In the context of the NIH Guidelines for Research Involving Recombinant DNA Molecules, recombinant DNA molecules are defined as either:

1. molecules that are constructed outside living cells by joining natural or synthetic DNA segments to DNA molecules that can replicate in a living cell, or
2. molecules that result from the replication of those described in (1) above.

Synthetic DNA segments that are likely to yield a potentially harmful polynucleotide or polypeptide (e.g., a toxin or a pharmacologically active agent) are considered equivalent to their natural DNA counterpart.

The NIH Guidelines are applicable to: All recombinant DNA research within the United States or its territories that

• Is conducted at or sponsored by an institution that receives any support for recombinant DNA research from NIH, including research performed directly by NIH.... [Section I-C-1-a-(1)]
• Involves testing in humans of materials containing recombinant DNA developed with NIH funds, if the institution that developed those materials sponsors or participates in those projects. Participation includes research collaboration or contractual agreements, not mere provision of research materials. [Section I-C-1-a-(2)]

All recombinant DNA research performed abroad that

• Is supported by NIH funds. [Section I-C-1-b-(1)]
• Involves testing in humans of materials containing recombinant DNA developed with NIH funds, if the institution that developed those materials sponsors or participates in those projects. Participation includes research collaboration or contractual agreements, not mere provision of research materials. [Section I-C-1-b-(2)]

If the host country has established rules for the conduct of recombinant DNA research, then the research must be in compliance with those rules. If the host country does not have such rules, the proposed research must be reviewed and approved by an NIH-approved Institutional Biosafety Committee or equivalent review body and accepted in writing by an appropriate national governmental authority of the host country. The safety practices that are employed abroad must be reasonably consistent with the NIH Guidelines. [Section I-C-1-b-(3)]
(NIH Guidelines For Research Involving Recombinant DNA Molecules)

Exemption from the NIH Guidelines

If the synthetic DNA segment is not expressed in vivo as a biologically active polynucleotide or polypeptide product, it is exempt from the NIH Guidelines. Genomic DNA of plants and bacteria that have acquired a transposable element, even if the latter was donated from a recombinant vector no longer present, are not subject to the NIH Guidelines unless the transposon itself contains recombinant DNA. Investigators apply to the IRB for this exemption by completing the Protocol Oversight Review Form—For HIV Clinical Vaccine Trials, Including Exemption from the NIH Guidelines.

Institutional Biosafety Committee Approval

An investigator who plans to use recombinant DNA must notify the UAB Institutional Biosafety Committee (IBC) of such intent. The IBC reviews each proposal, assesses the risks, and recommends a Biosafety Level of Containment as well as any special precautions that may be required. The investigator must obtain IBC approval before the IRB will issue approval.

Call Donna Williamson in UAB Biosafety at 934-4752 for additional information, or visit the biosafety web site: https://www.uab.edu/ohs/biosafety​