Institutional Biosafety Committee (IBC)

As mandated by the NIH Guidelines, UTMB’s Institutional Biosafety Committee (IBC) is responsible for reviewing recombinant or synthetic nucleic acid (r/sNA) molecule research conducted at or sponsored by UTMB. This review includes setting the containment level for the proposed research; assessing facilities, procedures, practices, and training and expertise of personnel involved in this research; and assessing biosafety issues for this research involving human research participants. In addition, the UTMB IBC oversees other potentially hazardous biological materials. Current IBC oversight includes:

• Recombinant and synthetic nucleic acid (r/sNA) molecules (purchased or manipulated) regulated by the NIH Guidelines
• Risk group 2, 3, and 4 infectious agents
• Select Agents and Toxins (greater than the permissible amounts), including regulated positive-strand RNA virus genomes
• Human and nonhuman primate products for research (e.g., blood, body fluids, tissue, commercial, established, and primary cell lines)
• Inactivation of biological material for removal from BSL3 and BSL4 laboratories to be further manipulated at a lower biosafety level (Inactivation SOPs), including regulated positive-strand RNA virus genomes
• Research that may be within scope of the USG DURC-PEPP Policy, including any amount of Select Toxins

A Notification of Use (NOU) is used to register work with the IBC.

A Bioagents, rDNA Materials, CDC & USDA Regulated Agents form is used for recombinant and synthetic nucleic acid (r/sNA) molecules regulated by the NIH Guidelines and risk group 2, 3, and 4 infectious agents.

• ·This form is located within EHS Assistant (EHSA) (see additional information in Forms below)

A Human and Nonhuman Primate Products form is used for human and nonhuman primate products.

• This form is located within InfoEd (see additional information in Forms below)

Inactivation SOPs are submitted to and reviewed by the Inactivation Subcommittee.

Research that may be within scope of  DURC and PEPP is reviewed by the IBC in its capacity as the Institutional Review Entity (IRE).

Some of these documents will require UTMB login

Policies

• IBC NOU Policy
• NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules
• Biosafety in Microbiological and Biomedical Laboratories (BMBL)- Current Edition
• Federal DURC/PEPP Policy 
• Federal DURC/PEPP Implementation Guide

Forms

Forms for Bioagents NOUs (EHSA)

• Notification of Use (NOU)- EHSA Form
  • Google Chrome is the preferred Internet browser with EHSA
  • Follow the link above for instructions or to assign a proxy
  • Amendments to NOUs originally submitted as a PDF must be renewed in entirety in EHSA
• Introduction to EHS Assistant- New Submission System for NOUs
• EHSA Guide for Bioagent NOUs
• NOU Co-PI Cover Page

Forms for Human and Nonhuman Primate Products NOUs (InfoEd)

• InfoEd
• User Guides for the Biosafety Protocols Module

Forms for both NOU types

• NOU Personnel Table
• Instructions for Personnel Table

 

Guidance

• IBC Guidelines for SARS-CoV-2 (COVID-19)
  • IBC Memo
  • Guidelines
• Viral Vector Guidance Document
• Guidelines for Submission of RNA Samples to UTMB NexGen Sequencing Core
• Minimum Training Requirements
• St. Louis Encephalitis Virus and West Nile Virus Biosafety Level Requirements
• Standard Precautions Courses (Required for Human and/or Non-human Primate Products NOUs)

Principal Investigators (PIs) are responsible for the following:

• Understand and comply with the NIH Guidelines in the conduct of recombinant or synthetic nucleic acid molecule research
• Be knowledgeable about and comply with or follow all applicable institutional and U.S. government policies, requirements, and regulations for oversight of biological and toxin research as detailed in the USG DURC-PEPP Policy 
• Submit a new NOU to the IBC to secure approval for all research involving r/sNA molecules, risk group 2, 3, and 4 infectious agents, and human and nonhuman primate products
• Amend an approved NOU prior to implementing changes to the research
• Ensure that all laboratory personnel have received the required training for the work they will perform
• Maintain the list of current personnel for each NOU
• Maintain current NOUs for work being conducted in their laboratory, with renewal every 5 years
• Complete annual review forms and notify the IBC of changes:
  • Submit NOU annual continuing review forms
  • Complete NIH-OSP annual continuing review forms
• Use the most current version of an NOU form/application to submit to the IBC (failure to do so may result in the NOU not being approved and delaying the commencement of the project)

For meetings occurring on or after June 1, 2025, all approved IBC meeting minutes are available. To request IBC meeting minutes from meetings prior to June 1, 2025, email your request . See UTMB Open Records for detailed information.