NIH Guidelines Flashcards
What is the purpose of the NIH Guidelines?
Specify the biosafety practices and containment principles for constructing and handling 1. Recombinant nucleic acid molecules; 2. Synthetic nucleic acid molecules that can base pair with naturally occurring nucleic acid molecules; 4. Cells, organisms, and viruses containing such molecules.
What are the components of a nucleic acid?
- Heterocyclic aromatic base (nucleobase)
- Five-atom ring sugar
- Sugar phosphate backbone
Define recombinant nucleic acids.
Molecules that are constructed by joining nuclei acid molecules and can replicate in a living cell
Define synthetic nucleic acids.
Molecules that are chemically or by other means synthesized or amplified, including those that are chemically or otherwise modified but can base pair with naturally occurring nucleic acid molecules
What modifications have chemists made to create novel nucleic acids?
Replace polyanionic backbone with uncharged analogues, replace ribose sugars, and replace standard base-pairs with non-standard analogues
Who do the NIH Guidelines regarding recombinant nucleic acids apply to?
All recombinant or synthetic nucleic acid research conducted at or sponsored by an institution that receives any support for the work from NIH. An individual must be associated with an institution that assumes the responsibilities assigned in the NIH guidelines.
How are issues of compliance addressed?
Addressed to NIH Office of Science Policy (OSP) and institution. IBC will take action and will send their finalized report with recommendations to NIH OSP.
What are the four biosafety risk groups?
RG1 - Agents not associated with disease in healthy adult humans
RG2 - Associated with human disease which is rarely serious and for which preventive or therapeutic interventions are often available
RG3 - Associated with serious or lethal human disease for which preventive or therapeutic interventions may be available
RG4 - Likely to cause serious or lethal human disease for which preventive or therapeutic interventions are not usually available.
Give example of Risk Group 1 agents.
AAV, animal viral etiologic agents not associated with disease in healthy adult humans (MMTV, FLV)
Give examples of RG2 agents.
Bacillus anthracis, Coxiella, Mycobacterium, Rabies, Streptobacillus, Plasmodium, LCMV
Give examples of RG3 agents.
Brucella, Coccidioides, VEEV, MERS-CoV, Prions
Give examples of RG4 agents.
Only viruses - Ebola, Herpes V, other hemorrhagic fever agents
What are the three main mechanisms of containment?
- Set of standard practices generally used in microbiological labs
- Special procedures, equipment, and lab installations that provide physical barriers
- Highly specific biological barriers - Unique to recombinant or synthetic nucleic acid molecules
What are the six categories of experiments covered?
- Require NIH Director and IBC approval before initiation
- Require NIH OSP and IBC prior
- Require IBC approval prior to human gene transfer
- Require IBC approval prior
- Require IBC notification simultaneous with initiation
- Exempt from NIH Guidelines
Descending order of oversight
What does Section III D-4 cover? What does the PI need to demonstrate?
Whole animals that have had their genome altered by introduction of nucleic acid into the germ line
PI needs to demonstrate that viral genome does not lead to productive infection for experiments involving agents in RG2, 3, and 4
Purchase of transfer of transgenic rodents is exempt
Who is responsible for adhering to the NIH Guidelines?
Institution and IBC
Who must the institution appoint to the IBC?
A Biological Safety Officer
At least one individual with expertise in plant containment principles PRN
At least one individual with expertise in animal containment principles
What must the institution file annually?
An annual report to NIH OSP that includes a roster of the IBC and biographical sketches of all the members
How quickly must the institution report sig problems, violations of the guidelines, or sig research-related accidents to NIH OSP?
Within 30 days
What members must be present on an IBC?
No fewer than 5 members.
Two must be unaffiliated.
One with expertise in containment principles
Must have a Biological Safety Officer if research at BL3, BL4, or large scale (>10L)
