These are stressful times. If you would like to contact a social worker, psychologist or child life specialist for information on community referrals or coping resources, you can call 312.227.4118 and leave a message. Your call will be returned within 24 hours, Monday through Friday. Non-urgent questions only. For emergencies, call 911.
For information on Novel Coronavirus (COVID-19), click here.
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All 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).
I. Initial Non-Clinical Research: Required Documents for Submission to IBC
Biosafety Registration for Non-Clinical Research
Should include information on research purpose and methodology including research personnel, type of recombinant and/or synthetic nucleic acids (source, vectors, etc.) and other biological agents, risk assessment, and level of biosafety containment.
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.
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.)
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.)
Material Safety Data Sheet
IRB Informed Consent forms
III. Amendments/Modifications to Non-Clinical or Clinical IBC Approved Registrations: Required Documents for Submission to IBC