WOMEN’S AND CHILDREN’S HEALTH NETWORK INSTITUTIONAL BIOSAFETY COMMITTEE TERMS OF REFERENCE Role The Women’s and Children’s Health Network (WCHN) Institutional Biosafety Committee’s (IBC) role is to assist the WCHN fulfil its responsibilities in regard to compliance with the Gene Technology Act 2000 and Gene Technology Regulations 2001. This is done principally by providing liaison between research groups that conduct work with genetically modified organisms (GMOs) and the Office of the Gene Technology Regulator (OGTR), including assessment / approval of applications and the certification of facilities. Desired outcomes The outcomes for the WCHN IBC are: To assess all applications for work with GMOs including exempt dealings and notifiable low risk dealings against appropriate OGTR guidelines. To assess and recommend applications for work with GMOs as licensed dealings before submission to the OGTR for approval. To review and recommend certification of facilities for work with GMOs before submission to OGTR for approval. To conduct annual inspections of certified facilities in accordance with OGTR guidelines. To maintain a register of applications and approved projects for work with GMOs. To provide an annual report to the OGTR of all projects and facilities authorised for work with GMOs. To act as a liaison point for communications between OGTR and researchers involved in work with GMOs. To provide a source of expert advice for researchers working with GMOs. To advise researchers of their responsibilities with regard to working with GMOs. Membership Chairperson The Chairperson of the IBC will be appointed by the Chief Executive Officer (or delegate) WCHN and must be a WCHN employee. D:\106733013.doc Composition Members the IBC will be appointed by the Chief Executive Officer (or delegate) WCHN. The IBC will have a minimum of six members, each of which should have appropriate knowledge and skills. The Chair, Deputy Chair and Executive Officer of the IBC will be WCHN employees. The members should include at least one person knowledgeable in the following areas: Microbiology Virology Molecular Biology Animal Facility management Lay person Other expertise may be appropriate depending on the nature of work with GMOs being done within the WCHN. Meeting Process The IBC will meet every two months (no meetings in January). A quorum will be half of the total membership plus one member. In the absence of the Chair of the IBC, the Deputy Chair will assume this role. There is no provision for proxies should members be unable to attend the meeting. Minutes of the meeting will be recorded, endorsed and signed by the Chair of the IBC and stored in accordance with Public Sector guidelines. Each meeting will be conducted in the following order: Preliminaries (including apologies, present, in attendance and welcome) Confirmation of previous minutes Business carried over New business (including new protocols) Correspondence Other business Next meeting Reporting The Chair of the WCHN IBC will report to the WCHN Executive via the Executive Director, Acute Services. In addition, the IBC reports to the Office of the Gene Technology Regulator (OGTR) annually and as required. Administrative support Provided by the Research Coordination Officer, WCHN Research Secretariat as the Executive Officer of the IBC. Review of Terms of Reference The Terms of Reference and membership of the WCHN IBC will be reviewed annually by the Chair, in consultation with the members of the IBC, and in the event of significant change, notified to the Executive Director, Acute Services. D:\106733013.doc Decision making process The IBC aims to make all decisions by consensus. Any concerns that members of the IBC have concerning applications or amendments should be expressed during meeting discussions. If these cannot be satisfactorily answered by those present and agreement reached, the applicant(s) should be invited to the meeting if possible or to the next meeting to speak to their proposal and answer questions with a view to modifying the relevant aspect(s) of the project such that consensus may be achieved. If after these discussions with the applicant(s) there is still no consensus about the issue, the Committee may explore conditions which, if placed on the application, may result in a consensus. It these are agreed then the application may be approved subject to those conditions. Grievance process If a member of the IBC or a researcher has any grievance about the operation (but not the decisions) of the Committee, they should discuss this, in confidence, with the Chairperson of the IBC who will, if necessary, liaise with the Executive Director, Acute Services WCHN. If the grievance cannot be resolved, the matter will be referred to the WCHN Executive. December 2011 D:\106733013.doc