Research Operations/ Standard Operating Procedures (SOPs)
Biomedical research at the University of Miami is performed in accordance with University Policies and Procedures designed to assure the safety of research personnel and the community, and to comply with applicable regulations, standards, and guidelines. Safety programs include Right-to-Know and Hazardous Communication (29 CFR §1910.1200), Laboratory Safety Program, Chemical Hygiene Plan (29 CFR §1910.1450), Bloodborne Pathogens Program (Exposure Control Plan) (29 CFR§1910.1030), Tuberculosis Infection Control Program (OSHA Directive CPL 2.106), Laser Safety Program, and Ergonomics Program. Related policies include Biomedical Waste, Hazardous Waste, and Laboratory Safety. Training is provided in Laboratory Safety, Biological Safety, Hazardous Waste, Shipment of Dangerous Goods, Hazardous Materials and Infectious Substances (49 CFR 100-185 and IATA Dangerous Goods regulations). An Occupational Health Program is provided for individuals having contact with research animals.
A written SOP is required for research involving Biosafety level 2 (BSL2) and higher agents as per the Biosafety in Microbiological and Biomedical Laboratories (BMBL), 5th Edition. Personal protective equipment is required for all laboratory employees. This equipment includes but is not limited to laboratory coats, gloves, safety goggles, splash shields, etc.
Procedures for the management of spills are detailed in the Laboratory Safety Manual, available on the above website. Simple releases are generally cleaned by laboratory personnel while complex releases are cleaned by personnel having training in hazardous waste operations (29 CFR - 1910.120). If a complex spill cannot be controlled in the above manner, the local fire department hazardous materials response team is called.
Established safety committees include: 1) the Institutional Biosafety Committee (IBC) as required by the NIH Guidelines, which reviews all research projects dealing with recombinant DNA procedures, 2) the Institutional Review Board (IRB), which reviews all protocols dealing with human subjects, 3) the Institutional Animal Care and Use Committee (IACUC), which reviews all protocols involving the use of animals. 4) Stem Cell Research Oversight (SCRO) committee which reviews all protocols involving the use of human embryonic stem cells and 5) the Radiation Control Committee.
Facility Equipment and Description (Related to the Research Environment)
The University of Miami is an academic and research institution with three campuses located in the cities of Miami and Coral Gables and in Virgina Key. Security is provided at all campuses on a 24/7 basis. All building access is controlled by electronic access card.
Specialized equipment includes: 1) Biosafety cabinets class IIA or IIB, 2) chemical fume hoods, 3) centrifuges with safety cups, and 4) laminar flow cabinets. The ventilation of laboratories is directional (negative) in relation to the corridors.
Radioactive Materials
The Radiation Control Center regulates all uses of radiation, including training and licensing of research personnel and laboratories under a broad license issued by the state of Florida.
Hazard Analysis (Related to the Research environment)
Biomedical research procedures present potential exposure hazards to laboratory employees and the community in general. These hazards include potential exposure to infectious substances and toxic chemicals. To work with potentially infectious substances all laboratory employees are required to work in a biosafety cabinet class IIA or IIB. Use of toxic chemicals such as organic solvents or mineral acids must be conducted in a chemical fume hood. All laboratories are required to have a biohazard and chemical spill kit appropriate to the volume and type of biological and chemical agents used.
Hazard surveillance is achieved through the Laboratory Safety Program, Radiation Control Center inspections, review of SOP’s for research with hazardous agents, and review by the various committees. Radioactive hazards are controlled at the point of purchase.
Biological Defense Research Program Requirements (Only applicable to the Biological Defense Research Program)
Not applicable to the University of Miami.
Facility Safety Director/Manager Assurance
Signed form attached.
University of Miami
Facility Safety Director/Manager Assurance
I assure that this institution has an existing institutional safety and occupational health program that meets appropriate federal, st
ate, and local regulations as required by law, as well as the National Institutes of Health Guidelines for
Research Involving DNA Molecules, dated Jan 2001.
I assure that all hazards associated with research laboratories have been identified, eliminated, and/or controlled in such a manner as to provide for a safe research laboratory environment.
I accept full responsibility for submitting the annual Facility Safety Plan Status Report including significant changes in facility, safety equipment, and safety procedure by one of the following: Facsimile: 301-619-6627, E-mail: cavelle.williams@det.amedd.army.mil, or Mail: Commanding General, U.S. Army Medical Research and Materiel Command, ATTN: MCMR-ZC-SSE, 504 Scott Street, Fort Detrick, MD 21702-5012.
I assure that I have consulted with all current PI’s holding USAMRMC awards concerning this institution’s safety policies and procedures and will consult with all future PI’s holding USAMRMC awards concerning this institution’ s safety policies and procedures.
Use of etiologic agents as defined in 32 CFR 626 □ Yes □ No
“Etiologic agent = a viable microorganism, or its toxin which causes or may cause human disease, and includes those agents listed in 42 CFR 72.3 of the Dept of HHS regulations, AND any material of biological origin that poses a degree of hazard similar to those organisms.
Brian Cumbie _________________________________
Name of Institution's Safety Director/Manager (print)
_____________________________ _________
Signature Date
Mailing Address: 1400 NW 10th Avenue, Room 405
Miami, Florida 33136
Phone Number: 305-243-3400
Fax: 305-243-3272
E-mail Address:
bxc933@miami.edu
