Use of Recombinant DNA (rDNA) Policy

Policy Summary

The purpose of this policy is to promote the safe use of Recombinant or Synthetic Neucleic Acid (rDNA), as well as communication and transparency with the community, in compliance with the NIH Guideline for Research Involving Recombinant DNA Molecules. Organisms used in rDNA research potentially can take on new and sometimes dangerous properties. Any research or academic activity involving rDNA must be reviewed and approved in advance by the Institutional Biosafety Committee (IBC), and must comply with the guidelines published by the National Institutes of Health (NIH), the university’s Biosafety Manual, and this policy.

Related Regulations

• NIH Guideline for Research Involving Recombinant DNA Molecules

Who is Governed by this Policy

• Faculty
• Staff
• Students
• Non-university entities using university property, equipment, or facilities

Policy

Prior Approval 

Prior to engaging in any research or academic activity involving rDNA, the activity must be reviewed and approved by the IBC. This includes work considered exempt by the NIH. No rDNA work may proceed until approval is obtained from the Biosafety Officer (BSO). 

Usage of rDNA 

Before using rDNA individuals must complete biosafety training. Individuals must comply with the Biosafety Manual and the NIH Guidelines for Research Involving Recombinant DNA Molecules throughout all stages of the activity. Workers also must comply with all requirements of their approval, all government regulations, and must cooperate in periodic reviews by the IBC. The IBC may make changes to the requirements for an agent at any time. 

An individual who willfully or negligently violates this policy, federal, or state rules and regulations governing the use of rDNA/biohazardous agents may have their approval use suspended or revoked by the Biosafety Officer pending review by the Associate Provost for Research Integrity and Compliance. 

If the activity also will involve select agents or pathogens, review and approval are required in accordance with the Use of Select Agents and Potentially Hazardous Biological Materials Policy. University departments proposing to engage in activity with rDNA (or with select agents) are also responsible for notifying the Office of Research Safety before engaging in the activity.

IBC forms and other information regarding the IBC, including details about the protocol submission, review process, the charter, and regulatory links are available on the OLS-IBC website.

Definitions

Recombinant DNA (rDNA): Molecules that are constructed outside living cells by joining natural or synthetic DNA segments to DNA molecules that can replicate in a living cell, and the molecules that result from the replication of those cells. [Ref: NIH rDNA Guidelines: Section B].

Procedures

GW Procedures can be found on the Office of Research Safety website, the GW Institutional Biosafety Committee (IBC) website, and the GW Biosafety Manual.

Forms

The GW Institutional Biosafety Committee (IBC) forms are available on the OLS-IBC website.

Related Information

• NIH Guideline for Research Involving Recombinant DNA Molecules
• Chemical Hygiene and Communications Policy
• Hazardous Waste Management Policy
• Use of Select Agents and Potentially Hazardous Biological Materials Policy
• Centers for Disease Control, Biosafety in Microbiological and Biomedical Laboratories

Contacts