NIH Guidelines for Biosafety Administrators

Provides an overview of the NIH Guidelines, including their applicability and scope, risk assessment and containment principles, stakeholder responsibilities, and supporting appendices. Learners explore how these elements support the safe oversight of research involving recombinant or synthetic nucleic acid molecules.

Recommended Use: Required
ID (Language): 22714 (English)
Author(s): William Greer, BS, CPIA, LAT, CM - University of Michigan

Examines higher-risk experiments covered by Sections III-A, III-B, and III-C of the NIH Guidelines. The module addresses major actions, recombinant molecules coding for toxins, human gene transfer research, and the institutional and federal reviews required before covered work begins.

Recommended Use: Required
ID (Language): 22715 (English)
Author(s): William Greer, BS, CPIA, LAT, CM - University of Michigan

Introduces experiments covered by Sections III-D-1 through III-D-3, which require Institutional Biosafety Committee review and approval before initiation. Learners examine recombinant work involving risk group agents, genetic material from higher-risk or restricted agents, and viral systems that may generate replication-competent viruses.

Recommended Use: Required
ID (Language): 22716 (English)
Author(s): William Greer, BS, CPIA, LAT, CM - University of Michigan

Continues the review of Section III-D with a focus on experiments involving whole animals, whole plants, large-scale cultures, recombinant influenza viruses, and gene drive-modified organisms. The module explains how experimental design, organism characteristics, environmental risks, and scale inform containment and oversight decisions.

Recommended Use: Required
ID (Language): 22717 (English)
Author(s): William Greer, BS, CPIA, LAT, CM - University of Michigan

Explores lower-risk experiments covered by Section III-E that may begin upon registration with the Institutional Biosafety Committee, with subsequent review required within a reasonable period. Topics include defective viral constructs, genetically modified plants and associated organisms, and certain experiments involving transgenic rodents.

Recommended Use: Required
ID (Language): 22718 (English)
Author(s): William Greer, BS, CPIA, LAT, CM - University of Michigan

Reviews the eight categories of very low-risk experiments that may be exempt from registration and review requirements under Section III-F. Learners examine criteria involving synthetic and natural nucleic acids, related host species, natural genetic exchange, transposable elements, and other experiments designated as low risk by the National Institutes of Health.

Recommended Use: Required
ID (Language): 22719 (English)
Author(s): William Greer, BS, CPIA, LAT, CM - University of Michigan

Provides an overview of regulations and guidance relevant to institutional biosafety programs, the responsibilities of key program stakeholders, and the role of the biosafety administrator. The module also introduces professional resources and the Certified Professional Biosafety Compliance Administrator certification offered by the Biosafety Administrators Association.

Recommended Use: Required
ID (Language): 22720 (English)
Author(s): William Greer, BS, CPIA, LAT, CM - University of Michigan