$3300

Amendments to Approved Research Projects

Investigator-initiated research projects within St Vincent’s Hospital or The Mater Hospital, Sydney

No fee

Cooperative/collaborative group research project without commercial sponsorship

No fee

Commercially sponsored research projects

Please Note: Fees are applied to each version change to Investigator's Brochures (or equivalent) and/or Protocol document (or equivalent). For example, if you would like to amend both the Investigator’s Brochure and the Protocol, the fee will be $550 +$550= $1100.

Note that amendment fees do not apply to minor administrative changes.

$550

Substantial amendments to commercially sponsored research projects

(e.g.changes in study design; please contact the Research Office if you are unsure about your amendment submission type)

$1665

RESEARCH GOVERNANCE FEES 2015

Site Specific Assessment (SSA) Review

Investigator-initiated research projects within St Vincent’s Hospital or The Mater Hospital, Sydney

No fee

Cooperative/collaborative/external (e.g. universities) group research projects without commercial sponsorship

$250

Commercially sponsored research projects

$3740

Any collaborative-type study with commercial sponsorship

$3740

SSA Review for Low/Negligible Risk (LNR) studies

Investigator-initiated research projects within St Vincent’s Hospital or The Mater Hospital, Sydney

No fee

Cooperative/collaborative/external (e.g. universities) group research projects without commercial sponsorship

$75

Commercially sponsored research projects

$3740

Any collaborative-type study with commercial sponsorship

$3740

Access Request Review

External research projects not requiring SSA

$100

External Entity Agreement for HREC Review for Sites External to the NSW PUBLIC HEALTH SYSTEM

Initiation of External Entity Agreement for HREC Review – valid for 5 years

$1000

Renewal of External Entity Agreement – valid for 5 years

$800

STUDY DEFINITIONS:

St Vincent’s Hospital Sydney has adopted the definitions from VMIA Managed Insurance ‘Guidelines for Clinical Trials’ (2009):

Investigator Initiated Research:

An investigator initiated research project has the following characteristics:

  • A pharmaceutical/device company is not acting as the Sponsor for the purposes of the CTN Scheme application
  • A pharmaceutical/device company is not directly funding the conduct of the study, that is making payment to the relevant hospital or investigator
  • The clinical trial addresses relevant clinical questions and not industry needs
  • The Principal Investigator or the Hospital/Institution is the primary author and custodian of the clinical trial protocol

Note – Investigator initiated trials can receive some industry funding or industry contribution, (e.g. educational grants, or supply of medication). However, the support must be declared in the protocol submission, to ensure that the clinical trial retain its “investigator initiated” status.

Commercially Sponsored Research:

A commercially sponsored research project has the following characteristics:

  • It is initiated by a pharmaceutical/device company or other commercial entity and not by an investigator at a NSW public health service site
  • The research is conducted to investigate a medication/device for commercial exploitation by its manufacturer/sponsor
  • The protocol has been developed and is the responsibility of a pharmaceutical/device company or other commercial entity

Co-operative/Collaborative Research:

Co-operative/Collaborative Research has the following characteristics:

  • The research must address relevant clinical questions and not pharmaceutical/device industry or commercial needs.
  • The co-operative group must declare the nature of any sponsorship from a pharmaceutical entity or any other entity that may directly benefit commercially from the research outcomes.
  • The co-operative group must be the primary author and custodian of the clinical trial protocol.

Infrastructure Fee:

St. Vincent's Hospital charges an infrastructure fee on all research projects. Infrastructure charges relate to those that cannot be identified readily (or specifically) with a particular sponsored project. These include maintaining and operating the Hospital's facilities and services including, but not limited to:

  • Clinical, laboratory and office space to conduct research and clinical trials activities;
  • Utilities including water, electricity, heating, gas and air conditioning;
  • Corporate support services including accounting, purchasing, payroll, human resources and legal counsel.