Institutional Biosafety Committee

The Institutional Biosafety Committee (IBC) is established under the NIH Guidelines to provide local review and oversight of nearly all forms of research utilizing recombinant or synthetic nucleic acid molecules (r/sNAs), viruses and toxins. The University of Miami IBC is responsible for reviewing and overseeing research r/sNAs and other biohazard materials. A full list of materials covered by th University of Miami's IBC can be found below in the "Relevant Regulations and Materials".

The IBC is a faculty-led committee appointed by the Vice Provost for Research and Scholarship (VPRS) and consists of experts in various fields including:

• Biosafety
• Human gene therapy
• Infectious disease
• Recombinant DNA
• Animal containment
• Plant containment
• Occupational health

The IBC is responsible for establishing, monitoring, and enforcing policies and procedures involving hazardous biological materials and r/sNAs to meet applicable federal, state, local and institutional regulations, and guidelines.

Environmental Health and Safety (EHS) partners with the IBC to provide technical expertise, and provides training, resources, and guidance to researchers to ensure safe laboratory practices and containment of biohazards, protecting personnel, the public, and the environment.

The IBC reviews and approves protocols for academic research and teaching laboratories involving the following materials:

1. r/sNA molecules, as covered by the NIH Guidelines including:
   1. Genetically modified animals and whole plants
   2. Clinical research studies involving r/sNAs, as described by the NIH Guidelines.
   3. Research classified as Biosafety Level 3 (BSL3) managed by the High Containment Program
   4. Animals or animal specimens known to be reservoirs/vectors of zoonotic diseases, as covered by the NIH Guidelines.
2. Infectious agents at Bioasafety Level and greater that can cause disease in healthy humans and/or significant environmental or agricultural impacts, as covered by the Biosafety in Microbiological and Biomedical Laboratories (BMBL).
3. Select agents and select toxins, as covered by the CDC DSAT regulations.
4. Research involving any agent listed in Appendix A (lists diseases requiring airborne (e.g., TB, measles) or droplet precautions (e.g., influenza, mumps)) or Appendix D (lists lab aerosol transmissible pathogens needing BSL 3 or higher containment, like Mycobacterium tuberculosis and SARS coronavirus) of the Aerosol Transmissible Diseases (ATD) Standard, CCR Title 8, Section 5199

Procedure for IBC Protocol Registration and Review

1. Principal Investigators must submit a registration form for all protocols requiring IBC review via the online SciShield system (formerly known as BioRaft) with the exception of Human Gene Transfer studies (see below).
2. The IBC staff will work with investigators to ensure that the protocol is complete and clear before being forwarded to the IBC chair for assignment to committee review. The IBC chair will assign a content expert reviewer, who will present the project at the next IBC meeting.
3. Experiments involving deliberate transfer of rDNA into human subjects require a Gene Transfer Form submission form also require Institutional Review Board (IRB) approval as well. Depending on the nature of the study (e.g., UM investigational product, industry-sponsored clinical trial), this may be UM IRB or an external IRB, IRB approval cannot be granted until IBC approval has been finalized. Transfer of rDNA into human subjects studies also requires the submission of the following.
   1. a study protocol or investigator brochure
   2. investigator brochure
   3. Biosafety SOP Human Gene transfer studies Form
4. Research utilizing recombinant or synthetic nucleic acid molecules (r/sNAs) with animals must also be approved by the University of Miami Institutional Animal Use and Care Committee (IACUC). IACUC protocols will not receive final IACUC approval until IBC approval is obtained. There is a 1 to 1 association between IACUC and IBC approvals. The IBC staff advises the IACUC staff of approved, denied, or tabled projects and ensure concordance of material between the IBC and IACUC submissions.
5. Experiments involving Select Agents as defined by the USDA or CDC must be registered with the CDC or USDA. These protocols must be submitted to the IBC commitee and to EHS Biosafety Officer to begin the CDC/USDA registration process and to obtain approval from the IBC.