Companies located in cities or towns with local ordinances that govern the use of recombinant or synthetic nucleic acid (r/sNA) molecules are generally required to hold Institutional Biosafety Committee (IBC) meetings in accordance with the National Institutes of Health (NIH) Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines). Meetings must be held annually at a minimum, and meeting minutes are required to be submitted to the local regulatory agency.
In addition to these requirements, certain organizations must also register their IBCs with the NIH Office of Science Policy (NIH-OSP).
Who Must Register an IBC?
Registering an IBC with the NIH-OSP is required for all entities that receive funding from the NIH for research using r/sNAs. In addition, if an organization is conducting r/sNA work, and is sponsored by an institution that also conducts NIH-sponsored research, they will need to register, irrespective of their funding source.
Depending on the terms of the grant contract, the requirement to register may also apply to organizations that receive funding from another federal agency such as the Biomedical Advanced Research and Development Authority (BARDA), the Defense Advanced Research Projects Agency (DARPA), and the Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) programs.
Registering is required so the NIH-OSP can document that sponsored institutions are complying with the NIH Guidelines. It should also be mentioned that entities not receiving federal funding can choose to register their IBC to demonstrate their dedication to following the NIH Guidelines.
What is the Registration Process?
Registrations are initiated by creating an account in the online IBC Registration Management System (IBC-RMS) by completing the IBC-RMS Request Access Form. Once access has been granted, users can log into the system and submit the required information listed below:
- IBC membership roster, including each member’s role and their biographical sketch/resume
- Contact information for the IBC Chair, Biological Safety Officer (BSO), and IBC administrative contact
- Link to IBC meeting minutes published on the organization’s public-facing webpage
- Reports of any significant incidents involving r/sNA research or violations of the NIH Guidelines that were reported to the IBC
The tutorial that can be accessed from the Support menu at the bottom of the IBC-RMS home page provides helpful information on registering. Safety Partners can also help guide you through the process and answer any questions you may have—contact us!
This blog was written by Beth Graham, Safety Partners’ Director of Quality, Research, and Training and Linda Epstein, Ph.D., Quality, Research, and Training (QRT) Specialist.
