::. Recombinant DNA Registration Program

Registration Document for Recombinant DNA Experiments, NIH Form 2690, is used to register all recombinant DNA (rDNA) work. The RD/HPRD Dual-Use Screening Survey must be submitted with NIH Form 2690. Principal Investigators (PI) working with rDNA must complete NIH Form 2690 and submit it to the NIH Institutional Biosafety Committee (IBC) Executive Secretary through the Division of Occupational Health and Safety (Bldg 13, Room 3K04) prior to the initiation of any experiment which requires approval under the NIH Guidelines for Research Involving Recombinant DNA Molecules. The NIH IBC, whose functions are defined under the Guidelines, reviews and approves research protocols involving the use of potentially infectious materials or rDNA techniques. The PI is responsible for compliance with the Guidelines in the conduct of rDNA research and ensuring that appropriate reviews and approvals are obtained prior to initiation of experiments. Principal Investigators (PI) working with rDNA must complete NIH Form 2690 submit it to the NIH Institutional Biosafety Committee (IBC) Executive Secretary through the Division of Occupational Health and Safety (Bldg 13, Room 3K04) prior to the initiation of any experiment which requires approval under the NIH Guidelines for Research Involving Recombinant DNA Molecules.

Please submit the RD/HPRD Dual Use-Screening Survey with the NIH Form 2690. In an effort to ensure that research performed at NIH is conducted and published in a timely manner with due consideration given to experiments potentially having dual-use concerns, the RD/HPRD Dual Use-Screening Survey must be completed prior to the initiation of research. A research project is considered dual-use in nature if the methodologies, materials or results could be used for public harm. It should be noted that an affirmative answer will not delay the progress of research, but indicates that further review and consideration may be warranted as the research advances.

When submitting the recombinant DNA registration and the RD/HPRD Dual-Use Screening Survey, the researcher should include a map of the vector and copy of the animal study proposal (if applicable). For more information, please contact your Safety and Health Specialist at (301) 496-2346.

• Registration Document for Recombinant DNA Experiments
• RD/HPRD Dual-Use Screening Survey
• The NIH Guidelines for Research Involving Recombinant DNA Molecules
• Guide to the NIH Guidelines for Recombinant DNA Research NIH Intramural Investigators
• Notice of NIH Guideline Compliance and Recent Changes

::. Human Pathogen Registration Program

At the NIH, the principal method by which potential exposure information for laboratory personnel is gathered is with the Registration of Materials (Potentially) Infectious for Humans form otherwise known as the Human Pathogen Registration Document (HPRD). All Principal Investigators (PIs) working with human pathogens; human blood, body fluids, or tissues; biological toxins; and the blood, tissues, or body fluids of old-world non-human primate (NHP) species must submit a properly completed HPRD to the NIH Biosafety Officer for subsequent review by the NIH IBC. Please submit the RD/HPRD Dual-Use Screening Survey with the Human Pathogen Registration Document (HPRD). The NIH Biosafety Officer is located in Bldg. 13, Room 3K-04. When submitting the HPRD, the Principal Investigator should include a copy of the animal study proposal (if applicable). For more information, please contact your Safety and Health Specialist at (301) 496-2346.

Please submit the RD/HPRD Dual Use-Screening Survey with the HPRD Form. In an effort to ensure that research performed at NIH is conducted and published in a timely manner with due consideration given to experiments potentially having dual-use concerns, the RD/HPRD Dual Use-Screening Survey must be completed prior to the initiation of research. A research project is considered dual-use in nature if the methodologies, materials or results could be used for public harm. It should be noted that an affirmative answer will not delay the progress of research, but indicates that further review and consideration may be warranted as the research advances. For more information, please contact your Safety and Health Specialist at (301) 496-2346.

National Institutes of Health (NIH) employees are at risk of infection and subsequent illness as a consequence of exposure to human blood or other potentially infectious body fluids and agents potentially infectious to humans. Risks also exist related to exposure to the blood, tissues, and body fluids of certain non-human primate (NHP) species. Therefore, this Exposure Control Program (ECP) has been developed to minimize employee exposure to bloodborne pathogens, such as Hepatitis B virus (HBV) and human immunodeficiency virus (HIV).

This ECP establishes the policy for the implementation of procedures that relate to the control of infectious diseases that may be contracted by the bloodborne route. The ECP is in compliance with the Occupational Safety and Health Administration (OSHA) Bloodborne Pathogens Standard (29 CFR 1910.1030) and serves as both the written program, for compliance purposes, and as a training document.

For more information, please contact your Safety and Health Specialist at (301) 496-2346.