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NIH Guidelines – Section III
Levels of Review

 

Level of Review

Example of recombinant DNA
research involving animals

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.