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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).

All research projects undertaken at St. Vincent’s Private Hospital Brisbane require prior approval from the SVHAC HREC. Please direct all enquires to the Research Governance Officer, svhac.hrec@shva.org.au, ph (07) 3326 3909.

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 minimum membership of an HREC is eight. As far as possible there should be:
(a) there should be equal numbers of men and women; and

(b) at least one third of the members should be from outside the institution for which the HREC is reviewing research.

This minimum membership is:
(a) a chairperson with suitable experience, whose other responsibilities will not impair the HREC’s capacity to carry out its obligations under the National Statement;

(b) at least two lay people; one man and one woman who have no affiliation with the institution and do not currently engage in medical, scientific, legal or academic work;

(c) at least one person with knowledge of, and current experience in, the professional care, counselling or treatment of people; for example, a nurse or allied health professional.

(d) at least one person who performs a pastoral care role in a community, for example, an Aboriginal elder, a minister of religion;

(e) at least one lawyer, where possible one who is not engaged to advise the institution; and

(f) at least two people with current research experience that is relevant to the research proposals to be considered at the meetings they attend. These two members may be selected, according to need, from an established pool of inducted members with relevant expertise.

(National Statement, sections 5.1.29 – 5.1.30)

The St Vincent’s Health and Aged Care Human Research and Ethics Committee meets these membership guidelines.

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 St Vincent’s Health and Aged Care HREC, and are able to provide advice and assistance with submissions to the Committee, as well as contact details for 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 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 Governance Officer.

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 important HREC dates for 2017 are as below and in attached document.

Submission Deadline Meeting Papers Distributed Meeting Date
20 January 2017 27 January 2017 10 February 2017
31 March 2017 7 April 2017 21 April 2017
19 May 2017 26 May 2017 9 June 2017
21 July 2017 28 July 2017 11 August 2017
22 September 2017 29 September 2017 13 October 2017
17 November 2017 24 November 2017 8 December 2017

What are the submission requirements?

To assist this process, researchers must ensure the appropriate documentation is submitted electronically. The specific documentation can vary depending on the nature of the research project, however some examples can include.

A completed SVHAC HREC Research Submission Cover Sheet (see Resources section below)

  • Cover letter signed by the Principal Investigator including:
    sponsor or principal researcher details for invoice purposes
  • A completed pdf or rtf copy of the Human Research Ethics Application form (HREA) – this includes any application for Low and Negligible Risk Research Projects.  For more information on the HREA, please visit https://hrea.gov.au 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 SVHAC HREC contact for complaints is:

    The Chair
    Dr Kim Alexander
    St Vincent’s Health & Aged Care Human Research Ethics Committee
    Holy Spirit Northside Private Hospital; 627 Rode Road
    Chermside QLD 4032
    Telephone: (07) 3326 3679

     
  • 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

HREA

As part of the initiative to streamline ethics approval, NHMRC has developed the Human Research Ethics Application (HREA) as a replacement for the National Ethics Application Form (NEAF). The aim of the HREA is to be a concise application to facilitate efficient and effective ethics review for research involving humans. The application will assist researchers to consider the ethical principles of the National Statement on Ethical Conduct in Human Research (2007) in relation to their research, rather than focus on requirements for approval.

Applications can now be made at www.hrea.gov.au. Information guides and training resources are provided by the NHMRC on the HREA website.

Important resources

Complaints Procedure

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 Manager, 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 Manager 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 Manager immediately. The Research Ethics Manager can be contacted either by email (svhac.hrec@svha.org.au) or by telephone (07) 3326 3679).

References

  1. NHMRC (2013). National Statement on Ethical Conduct in Human Research (updated May 2013), Australian Government.
  2. NHMRC (2007). Australian Code for the Responsible Conduct of Human Research. Australian Government.