Institutional Biosafety Committee

The Principal Investigator

Biosafety Roles and Responsibilities

Abstracted From the NIH Guidelines

The PI is responsible for full compliance with regulations in the conduct of research and for ensuring that the reporting requirements are fulfilled and will be held accountable for any reporting lapses.

Overall Responsibilities

PIs are required to:

• Assure that regulated activities have been approved by the IBC and that all other regulatory and safety requirements have been met prior to the initiation of a research project.
• Determine the biosafety level of research activities and ensuring that the appropriate procedures are followed.
• Report any significant problems, violations of the NIH guidelines, or any significant research-related accidents and illnesses to the IBC, NIH/OBA and other appropriate authorities (if applicable) within 30 days.
• Report any new information bearing on the NIH guidelines to the IBC and NIH.
• Have adequate training in good microbiological techniques.
• Adhere to IBC-approved emergency plans for handling accidental spills and personnel contamination.
• Comply with shipping requirements for recombinant DNA molecules.

PI Submissions to the NIH/OBA

PIs will:

• Submit information for certification of new host-vector systems.
• Petition, with notice to the IBC, for proposed exemptions to the NIH guidelines.
• Petition, with concurrence of the IBC, for approval to conduct certain experiments (see Sections III-A-1 & III-B).
• Petition for determination of containment for experiments requiring case-by-case review.
• Petition for determination of containment for experiments not covered by the NIH guidelines.
• Ensure that all aspects of Appendix M have been appropriately addressed before submitting a human gene transfer experiment to the NIH.

PI Submissions to the IBC

PIs will: 

• Submit initial determination of the required levels of physical and biological containment in accordance with the NIH/CDC and OSHA regulatory guidelines.
• Submit selection of appropriate microbiological practices and laboratory techniques to be used for the research.
• Submit the initial research protocol and any subsequent changes to the IBC for review and approval or disapproval.
• Remain in communication with the IBC throughout the project.

PI Responsibilities Before Initiating Research

Before research begins, PIs will:

• Make available to all laboratory staff the protocols that describe the potential biohazards and the precautions to be taken.
• Instruct and train laboratory staff in the practices and techniques required to ensure safety and 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).

PI Responsibilities While Conducting Research

During research, PIs will:

• Supervise the safety performance of the laboratory staff to ensure that the required safety practices and techniques are employed.
• Investigate and report any significant problems pertaining to the operation and implementation of containment practices and procedures in writing to the IBC, NIH/OBA and other appropriate authorities (if applicable).
• Correct work errors and conditions that may result in the release of recombinant DNA materials.
• Ensure the integrity of the physical and biological containment.
• Comply with reporting requirements for human gene transfer experiments conducted in compliance with the NIH guidelines.

The Institutional Biosafety Committee

Biosafety Roles and Responsibilities

Abstracted from the NIH Guidelines

Overall Responsibilities

At Nemours, the IBC oversees the use, storage and shipping of recombinant DNA, infectious agents and biohazardous materials in the course of research.

Membership and Procedures

• The IBC should comprise of no fewer than five members (including two not affiliated with the institution) that collectively have experience and expertise in recombinant DNA technology and the capability to assess the safety of recombinant DNA research and to identify any potential risk to public health or the environment.
• The IBC should:
  • Include people with expertise in recombinant DNA technology, biological safety and physical containment.
  • Include, or have available as consultants, people knowledgeable in institutional commitments and policies, applicable law, standards of professional conduct and practice, community attitudes and the environment.
  • Include at least one member representing the laboratory technical staff.
• No IBC member may be involved in the review or approval of a project in which he or she has been or expects to be engaged or has a direct financial interest.
• The institution can establish procedures that the IBC will follow in its initial and continuing review and approval of applications, proposals and activities.
• When possible, the institution is encouraged to open its IBC meetings to the public, and meeting minutes and proceedings will be accessible to the public.

IBC Functions

The IBC will: 

• Review research for compliance with the NIH, CDC and OSHA regulatory guidelines pertaining to biosafety and approving research projects, including:
  • Independent assessment of biosafety containment levels.
  • Assessment of the facilities, procedures, practices and training and expertise of personnel involved in research.
  • Ensuring that all aspects of NIH guidelines/Appendix M have been appropriately addressed by the PI
  • Ensuring that no research participant is enrolled in a human gene transfer experiment until the NIH-RAC review process has been completed, IBC approval has been obtained, IRB approval has been obtained and all applicable regulatory authorizations have been obtained.
  • For human gene transfer protocols selected for public RAC review and discussion, consideration of the issues raised and recommendations made and consideration of the PIs response to the RAC recommendations.
  • Ensuring that final IBC approval is granted only after the RAC review process has been completed.
  • Ensuring compliance with all surveillance, data reporting and adverse event reporting requirements.

• Notify the PI of the results of the IBC’s review and approval.
• Set containment levels.
• Lower containment levels for certain experiments.
• Review research periodically to ensure compliance with the regulatory guidelines.
• Adopt emergency plans covering accidental spills and personnel contamination resulting from recombinant DNA research.
• Report any significant problems with or violations of the NIH guidelines and any significant research-related accidents or illnesses to the appropriate institutional official and NIH/OBA within 30 days.
• Not authorize initiation of experiments not explicitly covered by the NIH guidelines until the NIH establishes the containment requirement.