Skip to main content

Recombinant DNA Research

NIH Guidelines and PI Responsibilities

NIH Guidelines For Research Involving Recombinant DNA Molecules

The IBC must approve all work with recombinant or synthetic nucleic acids covered by the NIH Guidelines prior to the start of the project.  Work defined as exempt according to the NIH Guidelines does not need IBC approval.  However, investigators should contact the biosafety officer prior to beginning a project to verify that everything they are working with is exempt.

As a condition for NIH funding of recombinant DNA research, institutions shall ensure that such research conducted at or sponsored by the institution, irrespective of the source of funding, shall comply with the NIH Guidelines.

  1. All NIH-funded projects involving recombinant DNA techniques must comply with the NIH Guidelines. Non-compliance may result in: (i) suspension, limitation, or termination of financial assistance for the noncompliant NIH-funded research project and of NIH funds for other recombinant DNA research at the institution, or (ii) a requirement for prior NIH approval of any or all recombinant DNA projects at the institution.
  2. All non-NIH funded projects involving recombinant DNA techniques conducted at or sponsored by an institution that receives NIH funds for projects involving such techniques must comply with the NIH Guidelines. Noncompliance may result in: (i) suspension, limitation, or termination of NIH funds for recombinant DNA research at the institution, or (ii) a requirement for prior NIH approval of any or all recombinant DNA projects at the institution.

NIH Definition of RDNA

Molecules that a) are constructed by joining nucleic acid molecules and b) that can replicate in a living cell, i.e. recombinant nucleic acids.

NIH Definition of Synthetic Nucleic Acid

Nucleic acid molecules that are chemically or by other means synthesized or amplified, including those that are chemically or otherwise modified but can base pair with naturally occurring nucleic acid molecules, i.e. synthetic nucleic acids.

Lentiviral Vector Exposure Guidelines

Lentivirus exposure protocol

Lab Incidents/Injuries Involving RDNA

RDNA Incident Reporting Template


Toxin Experiments

Frequently Asked Questions on Toxin Experiments

Office of the Vice President for Strategic Initiatives