Use of Recombinant DNA (rDNA)

Policy Summary

The purpose of this policy is to promote the safe use of 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 Recombinant DNA (rDNA) must be 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

• Students
• Staff
• Faculty

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 his/her approval use suspended or revoked by the Biosafety Officer pending review by the Associate Vice President for Research Integrity. 

If the activity also will involve select agents or pathogens, review and approval is required in accordance with the Policy for Compliance Regarding Select Agents and Pathogens.  University departments proposing to engage in activity with rDNA (or with select agents) also are responsible for notifying the Office of Laboratory Safety before engaging in the activity.  

IBC forms and other information regarding the IBC, including details regarding the 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 Laboratory 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

• Chemical Hygiene Policy 
• Hazardous Waste Management Policy 
• Policy for Compliance Regarding Select Agents and Pathogens
• Office of Health & Emergency Management Services 
• Centers for Disease Control, Biosafety in Microbiological and Biomedical Laboratories 

Contacts