Institutional Biosafety Committee
Clinical research at Lurie Children’s involving recombinant and synthetic nucleic acid molecules; cells, organisms, and viruses containing such molecules, and human gene transfer require prior approval from the Institutional Biosafety Committee (IBC).
The IBC is responsible for the review of all clinical research utilizing recombinant and synthetic nucleic acids in accordance with the NIH Guidelines for Research Involving Recombinant or Synthetic Acid Molecules (NIH Guidelines) and the Institutional Biosafety Program at Lurie Children's.
Below are instructions on how to submit clinical protocols for IBC review. Refer to the IBC Submission Deadlines and Meeting Dates for 2024 prior to submitting a protocol to the IBC.
Submit all applicable forms to the IBC and inquiries about the submission and review process to IBC@luriechildrens.org.
- Biosafety Registration for Clinical Research
- Should include information on research purpose and methodology including research/clinical personnel who may have direct contact with investigational agent or drug, justification for clinical trial including summary of preclinical studies, description of investigational agent/drug including type of recombinant and/or synthetic nucleic acids (source, vectors, etc.) and other biological agents, risk assessment including potential for carcinogenesis, replication competence and other health hazards in study participants, and level of biosafety containment.
- Safety Protocol(s)
- Should describe all measures taken for the safe handling, preparation, use, clean-up, disposal and storage of each type of biohazardous material to be used. Submit a copy of any relevant Institutional SOPs with the safety protocol. (i.e., the Investigational Pharmacy Policy on the Handling and Preparation of Study Biological Agents, etc.)
- Clinical Protocol
- Letters of Support
- Letter of Support from Infection Prevention and Control
- Other Letters of Support specific to the IBC to ensure the Research Support Services are aware of the biohazardous risks (i.e. Research Pharmacy, Clinical Research Unit, etc.)
- Investigator’s Brochure
- Vector/Transgene Map
- Material Safety Data Sheet
- IRB Informed Consent forms
- Amendment Form
- IBC Change in PI Form
- Personnel Addition Form
- New or Revised Forms as Applicable to the Amendment Submission:
- Biosafety Registration
- Safety Protocol
- SOPs
- Letters of Support
- Clinical Protocol
- Investigator Brochure
- Vector/Transgene Map
- Material Safety Data Sheet
- IRB Informed Consent forms
To inactivate a clinical IBC approved protocol, please utilize the Inactivation Form.
Please contact us at IBC@luriechildrens.org
- Safe Handling, Administration, and Disposal of Study Biological Agents Policy (8/14/20)
- NIH Office of Science Policy Guidelines
- FAQs- April 2019 Amendment of the NIH Guidelines
- Investigator Responsibilities under the NIH Guidelines
- Laboratory Safety Protocol Sample
- IBC SOP on Handling and Preparation of Biological Agents
- IBC Policy for Use of Human Cells and Tissues for Research
- Biosafety Considerations for Research with Lentiviral Vectors
