Institutional Biosafety Committee (IBC) Policies

The OUHSC Institutional Biosafety Committee (IBC) has the charge of reviewing and approving the biological safety of all OUHSC and OU-Tulsa basic and clinical research activities involving recombinant DNA, gene transfer including transfer to humans, microorganisms, viruses, and biological toxins. 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 bioloigcal safety procedures and requirements. These guidelines and regulations include:

• the National Institutes of Health (NIH) Guidelines for Research Involving Recombinant DNA Molecules (full text) (summary)

• the Centers for Disease Control and Prevention (CDC) and National Institutes of Health (NIH) publication entitled Biosafety in Microbiological and Biomedical Labs (full text) (summary)

• the CDC/United States Department of Agriculture (USDA) Select Agent Program (information and forms);

• 32 CFR Part 626 Biological Defense Safety Program and 32 CFR Part 627 Biological Defense Safety Program, Technical Safety Requirements (DA Pamphlet 385-69);

• the Occupational Safety and Health Administration (OSHA) Bloodborne Pathogen Standard (full text) (summary); and

• the Occupational Safety and Health Administration (OSHA) Occupational Exposure to Hazardous Chemicals in Laboratories Standard (full text) (summary).

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 http://www.cdc.gov/od/ohs/biosfty/bmbl5/Biological%20Risk%20Assessment%20Section%202_%20Final%20Document.pdf.

3. Develop laboratory specific standard operating procedures based on the risk assessment, guidelines and regulations. Help is available for BSL-2 microorganism/viruses,  animal work involving BSL-2 microorganisms/viruses, biological toxins, and select agents.

4. Complete and sign the appropriate form(s):

   • IBC Protocol Review/Approval Form - for grants/contracts involving the use of recombinant DNA, non-human gene therapy, microorganisms, and/or biological toxins, including those considered by the CDC and/or USDA to be "select agents."

   • IBC Human Protocol Approval Form: Gene Transfer, Microorganism Administration/Virus/Toxin Administration  - for grants/contracts involving the administration of recombinant DNA, microorganism/virus administration or toxin administration to humans.

   • Form for Resubmission of an IBC Approved Project or its Submission to a Different Funding Source - if the grant is a resubmission to the same or an alternate funding source and the previously approved protocol remains unchanged, this shortened form should be submitted. Minor modifications to approved protocols may also be submitted on the Resubmission form including project location changes, so long as the modification is described and appropriate changes to Standard Operating Procedures (SOPs) are included. If changes in any other item(s) occurs, such as organisms used, biosafety level or NIH classification, a completed IBC Protocol Review/Approval Form must be submitted. The IBC has established a policy that resubmission forms may only be used if the original protocol has been approved within the last three years.  If the original approval is older than three years, a new full protocol approval form must be submitted.

   • Transgenic/Knockout Vertibrate Animal Submission Form - this form is for grants/contracts 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. This 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.

   • Adverse Biosafety Event Report Form - adverse events, significant problems, violations of the NIH Guidelines, or any significant research-related accidents and illnesses must be reported to the IBC with this form.

   Effective April 23, 2004, the IBC will require that PIs use current forms. It is the responsibility of the PI to ensure that he/she is using the most current version of the form. In addition, ALL pages of these forms should be submitted, even if there is no information entered on them.

5. Submit the signed form(s) to the IBC Office, BMSB 207.  Investigators may be contacted by the IBC for additional information or clarification regarding the research project.  Once approved, the Principal Investigator will receive a letter from the IBC Office indicating approval and an IBC approval number.

The NIH Guidelines for Research Involving Recombinant DNA 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.  Until a separate IBC training module is developed, the IBC biosafety training may currently be accessed at https://www.ouhsc.edu/ehso/training/new_logon.asp as part of the EHSO on-line Laboratory Safety course, completion of which is already required annually under OUHSC policy.

When a laboratory submits a protocol through the IBC, the laboratory will be surveyed periodically by the Environmental Health and Safety Office to verify continued compliance with safety requirements.

ADDITIONAL REQUIREMENTS FOR HUMAN PROTOCOLS

All Consent Forms for clinical protocols involving gene transfer or the administration of microorganisms, viruses or biological toxins to humans must be reviewed and approved by the IBC. Any changes to approved Consent Forms must also be reviewed and approved by the IBC.

For protocols involving the transfer of recombinant DNA Molecules into one or more human research participant, the NIH Guidelines for Recombinant DNA Molecules have significant reporting requirements subsequent to the approval process. Appendix M-I-C of the Guidelines (found at http://www4.od.nih.gov/oba/rac/guidelines_02/Appendix_M.htm#_Toc7255842) detail these reports as follows:

• Under Appendix M-I-C-1, NIH must be notified no later than 20 working days after enrollment of the first research participant.
• Under Appendix M-I-C-2, NIH must be notified to identify OUHSC or OU-Tulsa as an additional clinical trial site.
• Under Appendix M-I-C-3, NIH must receive annual reports.
• Under Appendix M-I-C-4, NIH must be notified of any serious adverse event that is both unexpected and associated with the use of the gene transfer product (i.e., there is reasonable possibility that the event may have been caused by the use of the product

It is the PI's responsibility to ensure that these reporting requirements are met and that the OUHSC IBC receives copies of all correspondence and reports in a timely manner. A PI may delegate these reporting responsibilities to the corporate sponsor. However, written notification must be transmitted to the NIH OBA of the delegation and of the name(s), address, telephone and fax numbers of the corporate sponsor's contact person(s), copy the OUHSC IBC, and ensure that the OUHSC IBC receives copies of all such sponsor's reports in a timely manner.

Questions about the process for review should be directed to Marty Rose at BMSB 207, 405/271-7381. 
Scientific questions or questions about the IBC should be directed to Leon Unger, Ph.D., IBC Chair at 405/217-2227 ext. 1243.
Questions about safety issues should be directed to Cheri Marcham, Ph.D., CIH, CSP, CHMM in the Environmental Health and Safety Office at 405/271-3000.

Updated 1/2/08