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Institutional Biosafety Committee


The Institutional Biosafety Committee reviews registrations for Recombinant or Synthetic Nucleic Acid Molecules, Pathogens, potential Infectious Agents, Biological Toxins, and Human Clinical Trials that involve the use of these materials as mandated by the National Institutes of Health and/or Johns Hopkins Institutions Policies. The full IBC meets monthly for discussion and voting. A subgroup of the IBC meets one week prior to the full meeting to triage protocols for missing information necessary for full IBC review.

Registrations that require IBC review are assembled into packets at the end of each month and delivered to the IBC members the following week. The IBC triage meeting is normally scheduled for the second Tuesday of every month. The full IBC meeting is normally scheduled for the third Monday of every month.


Investigators at JHU who use or possess Recombinant or Synthetic Nucleic Acid Materials, Potential Infectious Agents/Pathogens, Biological Toxins, and/or Human-derived tissues and/or body fluids are responsible for registering these research materials with the Biosafety Office and describing the research programs and procedures in which they will be used. This rule applies to all independent investigators. Collaborators may not "piggy-back" on each other's registrations. Postdoctoral or Clinical fellows, graduate or undergraduate students, and research associates are covered by the registrations of their Principal Investigator.

The Principal Investigator is ultimately responsible for the registration, training, and safe handling of research materials handled by their personnel.


  • Registrations arrive in the Biosafety Office by campus mail, US mail, FAX, or hand delivery. Incoming Registrations are screened by the Biosafety Office to determine:

    1. Has the registration been completed correctly?
    2. Is the registration signed?
    3. Does the registration indicate the use of agents that have not been registered by the PI? For example, propagation of adenoviral vectors is frequently done with HEK293 cells, a human cell line. Thus, any investigator that registers adenoviral vectors is checked for human tissue registration. If none is noted, the investigator is queried as to whether human cells will, indeed, be utilized. Likewise, Recombinant or Synthetic Nucleic Acid Molecules Registrations that indicate transduction of cells are cross-checked for registered viral vectors and the investigator queried if none are found.

    Once a registration is determined to be complete, the registration is coded for entry into the database and a letter is sent to the investigator indicating the status of the registration. The following code letters precede the registration numbers transmitted to investigators:

    • DE - Recombinant or Synthetic Nucleic Acid Molecules Registration exempt from formal IBC review as defined in section III-E of the NIH Guidelines                                                  
    • DN - Recombinant or Synthetic Nucleic Acid Molecules Registration subject to formal IBC review
    • P - Infectious Agent/Pathogen registration. All are reviewed by the IBC.
    • T - Toxin registration. All are reviewed by the IBC.
    • GT - Clinical Research involving Gene Therapy, the introduction of Recombinant or Synthetic Nucleic Acid Molecules, potential Infectious Agents/Pathogens, or Biological Toxins into human subjects. All are reviewed by the IBC.
    • BC - Human tissue registration for clinical studies. Reviewed by the Biosafety Office.
    • B - Human tissue registration for laboratory-based studies. Reviewed by the Biosafety Office.
  • Submissions for IBC review should be mailed, faxed or otherwise delivered to the Biosafety Office at the following address:

    Institutional Biosafety Committee
    Biosafety Office/HSE
    2024 East Monument Street, Room B-200
    Baltimore, MD 21287

    Fax: 410-955-5929

    Because of the nature of the submission, the IBC requires the investigator to submit 14 copies of any study involving human subjects that requires IBC review and approval.

  • Johns Hopkins Bloodborne Pathogen Module - links to the Johns Hopkins Bloodborne Pathogens Online Training Module. This course is intended for those individuals who can not attend the instructor-led course offered quarterly by HSE.

Registration Descriptions

Descriptions for the various registrations required by the IBC and/or Biosafety Office are listed below. Download forms for these registrations.

  • All research involving Recombinant or Synthetic Nucleic Acid Molecules (naturally-derived or synthesized DNA or RNA) on campus must be accompanied by a valid Recombinant or Synthetic Nucleic Acid Molecules Registration. This is an NIH Requirement. An investigator does not need to file a separate registration for every project performed or funded in the laboratory if the projects involve similar recombinant or synthetic nucleic acid molecule activities. Clearly distinct projects such as "expression of signal transduction molecules in cell lines to assay function" and "expression of modified viral stocks to assay modes of infection" would require separate registrations. Be advised, however, that the NIH expects the investigator to identify the genetic elements or nucleic acid molecules that will be inserted into a given vector or host and to report the identity of constructs designed to replicate or express recombinant protein.  Recombinant or Synthetic Nucleic acid Molecules that can be used to express a biological toxin must also be registered for that toxin (see below).  Experiments involving Recombinant or Synthetic Nucleic Acid Molecules that are not exempt as defined in the NIH Guidelines are submitted to the Institutional Biosafety Committee (IBC) for review and assignment of Biosafety Containment Levels (BSL levels). IBC approval must be received prior to the commencement of the research project.

  • All Infectious Agents and Pathogens on campus must be registered through the Biosafety Office. Organisms listed as Select Agents may require additional effort (see Select Agent Policy, HSE 505 for details) This is a JHI Policy requirement. Each pathogen should be registered on a separate form. The only pathogens that can be combined on a single form are "like agents". For example, an investigator wishing to study Methicillin-resistant Staphylococcus may register this strain and a control strain of Staphylococcus on one registration. Likewise, someone wishing to register multiple forms of lentiviral vectors may register all on a single form. One may not, however, register lentiviral vectors and adenoviral vectors on the same form. All Infectious Agent/Pathogen registrations are reviewed by the IBC for the use of appropriate safety procedures and facilities. IBC approval and designation of appropriate BSL levels is necessary before commencement of the research project.

  • All Biological Toxins, organisms that generate Biological Toxins, and recombinant or synthetic nucleic acid molecules that can be used to express Biological Toxins must be registered through the Biosafety Office. Registration of Select Agent Toxins is mandatory and may require additional effort including CDC notification (see Select Agent Policy, HSE 505 for details). All Biological Toxin registrations are reviewed by the IBC and approval is necessary before commencement of the research project.

  • Human Subjects Research Involving the Introduction of Recombinant or Synthetic Nucleic Acid Molecules, Potential Infectious Agents or Pathogens, or Biological Toxins in Human Subjects

    Investigators who wish to introduce recombinant or synthetic nucleic acid molecules, potential infectious agents or pathogens, or biological toxins into human subjects must receive IBC approval in addition to IRB approval. The IBC evaluates the protocol for patient, staff, and environmental safety issues in their review. The following documents are required by the IBC for review of a Human Subject protocol:

    1. Recombinant or Synthetic Nucleic Acid Molecules registration form, if applicable.
    2. Infectious Agent/Pathogen registration form, if applicable.
    3. Biological Toxin registration form, if applicable
    4. Human tissue registration form.
    5. Investigator's brochure (usually the same one submitted to the IRB)
    6. Sponsor's Protocol
    7. Appendix M, if applicable, with Hopkins-specific responses. Please note that many studies include an Appendix M written by the sponsoring company for a PI at some other institution. The answers provided (who is doing the work, where will it be done, how many patients, etc.) may or may not reflect what will be done here at JHMI. In these cases, the IBC requests that the investigator provide answers to the Appendix M questions that specifically address the Hopkins component(s) of the project.
    8. Any RAC communications/approvals
    9. Any FDA communications/approvals
    10. IRB comments/approvals

    See Links section above for further information from the BSPH, JHMI, and Homewood IRB websites regarding research involving human subjects.

  • OSHA requires bloodborne pathogen training for all individuals who may come in contact with human blood, bloodborne pathogens, and other potentially infectious materials (29CFR part 1910.1030). Other potentially infectious materials are defined by OSHA as:

    1. The following human body fluids:
      semen, vaginal secretions, cerebrospinal fluid, synovial fluid, pleural fluid, pericardial fluid, peritoneal fluid, amniotic fluid, saliva in dental procedures, any body fluid that is visibly contaminated with blood, and all body fluids in situations where it is difficult or impossible to differentiate between body fluids.
    2. Any unfixed tissue or organ (other than intact skin) from a human (living or dead).
    3. HIV-containing cell or tissue cultures, organ cultures, and HIV- or HBV-containing culture medium or other solutions; and blood, organs, or other tissues from experimental animals infected with HIV or HBV.

    Human Tissue Registrations are reviewed upon receipt by Biosafety Office personnel. Investigators should expect to receive written confirmation of human tissue registration within a week of document delivery to the Biosafety Office.

  • Human tissues and body fluids in the clinical setting are handled under "Universal Precautions" or "Standard Precautions". These definitions do not neatly fit into the common biosafety containment levels of laboratory-based research. For this reason, clinical human tissue registrations are handled as a separate category. A clinical researcher only needs to possess one clinical research registration. There is no need to complete a registration for every clinical study as long as the list of personnel on the registration who may come in contact with the human tissues is inclusive for all studies.

    Since Question 8 of the Human Tissue Registration Form deals specifically with personnel, it is important that this section is filled out completely and accurately. The PI's name should always be listed. Then, if the blood draw/sample acquisition is done by the GCRC or Express Testing, or the nursing staff on CMSC 9 (for example) the PI can enter this on the next line of question 8. If the PI has an assistant or assistants who will handle or ship the tissue, these names should be listed in question 8 along with any additional investigators who may come in contact with the human tissue. Since human samples in clinical research are derived in standardized manners (blood draws, tissue samples, etc.), Clinical investigators do not need to complete question 9a-f of the form.

  • Human tissues (including human-derived cell lines) and human body fluids used in the laboratory setting are handled with BSL2 containment practices which include the use of a biosafety cabinet (or other approved containment procedures) for manipulation of the material.  An investigator only needs to have one human tissue registration for laboratory-based research. Investigators who maintain research laboratories and also oversee clinical studies should maintain a clinical-focus and a laboratory-focus registration given the differences between BSL2 and universal or standard precautions. Since research laboratory practices are not standardized and prone to creative influence, laboratory-focus human tissue registrations must include answers to question 9a-f.

Committee Members and Contact Info

  • The following roster of IBC members is current as of January 1, 2016:

    Gary S. Hayward, Ph.D., CHAIR IBC
    Professor, Department of Oncology
    Molecular Virology Laboratories
    Johns Hopkins School of Medicine

    Robert J. Adams, D.V.M.
    Associate Professor, Comparative Medicine
    Clinical Director, Animal Resources
    Johns Hopkins School of Medicine

    Barbara Biedrzycki, Ph.D., M.S.N., A.O.C.N., C.R.N.P.
    Nurse Practitioner/Clinical Research Associate
    Department of Oncology - Immunology Program
    Johns Hopkins School of Medicine

    Stephen C. Dahl, Ph.D., RBP
    Director, Biological Safety
    Biosafety Officer
    Johns Hopkins Institutions

    Dr. Brigitte Gaume, Ph.D.
    Non-affiliated Member

    Elizabeth A. Laffan, Ph.D.
    Non-affiliated Member

    M. Victor Lemas, Ph.D.
    Laboratory Director, Cell Therapy Core and
    Cell Processing and Gene Therapy Core
    Department of Oncology
    Johns Hopkins School of Medicine

    Claudia MacAuley, L.A.T.
    Non-affiliated Member
    Biosafety Officer, Laboratory of Molecular Neurovirology
    Veterans Administration Medical Center, Baltimore, MD

    Joseph Margolick, M.D.
    Professor, Department of Molecular Microbiology & Immunology
    Bloomberg School of Public Health

    Douglas Norris, Ph.D.
    Assistant Professor, Department of Molecular Microbiology & Immunology
    Bloomberg School of Public Health

    Weiying Pan, Ph.D.
    Associate Biosafety Officer
    Johns Hopkins Institutions

    Alan F. Scott, Ph.D.
    Associate Professor, Institute of Genetic Medicine
    Director, Genetic Resources Core Facility
    Johns Hopkins School of Medicine 

  • The Johns Hopkins Institutional Biosafety Committee is managed through the Biosafety Office which is located in room B-200 (basement) of the 2024 East Monument Street Building.

    Questions regarding the day to day operations of the IBC should be directed to the IBC Coordinator, Ms. Tylicia McRae.

    Institutional Biosafety Committee
    Biosafety Office/HSE
    Johns Hopkins Institutions
    2024 East Monument Street, Room B-200
    Baltimore, MD 21287

    Office: 410-955-5918
    Fax: 410-955-5929

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