Human research ethics committee
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, counselling 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
HREC staff have extensive experience preparing and reviewing submissions to the SVHAC HREC, and are able to provide advice and assistance with submissions to the Committee, as well as site specific applications for governance review. We encourage all researchers wishing to undertake projects involving humans across the network to make the SVHAC HREC Research Ethics and Governance Officer their first point of contact.
The SVHAC HREC is committed to the timely review of research submissions. To assist this process, researchers must ensure documents are submitted via email to the Research Ethics and Governance Officer.
The important HREC dates for 2018 are as below and in attached document.
|Submission closing date (3 weeks prior)
||2018 Meeting Scheduled
|29 December 2017
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 prinicipal 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
Telephone: (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
The SVHAC HREC is committed to fulfilling Section 5.6 of the National Statement on Ethical Conduct in Human Research1 and ensuring that research is conducted according to the Australian Code for the Responsible Conduct of Research2 by ensuring that all complaints are handled appropriately. All complaints will be handled promptly with due sensitivity and in recognition of principles of natural justice. The SVHAC HREC will efficiently, effectively and ethically deal with complaints made to the HREC irrespective of the source or nature of the complaint.
Research Participants, their families and other concerned parties have the right to communicate their concerns about any aspect of the services provided and are encouraged to do so. To facilitate this process, the HREC will ensure that all information sheets for research participants contain the contact information for the HREC Chair.
Complaints relating to the conduct of research
Complaints relating to the conduct of research approved by the SVHAC HREC will initially be investigated by the HREC Chair and the Research Ethics and Governance Officer, in line with SVHA policies relating to responsible conduct of research.
In the event of such a complaint being received, the researcher shall immediately be informed and the complaint investigated. If appropriate, the relevant protocol(s) may be suspended until the complaint has been resolved.
Complaints relating to the decisions of the HREC
Complaints about any decisions of the HREC that cannot be resolved by the Chair and Research Ethics and Governance Officer will be referred to the Facility CEOs (Holy Spirit Northside Private Hospital; St. Vincent’s Private Hospital Brisbane, St. Vincent’s Private Hospital Toowoomba) for further consideration.
What to do if you have a complaint or concern relating to research approved by the SVHAC HREC
If possible it is appropriate to resolve your concerns directly with the researcher in the first instance. If for any reason you do not feel comfortable in talking with the researcher, or if you are not satisfied with their response, please contact the Research Ethics and Governance Officer immediately. The Research Ethics and Governance Officer can be contacted either by email (email@example.com) or by telephone (07) 3326 3639).
- NHMRC (2013). National Statement on Ethical Conduct in Human Research (updated May 2013), Australian Government.
- NHMRC (2007). Australian Code for the Responsible Conduct of Human Research. Australian Government.