Biosafety

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, 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, please contact the IBC via email at biosafety@drexel.edu.

IBC Functions & Membership

The Institutional Biosafety Committee (IBC) is composed of faculty investigators from Drexel University who have a wide range of scientific expertise. The IBC also includes the University Biosafety Officer (BSO) and two members from agencies and institutions within the local community. The functions and membership of Institutional Biosafety Committees are specified in the NIH Guidelines [HTML] and NIH Guidelines [PDF] maintained by the Office of Science Policy (OSP).

The IBC meets on the last Tuesday of each month. To accommodate the University closing for winter break, the December meeting occurs on the third Tuesday of the 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.
Associate Professor
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

Submitting a Biosafety Protocol

Investigators who conduct research involving potential biological risks to University faculty, staff, or students are required to submit biosafety protocols to the Institutional Biosafety Committee (IBC). Once a protocol has been submitted to the committee, it is pre-reviewed by a subcommittee of the IBC. 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. The approval letter will include the approval date, protocol expiration date, project title, and IBC protocol number.

Biosafety Protocols:

Use the following guide to choose the proper forms for completing and submitting your biosafety protocol:

Form A: General Biohazard Form [DOCX]

• Complete this form 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.

Form B: Recombinant DNA Registration Addendum [DOCX]

• Complete for the use of:
  • Recombinant DNA or synthetic nucleic acid molecules, including those that are chemically or otherwise modified but can base pair with naturally occurring nucleic acid molecules
  • cells, organisms, and viruses containing such molecules
  • research involving gene drive modified organisms (GDMOs)

Form C: Hazardous Substance Addendum [DOCX]

• Complete for each chemical carcinogens, cytotoxic agents, mutagens, acute toxins, or teratogens used.

Form D: Animal Use Addendum [DOCX]

• Complete for each biohazardous agent used in animals.

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.

Amendments:

Form E: Protocol Amendment Form [DOCX]

• Complete to make changes to an approved and active biosafety protocol for IBC review. This form can 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.
• Amendments involving changes to procedure, use of new biohazards, changes in animal model, etc., will be reviewed by the full committee at the next meeting. For specific deadline and meeting dates, please see the Meeting Deadlines and Calendar.
• Addition/removal of personnel (except for change in PI see Form G [DOCX]) and other administrative changes may be approved by the Biosafety Committee Coordinator.
• Change in location may be approved by the Biosafety Committee Coordinator upon consulting with the Biosafety Officer.

Form G: Change in PI Amendment Form [DOCX]

• Complete to request a Change in Principal Investigator (PI).
• Signatures from the departing and incoming PI are required.
• An amendment involving changes to PI will be reviewed by the full committee at the next meeting. For specific deadline and meeting dates, please see the Meeting Deadlines and Calendar page.

Low Risk Research Involving Human Specimen Collection:

Form F: Low Risk Human Specimens Review Form [DOCX]

• Complete if you are performing low-risk research that involves the collection of human cells, tissues, fluids, or other patient-derived samples.

Human Specimen Collection IBC Checklist [DOCX]

• The Human Specimen Collection IBC Checklist can be used to help determine what type of IBC review is required and what forms need to be completed.

Biosafety Resources

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." As of April 2024, this also includes research involving gene drive modified organisms (GDMOs). The NIH Guidelines are maintained by the Office of Science Policy (OSP) at the NIH.

The NIH Guidelines includes details on the classification of human disease-causing agents based on 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 (alternatively, locate Appendix B on page 39 in the PDF version of the NIH Guidelines).

The Biosafety in Microbiological and Biomedical Laboratories (6th Edition) [PDF], 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 to Other Safety-Related Resources:

• Pathogen Safety Data Sheets and Risk Assessment - Pathogen Safety Data Sheets (PSDS) maintained by the Public Health Agency of Canada
• WHO Laboratory Biosafety Manual – Laboratory biosafety guidelines published by the World Health Organization (WHO)
• American Biological Safety Administration Risk Group Database App for iPhone
• American Biological Safety Administration Risk Group Database App for Android
• WHO Biosafety Risk Assessment Tool for iPhone
• WHO Biosafety Risk Assessment Tool for Android

2024 Biosafety Calendar [PDF]