A. Recombinant DNA

University policy requires Principal Investigators comply with the National Institutes of Health “Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules“, regardless of the funding source supporting that research. The Principal Investigator is responsible for registering all research studies involving Recombinant DNA with the Institutional Biosafety Committee. Use Schedule G of the online Laboratory Safety Plan to submit applications to use Recombinant or Synthetic Nucleic Acid Molecules. The types of experiments that require reporting to the IBC or obtaining prior approval from the IBC include: those using human or animal pathogens as host-vector systems; cloning DNA from human or animal pathogens into a non pathogen host-vector system; and, experiments involving whole animals and plants, including transgenic species.

B. Use of Transgenic Animals or Plants

Use Schedule H of the online Laboratory Safety Plan to submit applications to the IBC for the use of transgenic animals or plants that are imported, bought or transferred from other labs, institutions or companies. For transgenic animals that your laboratory prepares, use Schedule G. For Schedules G and H, you must fully describe the genetic alterations and/or foreign gene expression.

C. Schedule F

Lab reagents requiring BSL-2 containment or above must be registered on the PI’s Laboratory Safety Plan; examples include human pathogens, pathogens of concern in UNC vivariums, viral vectors used in recombinant or synthetic nucleic acid molecule research, human source material such as blood (including well established cell lines), non-human primate material, and biological toxins. Refer to Chapter 2 for further requirements when submitting a new or updated Laboratory Safety Plan.

D. BSL-2 Checklist

To ensure laboratories meet basic requirements at the federal, state, and local levels for BSL-2 practices and containment, the BSL-2 checklist must be completed for each space designated at BSL-2. In 2007, the CDC enhanced requirements for all work at BSL-2.

E. Standard Operating Procedures (SOPs)

Certain work with biological hazards requires written standard operating procedures to define facilities, practices, and responses. An example is work conducted at enhanced containment where all workers are required to conform to a specific set of procedures. Submit SOPs to EHS for review by the Institutional Biosafety Committee.