Research Biosafety Committee Terms of Reference The St. Michael s Hospital Research Biosafety Committee is charged with ensuring that all activities within St. Michael s Hospital research community involving biohazardous agents are conducted in a safe manner and in conformity with generally accepted standards. St. Michael s Hospital affirms that the primary responsibility for the safety of staff, students and the public lies with the principal investigator using or authorizing the use of such agents. The Vice-President of Research has been charged with the responsibility for approval of regulations and actions with respect to the Occupational Health and Safety Act and the Environmental Protection Act. The Vice-President of Research has delegated this responsibility to St. Michael s Hospital Research Biosafety Committee and its Chair. 1. Membership Chair Director, Research Operations (ex officio) Manager, Research Facilities Occupational Hygienist Occupational Medicine Consultant Radiation Safety Officer Representative, Clinical Research Representative, Wet Bench Research 2. Authority St. Michael s Hospital (through senior administrators) acknowledges a responsibility to provide a policy and procedural framework designed to ensure that work is being conducted safely and in conformity with the Occupational Health and Safety Act, The Environmental Protection Act, the Nuclear Safety and Control Act and the guidelines as described in the Laboratory Biosafety Guidelines, Health Canada.
The Vice-President of Research has been charged with the responsibility for approval of regulations and actions with respect to the Occupational Health and Safety Act and the Environmental Protection Act and has delegated this responsibility and power to St. Michael s Hospital Research Biosafety Committee and its Chair. 3. Structure Chair The Chair is appointed by the Vice-President of Research for a 3 year (renewable) term. The Chair shall be a senior academic with extensive experience in working with biohazardous agents. Members Members are appointed by the Vice-President of Research on the recommendation of the Chair for a 3 year (renewable) term. They are selected on the basis of their location and experience in working with biohazardous agents with representation from occupational health, infection control, research facilities, radiation safety, wet bench research, clinical research and employee health. Their function is to assist and advise the Chair in all matters relating to biosafety within the research community of St. Michael s Hospital. Ex Officio Members Ex officio members include Hospital administrators whose responsibilities include the implementation and maintenance of biosafety standards and regulations. They are full voting members of the Committee. Ex officio members include: Director, Research Operations Meetings The Committee shall meet 6 times per year. The Committee shall keep minutes of meetings. Quorum A quorum shall be a simple majority of the voting members. 4. The Committee - Responsibility 1. Will review protocols which have potential biosafety hazards to ensure that appropriate controls are in place; 2. Will coordinate annual biosafety inspections and certification of SMH research labs in collaboration with the Occupational Hygienist,
Radiation Safety Officer, Infection Control and Fire Safety and Security officers: 3. Will assist the Occupational Health Service in matters related to health, hygiene and safety; 4. Will protect the health of staff by developing safety standards for the conduct of research and teaching involving biohazardous agents by members of St. Michael s Hospital; 5. Will coordinate training and safety education to all personnel working with biohazardous agents in collaboration with the Occupational Hygienist, Radiation Safety Officer, Infection Control and Fire Safety and Security officers; 6. Will take all reasonable steps to ensure that research and teaching activities of members of St. Michael s Hospital involving biohazardous agents are performed in compliance with the requirements of St. Michael s Hospital and any relevant guidelines or legislation; 7. Will advise the Vice-President of Research on the needs of the St. Michael s Hospital research community for biosafety facilities, policies and programs; 8. Will decide upon appeals resulting from the refusal to grant a licence or from the withdrawal of a licence by the Chair or his/her designate. 9. Will ensure the upkeep and distribution of a Lab Safety Manual which will describe the requirements and procedures established by St. Michael s Hospital for work with potentially hazardous biological agents. All work conducted by Hospital employees with potentially hazardous biological agents on Hospital premises or under the control of St. Michael s Hospital is to be performed in accordance with the requirements of the Manual. 5. The Chair - Responsibility 1. Will approve and license, at the appropriate bio-containment level(s), all uses of biohazardous agents within St. Michael s Hospital; 2. Will investigate compliance with any applicable regulations, guidelines or safety standards whenever it is believed or complained on reasonable grounds that any breach thereof or other safety hazard may have occurred or be occurring, and for that purpose, to enter any laboratory or other premises on the grounds or under the jurisdiction of St. Michael s Hospital at any time, and to examine the equipment, operations, materials and systems therein; 3. Will withdraw the licence related to any work that is considered to pose an undue biosafety risk and to require the immediate cessation of that work; 4. Will delegate the approval and withdrawal of licences and the investigation of compliance to another member of the Committee when necessary due to absence or illness;
5. Will report promptly to the Vice-President of Research for transmittal to the Joint Health and Safety Committee, any instances under the jurisdiction of the Committee where: o an order is issued by the relevant Ministry or any other regulatory authority and there is not full compliance within the specified time; o employees refuse to work for reason of danger to their health or safety; or o any other significant event occurs where the Joint Health and Safety Committee should be informed to enable it to perform, on behalf of the hospital s senior administration, its responsibilities pursuant to the Occupational Health and Safety Act, the Environmental Protection Act or any other applicable legislation: 6. Will submit, on behalf of the Committee, a quarterly report to the Joint Health and Safety Committee. 6. Guidelines for Reviewing Applications The review of applications by the Biosafety Committee is focused on understanding the biosafety of protocols used in research. It is imperative that the protocols provide a safe working environment for the researchers and investigators. Once a protocol has been reviewed and approved, it is accepted by the Committee as consistent with biosafety laboratory standards and/or principles. The primary guideline applied is the Health Canada Laboratory Biosafety Guidelines, 3rd Edition, 2004. It is often asked what types of protocols need to be reviewed by the biosafety committee. This question is difficult to answer specifically. Generally, the Committee reviews the following types of applications for approval: 1. the hazards of the chemical are presently under study or an MSDS is not available, 2. an agent under Food/Drug classification is being used and has hazardous implications for staff, 3. staff or the Principal Investigator has concerns about the safety of a protocol, 4. the biological agent requires containment at a risk level, as described in the Laboratory Biosafety Guidelines from Health Canada, that the lab is not certified to provide, 5. radioisotopes are going to be used. A sub-committee consisting of the Chair, the Occupational Hygiene Representative and the Manager of Research Facilities may provide interim approval for an application.
However, such interim approvals must be subject to discussion and final approval at a full meeting of the committee. 7. Application Process 1. A signed original and an electronic copy of a properly completed application form should be forwarded to the Coordinator, Research Biosafety Committee prior to the deadline. (A copy of the protocol, with the areas of concern highlighted, must accompany the application.) 2. Members of the Committee will receive a copy of the application and return their questions and/or concerns to the Coordinator. 3. The applicant will be contacted prior to the scheduled meeting and requested to respond to questions. 4. Responses will be provided to all at the meeting and after full discussion, a vote will be taken. 5. Letters of approval or rejection will be sent promptly by the Chair. September, 2006