Principal Investigator Responsibilities
Principal Investigators (PI) who conduct recombinant DNA research are responsible for full compliance with the NIH Guidelines. These responsibilities include:
- 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 recombinant DNA 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 recombinant DNA molecules.
- Adhere to Institutional Biosafety Committee (IBC)-approved emergency plans for handling accidental spills and personnel contamination, found in the University biosafety manual.
Before initiating research subject to the NIH Guidelines, the PI 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 appropriate microbiological practices and laboratory techniques to be used for the research.
- Submit a completed Memorandum of Understanding and Agreement (MUA) to the IBC for review and approval.
- Seek NIH Office of Biotechnology Activities (OBA)'s determination of containment for experiments that require case-by-case review.
- Petition OBA, 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 Guidelines.
While conducting research subject to the NIH Guidelines, the PI must:
- Determine the need for IBC review before modifying recombinant DNA research already approved by the IBC.
- 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 Biological Safety Officer or IBC Chairperson.