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Experiments Involving Recombinant DNA

Introduction

The NIH Guidelines for Experiments Involving Recombinant DNA Molecules (NIH Guidelines) was published in the 1970s in response to scientists' concerns about the dangers of creating recombinant organisms. It has been revised, relaxed and updated many times since then, but is still the standard for classifying recombinant DNA (rDNA) experiments according to hazard and recommending appropriate containment levels. All work with rDNA at the University is registered with the Institutional Biosafety Committee (IBC) or the Department of Environmental Safety (DES) and must comply with the NIH Guidelines.

Applicable University Policy

VI-17.00(A) - UM Policy on Biosafety

Applicable Regulations

NIH Guidelines for Research Involving Recombinant DNA Molecules: Though technically not a regulation, NIH requires that any institution receiving NIH funding comply with this document.

Summary of Requirements

• Compliance is a condition for NIH funding;
• Institution must establish an IBC;
• IBC reviews and approves rDNA experiments and sets containment;
• University Policy requires registration of all experiments involving genetically engineered organisms, including those exempt from the NIH Guidelines.

Training

Training is the responsibility of the Principal Investigator. However, DES is available to provide training upon request.

Reporting

All significant accidents, violations of the NIH Guidelines, or any significant research- related accidents and illnesses must be reported to NIH within thirty days (30) by the Principal Investigator or IBC.

Inspections

There are no specific requirements for inspections in the NIH Guidelines. However, DES conducts annual inspections of laboratories that conduct research at BSL2 or BSL3 containment.

Recordkeeping

DES maintains records of registrations approved by the Biosafety Officer or the IBC.

Written Program

The NIH Guidelines requires that a Biosafety Manual be prepared for laboratories working at the BSL2 level of containment or higher. DES has prepared a Biosafety Manual that may be used by university laboratories.

University Resources

Written 5/98
Revised 4/05

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