VCOM Institutional Policy and Procedure Manual

VCOM Policy and Procedure

Policy #R012

2.7. Approval Procedure The IEBC may appoint subcommittees for the following:

Recombinant DNA Pathogens and Oncogenes

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Carcinogens and Toxins Each IEBC request will be pre-reviewed by the Associate Dean for Biomedical Affairs and Research and forwarded to the IEBC when deemed complete. The committee will either approve the application and determine the appropriate biosafety requirements, or in special cases, request a second review by an outside consultant or a subcommittee with special expertise. In some instances, the PI may be asked to appear before the IEBC. The IEBC will also determine if a lab inspection is needed. Once the review and notification letter regarding the lab inspection are prepared they will be sent to the IEBC, the IBO, and the PI. Additional information may be requested such as a clarification of comments posed by the reviewer or the need for scheduling a lab inspection. The PI will be responsible for submitting the request in a timely manner. If a project involving human subjects requires IEBC approval, the IRB is responsible for requesting the IEBC approval. Once approval is granted, it is the responsibility of the PI to ensure that approval letters are properly directed to any funding agency or sponsor. 2.8. Compliance The IEBC has express authority to: (1) monitor research covered by approval letters it has issued; and (2) enforce biosafety requirements, including the suspension of research, or recommending to the Provost, Dean and Executive Vice President, penalties, and sanctions for non-complaint investigators. The IEBC is responsible for providing information and advising research investigators concerning the approved methods for the handling and disposing of radioactive materials and toxic chemicals. Certain hazardous agents and materials require approval prior to use at the College. The IEBC maintains a certification list of those VCOM principal investigators who have registered their recombinant DNA and potentially hazardous agents or materials. A copy of this registration list is on file with the Chief of Operations. If a project will involve radiation or hazardous or highly toxic chemicals, the IEBC must be notified and Institutional Biosafety Officer (IBO) or IEBC approval must be obtained well in advance of submitting the grant application to the Office of Research Administration (ORA) or, if applicable, the Institutional Research Board (IRB). If the number and date of approval are not provided on the VCOM ORA Approval Form, or if the approval is listed as “pending,” signature of the sponsored project application will be delayed until IEBC has confirmed that the project will not pose unacceptable risks or requirements. 3.1. Radioactive Materials The IEBC administers the radiation control program at VCOM, in conjunction with the Radiation Safety Officer (RSO). The RSO is responsible for overseeing the procurement and receipt of radioactive materials, and provides for radioactive waste disposal. A review body of the IEBC certifies the responsible investigator and facilities to be used for each radioactive nuclide. The IEBC establishes the institutional policies regarding radioactive materials. The RSO works closely with the PI to ensure safe handling, use, and disposal of radioactive materials in compliance with state and/or federal laws. Copies of the policies will be distributed periodically and may be obtained from the Chief of Operations. 3. P OLICY R EGARDING THE D ISPOSAL OF H AZARDOUS A GENTS AND T OXIC C HEMICALS

VCOM Policies and Procedures Governing Environmental Health & Safety

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