Appendix F - NIH Oversight of Research Involving Recombinant DNA
The NIH Guidelines for Research Involving Recombinant DNA Molecules (https://osp.od.nih.gov/wpcontent/uploads/NIH_Guidelines.html) contain procedures for the containment of rDNA research. The
Guidelines apply to all institutions that receive NIH funding for rDNA. All Investigators at the institution
must comply with the Guidelines, even if their individual research is not funded by NIH. Consequences
of noncompliance include suspension, limitation, or termination of NIH funds for rDNA research at the
institution, or a requirement for prior NIH approval of rDNA projects at the institution.
The original guidelines were issued in 1976 due to public concern for safety, environmental impact, and
ethical implications of rDNA research. The purpose of the guidelines is to specify safe handling practices
and containment levels for rDNA molecules, organisms and viruses containing rDNA molecules, and
transgenic animals.
Responsibilities under the Guidelines:
The Institution must: establish an Institutional Biosafety Committee to ensure compliance with
the NIH Guidelines by investigators and report any significant problems, violations or significant
research-related accidents or illnesses to NIH within 30 days.
The Institutional Biosafety Committee must: review, approve and oversee rDNA research to
ensure compliance with the Guidelines, determine necessity of health surveillance of
personnel, ensure training for IBC members, staff, PIs, and laboratory staff,
set biosafety containment levels as required by the Guidelines for some experiments under IIID-4-b
Incident Reporting to NIH
The following incidents must be reported to NIH OBA within 30 days: any significant problems or
violations of the NIH Guidelines, e.g. failure to adhere to the containment and biosafety practices in the
Guidelines, any significant research-related accidents and illnesses, e.g. spill or accident leading to
personal injury or illness or a breach in containment, e.g. escape or improper disposition of a transgenic
animal.
The following incidents require immediate reporting to NIH OBA: spills or accidents involving rDNA
requiring BSL2 containment resulting in an overt exposure, e.g. needlestick; splash in eyes, nose, mouth;
or accidental aerosolization/inhalation.