Did you know many common work projects need a biosafety registration at NIH? Examples include cloning and expression of proteins in prokaryotic and eukaryotic systems, working with viral vectors (including the use of commercial kits), working with potentially infectious materials like human blood and body fluids and established cell lines, and developing transgenic models in vertebrates and invertebrates.
For the NIH intramural research program, the ORS Division of Safety (DS) is responsible for ensuring the safe conduct of all biological research in NIH facilities. For work with biological agents and recombinant activities, our policies dictate a risk assessment review process by your corresponding Institutional Biosafety Committee (IBC). This process begins with the mandatory registration of research involving any human, animal or plant pathogens, acute biological toxins, and other unique or even subtle recombinant nucleic acid experiments as outlined in the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules, published by the NIH Office of Science Policy. These registrations are formally reviewed and approved by the corresponding NIH IBC for work at assigned biological safety levels, following necessary practices.
Certain situations may require reviews by committees other than the IBC: working with in vivo systems requires review by your area's Animal Care and Use Committee (ACUC); gene transfer experiments in humans require additional oversight by the NIH Institutional Review Board (IRB); and certain experiments involving potential dual-use considerations may involve additional oversight by the NIH Dual Use Research Institutional Review Entity (DURC-IRE). See the NIH Office of Intramural Research Sourcebook and Executive Orders regarding biological research to learn more.
All Principal Investigators (PIs) must submit registrations describing their biological research for approval by their appointed NIH IBC. PIs must ensure all researchers are aware of the potential risks associated with their research. To manage registrations, each IBC uses web-based platforms for submitting research registrations and amendments. Accessed using NIH two-factor authentication with an NIH PIV card, researchers can register work in a “project-based" format. Administrative changes to approved registrations (editing personnel and labs) are made in real time, and substantive changes are submitted for review via formal amendment submission process.
To make sure you are covered, contact your Biological Safety Officer (BSO) today. They are here to support the safe progress of your work!
