D/6.6 University Biosafety Committee charter

Contact Officer	Director, Office of Research Ethics and Integrity
Approval Date	03/12/2018
Approval Authority	Vice-Chancellor and President
Date of Next Review	01/12/2021

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).

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6.6.2 Accountability

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

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 provides advice on matters regulated by the Biosecurity Act 2015 (Cth)
monitor and provides advice on permits required under the Biosecurity Act 2014 (Qld)
monitor and provides advice on any other law relating to biological agents and materials.

Policy, procedures and guidelines

develop and approve policy, procedures and guidance relating to the biosafety of biological agents and materials, including:
- genetically modified organisms (GMOs)
- Security Sensitive Biological Agents (SSBAs)
- high-risk biological agents and materials as defined in the University Biosafety Committee Standard Operating Procedures (QUT staff and student access only) which includes human pathogens, infectious animals, plant pathogens, biological toxins and material regulated under Biosecurity Act 2014 (Qld) e.g. pest weeds.
- biological agents and 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 & Prohibited Goods and Packaging Post Guide
- other biological materials regulated by law.

Review, approval and monitoring of activities/projects

review research and teaching activities/projects involving dealings with GMOs and high-risk biological agents and 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 Gene Technology Regulator (OGTR)
approve only those activities/projects which it considers are ethically acceptable and conform to the requirements of the legislation and standards relating to biological agents and materials
where required, refers activities to the Gene Technology Regulator
monitor the conduct of approved activities/projects until their completion so as to ensure continued compliance with relevant requirements, and may withdraw approval
maintain a register of proposed and approved dealings with GMOs, high-risk biological agents and materials, Queensland Biosecurity permits and Biosecurity permits that have a requirement to be used in an Approved Arrangement (AA).

Facilities and monitoring

monitor annual inspections of regulated (e.g. OGTR certified and Approved Arrangement Premises) and non-regulated physical containment facilities
monitor the annual report of backflow and mechanical ventilation integrity of physical containment (PC) facilities from the Facilities Management Department
through the Facilities Management Department stakeholder process, participate in the decision making processes regarding new or redeveloped regulated and non-regulated physical containment areas and recommends the certification of regulated facilities
advise the Executive Director, Facilities Management on the award of a pathogenic waste contract.

Incidents involving biological agents and materials

monitor reports of incidents and accidents that involve research or teaching activities/projects or other events where biological agents and materials are involved
review non-compliances that involve research or teaching projects/activities or other events that involve biological agents and materials and/or facilities where biologicals agents and materials are used.

Training and advice

ensure a system is in place for training of QUT staff and students in the use of biological agents and materials e.g. GMOs and infectious material
advise faculty/institute health and safety committees in relation to research and teaching activities involving biological agents and materials
advise the Deputy Vice-Chancellor and Vice-President (Research) and the Provost on dealings with GMOs and biological agents and materials, including procedural matters.

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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 University Biosafety Committee has been requested or required to provide assessment and advice.

The minimum membership of the University Biosafety Committee includes:

a Chairperson, with suitable experience and senior academic standing nominated by the Vice-Chancellor and President. The Chair should be knowledgeable in the University's policies and procedures, Australian standards and community issues
at least six members with expertise in recombinant Deoxyribonucleic Acid (DNA) technology nominated by the Deputy Vice-Chancellor and Vice-President (Research) including a:

bacteriologist
cell biologist
plant scientist
virologist
scientist with expertise in in-vivo experimentation
scientist with expertise in large scale fermentation projects

the QUT Senior Biosafety Officer ex officio
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 University Biosafety Committee, nominated by the Deputy Vice-Chancellor and Vice-President (Research).
one senior engineer with suitable expertise in engineering systems associated with biosafety in facilities, nominated by the Executive Director, Facilities Management (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 (in some categories). Exact membership numbers 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 Office of Research Ethics and Integrity (OREI) may act in this capacity.

Terms of office are as detailed in section 6 of Council Procedure 1 (Committees).

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6.6.5 Attendance

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.

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6.6.6 Meeting frequency

University Biosafety Committee meets at least quarterly.

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6.6.7 Reporting and communication

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). Reports to Council should address the number and type of activities/projects considered for approval and the outcomes, risk management, physical facilities available for regulated work, any administrative or other difficulties being experienced, and any actions that have supported the educational and training needs of Committee members and researchers.
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.

University Biosafety Committee may refer matters to University Human Research Ethics Committee, University Animal Ethics Committee, University Health, Safety and Environment Committee and/or faculty/institute health, safety and environment committees and 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).

To comply with the requiremnts of the Gene Technology Act 2000 (Cth), Gene Technology Regulations 2001 (Cth) and corresponding Queensland legislation, and the requirement of any statute, rule, regulation or other legal obligation applicable to University Biosafety Committee, University Biosafety Committee has approved Standard Operating Procedures (QUT staff and student access only).

Consideration of non-QUT research

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 affiliation 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

Any complaints or concerns about the University Biosafety Committee's review process or a decision should be directed in the first instance to the Chair of the Committee. The University Biosafety Committee's Standard Operating Procedures (QUT staff and student access only) provides further details regarding the process and investigation.

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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).

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Modification History

Date	Sections	Source	Details
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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