IBC Investigator Responsibilities

IBC Investigator Responsibilities

Principal Investigator Responsibilities

Principle 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.
  • 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 the IBC-approved emergency plans for handling accidental spills and personnel containment.

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.
  • Seek NIH OBA’s determination regarding containment for experiments that require case-by-case review.
  • Petition NIH 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 the 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 or synthetic nucleic acid 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 IBC, NIH OBA, and, as applicable, the Biological Safety Officer, and other appropriate authorities.

PIs conducting human gene transfer research subject to Section III-C of the NIH Guidelines must:

  • Ensure that all aspects of Appendix M have been appropriately addressed prior to submission of a human gene transfer experiment to NIH OBA for review by the NIH Recombinant DNA Advisory Committee (RAC).
  • Provide a letter signed by the PI(s) on institutional letterhead acknowledging that the documentation being submitted to NIH OBA complies with the requirements set forth in Appendix M.
  • Not enroll research participants in a human gene transfer clinical trial until the RAC review process has been completed; IBC approval (from the clinical trial site) has been obtained; Institutional Review Board approval has been obtained; and all applicable regulatory authorization(s) have been obtained.
  • Comply with reporting requirements for human gene transfer experiments (Appendix M-I-C of NIH Guidelines).