The Drexel University Institutional Biosafety Committee (IBC) provides guidance to all faculty, professional staff and students who wish to conduct research and teaching activities involving biological hazards such as recombinant DNA (as defined by the National Institutes of Health guidelines), pathogenic organisms, human/primate samples, chemical carcinogens and cytotoxic agents. The IBC is responsible for reviewing all proposed projects involving biohazardous materials in order to protect the health and safety of University students, visitors, faculty and professional staff.
The IBC operates in accordance with standards and guidelines from the National Institutes of Health (NIH) and the Centers for Disease Control and Prevention (CDC), as well as regulations established by the Occupational Safety and Health Administration (OSHA). It also conducts operations consistent with city, state and institutional standards and regulations.
Investigators who conduct research involving potential biological risks to University faculty, staff or students are required to submit biosafety protocols to the IBC. For more information on biosafety protocol submission, review, revision, and approval.
The IBC is composed of faculty investigators from Drexel University and the Drexel University College of Medicine who have a wide range of scientific expertise. The Committee also includes two members from agencies and institutions in the local community, the University Biosafety Officer, and a Recombinant DNA Officer. The functions and membership of Institutional Biosafety Committees are specified in Section IV-B-2 [IBC] of the NIH Guidelines maintained by the Office of Biotechnology Activities.
The normally meets on the last Tuesday of each month. The meeting calendar and deadlines for protocol submission and revision are available on the Meeting Deadlines and Calendar [PDF].
The IBC operates in accordance with practices outlined in Institutional Biosafety Committee IBC Policies and Procedures [PDF].
The current co-chairs of the IBC are:
Fred Krebs, Ph.D.
Department of Microbiology and Immunology
Drexel University College of Medicine
Arthur Frank, M.D., Ph.D.
Professor and Chair
Department of Environmental & Occupational Health
Drexel University Dornsife School of Public Health
Investigators who conduct research involving potential biological risks to University faculty, staff, or students are required to submit biosafety protocols to the IBC. Once a protocol has been submitted to the committee, it is pre-reviewed by select members of the committee. Reviewer comments and requests for revision are returned to the investigator with sufficient time to complete the revisions and submit a revised protocol for review at the next IBC meeting. Once a project has been approved, an approval letter is prepared and sent to the investigator. that will include the approval date, protocol expiration date, project title, and IBC protocol number.
Use the following guide to choose the proper forms for completing and submitting your biosafety protocol:
Complete the General Biohazard Form (Form A) [DOCX] for all biosafety protocols.
If your research includes the use of pathogenic organisms or human/primate samples but does not involve recombinant DNA (rDNA), hazardous chemicals, or animals, then this is the only form required to submit your protocol for approval.
Recombinant DNA Registration Addendum (Form B) [DOCX].
For use of chemical carcinogens or cytotoxic agents, also submit a Hazardous Substance Addendum (Form C) [DOCX]
For use of biohazardous agents in animals, submit an Animal Use Addendum (Form D) [DOCX]
Biosafety protocols are reviewed at the monthly IBC meeting. Completed protocols must be submitted in advance of the monthly meeting with sufficient time for pre-review and revision prior to the meeting. For specific deadline and meeting dates, please see the Meeting Deadlines and Calendar page.
To make changes to an approved and active biosafety protocol, complete a Protocol Amendment Form (Form E) [DOCX] for IBC review. This form can be filed with the IBC at any time and be used to:
- provide information on new personnel to be added to the protocol,
- indicate personnel who are no longer involved in the project,
- indicate a change to the project that deviates from the approved protocol, or
- record a change in the location of laboratory facilities.
The IBC approves biosafety protocols for a period of three (3) years. At the end of years 1 and 2 of an active protocol, you will be asked to submit a Periodic Review Form [DOCX], to be reviewed and approved by the IBC. Annual reviews are required to maintain an active protocol.
If you are performing low-risk research that involves the collection of human cells, tissues, or fluids, you will be asked by the Drexel University Institutional Review Board (IRB) to submit a Human Specimens Registration Form (Form F) [DOCX].
Federal Government Resources
The NIH Guidelines provide details regarding "the practices for constructing and handling: (i) recombinant nucleic acid molecules, (ii) synthetic nucleic acid molecules, including those that are chemically or otherwise modified but can base pair with naturally occurring nucleic acid molecules, and (iii) cells, organisms and viruses containing such molecules." The NIH Guidelines are maintained by the Office of Biotechnology Activities at the NIH.
The NIH Guidelines includes details on the classification of human disease-causing agents on the basis of hazard. In this classification system, etiologic agents are assigned to Risk Group 1 (RG1) through RG4 (with RG4 indicating the highest level of risk). A list of agents by Risk Group can be found in Appendix B of the NIH Guidelines.
The Biosafety in Microbiological and Biomedical Laboratories (BMBL), which is published by the CDC, is an essential resource for establishing practices that address the safe use of infectious pathogens and hazardous biological materials in biomedical research. Practices outlined in the BMBL are founded on two basic principles: containment and risk assessment. The BMBL includes practices appropriate for laboratory operations under Biosafety Level 1 (BSL-1) through BSL-4 containment.
The IBC must also consider occupational regulations maintained by the Occupational Safety and Health Administration (OSHA). The OSHA website includes a Laboratory Safety page, which includes information on working with small animals and using biological safety cabinets.
Links on this page point to additional safety resources available online. For links to the Drexel University Laboratory Safety Manual, the NIH Guidelines, the CDC BMBL, and other resources relevant to IBC operation, go to the Safety Manual and Guidelines page.
Links to Other Safety-Related Resources:
||Reviewers' Comments to PI Due Date
||PI's Revised Protocol Submission Deadline
2021 Biosafety Calendar [PDF]
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