Parent Page: Committees id: 30877 Active Page: IBC Policies and Proceduresid:33114

IBC Policies and Procedures

The OU Institutional Biosafety Committee (IBC) is responsible forreviewing and approving the biological safety of all basic and clinical research activities at OUHSC, OU-Tulsa, and OU-Norman involving recombinant and synthetic nucleic acid molecules, gene transfer (including transfer to humans), the generation of transgenic animals, microorganisms, viruses, and biological toxins. Recombinant and synthetic nucleic acid molecules include those constructed by joining nucleic acid molecules, those synthesized or amplified chemically, and molecules resulting from their replication. Some synthetic nucleic acids are exempt from NIH guidelines if they cannot replicate, are not designed to integrate into DNA, and do not produce lethal toxins. Detailed IBC policies and procedures can be accessed here: IBC POLICIES AND PROCEDURE

Categories of Biohazardous Material Needing IBC Review and Approval

  • Recombinant or Synthetic Nucleic Acid Molecules
  • Biohazardous Agents Infectious Agents towards Humans
  • Animal and Plants
  • Toxin
  • Recombinant DNA involved in Human


Prior to the commencement of any project involving the use of such material, the Principal Investigator (PI) must perform the following steps:

  1. Review the applicable guidelines and regulations and become familiar with the biological safety procedures and requirements. These guidelines and regulations include:
  2. Perform a risk assessment of the agents and procedures to determine potential safety and environmental hazards. See CDC guidance on performing the risk assessment at
  3. Develop laboratory specific Standard Operating Procedures (SOPs) based on the risk assessment, guidelines and regulations
  4. Complete and submit the appropriate form(s):
    • New Protocol For new grants/contracts/projects involving the use of recombinant or synthetic nucleic acid molecules, non-human gene therapy, microorganisms, and/or biological toxins; for grants/contracts involving the transfer of recombinant or synthetic DNA molecules, or DNA or RNA derived from recombinant or synthetic nucleic acid molecules, into one or more human research participant, the administration of microorganism/virus administration or toxin administration to humans; and for grants/contracts/projects involving the generation of animals in which the animal's genome will be altered by stable introduction of recombinant DNA, or DNA derived therefrom, into the germ-line or modified to eliminate specific gene(s) (transgenic/knockout animals) where such animals are created in an OUHSC facility, the IBC Biosafety Protocol Form should be completed and submitted. This IBC Biosafety Protocol Form is also required for the mating of two transgenic lines to create a double transgenic. This form is not required for the purchase and/or use of transgenic vertebrate animals when these animals are obtained from a source outside OUHSC/OU-Tulsa. The PI on the grant must provide the electronic signature on the form.
    • Amendments  If the original protocol was submitted and approved in TOPAZ Enterprise with the last three years, amendments are limited to administrative changes only, e.g. protocol associates, funding agency.  Please contact the IBC office at in order to have a limited transfer of your protocol transferred from Enterprise.  The transferred protocol will include administration and a copy of your protocol in PDF form.  Other amendments including new procedures will need to be addressed by submission of a new protocol.
  5. Submit a current inventory of organisms/viruses classified as BSL2 and above and biological toxins with an LD50 <100 ug/kg (even if no such materials are under the PI's control) at and update this inventory at least annually.
  6. Report any significant problems, violations of the NIH Guidelines, or any significant research-related accidents and illnesses to the IBC through the Biological Safety Officer immediately. Examples of situations that need to be reported include any spills or accidents in BL2 laboratories resulting in an overt exposure, spills of high-risk recombinant materials occurring outside of a biosafety cabinet, spills or accidents occurring in BL3 laboratories resulting in an overt or potential exposure, skin punctures with needles containing recombinant DNA, and the escape or improper disposition of a transgenic animal.
  7. Be adequately trained in good microbiological techniques.
  8. Adhere to Institutional Biosafety Committee approved emergency plans for handling accidental spills and personnel contamination.
  9. Comply with shipping requirements for recombinant or synthetic nucleic acid molecules (contact the Biological Safety Officer for information on these requirements).

IBC approval is not grant-specific and there is no need to submit multiple protocols for different funding sources if the same methodologies are used.  IBC approval is for 3 years regardless of the funding period.  A new protocol must be submitted every three years.  Minor modifications to approved protocols, such as NIH becoming a funding source, protocol associates, or project location, may be submitted with the Protocol Amendment form as long as the modification is described and appropriate changes to SOPs are also submitted. If a change occurs in any other item(s), such as gene, vector, organism, virus or toxin used; Biosafety level; NIH classification; or any substantive change to the procedures or SOPs to be used, a completed IBC Biosafety Form must be submitted.


The NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines) requires OUHSC to provide appropriate training for Principal Investigators (PIs) and laboratory staff regarding laboratory biosafety and implementation of the NIH Guidelines. Moreover, the Centers for Disease Control and Prevention (CDC) require training for persons working with infectious materials and toxins. IBC training is found on OnPoint and you must be assigned the training in order to complete it.  Please contact your supervisor and/or payroll coordinator if you have not been assigned this training.

The IBC will require that all personnel identified on any submitted IBC protocol be current for biosafety training and will hold those IBC protocols until such time as the identified personnel become current. All personnel listed on the protocol must complete the the biosafety training.

In addition to this general biosafety training, the NIH requires training on the hazards and safety procedures specific to the project. The IBC requires that the project-specific training for any work performed at biosafety level 2 (BSL2) or above and all toxin work be provided by the PI to all personnel participating in the project. 

The IBC, through the Biological Safety Officer (BSO), will verify that laboratory facilities to be used in a proposed protocol are sufficient before the protocol is approved. The laboratory will be surveyed periodically by the BSO/Environmental Health and Safety Office to verify continued compliance with safety requirements and sufficient and appropriate laboratory facilities are used. In addition, the BSO reviews renovation and construction plans for laboratory facilities on behalf of the IBC. Any concerns that cannot be resolved are forwarded to the full Committee.

Other Policies

Beginning February 1, 2014, the IBC will provide oversight of the BSL3 Facility located in the BRC North building. This will include making sure that the policies and procedures for this facility are implemented by the BSL3 Facility Manager, revising policies and procedures as necessary, mediating any issues between users of the facility and the Facility Manager, and recommending sanctions for users not following policies and procedures to the Vice President of Research.

IBC meeting dates are found at IBC meetings are open to the public when possible and consistent with protection of privacy and proprietary interests. For information regarding meeting times and locations, contact the If public comments are made on IBC actions, the IBC Chair will forward both the public comments and IBC’s response to NIH Office of Biotechnology Activities.

All requests made by the public regarding the IBC will be handled by or coordinated with the Open Records Officer or Office of Legal Counsel. When processing such requests, the University reserves the right to redact minutes or other IBC documents that will be made available to the public. Information that might be redacted includes but is not limited to: private information (names, addresses, telephone numbers, e-mail addresses), proprietary information, trade secrets, names of investigators, names of individual reviewers, location of biohazardous agents, and any information that might compromise institutional or national security. The full policy for redaction of minutes may be found here.

The IBC Conflict of Interest policy may be found here.

Questions about the process for review, safety issues, or Topaz, please contact

Scientific questions or questions about the IBC Committee should be directed to IBC@ouhsc.eduArto-Baghdayan or  Ralf Janknecht, Ph.D., IBC Chair


  1. What is the purpose of the IBC protocols (SOP)? 

The IBC protocol aims to outline the administrative actions taken by the University of Oklahoma Health Sciences Center to ensure a safe, healthy, and secure environment for individuals involved in microbiological and biomedical laboratories. 

  1. What documents does OU comply with regarding biosafety practices? 

OU complies with the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules, Biosafety in Microbiological and Biomedical Laboratories (BMBL 6th edition), and the Occupational Safety and Health Administration (OSHA) Bloodborne Pathogen Standard. 

  1. What is the role of the Institutional Biosafety Committee (IBC)? 

The IBC serves as the cornerstone of institutional oversight, ensuring safety and compliance with guidelines for research involving recombinant or synthetic nucleic acid molecules, microorganisms, viruses, and biological toxins. 

  1. How is the IBC structured and what authority does it have? 

The IBC must have at least five members with expertise in relevant fields. It has the authority to approve, modify, disapprove, suspend, or terminate research activities to ensure compliance with guidelines and regulations. 

  1. What types of reviews does the IBC conduct? 

The IBC conducts reviews such as Chair Review, Designated Committee Review, and Full Committee Review based on the nature and biohazard level of the research protocols. 

  1. What are the responsibilities of the Principal Investigator (PI)? 

The PI is responsible for risk assessment, developing Standard Operating Procedures (SOPs), submitting protocols for IBC review, supervising safety practices, and reporting any issues or accidents related to the research. 

  1. How often does the IBC meet, and what is the quorum requirement? 

The frequency of IBC meetings depends on the volume of protocols. A quorum, defined as more than half the regular voting members, is required for official IBC business. 

  1. What types of experiments require IBC approval? 

Experiments involving risk Group 2, 3, 4 agents, cloning DNA from these agents, using infectious DNA or RNA viruses, and other specified activities require IBC approval before initiation. 

  1. How does the PI ensure compliance with biosafety guidelines? 

The PI must complete biosafety training, adhere to IBC-approved emergency plans, and comply with shipping requirements for recombinant or synthetic nucleic acid molecules. 

  1. What is the process for IBC protocol renewal? 

Protocols are subject to renewal every three years. PIs are notified 90, 60, and 30 days prior to expiration, and it is their responsibility to ensure protocols are current. 

  1. How are conflicts of interest handled in the IBC? 

Any IBC member with a conflict of interest regarding a research project must recuse themselves from voting on that project. 

  1. What is the role of the Biosafety Officer (BSO) in the IBC? 

The BSO is responsible for periodic inspections, reporting problems or violations, developing emergency plans, providing technical advice, and ensuring laboratory standards are followed. 

  1. What authority does the IBC have in overseeing research involving recombinant or synthetic nucleic acid molecules? 

The IBC has the authority to approve, require modification, disapprove, suspend, or terminate research activities to ensure compliance with NIH Guidelines. 

  1. How often does the IBC meet, and what is the quorum requirement? 

The IBC meets monthly as needed, and a quorum is defined as more than half the regular voting members present. 

  1. What experiments covered by the NIH Guidelines require IBC approval before initiation? 

Experiments involving risk Group 2, & 3 agents as host-vector systems, cloning DNA from these agents, use of infectious DNA or RNA virus, whole animals and plants require prior IBC approval.