Relevant section(s) of “NIH Guidelines”

Examples of recombinant DNA research

Level of review

PI Action Required

III - A

·   Experiments that compromise the control of disease agents in medicine through deliberate transfer of a drug resistant trait into microorganisms not known to acquire the trait naturally (III-A-1-a)

IBC, RAC review, and NIH Director review and approval

Submit RD application to IBC. Await authorization to begin experiments

III - B

·   Cloning of DNA encoding molecules toxic to vertebrates that have an LD₅₀ <100ng/kg  body weight (III-B-1)

·   Experiments conducted with a recombinant DNA modified restricted agent in a whole animal

IBC approval and NIH review for containment determinations

Submit RD application to IBC Await authorization to begin experiments

III - C

·   Experiments involving the deliberate transfer of recombinant DNA into one or more human research participants (III-C-1)

IBC and IRB approval and NIH review before research participant enrollment

Submit RD application to IBC. Await authorization to begin experiments

III - D

·   Experiments involving the introduction of recombinant DNA into Risk Group 2, Risk Group 3, Risk Group 4, or Restricted agents (RG2: III-D-1-a; RG3: III-D-1-b; RG4: III-D-1-c; Restricted Agent: III-D-1-d)

·   Experiments in which DNA from Risk Group 2, Risk Group 3, Risk Group 4, or Restricted agents is cloned into non-pathogenic prokaryote or lower eukaryote host-vector systems (RG2, RG3, RG4: III-D-2-a; Restricted Agent: III- D-2-b [case-by-case review])

·   Experiments involving the use of infectious DNA or RNA viruses or defective DNA or RNA viruses in the presence of helper virus in tissue culture systems (RG2: III-D-3-a; RG3: III-D-3-b; RG4: III-D-3-c; infectious or defective restricted poxviruses: III-D-3-d; other agents not covered above: III-D-3-e)

·   Experiments involving whole animals. Recombinant DNA, or DNA or RNA molecules derived therefrom (from any source except > ²/₃^rds of eukaryotic viral genome) transferred to any non-human vertebrate or any invertebrate organism (III-D-4)

IBC approval before initiation

Submit RD application to IBC. Await authorization to begin experiments

III - E

·   Creating stable germline alterations of rodents using recombinant DNA (from any source except > ²/₃^rds of eukaryotic viral genome) when these experiments only require BSL-1 containment

IBC notice at initiation

Submit RD application to IBC simultaneously with commencement of experiments

III - F

·   Purchase or transfer of transgenic organisms (III-F-6, Appendix C-VI)

·   Cloning of all other DNA in E. coli K-12 (III-F-6, Appendix C-II), S. cerevisiae or S. uvarum (III-F-6, Appendix C-III), and B. subtilis or B. licheniformis (III-F-6, Appendix C-IV) host-vector systems (with the exception of DNA from Risk Group 3 or 4, or restricted organisms)

Exempt from NIH Guidelines. IBC registration not required if experiment not covered by Sections III-A, III-B, or III-C *

Contact NIH BSO to discuss whether the experiments may be exempt from the guidelines