NIH Guidelines

The NIH Guidelines covers a specific subset of potentially biohazardous materials involving recombinant and/or synthetic nucleic acid molecules.

There are 6 types of experiments covered by the Guidelines. Each requires increasing levels of oversight by the institution and federal government.

Image
Chart covering the six types of covered by the NIH Guidelines

Standards & Regulations

Incident Reporting

It is important to always report any laboratory incidents or exposures to the EH&S Biological Safety Officer and/or the IBC Chair. Incident reporting serves two primary goals: 

  1. Determine the underlying root cause(s) in order to prevent opportunities for future recurrence. 
  2. Maintain federal compliance since certain accidents or incidents involving recombinant or synthetic nucleic acids molecules must be reported to the NIH. 

Incidents that require immediate (within 24 hours) reporting:

Spills and accidents which result in overt exposures to organisms containing recombinant or synthetic nucleic acid molecules must be immediately reported to the EH&S Biological Safety Officer, Institutional Biosafety Committee, and NIH OSP.

Incidents that must be reported within 30 days to the NIH OSP via the IBC:

  1. Any significant problems.
  2. Any violation of the NIH Guidelines.
  3. Any significant research-related accident or illness.