D/6.6 University Biosafety Committee charter

Policy Owner	Director, Office of Research Ethics and Integrity
Approval Date	25/05/2022
Approval Authority	Vice-Chancellor and President
Date of Next Review	01/12/2023

6.6.1 Purpose
6.6.2 Accountability
6.6.3 Responsibilities
6.6.4 Membership
6.6.5 Attendance
6.6.6 Meeting frequency
6.6.7 Reporting and communication
6.6.8 Procedures
6.6.9 Secretariat
Related Documents
Modification History

6.6.1 Purpose

The primary responsibility of the University Biosafety Committee is to ensure, as far as practicable, that potentially hazardous research and teaching is conducted under controlled conditions and is carried out in a way that staff and students, the public and the environment are protected. The functions of the University Biosafety Committee support compliance with the QUT Code for responsible conduct of research (D/2.6) and legislative requirements relevant to biosafety.

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6.6.2 Accountability

The University Biosafety Committee is a management committee accountable to the Vice-Chancellor and President through the Deputy Vice-Chancellor and Vice-President (Research) for fulfilling its responsibilities.

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6.6.3 Responsibilities

The University Biosafety Committee will undertake the following:

Compliance with legislation and standards

perform the functions of an Institutional Biosafety Committee in accordance with the Gene Technology Act 2000 (Cth), Gene Technology Regulations 2001 (Cth) and corresponding Queensland legislation
perform the functions of a Biosafety Committee in accordance with Australian/New Zealand Standard AS/NZS 2243.3 Safety in laboratories - Microbiological safety and containment
perform, if required, the functions of a Management Committee as outlined in the Security Sensitive Biological Agent Standards and in accordance with the National Health Security Act 2007 and National Health Security Regulations 2008 and associated guidelines
monitor and provide advice on matters regulated by the Biosecurity Act 2015 (Cth)
monitor and provide advice on matters regulated by the Biosecurity Act 2014 (Qld)
monitor and provide advice on any other legislation relevant to biosafety.

Policy, procedures and guidelines

contribute to the development of and approve policy, procedures and guidance relating to the biosafety of biological materials, including:
- genetically modified organisms (GMOs)
- Security Sensitive Biological Agents (SSBAs)
- high-risk biological materials as determined by the University
- biological materials as governed by the Australian Code for the Transport of Dangerous Goods by Road & Rail, International Aviation Transport Authority (IATA) standards, manuals and guidelines and Australia Post Dangerous and Prohibited Goods and Packaging Post Guide
- other biological materials used in research and teaching activities.

Review, approval and monitoring of activities

review research and teaching activities involving dealings with GMOs and high-risk biological materials
confirm that all proposals for exempt and notifiable low-risk dealings with GMOs are correctly classified, within current regulations, and communicates the correct information to the Office of the Gene Technology Regulator (OGTR)
approve only those activities which it considers are acceptable and conform to the requirements of the legislation and standards relating to biological materials and biosafety
where required, refer activities to the Gene Technology Regulator
oversee the conduct of approved activities until their completion to ensure continued compliance with relevant requirements.

Facilities and monitoring

review outcomes of annual inspections of certified (e.g. OGTR and Approved Arrangement Biosecurity) and non-certified physical containment facilities
review the annual report of backflow and mechanical ventilation integrity of physical containment (PC) facilities from Facilities Management.

Incidents involving biological materials

review reports of incidents and accidents that involve research or teaching activities where biological materials are involved
provide advice and recommendations to the University regarding non-compliances that involve research or teaching activities that involve biological materials and/or facilities where biological materials are used.

Training and advice

contribute to the development of and approve a system for the training of QUT staff and students in the use of biological materials. e.g. GMOs and infectious material
advise the Deputy Vice-Chancellor and Vice-President (Research) and the Provost on matters that involve biological materials and biosafety.

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6.6.4 Membership

The membership of the University Biosafety Committee is constituted in accordance with the requirements of the Gene Technology Act 2000, Gene Technology Regulations 2001 (Cth) and corresponding Queensland legislation.

The University Biosafety Committee must be constituted by members possessing the collective technical and scientific expertise to assess and advise on the identification and management of risks associated with dealings with GMOs for which the University Biosafety Committee has been requested or required to provide assessment and advice.

The membership of the University Biosafety Committee includes:

a Chairperson, with suitable experience and senior academic standing (or equivalent) nominated by the Deputy Vice-Chancellor and Vice-President (Research). The Chair should be knowledgeable in the University's policies and procedures, relevant Australian legislation and community issues
at least six members with suitable technical and/or scientific expertise to allow assessment and provision of advice on applications and matters that are considered by the University Biosafety Committee. Members may possess expertise in more than one area, and multiple members may have expertise in the same area/s. Members are nominated by Executive Deans and/or the Deputy Vice-Chancellor and Vice-President (Research)
at least one independent member, free of any business or other relationship with QUT that could materially interfere with the exercise of unfettered and independent judgment in contributing to decisions made by the University Biosafety Committee, nominated by the Deputy Vice-Chancellor and Vice-President (Research)
a representative from Facilities Management with suitable technical expertise in systems associated with biosafety and biocontainment in facilities, nominated by the Executive Director, Facilities Management (rights of audience and debate only)
other members as recommended by the Chair and approved by the Deputy Vice-Chancellor and Vice-President (Research) (e.g. representatives from outside organisations)
QUT Senior Biosafety Officer ex officio (rights of audience and debate only).

To enable the University Biosafety Committee to have available the skills and expertise necessary for matters under review, exact membership numbers have not been prescribed and are determined by the Deputy Vice-Chancellor and Vice-President (Research).

The University Biosafety Committee shall nominate one member as Deputy Chair. In addition to the usual duties of a Deputy Chair, the Deputy Chair acts as Chair in the Chair’s absence or while applications or other matters involving the Chair are under consideration. In instances where both the Chair and Deputy Chair are absent from the University, the Director of the Office of Research Ethics and Integrity, or delegate may act in this capacity.

Nominated members of the Committee serve a term of office of up to two years. The length of a nominated member’s term of office is recommended to the nominator by the Chair, on advice from the Secretariat.

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6.6.5 Attendance

The University Biosafety Committee may invite the advice of an expert (who is not otherwise a member of the University Biosafety Committee) to address any specific, short-term skills deficit in the University Biosafety Committee in order for the committee to possess the collective and technical expertise to consider the matters before it.

Observers may attend meetings at the invitation of the Chair, with rights of audience only. Individuals must conduct themselves in accordance with Section 12 of Council 1 Procedures (Committees).

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6.6.6 Meeting frequency

The University Biosafety Committee meets at least quarterly. The frequency of meetings is approved by the Deputy Vice-Chancellor and Vice-President (Research). Additional meetings may be held at the discretion of the Chair if urgent matters require review in advance of the next scheduled meeting.

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6.6.7 Reporting and communication

The University Biosafety Committee reports to:

QUT Council, Risk and Audit Committee, University Research Committee and University Academic Board annually through the Deputy Vice-Chancellor and Vice-President (Research).
University Health, Safety and Environment Committee as appropriate.
External bodies such as the OGTR and any other Commonwealth or State regulatory body or authority as required by statute, rule, regulation or other legal obligation.

The University Biosafety Committee may refer matters to the University Human Research Ethics Committee, the University Animal Ethics Committee, University Health, Safety and Environment Committee, faculty/divisional health, safety and environment committees and/or the Director, Office of Research Ethics and Integrity as necessary.

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6.6.8 Procedures

The University Biosafety Committee is established in accordance with legislation governing the use of biological material in Australia and Council Procedure 1 (Committees).

The University Biosafety Committee has approved Standard Operating Procedures (QUT staff and student access only) that should be read in conjunction with this charter.

Consideration of non-QUT research

The University Biosafety Committee normally considers applications only from QUT staff and students. For an outside organisation to access the University Biosafety Committee there must be a formal agreement between QUT and the organisation. In addition, the organisation needs to be accredited with the Office of the Gene Technology Regulator. Any such requests received by the University Biosafety Committee will be assessed on a case-by-case basis.

Complaints and Non-compliance

Complaints and non-compliance relating to research or teaching activities, or any party or individual where biological materials are involved, should be directed to the Office of Research Ethics and Integrity (OREI).

The Manager, OREI or delegate is responsible for the initial review of complaints and will refer complaints to the relevant party as appropriate.

The University Biosafety Committee will ensure, when applicable, that:

activities that pose a biosafety risk to individuals, animals or the environment cease immediately
the issue is addressed in a timely matter
approval for any activities is suspended or withdrawn
the matter is reported to relevant government regulators and authorities
the matter is referred to the University for further actions.

Complaints about the conduct of the University Biosafety Committee's review or decision-making processes are directed to the Chair of the Committee in the first instance. If the complaint relates directly to the conduct of the Chair the matter will be referred to the Director, Office of Research Ethics and Integrity.

The University Biosafety Committee's Standard Operating Procedures (QUT staff and student access only) provide further details regarding the complaints and non-compliance processes.

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6.6.9 Secretariat

A nominee of the Vice-President (Administration) and University Registrar is secretary, on recommendation of the Deputy Vice-Chancellor and Vice-President (Research). The Office of Research Ethics and Integrity provides administrative support to the University Biosafety Committee and coordination of meetings.

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Modification History

Date	Sections	Source	Details
25.05.22	All	Vice-Chancellor and President	Revised charter following management committee self-assessment outcomes
26.11.21	All	Vice-Chancellor and President	Revised terms of reference in accordance with committee self-assessment review, including an update to committee responsibilities, membership and the procedures for reporting of complaints and non-compliance
22.09.20	All	Director, Governance and Legal Services	Date of Next Review extended to accommodate the committee review and self-assessment process deferred to 2021
03.12.18	All	Vice-Chancellor and President	New committee charter and revised terms of reference and membership
24.11.16	All	Vice-Chancellor	Revised terms of reference and membership in accordance with committee self-assessment review and to align with legislation
02.12.14	All	Vice-Chancellor	Periodic review - policy revised
11.04.14	All	Vice-Chancellor	Committee renamed to University Biosafety Committee and revised terms of reference and membership provisions
17.12.10	All	QUT Institute Biosafety Committee	Periodic review - no change required
13.09.10	All	Vice-Chancellor	Revised terms of reference to include reporting through Audit and Risk Management Committee to Council, and change of name to QUT Lead Health and Safety Committee
17.05.09	All	Vice-Chancellor	Revised terms of reference and membership provisions (endorsed by QUT Institute Biosafety Committee 13.02.09 and 07.11.08)
27.05.08	All	Vice-Chancellor	Revised terms of reference and membership of QUT Institute Biosafety Committee (endorsed by University Academic Board 04.04.08 and University Research and Innovation Committee 07.03.08); renumbered to D/6.6 (formerly D/6.1.3)
30.06.05	All	Vice-Chancellor	Revised membership provisions (QUT Institute Biosafety Committee) in accordance with Final Report on Implementation Plan for 2003/2004 Vice-Chancellor's Committees Review
06.12.04	All	Vice-Chancellor	Revised committee title, terms of reference and membership provisions, to encompass risk management and biosafety requirements (endorsed by University Academic Board 19.11.04)
29.06.04	All	Vice-Chancellor	Revised terms of reference and membership provisions, in accordance with recommendations of Vice-Chancellor's Panel of the 2003/2004 Committees Review
05.08.03	All	Acting Pro-Vice-Chancellor (Research and Advancement)	Revised membership provisions to include Research Ethics Officer
27.06.03	All	Secretariat Manager	Added statement re conflict of interest in accordance with Internal Audit Report on Potential Conflict of Interests - Report No 2002/40 (April 2003)
14.05.03	All	Pro-Vice-Chancellor (Research and Advancement)	Revised terms of reference
03.09.01	All	Pro-Vice-Chancellor (Research and Advancement)	Revised Membership Categories
09.07.01	All	Pro-Vice-Chancellor (Research and Advancement)	Revised Committee name, terms of reference and membership in accordance with new regulatory body
03.03.99	All	Pro-Vice-Chancellor (Research and Advancement)	Revised terms of reference and membership
15.01.99	All	Pro-Vice-Chancellor (Research and Advancement)	Change to Committee title
04.11.98	All	Pro-Vice-Chancellor (Research and Advancement)	Revised terms of reference and membership

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