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 and synthetic nucleic acid molecules*, gene transfer including transfer to humans, the generation of transgenic animals, microorganisms, viruses, and biological toxins. The definition of recombinant and synthetic nucleic acid molecule includes:
- molecules that a) are constructed by joining nucleic acid molecules and b) that can replicate in a living cell, i.e., recombinant nucleic acids;
- nucleic acid molecules that are chemically or by other means synthesized or amplified, including those that are chemically or otherwise modified but can base pair with naturally occurring nucleic acid molecules, i.e., synthetic nucleic acids, or
- molecules that result from the replication of those described in either of the above.*
* Note that the National Institutes of Health (NIH) Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules has identified criteria for some synthetic nucleic acids that are exempt from the NIH requirements. Specifically, synthetic nucleic acids molecules are exempt that:
(1) can neither replicate nor generate nucleic acids that can replicate in any living cell (e.g., oligonucleotides or other synthetic nucleic acids that do not contain an origin of replication or contain elements known to interact with either DNA or RNA polymerase), and
(2) are not designed to integrate into DNA, and
(3) do not produce a toxin that is lethal for vertebrates at an LD50 of less than 100 nanograms per kilogram body weight.
An example of an exempt molecule would be research with a synthetic short-interfering RNA (siRNA) that targets an HIV viral protein required for transcription activation, even if this siRNA is injected into animals or used in cell culture.
Prior to the commencement of any project involving the use of such material, the Principal Investigator (PI) must perform the following steps:
- Review the applicable guidelines and regulations and become familiar with the biological safety procedures and requirements. These guidelines and regulations include:
- 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/biosafety/publications/bmbl5/bmbl5_sect_ii.pdf.
- Develop laboratory specific Standard Operating Procedures (SOPs) based on the risk assessment, guidelines and regulations
- 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 firstname.lastname@example.org 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.
- 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 http://apps.ouhsc.edu/IBCinventory/newbiologicalovt/login.asp and update this inventory at least annually.
- 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.
- Be adequately trained in good microbiological techniques.
- Adhere to Institutional Biosafety Committee approved emergency plans for handling accidental spills and personnel contamination.
- 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.
Additional Requirements for Human Protocols :
All clinical protocols and Consent Forms 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 protocols or Consent Forms must also be reviewed and approved by the IBC. The IRB is responsible for identifying any need for IBC review that the PI has not recognized. In cases where an external IRB is used, the Scientific Review Committee of the Stephenson Cancer Center will determine if IBC review should be sought and will act as intermediary between the IBC and the external IRB to resolve concerns or questions from the IBC.
For protocols 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 participants, the NIH Guidelines have significant reporting requirements subsequent to the approval process. Appendix M-I-C of the Guidelines (found at http://osp.od.nih.gov/sites/default/files/NIH_Guidelines.html#_Toc351276401) 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.
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 http://compliance.ouhsc.edu/ibc/Home/MeetingDates/OUHSC.aspx. 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 IBC@ouhsc.edu. 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 IBC@ouhsc.edu.
Scientific questions or questions about the IBC Committee should be directed to Biological Safety Officer, Dr. James F Papin, or Ralf Janknecht, Ph.D., IBC Chair.