NIH Guidelines – Section III
Levels of Review
Level of Review |
Example of recombinant DNA |
Relevant section(s) of the NIH Guidelines |
|---|---|---|
IBC, RAC review, and NIH Director review and approval |
Experiments that compromise the control of disease agents in medicine through deliberate transfer of a drug resistance trait
|
III-A |
IBC approval and NIH review for containment determinations |
Experiments conducted with a recombinant DNA modified restricted agent in a whole animal
|
III-B |
IBC and IRB approval and NIH review before research participant enrollment
|
Not applicable
|
III-C |
IBC approval before initiation |
Creating stable germline alterations of an animal’s genome, or testing viable rDNA modified microorganisms on whole animals, where BL-2 containment or greater is necessary
|
III-D |
IBC notice at initiation |
Creating stable germline alterations of rodents using recombinant DNA when these experiments require only BL-1 containment
|
III-E |
Exempt from the NIH Guidelines. IBC registration is not required if experiment not covered by Sections III-A, III-B, III-C |
Purchase or transfer of transgenic rodents |
III-F |
To see the complete NIH Section III Guidelines, visit Experiments Covered by the NIH Guidelines.