Institutional Biosafety Committee

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

• Assuring 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.
• Determining the biosafety level of research activities and ensuring that the appropriate procedures are followed.
• Reporting 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.
• Reporting any new information bearing on the NIH Guidelines to the IBC and NIH.
• Having adequate training in good microbiological techniques.
• Adhering to IBC-approved emergency plans for handling accidental spills and personnel contamination.
• Complying with shipping requirements for recombinant DNA molecules.

Information to Be Submitted by the PI to NIH/OBA

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

Submissions by the PI to the IBC

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

Responsibilities of the PI Before Initiating Research

• 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).

Responsibilities of the PI During the Conduct of the Research

• 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.

• Establishes policies and procedures to ensure the safe conduct of research involving biohazardous material in compliance with regulatory guidelines. This includes establishing an IBC.
• Provides for appropriate training regarding biosafety.
• Files required reports with the NIH.

Biosafety Roles and Responsibilities of the Institution

Abstracted from the NIH Guidelines

Overall Responsibilities

• Ensuring that research is conducted in accordance with regulatory guidelines pertaining to biosafety. This includes having policies that provide for the safe conduct of such research and establishing an Institutional Biosafety Committee (IBC).
• Appointing at least one individual with expertise in animal containment principles (who is a member of the IBC) if recombinant DNA research that requires IBC approval is conducted.
• When the institution conducts recombinant DNA research involving human subjects, ensuring that the IBC has adequate expertise and training; all aspects of Appendix M to the NIH Guidelines have been appropriately addressed by the Principal Investigator (PI) before submission to NIH/OBA; and no research participant will be enrolled in a human gene transfer experiment until the RAC review process has been completed, IBC approval has been obtained, Institutional Review Board (IRB) approval has been obtained and all applicable regulatory authorizations have been obtained.
• Ensuring appropriate training for the IBC Chair and members, Biological Safety Officer and other containment experts, PIs and laboratory staff regarding laboratory safety and implementation of and compliance with the biosafety regulations. The IBC Chair is responsible for ensuring that committee members are appropriately trained regarding IBC procedures and review criteria, and the PI is responsible for ensuring that laboratory staff are appropriately trained regarding laboratory-specific policies and procedures.
• Determining the necessity for health surveillance of personnel involved in connection with individual recombinant DNA projects.
• Reporting any significant problems, violations of the NIH Guidelines or any significant research-related accidents and illnesses to NIH/OBA within 30 days.
• Filing a required annual report with NIH/OBA that includes a roster and biographical sketches of all IBC members.

Biosafety Roles and Responsibilities of the Institutional Biosafety Committee

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 will comprise no fewer than 5 members (including 2 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; and 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.

Functions

• Reviewing research for compliance with the NIH, CDC and OSHA regulatory guidelines pertaining to biosafety and approving research projects. This review includes:
  • 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.

• Notifying the PI of the results of the IBC’s review and approval.
• Setting containment levels.
• Lowering containment levels for certain experiments.
• Periodically reviewing research to ensure compliance with the regulatory guidelines.
• Adopting emergency plans covering accidental spills and personnel contamination resulting from recombinant DNA research.
• Reporting 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.
• The IBC may not authorize initiation of experiments not explicitly covered by the NIH Guidelines until the NIH establishes the containment requirement.