• Section 1 - Establishment
• Section 2 - Glossary
• Section 3 - Membership
• Section 4 - Functions and responsibilities
• Section 5 - Meetings

Section 1 - Establishment

(1) The Institutional Biosafety Committee (IBC) of Charles Sturt University (the University) is established to ensure the University’s activities and facilities involving hazardous biological agents meet safety ethical and professional standards as well as compliance with the Gene Technology Act (2000) and associated Regulations.

Section 2 - Glossary

(2) Nil

Section 3 - Membership

(3) The Institutional Biosafety Committee (IBC) members are nominated by the Deputy Vice-Chancellor (Research and Engagement) in accordance with the requirement of the Gene Technology Act 2000 and the Gene Technology Regulations (2001) and the Guidelines for Accreditation of Organisations.

(4) The IBC shall comprise members with the collective technical scientific expertise to review and assess all the matters which are referred to it for consideration, assessment or advice. The IBC may rely on the advice of an expert, external to the Committee, to address specific, short-term skills deficits of the IBC.

(5) The IBC shall comprise the following membership:

1. A Presiding Officer – appointed by the Deputy Vice-Chancellor (Research and Engagement).
2. Faculty of Science Technical Services representative x 2 as nominated by the Faculty Technical Manager.
3. One representative from each School’s enterprises.
4. One representative from the Division of Human Resources, Work Health and Safety.
5. One representative from each School of Animal and Veterinary Sciences, School of Agricultural, Environmental and Veterinary Sciences and School of Biomedical Sciences.
6. A layperson who is independent of the University and has no ongoing, substantive association (including personal, pecuniary or research interests) with matters likely to be considered by the IBC.

(6) Additional School representation may be appointed at the recommendation of the Executive Dean, Faculty of Science and Health.

(7) The IBC may include additional members, as it deems necessary to ensure its adequate functioning and representation of the nature of dealings with animals and/or GMOs undertaken by the University.

(8) The University has indemnified the members of the IBC, in relation to all areas of the IBC operations in particular for those involving gene technology, against professional legal liability.

Terms of office

(9) Committee membership tenure shall be three years or less in the following circumstances:

1. the committee member leaves the University;
2. is no longer a member of the organisational unit or role being represented;
3. withdraws from their position; or
4. does not meet membership requirements such as minimum attendance.

(10) All members may be re-appointed by approval by the Deputy Vice-Chancellor (Research and Engagement) and may serve for consecutive terms.

(11) A member’s term of office may be extended in order to avoid more than 50% of the membership from being turned over.

(12) Appointment to the Committee must be approved by the Deputy Vice-Chancellor (Research and Engagement) or delegate following consultation with the Presiding Officer.

(13) The Presiding Officer is appointed by the Deputy Vice-Chancellor (Research and Engagement).

(14) The Deputy Presiding Officer is elected by the Committee at its first meeting of the new term of office.

(15) The Committee will appoint an Executive, including the Presiding Officer and at least two members from those listed at clause 5(b)-(e)

(16) The Executive of the IBC will be appointed by the Committee at its first meeting of the new term of office and then reviewed as required.

Non-attendance

(17) All committee members must attend 70% of scheduled meetings on an annual basis, subject to mitigating circumstances. Where committee members cannot attend meetings apologies must be given to the governance officer.

(18) Committee members who have continued absences from scheduled meetings will be approved by the Presiding Officer or nominee to discuss continued membership. If the committee member opts to remain on the Committee but continues to be absent from the meetings they will be asked to end their term on the Committee.

(19) Only the Deputy Vice-Chancellor (Research and Engagement) has the authority to cease the membership before the term has expired.

Section 4 - Functions and responsibilities

(20) In accordance with the conditions of the University's accreditation instrument under the Gene Technology Act, the Institutional Biosafety Committee is responsible for identifying risks at the University posed by biological and microbiological materials (including genetically modified organisms (GMOs)) used in teaching or research and monitoring the management of those risks in accordance with the provisions of the Gene Technology Act (2000) and the Gene Technology Regulations (2001), and other related state or federal legislation.

(21) The powers and responsibilities of the IBC are:

1. With respect to microbiological materials (including GMOs) used in teaching or research within the University, that can produce harm to the health of workers, as defined under the Model Work, Health and Safety Bill 2011 (to include staff, students and visitors at Charles Sturt University), or cause harm to the environment:
   1. certify that laboratories are of an approved containment standard before they are used for particular teaching, research or commercial activities;
   2. consider and approve applications for dealings with GMOs from the University staff and students. Such approvals will include approval of the classification of the dealing;
   3. consider and provide advice to Charles Sturt University works with respect to applications for dealings with GMOs which require licensing from the Gene Technology Regulator;
   4. approve, promulgate and monitor relevant policies, procedures and guidelines applying to risks and hazards posed by biological and microbiological materials (including GMOs) at the University. Such policies, procedures and guidelines shall be published in a Biosafety Manual;
   5. keep a record of all organisms of Risk Category 2 or above held in laboratories, and inspections and certification of facilities.
2. Receive annual reports from Laboratory Managers that notify the IBC of the acquisition, distribution and destruction of microbiological materials in their laboratories during the previous twelve months;
   1. additional reports may be required by the IBC, or submitted by the Laboratory Managers in exceptional circumstances.
3. Report quarterly to the University Finance, Audit and Risk Committee through the Deputy Vice-Chancellor (Research and Engagement) on mechanisms to minimise the risk to all staff, students and visitors to the University.
4. Submit an annual report on its activities to the University Council.
5. Receive and respond to complaints and issues of non-compliance raised by any person.

Members responsibilities

Presiding officer

(22) The Presiding Officer of the Institutional Biosafety Committee is responsible for the leadership and operation of the Committee.

(23) The Presiding Officer is required to adhere to the responsibilities, accountabilities and other details set out in the Accountability Statement – Presiding Officer, Biosafety Committee.

Deputy Presiding Officer

(24) The Deputy Presiding Officer will act in the role of the Presiding Officer in the absence of the Presiding Officer.

Executive of the Biosafety Committee

(25) The Executive of the IBC shall review proposals and applications that require a response between scheduled meetings of the Committee.

(26) The Executive may reserve the right to defer the discussion and approval of proposals or applications to the next meeting of the full Committee.

Advisory role

(27) The Committee shall advise staff and students of the University on compliance matters relating to biological and microbiological materials (including genetically modified organisms (GMOs)) in teaching and research activities.

(28) The Committee shall respond to enquiries received requesting expert advice on concerns and compliance, application processes and other related matters involving biological and microbiological materials (including genetically modified organisms (GMOs)).

(29) The Committee shall advise the Deputy Vice-Chancellor (Research and Engagement) regarding the level of resourcing required by the Committee.

Governance and administrative support

(30) The Research Integrity, Ethics and Compliance Unit, Office of the Deputy Vice-Chancellor (Research)will provide administrative and secretariat support to the Committee, and can be called upon for protocol and procedural advice.

(31) A governance officer will be appointed to support the Committee in the administration of its business, including the following responsibilities:

1. being the first point of contact for applicants wishing to make application or liaise with the Committee;
2. ensuring that proposals are provided to the Committee for consideration;
3. ensuring that the decisions of the Committee are conveyed to investigators and teachers in a timely manner;
4. ensuring that Committee records are maintained and made available for review by the University and authorised external reviewers;
5. ensuring that the University submits the appropriate licence applications, renewals and reports as required; and
6. where requested by the Committee, assist with arranging audits and inspections for committee members of the facilities biological and microbiological materials (including genetically modified organisms (GMOs)), or prior to use in the case of any proposed new facility.

(32) Decisions about allocation of committee tasks to the governance officer/s is the responsibility of the Manager, Research Integrity, Ethics and Compliance Unit, who may seek advice from the Presiding Officer.

(33) Governance officer/s who attend committee meetings have the right of audience and debate, particularly in relation to providing advice on procedural matters and corporate knowledge.

Section 5 - Meetings

Quorum

(34) A quorum is the majority of the committee members present at the meeting.

(35) A quorum may be established through telephone or video conference links.

(36) Only quorate meeting of the Committee shall consider and approve new applications, this can be dealt with via e-mail.

(37) Members who are unable to attend meetings must send through their apologies and are encouraged to submit their comments on applications to the Presiding Officer before the meeting, for consideration during the meeting.

Meetings

(38) The Committee will meet at least once each quarter.

(39) Meetings for the first and second quarters will be scheduled to allow enough time for approvals to be returned to applicants prior to the commencement of each academic session.

(40) At least one meeting each year should be scheduled face to face.

(41) A schedule of meeting dates and agenda closing dates is posted on the Biosafety Committee website by the beginning of each academic year.

(42) In exceptional circumstances, the schedule of meetings may be altered by the Presiding Officer, in consultation with the governance officer.

(43) Applications are allocated to an agenda based on their submission date and agenda closing dates.

(44) Where an application requires a response before the next quarterly meeting, the application will be considered by the Executive of the Biosafety Committee, either via teleconference or asynchronously where members shall, in writing, provide comments on applications and any approvals where possible.

(45) If required, the governance officer of the Committee may, on behalf of the Presiding Officer, convene an extraordinary meeting of the Committee to review urgent committee business.

(46) In those cases where an extraordinary meeting of the Committee cannot be convened, the governance officer may circulate proposals and other items of business to the committee members who shall consider them asynchronously and, in writing, provide comments on applications and any approvals where possible.

Agenda and minutes

(47) Agendas are circulated to the Committee one week before each scheduled meeting.

(48) Minutes of the Committee are circulated to members within two weeks following the meeting.

Related expenses

(49) External members may claim a meeting allowance in accordance with the Research Integrity Committee – Meeting allowances Schedule.

Conflicts of interest

(50) Where a member has a perceived or material conflict of interest as described in the University’s Conflict of Interest Procedure, they must declare this to the Presiding Officer and at the committee meeting before discussion of the item of business.

(51) The Presiding Officer will determine if members with a conflict of interest will remain present for the discussion of the item but not take part in a decision, or if the member must withdraw from the meeting for the discussion of matters that relate to that conflict of interest. Once such members have withdrawn, the remaining members must still constitute a quorum.

Confidentiality

(52) Matters discussed and papers considered during a committee meeting are confidential to committee members and those with the right of audience and debate.

(53) Specific papers considered during a meeting and records of specific meeting discussions may be shared by the Presiding Officer, or by the governance officer with the permission of the Presiding Officer, with authorised officers of the University who can demonstrate a need to access the relevant information for the performance of their duties.

Variations

(54) Variations to the terms of reference and/or membership of the Committee must be approved by the Deputy Vice-Chancellor (Research and Engagement).