PI Responsibilities
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Principal Investigators (PI) who conduct research with recombinant or synthetic nucleic acid (r/s NA) molecules, including gene drive modified organism (GDMOs), are responsible for full compliance with the NIH Guidelines. These responsibilities include:
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- Obtain IBC approval (i.e., an “IBC Registration”)
- Be adequately trained in good microbiological techniques.
- Provide laboratory research staff with protocols describing potential biohazards and necessary precautions.
- Instruct and train laboratory staff in: (i) the practices and techniques required to ensure safety, and (ii) the procedures for dealing with accidents.
- Inform the laboratory staff of the reasons and provisions for any precautionary medical practices advised or requested (e.g., vaccinations or serum collection).
- Supervise laboratory staff to ensure that the required safety practices and techniques are employed.
- Correct work errors and conditions that may result in the release of r/s NA materials.
- Ensure the integrity of physical containment (e.g., biological safety cabinets) and biological containment (e.g., purity and genotypic and phenotypic characteristics).
- Comply with permit and shipping requirements for r/s NA molecules.
- Adhere to emergency plans for handling accidental spills and personnel contamination, found on the Environmental Health and Safety website.
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When conducting research subject to the NIH Guidelines, the PI must:
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- Determine the need for IBC review before modifying r/s NA research already approved by the IBC.
- Submit any subsequent changes (e.g., changes in the source of DNA, RNA? or host-vector system) to the IBC for review and approval.
- Remain in communication with the IBC throughout the duration of the project.
- Report any significant problems pertaining to the operation and implementation of containment practices and procedures, violations of the NIH Guidelines, or any significant research-related accidents and illnesses to the Biological Safety Officer.
Resources
Princeton University Office of Environmental Health and Safety's Biological Safety
The National Institutes of Health (NIH) (NIH Guidelines) specify the biosafety practices and containment principles for constructing and handling: (i) recombinant nucleic acid molecules, (ii) synthetic nucleic acid molecules, including those that are chemically or otherwise modified but can base pair with naturally occurring nucleic acid molecules, and (iii) cells, organisms, and viruses containing such molecules In addition, these guidelines mandate the establishment of an Institutional Biosafety Committee (IBC) for the review and oversight of biological research and outline roles and responsibilities for biosafety.
Biosafety in Microbiological and Biomedical Laboratories (BMBL) published by the Centers for Disease Control and Prevention is the code of practice for biosafety -- the discipline addressing the safe handling and containment of infectious microorganisms and hazardous biological materials.
The NIH Office of Science Policy (OSP) promotes science, safety, and ethics in biotechnology through advancement of knowledge, enhancement of public understanding, and development of sound public policies. OSP accomplishes its mission through analysis, deliberation, and communication of scientific, medical, ethical, legal, and social issues.
NIH Guidelines FAQs of Interest to the IBC
NIH OSP - Animal experiments covered under the NIH Guidelines for Research Involving Recombinant DNA Molecules provides a table for determining whether proposed breeding or creation of transgenic animals requires IBC review.
The National Select Agents Registry Program (NSAR) oversees the activities of possession of biological agents and toxins that have the potential to pose a severe threat to public, animal or plant health, or to animal or plant products. The NSAR currently requires registration of facilities including government agencies, universities, research institutions, and commercial entities that possess, use or transfer biological agents and toxins.
The U.S. Departments of Health and Human Services (DHHS) and Agriculture (USDA) implemented the provisions of Public Law 107-188, the "Public Health Security and Bioterrorism Preparedness Response Act of 2002" through a series of regulations. These regulations culminated with the publication of the final Select Agents Regulations (42 CFR Part 73, 7 CFR Part 331, 9 CFR Part 121) in the Federal Register on March 18, 2005. The Final Rules were published in the Federal Register on March 18, 2005 and became effective on April 18, 2005.
The "Public Health Security and Bioterrorism Preparedness and Response Act of 2002" (Public Law 107-188) requires that all persons possessing select biological agents or toxins deemed a threat to public health, animal or plant health, or animal or plant products register with the appropriate federal agency.
If you anticipate using Select Agents, you must contact the University Biosafety Officer (Meagan Fitzpatrick at 8-6258, [email protected]) regardless of the planned quantity. You should be aware that if registration is required for your work, the CDC registration process and security risk assessment through the FBI will take an estimated 8 weeks and possibly longer. Furthermore, sources of research funds to cover the costs of facility security improvements associated with compliance will need to be identified.
Research with certain high-consequence pathogens and toxins requires the IBC to serve as a screening mechanism for ensuring compliance with The United States Government Policy for Institutional Oversight of Life Sciences Dual Use Research of Concern. Additional information can be found here: https://ria.princeton.edu/research-biohazards/policies-and-guidelines/d…