Tissue Culture Research and the NIH Guidelines

Some research using cells grown in culture is exempt from IBC review under the NIH Guidelines (NIH Guidelines I-B, III-F, Appendix C-I). Exempt experiments include: growth of unmodified cells in culture, transfection of cells with recombinant or synthetic nucleic acids that cannot replicate in a living cell, and many experiments involving transfection of cells with replication-competent recombinant or synthetic DNA.

Some research involving transfection of tissue culture cells may still require IBC review. Non-exempt experiments include, but are not limited to, those involving large volumes (>10 liters) of culture, modification of plant cells, and cloning genes from pathogens or genes involved in synthesis of toxins (see NIH Guidelines section C-I-A). It is the responsibility of the PI to determine whether their experiments involving transfection of cells grown in culture require review.

Experiments involving viral transduction of cultured cells are NOT exempt and always require IBC review (NIH Guidelines III-D for most viruses, III-E for RG1 viruses such as AAV).