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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.
- 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.
- 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.
Lab Incidents/Injuries Involving RDNA
RDNA Incident Reporting Template
Toxin ExperimentsFrequently Asked Questions on Toxin Experiments