Human Research Ethics Committee

The HREC is constituted and acts in accordance with the:

• National Statement on Ethical Conduct in Human Research (2007) (Updated in 2018)
• Declaration of Helsinki
• Australian Code for the Responsible Conduct of Research
• Note for Guidance on Good Clinical Practice.

The roles of the HREC are to:

• ensure that the design and conduct of any human research project that it reviews conforms with the National Statement on Ethical Conduct in Human Research (National Statement), the Australian Code for the Responsible Conduct of Research and the principles of Good Clinical Practice (GCP).
• ensure that participants involved in any human research study that the HREC reviews and approves, are accorded the respect and protection that is due to them.
• facilitate and foster human research that is of benefit to Australian communities.
• ensure that any decision it makes complies with relevant Queensland and Australian laws.

 In fulfilling these roles, the HREC will:

• receive and review proposals for human research projects to determine whether they meet all relevant ethical standards.
• ensure that it is sufficiently informed on all aspects of a research proposal, including its scientific and statistical validity, before deciding whether a proposal is acceptable on ethical grounds and conforms with the National Statement.
• decide whether participants in all reviewed and approved human research projects will be accorded the protection and respect that is due to them.
• advise the RBWH and researcher applicants whether or not reviewed research proposals meet relevant ethical standards and have, or have not been approved and provide reasons linked to the National Statement for those decisions.
• determine, in relation to each reviewed and approved research project, that there will be mechanisms to monitor the conduct of the research and that the frequency and type of those mechanisms reflect the degree of risk to participants.
• offer relevant advice and assistance to other institutions who do not have a formally constituted HREC.
• have the authority to delegate to a sub-committee in order to assist in the expeditious and effective ethical review of research proposals. The HREC will remain responsible and accountable for the activities and recommendations of any sub-committees.

2022 HREC application closing dates & HREC meeting dates

The RBWH HREC has monthly deadlines for the submission of new greater than low risk research applications.  Researchers need to complete the HREA  and submit their application by 12.00 pm on the closing date  for consideration at the next HREC meeting. The HREC has introduced a process whereby research applications are sent out to HREC reviewers as soon as they are submitted.  This has the advantage of questions and responses being able to be actioned prior to the HREC meeting.  This process reduces the number of days to approval for research studies.

Low risk research projects (submitted on an HREA) and requests for exemption from HREC review for Quality Assurance (QA) / Audit activities (submitted on the LNR form), do not need to be submitted for a closing date and can be submitted at any time, as the HREC provides an expedited review process for these types of applications.

Fees

There are fees for Ethics review and site authorisation of commercially sponsored research, as well as for research conducted by private institutions. The fee for the Ethics review of a research project with full industry sponsorship is $4500. The Site-Specific Assessment fee is $4500 per site for research projects with full industry sponsorship. The fee for subsequent major HREC or governance amendments is $650.  The fees for the addition of sub-studies to research projects with full industry sponsorship will be determined on a case-by-case basis (typically $2000 or, in some cases, the full fee of $4500).  All prices are inclusive of GST.

For commercially sponsored research studies, the Invoicing and Fee Form is to be submitted with all new research applications and amendment submissions.

HREC Membership

The HREC is constituted in conformity with the National Statement and will have at least eight (8) members, both men and women, namely:

• A chairperson, with suitable experience, whose other responsibilities will not impair the HREC’s capacity to carry out its obligations under the National Statement;
• At least two members who are 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, and who are preferably from the community in which the institution is located;
• At least one member with knowledge of, and current experience in, the professional care, counselling or treatment of people; for example a nurse, medical practitioner, or allied health professional;
• At least one member who performs a pastoral care role in a community, for example, an Aboriginal elder or a minister of religion;
• At least one member who is a practicing lawyer, but where possible one who is not engaged to advise the institution;
• At least two members with current research experience that is relevant to research proposals to be considered at the meetings they attend; and
• Additional members as required from time to time to assist with scientific review and ethical decision making.

HREC members volunteer their time to review ethics applications before a meeting and to meet once a month. HREC membership is for 3 years with the opportunity for renewal. Prospective members of the HREC may be recruited by an expression of interest, direct approach, nomination and advertisement, and are appointed in accordance with the National Statement on Ethical Conduct in Human Research [Sections 5.1.34-5.1.36]. If you are interested in contributing once every two months, please contact the HREC Chairperson (Dr Gordon McGurk – email: gordon.mcgurk@health.qld.gov.au; or telephone: 07 3647 1003).

Members

Observing at the Ethics Committee meeting

The HREC offers research staff the opportunity of attending HREC meetings as observers. This assists staff to gain an appreciation and understanding of the purpose of the ethical review process and observe the discussions which take place at meetings. For more information, or to express an interest in observing, please contact the HREC Coordinator (telephone: (07) 3646 5280 or email: MetroNorthResearch-Ethics@health.qld.gov.au).

Terms of reference

• Terms of reference
• Standard Operating Procedures for Queensland Health HREC Administrators