Application Fees for Review of Clinical Trials Involving Therapeutic Substances

WOMEN’S & CHILDREN’S HEALTH NETWORK (WCHN)

HUMAN RESEARCH ETHICS COMMITTEE (HREC)

APPLICATION FEES FOR ETHICAL REVIEW OF RESEARCH – SINGLE SITE

(WCHN ABN –64021748126)

Fees are levied for review, by the WCHN Human Research Ethics Committee, of commercially sponsored and Collaborative Trial Group research applications. Significant WCHN funding is required to support review activities. Funds generated support both the WCHN HREC and the Drug and Therapeutics Committee Clinical Trials Group (DTC CTG) when the application involves a drug or therapeutic substance.

Review of an application with commercial sponsorship / Amendments to research projects with commercial sponsorship / Collaborative Trial Group (CTG) applications3 / Sub-study add-on review4 / Site Specific Assessment (SSA) Form review
$3,500
(GST excluded) / Minor/administrative amendments 1
$200
(GST excluded) / $1,750
(GST excluded) / $1500
(GST excluded) / $3000
(GST excluded)
Other amendments 2
$600
(GST excluded)

1 Minor/administrative amendments are those that do not impact or alter the risk level of the project, and which can be reviewed and assessed easily, e.g. updated contact details on a participant information sheet.

2 Other amendments include protocol amendments, Investigator Brochure revisions, and other amendments which are more complex in nature or which may alter the risk level of the project.

3 This fee represents the upper threshold for review of CTG research applications and may be reduced or waived at the request of the applicant. In such instances, the fee will be determined by the Chair of the WCHN HREC and the Chair of the DTC, CTG (if the application involves a drug or therapeutic substance), taking into account the level of funding and the complexity of the application.

4 This fee is for sub-studies submitted for review after ethics approval is granted to the overarching (full) application.

The above fees relate to single site research at the WCHN. For fees relating to research ethics and governance review of multi-site commercially sponsored and Collaborative Trial Groups, refer to:

Please note - If an application involving a drug or therapeutic substance is at such an early stage of development that the DTC CTG requires external expertise to evaluate (eg, for toxicological data) additional fees may be charged to cover costs incurred.

Contacts

• Ms Brenda Penny ( Executive Officer WCHN HREC) 08 8161 6521
• Dr Tamara Zutlevics (Chair WCHN HREC): 08 8161 6149
• Mr Sean Turner (Chair WCHN DTC CTG): 08 8161 8350

02/04/20121