All research contracts and site-specific assessments in relation to research undertaken at the Princess Alexandra Hospital will be reviewed by the office of the PAH Centres for Health Research to ensure appropriate and complete legal agreements have been entered into.
Research applications will be forwarded to the District CEO for approval when the ethics, the legal and site specific requirements have been met.
All documents including Clinical Trial Agreements, CTN, forms of indemnity and certificates of currency are to be submitted to the Princess Alexandra Hospital Centres for Health Research (Level 1, Building 35).
The legal documents should be submitted, wherever possible, at the same as the protocol and associated documents. The aim is to continue to improve the processing and turnaround time associated with approval of research projects.
This legal review process of clinical trial agreements and associated indemnity/insurance documents feeds into the Site Specific Assessment outlined below and the overall approval process.
Research External to Queensland Health
Researchers external to Queensland Health or those undertaking research in their private rooms wishing to utilise the services of the Metro South HREC must submit a Medicines Australia indemnity form for 'HREC Review Only'.
Site Specific Assessment Form (SSA)
The Site Specific Assessment forms part of the requirement of research governance. The assessment is a separate process to the ethical review process undertaken by the Human Research Ethics Committee as required under the National Statement on Ethical Conduct in Human Research 2007. The Centres for Health Research staff provide support in relation to the HREC and research governance.
Note: SSA forms only need to be submitted to the PAH if the study is being conducted on the PA site or with PA patients.
Completing a SSA Form
A standard SSA Form, registered on-line through the NEAF portal using the QH on-line form website, is completed and submitted to the Centres for Health Research. Information on procedures and completion of the SSA can be found on http://www.health.qld.gov.au/ohmr/html/regu/for_researcher.asp and http://www.ethicsform.org/au/Help/Guidance.aspx respectively.
Key Requirements of the SSA
Note: If the Principal Investigator is the head of a Unit then the signature of the Divisional Chair should be obtained. If the Principal Investigator is the Divisional Chair then the appropriate signatory is the Executive Director of Medical Services.
The schedule of fees for commercially sponsored research and also fees associated with site specific assessment is in accordance with Queensland Health requirements. For further information refer to the Queensland Health Office of Health and Medical Research website.
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