Conducting Research

All Principal Investigators who conduct research at institutions that are subject to the NIH Guidelines must comply with the requirements even if the NIH does not directly fund their own research projects. Section IV-B-7 of the NIH Guidelines states, "on behalf of the institution, the Principal Investigator is responsible for full compliance with the NIH Guidelines." Please refer to NIH Guidelines for more specific details of Principal Investigator Responsibilities.

Principal Investigator Responsibilities

Principal Investigators (PIs) are responsible for full compliance with the NIH Guidelines during the conduct of research involving recombinant or synthetic nucleic acid molecules. As part of this general responsibility, the PI should:

• 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 or synthetic nucleic acid materials.
• Make an initial determination of the required biosafety level (BSL) for containment practices and procedures and the applicable NIH Section classification.
• Ensure the integrity of physical containment (e.g., biological safety cabinets) and biological containment (e.g., host-vector systems that preclude survival of the agent outside the laboratory.)
• 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.

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 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.
• 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:

• Refrain from initiating or modifying research that requires IBC approval until the research or proposed modification has been IBC approved.
• 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 or illnesses to the IBC, NIH, and other appropriate authorities. Examples of significant problems: skin puncture with needle containing r/sNA, escape of transgenic animal, spill of high-risk materials outside of a biosafety cabinet.

Send questions to IBC@up.edu.