Health and Human Services Homepage

  U.S. Department of Health and Human Services | National Institutes of Health

NIH Institutional Biosafety Committee



Institutional Biosafety Committee

Policy

The initiation of any experiment at the NIH Clinical Center involving recombinant DNA (rDNA) molecules requires review by the NIH Institutional Biosafety Committee (IBC). Principal Investigators (PI) intending to work with rDNA must register their experiments through PI-Dashboard before experiments begin.

The NIH IBC, whose functions are defined under the Guidelines, reviews and approves research protocols involving the use of rDNA techniques or potentially infectious/toxic materials.

The NIH IBC may determine that: (1) a protocol submission would significantly benefit from public RAC review and discussion and (2) that one or more of the following NIH RAC review criteria are met: (i) the protocol uses a new vector, genetic material, or delivery methodology that represents a first-in-human experience, thus presenting an unknown risk; or (ii) the protocol relies on preclinical safety data that were obtained using a new preclinical model system of unknown and unconfirmed value; or (iii) the proposed vector, gene construct, or method of delivery is associated with possible toxicities that are not widely known and that may render it difficult for oversight and federal regulatory bodies to evaluate the protocol rigorously, and is therefore requesting RAC review and public discussion.

This decision will be documented in the IBC approval document and sent to the PI to include in the submission to the Office of Science Policy. The Principal Investigator shall then submit the documentation as outlined in Appendix M-I-A at least 8 weeks prior to the next scheduled meeting in order to be reviewed at that RAC meeting.

Procedures

Please refer to the NIH IBC instructions document.
Return to top