Institutional Biosafety Committee
1.
Responsibilities
The Fox Chase Cancer Center (FCCC), hereafter referred to as the “Center”, has an established Institutional
Biological Safety Committee (IBC). The National Institutes of Health (NIH) sets requirements for
research and clinical trials utilizing recombinant DNA and recombinant RNA. Listed below are the
responsibilities of the Institutional Biosafety Committee (IBC), biological safety officer, Safety
Office, principal investigators, clinical supervisor, lab staff, and public staff members as required by
NIH. These groups and individuals work together to ensure that the Center maintains a safe research
working environment when recombinant DNA (rDNA) materials, infectious agents, potentially
hazardous agents (e.g., carcinogens, highly toxic materials, and pathogens are handled in laboratory
activities.
The primary document used by the IBC to review recombinant DNA projects at the Center is the NIH
Guidelines, “The Guidelines for Research Involving Recombinant DNA Molecules.” The NIH
Guidelines are available on the Internet at:
http://www4.od.nih.gov/oba/rac/guidelines/guidelines.html
Laboratory and animal biosafety practices, facilities, and controls are described in the current edition
of CDC/NIH Biosafety in Microbiological and Biomedical Laboratories (BMBL). The Center
researchers should use the BMBL and the NIH Guidelines to determine proper controls for infectious
material and recombinant DNA use.
NIH grants may be suspended or terminated by the NIH if the Center does not adhere to the NIH
Guidelines.
2. Institutional Biosafety Committee (IBC)
The Center’s IBC is registered with NIH to review and approve the use of recombinant DNA (rDNA)
and RNA. Certain experimental protocols (e.g., human gene transfer) may also require prior approval
by NIH's Recombinant DNA Advisory Committee (RAC). The IBC:
1. Oversees the biosafety program;
2. Meets quarterly to review research involving recombinant DNA, biological hazardous
materials, carcinogenic, pathogenic, toxic, etiologic and/or infectious agents;
3. Retain the Center’s IBC Registration for Recombinant DNA, Pathogens, Toxins, and/or
Etiologic Agents Experiments;
4. Reviews and requires approval of BSL-2 or higher work based on the Principle Investigator’s
(PI) submitted IBC Registration form.
5. Reviews and requires approval of clinical trials involving rDNA use in humans at the Center.
Fox Chase Cancer Center
Institutional Biosafety Committee
6. Annually reviews and approves the Laboratory Bloodborne Pathogen Exposure Control Plan;
7. Reviews and approve BSL-2/3 or above risk-specific manuals; and
8. Initiates investigations into noncompliance.
3. Biosafety Officer
1. Provides consultation and technical information to Center researchers on the handling of
recombinant DNA, biological hazardous, carcinogenic, pathogenic, toxic or etiologic agents;
2. Reviews and approves amendments to PI submitted IBC Registration form(s) for changes,
e.g., staff changes and summarizes for IBC;
3. Provides advice to principal investigators, clinical supervisors, and the IBC on lab security
and biological safety; and
4. Reports all significant violations of the NIH Guidelines, Bloodborne Pathogen Standard
and/or the Center’s Laboratory Safety Guidelines to the IBC.
4. Center’s Safety Office
1. Provides the administrative support for the biosafety committee and program with the
guidance of the IBC chairman;
2. Conducts annual laboratory safety audits for all Biosafety level work areas and summarizes
for IBC;
3. Reports all biological hazard exposure-related accidents and illnesses to the IBC;
4. Maintains the Center’s Safety Manual with respect to biological safety;
5. Oversees the annual certification of biosafety cabinets;
6. Manages the testing and certification of newly installed, moved or repaired biosafety cabinets;
7. Recommends purchases of biosafety cabinets and other related safety equipment;
8. Coordinates decontamination service for facilities and equipment when needed.
The Safety Office provides information for bloodborne pathogens for new laboratory staff prior to
them beginning to work with blood or body fluids, and then annually thereafter. Principal
investigators and clinical supervisors are responsible for providing training specific to the procedures
and potential hazards in their areas of responsibility.
A postdoctoral fellow or staff scientist who works under his or her own grant in a lab of an authorized
principal investigator must be included on that PI's IBC Registration form.
5. Principal Investigator (PI)
1. Principle Investigators are responsible for submitting an IBC Registration Form to the IBC
Committee, when working with recombinant DNA, (rDNA), infectious agents, pathogens and
potentially hazardous materials (e.g., carcinogens, highly toxic materials, (BSL-2 or higher) is
performed in laboratory.
2. Advises the IBC and Safety Office through amendments to their submitted IBC Registration
form of any significant changes in protocol for the use of biological hazards, location of
projects, and changes in staff;
3. Ensures research staff and support personnel are properly trained and their training is
documented for the specific procedures and potential hazards of their labs.
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Fox Chase Cancer Center
Institutional Biosafety Committee
4. Establish policies for access to their laboratory spaces such that only persons who have been
advised of the potential hazards and meet specific entry requirements (e.g., immunization)
may enter;
5. Ensures that research staff with potential exposure to pathogens (bloodborne) complete any
required annual training.
6. Enforces the Center's standards and policies regarding safety.
7. Report any adverse reaction to human gene transfer, if registered with the IBC.
8. Inspects the lab periodically to ensure that safety practices are being followed;
9. Encourages staff to report any changes in their health status which may be related to handling
infectious agents.
10. Report all significant violations of the NIH Guidelines and all research-related accidents and
illnesses to the BSO;
11. Complies with packaging and training requirements for the transportation of infectious
materials (BSO provides support and information for the shipping of infectious materials).
6. Laboratory Staff
1.
2.
3.
4.
Complete all required safety training;
Observe established guidelines and policies for biological safety as required;
Inform the immediate supervisor of any unsafe practices or conditions in the work area;
Report all significant violations of the NIH Guidelines and all research-related accidents and
illnesses to the BSO;
5. Report any change in health status to the supervisor if there is a possibility it may be workrelated;
6. Report spills and incidents involving infectious material to the supervisor; and
7. Contact Safety Office in the event of a large spill of infectious materials (>200 mL).
7. New Staff Members
1. Workers new to the Center are not authorized to work with infectious agents or recombinant
DNA until their PIs provides them the appropriate train in biological safety.
2. Report all significant violations of the NIH Guidelines and all research-related accidents and
illnesses to the BSO;
3. New workers are not authorized to handle blood or body fluids until they have completed
training in working with bloodborne pathogens.
Approvals
Institutional Biosafety
Committee:
Signature
Date:
Administrative:
File: M:\My Documents\IBC\Charter Info, 08-07 Institutional Biosafety Committee Charter.
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