Charter
Institutional Biosafety Committee
University of Maryland Baltimore
July 2007
Purpose: The University of Maryland Baltimore (UMB) Institutional Biosafety Committee (IBC) will review recombinant DNA research conducted at or sponsored by UMB for compliance with the NIH Guidelines for Research Involving Recombinant DNA Molecules (NIH Guidelines) and approve those research projects that are found to conform with the NIH Guidelines. The UMB Risk Management Committee has also charged the IBC to review and approve research conducted with microorganisms pathogenic to humans, plants, or animals as well as research using select agents. The IBC will also provide recommendations to the Risk Management Committee for the development of University policies and procedures that will provide for the safe conduct of biomedical research and ensure compliance with local, state and federal regulations.
Membership: The Vice President for Administration, with assistance from the IBC, recruits and nominates Institutional Biosafety Committee members. The Biosafety Officer (BSO) is a permanent member and serves as an administrative resource. Committee members will be drawn from the University's schools, major functional units, and non-affiliated institutions to meet the requirements of the NIH Guidelines. At least two members shall not be affiliated with the University and will represent the interest of the community with respect to health and protection of the environment. Members will serve on the committee for an indefinite term.
Chairperson: The Vice President for Administration, with assistance from the IBC, recruits and appoints the chairperson of this committee.
Responsibilities: The IBC responsibilities are derived from those listed in the NIH Guidelines. The IBC will:
- Review recombinant DNA research conducted at or sponsored by the institution for compliance with the NIH Guidelines and approving those research projects that are found to conform with the NIH Guidelines
- Notify the Principal Investigator (PI) of the results of the IBC’s review and approval
- Lower containment levels for certain experiments as specified in Section III-D-2-a of the NIH Guidelines.
- Set containment levels that are not set by the NIH Guidelines.
- Periodically review recombinant DNA research conducted at the institution to ensure compliance with the NIH 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 Office of Biotechnology Activities (OBA) within 30 days, unless the IBC determines that a report has already been filed by the Principal Investigator.
The IBC may not authorize initiation of experiments that are not explicitly covered by the NIH Guidelines until NIH (with the advice of the RAC [Recombinant Advisory Committee] when required) establishes the containment requirement.
Procedures:
1. The administrative functions of the IBC will be handled by the Biosafety Division of the Department of Environmental Health and Safety (EHS). All recombinant DNA work, work involving the use of microorganisms pathogenic to humans, plants, or animals, and any work with Select Agents and Toxins at or sponsored by UMB will be registered through EHS.
2. Recombinant DNA research will be reviewed as follows:
- Experiments that require NIH and IBC approval prior to initiation- Section III A and III-B.
The BSO will review the registration and determine if it requires NIH and IBC approval before initiation. A registration packet will be submitted to the Recombinant DNA Advisory Committee (RAC) and the IBC. The IBC will review and approve all registrations in this category at a convened meeting.
- Experiments that require IBC and IRB approval and RAC review prior to research participant enrollment -III-C.
The BSO with coordination with the IRB will review the registration and determine if it requires RAC review and IBC approval prior to initiation. The IBC will review and approve all registrations in this category at a convened meeting.
- Experiments that require IBC approval before initiation- Section III-D.
The BSO will review the registration and determine if it requires IBC approval before initiation. The IBC will review and approve all registrations in this category at a convened meeting.
- Experiments that require IBC notice simultaneous with initiation- Section III-E.
The BSO will review the registration and determine if it requires notification of the IBC, and will inform the PI that the registration has been reviewed and the containment level that is required. The BSO will submit the registration at the next IBC meeting for review and comment. At this time, the committee may change the conditions of the approval if it feels this to be necessary.
- Experiments that are exempt from the NIH Guidelines -
Section III-F.
The BSO will review the registration and determine if it is exempt, and will inform the PI that the registration has been reviewed and the containment level that should be used. The IBC will not review exempt experiments.
3. Work involving the use of microorganisms pathogenic to humans, plants, or animals as well as Select Agents and Toxins will be reviewed as follows:
- Biosafety Level 2. The BSO will review registrations involving non-recombinant Risk Group (RG) 2 pathogens and notify the PI of the containment level required.
- Biosafety Level 3. The IBC will review and assign containment for all registrations involving non-recombinant RG 3 human pathogens at a convened meeting. The IBC will also approve all Standard Operating Procedures for work with RG 3 human pathogens.
- Select Agents and Toxins. The IBC will review and approve all registrations of Select Agents and Toxins at a convened meeting.
Quorum: A minimum of 5 members must be present at IBC meetings in order to conduct business.
Meetings: Meetings will be held monthly or at the call of the Chairperson.
Sub-committees: The Institutional Biosafety Committee has the authority to appoint subcommittees and ad hoc committees of subject matter experts to address specific issues.
Annual Review and Changes to this Charter: This charter will be reviewed annually. It may be modified or amended by approval of a majority of voting members of the IBC.
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