Recombinant DNA inserted into the genome of transgenic mice may NOT be covered by the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules.

The statement that recombinant DNA inserted into the genome of transgenic mice may not be covered by the NIH Guidelines is accurate in certain circumstances. Specifically, the NIH Guidelines do apply to research involving recombinant or synthetic nucleic acid molecules, but there are exceptions. For example, if the recombinant DNA is present in a manner that does not pose a risk of forming a pathogen or if the inserted DNA does not affect the biological properties of the organism in a significant way, it may not be subject to the stringent regulations laid out by the NIH.

Transgenic mice are typically developed for various research purposes, including studying gene function, modeling human diseases, and investigating drug effects. However, if the transgene serves only as a marker or is expressed at a low level without any adverse effects, researchers may be allowed to bypass some guidelines.

The issuance of exemptions is often based on a careful assessment conducted by the Institutional Review Committee or the Institutional Animal Care and Use Committee. The complexity surrounding this area of research necessitates strict adherence to regulatory oversight while allowing for flexibility under specific conditions, which is why the determination of coverage by NIH guidelines can vary.