All 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).
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
II. Amendments/Modifications to Clinical IBC Approved Registrations: Required Documents for Submission to IBC