Claremont McKenna College maintains an Institutional Biosafety Committee (IBC) to provide institutional oversight of research involving recombinant or synthetic nucleic acid molecules and other biological materials within the committee’s scope.
The IBC reviews covered activities to ensure that appropriate containment, laboratory practices, training, facilities, and other safeguards are in place. The committee operates in accordance with the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules and applicable CMC policies.
Research involving recombinant or synthetic nucleic acid molecules may include work with plasmids, viral vectors, genetically modified cells or organisms, gene-editing systems, or the administration of these materials to whole animals.
If you are unsure whether your proposed work requires an IBC protocol, notification, or exemption determination, contact the IBC Chair before beginning the work.
The IBC Application and Review Process
Principal Investigators should submit an IBC Protocol Registration Form sufficiently in advance of the proposed project start date to allow time for administrative review, committee review, and any required revisions.
The IBC Chair or designee will first conduct an administrative review to:
Determine whether the activity is subject to the NIH Guidelines;
Identify the applicable NIH Guidelines section;
Evaluate whether the submission is complete;
Determine the appropriate review pathway; and
Identify any additional information, safety procedures, or institutional reviews that may be required.
Depending on the proposed work and its classification under the NIH Guidelines, a submission may undergo full committee review or an administrative determination.
New protocols requiring IBC approval will ordinarily undergo full committee review. Subsequent amendments or continuing reviews involving only minor changes and no meaningful change to biosafety risk may be eligible for designated member review or administrative review, as permitted by the IBC policy. Projects requiring review by the full committee will be considered at a convened meeting with quorum present.
Following review, the Principal Investigator will receive written notice of the IBC’s determination. Possible determinations include:
Approved
Approved with conditions
Needs additional information
A determination of “needs additional information” means that the committee requires clarification or revisions before it can complete its review.
When Work May Begin
The required timing of IBC review depends on how the activity is classified under Section III of the NIH Guidelines.
Activities classified under Sections III-A, III-B, III-C, or III-D may not begin until all required institutional and external approvals have been obtained.
Certain activities classified under Section III-E require that a registration document be submitted to the IBC at the time the work begins. The IBC may review and establish conditions for the activity as necessary.
Activities that meet an exemption under Section III-F or Appendix C may not require IBC approval under the NIH Guidelines. However, investigators should not independently determine that proposed work is exempt. An exemption determination should be obtained from the IBC Chair or designee before relying on an exemption.
Activities Requiring IBC Submission
An IBC submission may be required for activities involving:
Recombinant or synthetic nucleic acid molecules;
Recombinant or replication-defective viral vectors;
Genetically modified microorganisms, cells, or animals;
Gene-editing systems;
Deliberate transfer of recombinant or synthetic nucleic acid molecules, viral vectors, or genetically modified cells into whole animals;
Certain work involving human or nonhuman-primate cells or tissues in combination with recombinant or synthetic materials; or
Other biological activities referred to the IBC for institutional biosafety review.
The IBC makes the final determination regarding applicability of the NIH Guidelines, the appropriate review category, and required containment.
Certain activities—including plant research, work involving Select Agents or Toxins, dual-use research or research subject to current federal dual-use oversight requirements, gene-drive-modified organisms, and recombinant or synthetic nucleic acid molecule work at a scale greater than 10 liters—are outside CMC’s currently established research scope. Investigators considering these activities must consult the IBC Chair and the Environmental & Chemical Hygiene Officer (ECHO) before planning, acquiring materials, or initiating the work.
Investigators considering activities that may fall under Sections III-A or III-B of the NIH Guidelines must also consult the IBC Chair before planning or initiating the proposed activity.
Animal Research
Projects involving the administration of recombinant or synthetic nucleic acid molecules, viral vectors, genetically modified cells, or related materials to live vertebrate animals may require review by both the IBC and the Institutional Animal Care and Use Committee.
IBC review addresses the biosafety aspects of the work, including:
The biological properties of the vector and insert;
Potential shedding or release from treated animals;
Risks associated with administration and sharps use;
Animal housing and containment;
Cage, bedding, carcass, and tissue-handling precautions;
Decontamination and waste disposal; and
Potential exposures involving research personnel or animal-care staff.
IBC approval does not replace IACUC approval. All required committee approvals must be in place before covered animal activities begin. For more information, refer to the IACUC Homepage.
Amendments, Renewals, and Incident Reporting
Principal Investigators must submit an amendment before implementing changes that may affect biosafety risk, containment, or classification under the NIH Guidelines.
Changes requiring review may include modifications to:
The vector, construct, insert, or gene product;
The host organism, cell line, animal species, or animal strain;
The route of administration, dose, titer, volume, or research scale;
Viral vector production, packaging, purification, or concentration;
The location or containment level of the work;
Procedures that may generate aerosols or involve sharps;
Decontamination or waste-handling procedures; or
Personnel performing the covered activities.
Protocols must be renewed according to the approval period established by the IBC. Research may not continue beyond the protocol expiration date unless the required renewal has been approved.
Spills, exposures, needlesticks, sharps injuries, loss of containment, animal escapes involving covered materials, illnesses potentially related to the research, and significant deviations from an approved protocol must be reported promptly in accordance with CMC procedures.
Required Training
All individuals performing activities covered by an IBC protocol must complete the required training administered through the Collaborative Institutional Training Initiative (CITI) Program before independently conducting the covered work.
Additional training may be assigned by the IBC, IBC Chair, or ECHO depending on the biological materials, procedures, containment requirements, and potential hazards associated with the work.
For a complete list of applicable training requirements, review the Required IBC CITI Training Courses section below.
Forms and Resources
IBC Protocol Registration Form
IBC Amendment Form (in-progress)
IBC Continuing Review or Renewal Form (in-progress)
CMC IBC Policy
CMC Laboratory Safety Manual (in-progress)
NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules
Required IBC CITI Training Courses
Biosafety in Microbiological and Biomedical Laboratories (BMBL)
For questions regarding IBC requirements, protocol submission, or the applicability of the NIH Guidelines, contact the IBC Chair.