Recombinant or synthetic nucleic acid (r/sNA) molecules

Reference for researchers

This reference aims to help you, the investigator, seek appropriate approvals for your work. It can help you meet National Institutes of Health guidelines in the course of your investigation.

NIH Guidelines

Virtually all research involving recombinant DNA molecules at WSU is subject to the National Institutes of Health “Guidelines for Research Involving Recombinant DNA Molecules” (NIH Guidelines). These guidelines address the safe conduct of research that involves construction and handling of r/sNA molecules and organisms containing them.

Definition of r/sNA molecules

Recombinant or synthetic nucleic acid (r/sNA) molecules are constructed outside of living cells. They are made by joining DNA or RNA segments (natural or synthetic) to DNA or RNA molecules that can replicate within a living cell. They may also result from replication of previously constructed recombinant molecules.

When NIH Guidelines do not apply

NIH Guidelines do not apply to transgenic plants that are released in the field in compliance with a U.S. Department of Agriculture–Animal Plant Health Inspection Service (USDA–APHIS) notification or permit.

Compliance is mandatory

Although the word “guidelines” may suggest that compliance is optional, compliance is a condition of the contractual agreement between the NIH and any institution that receives its funding. Failure to follow NIH Guidelines can jeopardize NIH funding for the entire institution.

What researchers must do

All researchers who are using r/sNA molecules as part of their research must file a Biosafety Approval Form (BAF) with the Institutional Biosafety Committee (IBC). A BAF is required regardless of the funding source.

The IBC reviews all BAFs and provides recommendations and approvals as appropriate. The WSU biosafety officer supports the review process by assisting researchers with BAF questions, biosafety manuals, and training.

Principal investigator’s responsibilities

Under NIH Guidelines, both the institution and researchers are charged with specific responsibilities for compliance. Some of these responsibilities go beyond general laboratory safety requirements.

Is your work covered by NIH Guidelines or exempt?

There are 6 categories of experiments involving recombinant or synthetic nucleic acid molecules:

• Section III-A: Require Institutional Biosafety Committee (IBC) approval and NIH Director approval before initiation
• Section III-B: Require NIH Office of Science Policy and IBC approval before initiation
• Section III-C: Require IBC and Institutional Review Board approvals before research participant enrollment
• Section III-D: Require IBC approval before initiation
• Section III-E: Require IBC notification simultaneous with initiation
• Section III-F: Exempt from NIH Guidelines, required by WSU Policy

The NIH answers frequently asked questions (pdf) about exempt experiments involving rDNA.

Even if your work is exempt, you must still file a Biosafety Approval Form (BAF) with the IBC. This allows the IBC to verify exemption status. The IBC also generates documentation of NIH compliance that may be required by funding agencies.

Adapted from Laboratory Safety Monograph, A Supplement to the NIH Guidelines for Recombinant DNA Research (pdf), prepared by the Office of Research Safety National Cancer Institute and the Special Committee of Safety and Health Experts, Jan. 2, 1979; U.S. Department of Health, Education, and Welfare, Public Health Service, National Institutes of Health