Recombinant and Synthetic Nucleic Acid Research: Research involving recombinant or synthetic nucleic acid molecules must be conducted in accordance with the current edition of the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules.

Research Involving Infectious Agents: Research involving infectious agents must be conducted in accordance with the NIH/CDC publication Biosafety in Microbiological and Biomedical Laboratories (BMBL).

In addition, any substantive changes to approved procedures or the types of recombinant or synthetic nucleic acid molecules or infectious agents used in a project must be submitted to the IBC as an amendment to the active registration. Changes in key personnel, laboratory locations, or other aspects of an approved registration must also be reported and approved as applicable.

A Continuing Review must be submitted each year for every approved registration. A new registration application must be submitted every three years.

Allowing research activities to continue under an expired registration is not permitted under NIH requirements and institutional policy.

Investigators should be aware that conducting research under an expired registration may violate NIH requirements, sponsor terms and conditions, and applicable regulations governing the research. Such activities may constitute a significant noncompliance issue.

Significant noncompliance may be reportable to the NIH, funding agencies, and other regulatory authorities, as applicable.