Human research is research conducted with or about people, or their data or tissue (NHMRC, 2013). St Vincent’s Health Australia understands the vital role that research plays in improving health outcomes across the service. Supporting research initiatives is part of the organisational strategic plan to achieve Exceptional Care.
It is a requirement for institutions like St Vincent’s to have a process in place for the ethical and governance review of human research. All research projects being conducted at, or recruiting participants from St Vincent’s Health Australia facilities in Queensland, require ethics approval by the St Vincent’s Health & Aged Care Human Research Ethics Committee (SVHAC HREC).
The SVHAC HREC is registered with the National Health and Medical Research Council (NHMRC) (NHMRC Registration No: EC00324). It is constituted in accordance with the National Statement on Ethical Conduct in Human Research 2007 (National Statement).
The SVHAC HREC is comprised of:
- a Chairperson
- two lay persons (one man, one woman)
- three persons with knowledge of and current experiences in the professional care, counseling or treatment of people
- a Minister of Religion
- a Lawyer
- three Doctors/ persons with current research experience that is relevant to research proposals to be considered at meetings.
- an Ethicist.
Being part of a Catholic health and aged care organisation, it is also required that all research submissions comply with the Code of Ethical Standards for Catholic Health and Aged Care Services in Australia.
How to lodge a research submission
The SVHAC HREC is committed to the timely review of research submissions. To assist this process, researchers must ensure documents are submitted together electronically to the Secretariat and large files with multiple attachments are ‘zipped’. Large hardcopy documents can be posted.
The SVHAC HREC Secretariat
St Vincent's Health and Aged Care Human Research Ethics Committee
PO Box 555
Spring Hill QLD 4000
Otherwise researchers may fill in the form at the bottom of the page:
Once the submission has been received, it will be reviewed and categorised as either low/negligible risk or high risk. Low/negligible risk research may qualify for expedited review outside of the scheduled HREC meeting times. Any research that is determined to be more than low risk will require full ethics review. The SVHAC HREC conducts full ethics review at its bi-monthly meetings.
The scheduled meeting dates for 2017 are as follows:
|Submission closing date (3 weeks prior)||2017 Meetings scheduled|
|20 January||10 February|
|31 March||21 April|
|19 May||9 June|
|21 July||11 August|
|22 September||13 October|
|17 November||8 December|
What are the submission requirements?
To assist this process, researchers must ensure the following documents are submitted electronically to the Secretariat:
- a completed Research Submission Cover Sheet and Checklist (see Important Resources section)
- cover letter signed by the Principal Investigator including:
- a brief description of the project
- phase of study (if it is a clinical trial)
- list of St Vincent’s Health Australia Queensland sites
- list of supporting documents with version dates/numbers
- sponsor or principal researcher details for invoice purposes
- signed, completed copy of the NEAF or low/negligible risk form (note – the NEAF submitted must include reference to the SVHAC HREC and the proposed site
- study protocol with version number/date
- resumes of researchers and key staff involved in study
- participant information and consent form/s – master and site specific
- participant information must include a contact for complaints that is independent from the research team. The independent SVHAC HREC contact for complaints is:
St Vincent’s Health & Aged Care Human Research Ethics Committee
PO Box 555
Spring Hill QLD 4000
Tel: (07) 3326 3749
- Medicines Australia Form of Indemnity for Clinical Trials – HREC Review only document
- indemnity and insurance information
- CTN (Clinical Trial Notification scheme) form
- CTX (Clinical Trial Exemption scheme) form
- CTA (Clinical Trial Agreement) may be required for site approval
- Evidence of site approval from the CEO or delegate of the site and completion of the Site Approval document
- investigator brochures, questionnaires, tools, equipment or instruments, etc;
- advertising material
- letter of invitation, for example, to GPs
- additional correspondence and evidence of other HREC approvals
- Research Submission Cover Sheet and Checklist PDF [126 KB]
- Research Submission Cover Sheet and Checklist DOC [401 KB]
- CTN and CTX forms are accessed through the TGA website
- Schedule of fees PDF [54 KB]
- Low negligible risk form PDF [164 KB]
- NEAF including quick reference map and frequently asked questions
- Australian Privacy Principles:
Guidelines under section 95 of the Privacy Act 1988
Guidelines under section 95A of the Privacy Act 1988
- Accessing medical records for non SVHAC researchers PDF [182 KB]
- HREC Flowchart PDF [194 KB]
- NHMRC Values and Ethics: Guidelines for Ethical Conduct in Aboriginal and Torres Strait Islander Health Research
- SVHAC HREC Terms of Reference PDF [71 KB]
- SVHAC HREC Annual/Final Report PDF [112 KB]
- SVHAC HREC Annual/Final Report DOC [396 KB]
If you are a participant in a study approved by the SVHAC HREC and would like to make a complaint about any aspect of the study, the way it is being conducted or have any questions about your rights as a research participant, please contact the Human Research Ethics Secretariat on tel: 07 3326 3749.
If you are a researcher wishing to know about the complaints process, please refer to the SVHAC HREC Terms of Reference.
- NHMRC (2013). National Statement on Ethical Conduct in Human Research (updated May 2013), Australian Government.