Principal Investigators (PIs) are responsible for full compliance with the NIH Guidelines during the conduct of research involving recombinant or synthetic nucleic acid molecules.
Before research begins, investigators must:
- Determine whether the research is subject to Section III-A, III-B, III-C, III-D, or III-E of the NIH Guidelines.
- Propose physical and biological containment levels in accordance with the NIH Guidelines when registering research with the IBC.
- Propose appropriate microbiological practices and laboratory techniques to be used for the research.
- Submit a research protocol to the IBC for review and approval.
- Seek NIH OSP’s determination regarding containment for experiments that require case-by-case review.
- Petition NIH OSP, with notice to the IBC, for proposed exemptions from the NIH Guidelines.
- Obtain IBC approval before initiating research subject to the NIH Guidelines.
- Seek NIH approval, in addition to IBC approval, to conduct experiments specified in Sections III-A and III-B of the NIH Gui
- Provide laboratory research staff with protocols describing potential biohazards and necessary precautions.
- Inform the laboratory staff of the reasons and provisions for any precautionary medical practices advised or requested (e.g., vaccinations or serum collection).
During research, investigators must:
- Maintain current training appropriate for their research program and ensure that personnel obtain and maintain this training as well.
- 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 recombinant or synthetic nucleic acid materials.
- Warn laboratory staff of use of materials that may present an increased danger to researchers with unusual health conditions (e.g., pregnancy, respiratory conditions like cystic fibrosis or chronic obstructive pulmonary disease).
- Comply with permit and shipping requirements for recombinant or synthetic nucleic acid molecules.
- Adhere to IBC-approved emergency plans for handling accidental spills and personnel contamination.
- Determine the need for IBC review before modifying recombinant or synthetic nucleic acid research already approved by the IBC.
- Using RCS, submit any subsequent changes (e.g., changes in the source of DNA or host-vector system) to the IBC for review and approval or disapproval.
- 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 IBC, NIH OSP, and, as applicable, the Biological Safety Officer, Greenhouse or Animal Facility Director, and other appropriate authorities.