Chapter 26

BIOSAFETY

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Work Process F. Institutional Biosafety Committee

Institutional Biosafety Committee (IBC) Charter

Policy and Purpose

Text Box:  
IBC meeting. Source: Berkeley Lab EHS.
IBC meeting. Source: Berkeley Lab EHS.

Berkeley Lab requires maintenance of a qualified Institutional Biosafety Committee (IBC) to perform key biosafety functions as required by and in accordance with this charter and the NIH, CDC, DOE, and Berkeley Lab standards.

The IBC is responsible for oversight, administration, and review of Berkeley Lab policies and projects involving research with biological materials that may pose safety, health, or environmental risks. The IBC reports to the Laboratory Director to provide institutional assurance that research is conducted safely. To this end, the IBC assists and advises researchers and line managers in meeting their responsibilities to ensure that the biological aspects of the research are conducted in a safe manner using established biosafety standards, principles and functions of Integrated Safety Management (ISM), and work authorization (e.g., ES&H Manual, Safe Work Authorizations). Safe research includes worker safety, public health, agricultural and environmental protection, ethics, and compliance with applicable biosafety standards and Berkeley Lab policies. A graded process is used to define, document, review, and approve biological work and controls as detailed in ES&H Manual, Biosafety. This process involves IBC approval and line management authorization of biological work.

Functions

Functions of the IBC include:

In this program, the IBC performs initial and periodic review and approval of required project biosafety documentation that demonstrates the work will be conducted in a safe manner. Researchers and line managers are responsible for identifying and submitting project documentation to the IBC prior to performing biological work and periodically thereafter. The IBC’s review includes:

o    Assessment of the containment levels, facilities, procedures, practices, training, and expertise of personnel involved in the proposed research and in comparison to biosafety standards;

o    Concurrence or approval of research projects that have adequate controls and conform to the biosafety standards; and

o    Notifying the PI of the results of the IBC’s review or approval

 

IBC Membership

The Laboratory Director formally appoints all IBC members, and IBC membership is for a minimum three-year period of service. IBC member nominations are managed in the following manner:

As required by NIH, the IBC must have at least five members that are selected to collectively have the experience, expertise, and capability needed to assess the breadth and safety of recombinant and other Berkeley Lab research with biological materials, agents, and organisms as needed to identify any potential risks to workers, public health, or the environment. Based on the types of research activities at Berkeley Lab, the IBC will normally have the following minimum representation:

IBC practices include:

The IBC may use consulting experts or establish working groups to execute its responsibilities or acquire needed expertise for select tasks. Consultants or working group members may include, for example, persons knowledgeable in institutional commitments and policies, applicable law, standards of professional conduct and practice, community attitudes, the environment, or any scientific area where the IBC members do not have expertise. Consultants or working group members are not IBC voting members unless nominated and appointed as described previously.

IBC Meetings

The IBC will conduct meetings approximately quarterly and as needed for the conduct of business. A proposed agenda will be developed and distributed before the meeting. Meetings will proceed with no less than five voting members present. Meeting minutes will be taken to accurately reflect the topics of discussion. Meeting minutes will be reviewed, approved by the members, and maintained on file. Meetings will be opened to the public, and minutes will be provided to the public, when requested by the public and in accordance with the scope and requirements of the NIH Guidelines.

IBC and Biosafety Standards

The following standards have specific requirements for IBCs and biological work:

Additional biosafety standards related to Berkeley Lab biological work are summarized below:

IBC Charter Approval

IBC members will review proposed amendments to this charter and make recommendations regarding adoption of amendments. The IBC Chair will submit IBC recommendations regarding charter amendments to the Laboratory Director. The Laboratory Director will approve amendments to the IBC Charter.

 

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