Applications by individual researchers for non-sponsored projects or for competitive grant applications do not attract a fee.

An application fee will apply to projects which are sponsored by commercial entities (e.g. pharmaceutical companies or other industry bodies). Fees are payable on initial submission with further fees being charged for amendments.

Commercial sponsorship may be financial or in-kind (e.g. provision of drugs or devices). Fees for in-kind support by commercial agencies may be waived for investigator-initiated studies if the following conditions are included in a WA Health approved clinical trial agreement:

1. The IP arising from the study is not restricted by the commercial agency
2. The data arising from the study is not provided to the commercial agency for marketing or publicity purposes
3. The investigator retains full publication rights. There should not be a right-of-review restriction by the commercial agency.

The fee* structure for commercially sponsored trials is as follows:

New applications that require HREC review (including submissions under NMA where CAHS is the lead HREC)	$3850
HREC Review on behalf of each additional site that is part of an NMA application	$660
Review of an Amendment (including those requesting an extension of approval) **	$660
Further review of an amendment/requirement for resubmission of amendment (each occasion)	$320
Applications submitted for review by the Low and Negligible Risk (LNR) ethics review pathway	$275
Applications that require an excessive level of administrative support	$50 per query to a maximum of $500

 

Protocol amendments that introduce major new aims (i.e. a new primary or secondary objective) or which introduce major new safety considerations and which require extensive scientific and/or ethical review may attract a higher fee. This includes the addition of new sub-studies.

Submission of incomplete applications requiring significant administrative support on behalf of the HREC may be subject to additional fees. This charge will apply to both commercially sponsored and non-sponsored studies.

*all fees are inclusive of GST

**this fee may be waived at the discretion of the HREC