An institution’s laboratory biosafety program represents a partnership between Environmental Health and Safety (EH&S) and the Institutional Biosafety Committee (IBC) with the goal of assuring that research involving biological agents is conducted in a safe and responsible manner, and that these activities are in compliance with external regulations and applicable institutions policies.
Biosafety must address the safe handling and containment of infectious microorganisms and hazardous biological materials. The CDC Biosafety in Microbiological and Biomedical Laboratories (BMBL) has become the code of practice for biosafety. The principles of containment and risk assessment introduced in 1984 remain steadfast today.
The NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines) detail safety practices and containment procedures for basic and clinical research involving recombinant or synthetic nucleic acid molecules, including the creation and use of organisms and viruses containing recombinant or synthetic nucleic acid molecules. These Guidelines apply to all research projects (NIH-funded and non-NIH-funded) that involve recombinant or synthetic nucleic acid molecules and are conducted at or sponsored by an organization that receives NIH support for recombinant or synthetic nucleic acid molecule research.
Definitions: (per NIH Guidelines)
Recombinant and Synthetic Nucleic Acid Molecules:
In the context of the NIH guidelines, recombinant and synthetic nucleic acids are defined as:
- molecules that are; a) constructed by joining nucleic acid molecules and; b) that can replicate in a living cell, i.e., recombinant acids;
- nucleic acid molecules that are chemically or by other means synthesized or amplified, including those that are chemically or otherwise modified that can base pair with naturally occurring nucleic acid molecules, i.e., synthetic nucleic acids; or
molecules that result from the replication of those described in (1) or (2) above.
The NIH Guidelines apply to both basic and clinical research studies. Specific guidance for the conduct of human gene transfer studies appears in Appendix M of the NIH Guidelines.
Two specific requirements of the NIH Guidelines are discussed below, but the grantee should carefully review the NIH Guidelines in their entirety to ensure compliance with all of the requirements for projects involving recombinant or synthetic nucleic acid molecules.
Institutional Biosafety Committee
Each institution that conducts research involving recombinant or synthetic nucleic acid molecules, or biohazards including contractors under grants, must have policies and procedures to ensure compliance with the NIH Guidelines and must establish a standing IBC. The IBC is required to review each proposed project for recombinant or synthetic nucleic acid molecule experiments to ensure that the procedures, project, personnel, and facilities are adequate and in compliance with the NIH Guidelines.
Investigators and Institutional Staff
Section IV of the NIH Guidelines also specifies the roles and responsibilities of PIs, biological safety officers (BSOs) and grantee institutions with respect to the safe conduct and oversight of recombinant or synthetic nucleic acid research. Investigators, laboratory staff, BSOs, and institutional officials should read and be aware of their duties and expected biosafety practices, as described by the NIH Guidelines.