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Institutional Biosafety Committee
University of Maryland, Baltimore
Purpose: The University of Maryland, Baltimore (UMB) President, acting through the UMB Chief Academic and Research Officer (CARO), has charged to the UMB Institutional Biosafety Committee (IBC) to review recombinant and synthetic nucleic acid molecule research conducted at or sponsored by UMB for compliance with the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (“NIH Guidelines”) and approve or disapprove those research projects in accordance with the publication Biosafety in Microbiological and Biomedical Laboratories 5th edition and their compliance with the NIH Guidelines. The IBC also provides oversight of research conducted with microorganisms pathogenic to humans, plants, or animals; research using Biological Select Agents and Toxins (BSAT); and research using human tissue, blood, or cell cultures.
The IBC will coordinate its protocol review processes with UMB Institutional Review Board (IRB) review when a protocol requires review by both committees. Similarly, the IBC will coordinate its review processes with the UMB Institutional Animal Care and Use Committee (IACUC) when review by both committees is required. When an IRB or IACUC protocol also requires review by the IBC, the work described in the protocol may not commence until both committees have approved the research. By separate agreement, the IBC will perform specified review functions for affiliated institutions.
The IBC will provide recommendations to the UMB CARO for the development of University policies and procedures that will promote safe conduct of biomedical research and compliance with local, state and federal regulations.
Membership: The UMB Biosafety Officer (BSO), in consultation with the IBC, recruits and appoints IBC members. Committee members will be drawn from UMB’s schools, major functional units, and non-affiliated institutions to meet the requirements of the NIH Guidelines. Members will serve on the IBC for three-year terms, and may be reappointed to successive terms.
The BSO, in consultation with the IBC and the CARO, may remove a Committee member when necessary, e.g., due to resignation, excessive absence, lack of contribution, or unavailability.
There will be a minimum of five members. Additional membership requirements are as follows:
- The BSO is a permanent voting member and serves as an administrative resource.
- At least two members shall be persons who are not affiliated with UMB; those members will represent the interest of the community with respect to health and protection of the environment.
- At least one member will be a person with expertise in animal containment principles.
- At least one member will possess expertise in human research in the event that a registration involves the use of recombinant or synthetic nucleic acid molecules in human research participants. (Unlike the other membership requirements, this can be met by either a full or ad hoc member.)
Chairperson: The BSO, in consultation with the IBC, nominates candidates for the chairperson of the committee from the membership. The CARO appoints the chairperson. In the usual case, the chairperson will be a full-time faculty member of UMB. Responsibilities of the chairperson include oversight of IBC meetings and being a point of contact for the NIH. As specified by the NIH Guidelines, the chairperson is responsible for ensuring that IBC members are appropriately trained (Section IV-B-1-h).
Vice Chairperson: The chairperson, in consultation with the BSO, shall recruit and invite a vice chairperson to fulfill the duties of the chairperson in his or her absence or recusal. The CARO appoints the vice chairperson. If both the chairperson and vice chairperson are unavailable for a scheduled meeting, the BSO may decide to postpone business or appoint a temporary substitute.
Responsibilities: The IBC responsibilities are derived from those listed in the NIH Guidelines and the “United States Government Policy for Institutional Oversight of Life Sciences Dual Use Research of Concern” (“USG Policy”). The IBC will:
- Review research with recombinant or synthetic nucleic acid molecules conducted at or sponsored by UMB, for compliance with the NIH Guidelines, approving those research projects that are found to conform to the NIH Guidelines.
- Notify the Principal Investigator (PI) of the results of the IBC’s review and approval or disapproval.
- Lower containment levels for certain experiments as specified in Section III-D-2-a of the NIH Guidelines.
- Set containment levels for experiments specified in Section III-D-4-b or for other experiments that are not set by the NIH Guidelines.
- Periodically (typically annually) review recombinant or synthetic nucleic acid molecule research conducted at UMB for compliance with the NIH Guidelines.
- Adopt emergency plans covering accidental spills and personnel contamination resulting from recombinant or synthetic nucleic acid molecule research.
- Report any significant problems with or violations of the NIH Guidelines and any significant research-related accidents or illnesses to the CARO and NIH Office of Science Policy (OSP) in accordance with the NIH Guidelines, unless the IBC determines that an adequate report has already been filed by the PI.
- File a report with OSP which includes an up-to-date roster of all IBC members whenever a change in membership occurs or when the previous registration has expired (one year from submission).
- Review research with infectious agents conducted at or sponsored by UMB for applicability of the USG Policy (see section on “Dual Use Research” for more information).
The IBC may not authorize initiation of research or experiments that are not explicitly covered by the NIH Guidelines until NIH establishes the containment requirement.
Procedures: The administrative functions of the IBC will be handled by the Biosafety staff of the UMB Office of Environmental Health and Safety (EHS). The following research conducted at or sponsored by UMB will be registered through EHS:
- All recombinant or synthetic nucleic acid molecule work (see 1 below).
- Work involving the use of microorganisms pathogenic to humans, plants, or animals (see 2 below).
- Any work with BSAT, including research with botulinum toxins at any quantity (see 2 below),
- Work involving human tissue, blood, or cell cultures (see 3 below).
1. Recombinant or synthetic nucleic acid molecule research will be reviewed as follows:
A. Experiments that require NIH and IBC approval prior to initiation (Sections 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 NIH OSP and the IBC. The IBC will review and approve or disapprove all registrations in this category at a convened meeting.
B. Experiments that require IBC and IRB approval prior to research participant enrollment (Section III-C).
The BSO with coordination with the IRB will review the registration and determine if it requires IBC approval prior to initiation. The IBC will approve or disapprove the registration at a convened meeting.
C. 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 or disapprove all registrations in this category at a convened meeting.
D. 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. The IBC may change the conditions of the approval at any time it deems necessary to ensure UMB compliance.
E. 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 vote on exempt experiments.
2. Work involving the use of microorganisms pathogenic to humans, plants, or animals as well as BSAT will be reviewed as follows:
A. Risk Group 2
The BSO will review registrations involving non-recombinant Risk Group (RG) 2 pathogens and notify the PI of the containment level required.
B. Risk Group 3
The IBC will review and assign containment for all registrations involving non-recombinant RG 3 human pathogens at a convened meeting. The IBC also will approve or disapprove all Standard Operating Procedures for work with RG 3 human pathogens.
C. Risk Group 4
Research with RG 4 pathogens is currently not permitted at UMB.
D. Biological select agents and toxins (BSAT)
The IBC will review and approve or disapprove all registrations of BSAT (as defined by 42 CFR Part 73, 7 CFR Part 331, and 9 CFR Part 121) at a convened meeting. Research involving botulinum toxins at quantities considered exempt from BSAT regulation must still be registered with the IBC so that it may be reviewed by the Institutional Review Entity for potential Dual Use Research of Concern.
3. Work involving human materials, such as tissue, blood, or cell cultures, will be reviewed by the BSO, who will notify the PI of the containment level required.
Meetings: Meetings will be held monthly or at the call of the chairperson. When possible and consistent with protection of privacy and proprietary interests, IBC meetings will be open to the public (NIH Guidelines, Section IV-B-2-a-6).
Quorum and Voting: A minimum of 5 members must be present at IBC meetings in order to conduct business. If the quorum does not include at least one member who is not affiliated with UMB, the chairperson may defer action on items in order to permit their consideration with community input. Only protocols receiving approval of a majority of votes of members in attendance will be approved by the IBC. The CARO has authority to disapprove a protocol approved by IBC, but may not approve a protocol subject to IBC review that has not received IBC approval.
When conducting a vote on an IBC protocol, the person running the meeting shall explicitly present an opportunity for dissension. Votes against a motion are kept anonymous in the minutes by default. Notation of a dissenter's name will only be included at his or her explicit request. If a member or members choose to vote against a motion, the BSO will determine if the dissenting vote(s) are "major" or "minor."
- If the dissenting vote is considered "minor" (e.g., a change in wording is needed), a sentence will be included in the minutes describing the reasoning behind the dissent.
- If the dissenting vote is considered "major" (e.g., belief that the risk of the work outweighs the scientific advancement), a minority opinion will be written and delivered to the CARO in addition to notation on the minutes.
IBC Minutes: Minutes will be reviewed by the chairperson and then released to all committee members for review. The minutes will be voted on by the IBC at the next convened meeting before being considered final.
At a minimum, NIH-advised minutes should reflect the date and place of the meeting, whether minutes of the prior meeting were approved, individuals in attendance, whether and why the meeting was open or closed, all major motions, major points of order, and whether motions were approved. In general, the minutes should offer sufficient detail to serve as a record of major points of discussion and the committee’s rationale for particular decisions, documenting that the IBC has fulfilled its review and oversight responsibilities as outlined under Section IV-B-2-b of the NIH Guidelines. Minutes do not need to be transcripts or kept at a level of detail that attributes each remark to a specific individual.
Confidentiality: Upon request, UMB shall make IBC meeting minutes available to the public (NIH Guidelines, Section IV-B-2-a-7). If public comments are made on IBC actions, the BSO will forward both the public comments and the IBC’s response to OSP.
It is expected that IBC members will not disclose the details of meetings or associated submissions with individuals not affiliated with the IBC. Such disclosures could compromise Principal Investigators’ research goals and proprietary interests as well as the willingness of members to conduct open discussions. Members contacted for information should forward requests to the BSO, who will consult with the Office of University Counsel and the Office of Media Relations as appropriate.
Conflict of Interest: IBC members must disclose to the Committee any potential, actual, or perceived conflict of interest of a financial, professional, or personal nature that may affect any aspect of the research, and compliance with applicable UMB, state and federal requirements regarding conflict of interest. The individual who has disclosed a conflict will be recused from voting on the specific matter but may provide information requested by the IBC. A notation will be made in the meeting minutes indicating that a recusal occurred. A PI that is not an IBC member is permitted to attend the IBC meeting at which his or her submission will be discussed in order to provide information to the committee, but that PI will not be present during deliberation and voting.
Subcommittees: The IBC has the authority to appoint subcommittees and ad hoc committees of subject matter experts to address specific issues.
Dual Use Research: The IBC screens all registrations involving infectious agents for potential Dual Use Research and Dual Use Research of Concern (DURC). If research does not involve an agent or toxin listed in Table 1, but does fit one or more of the categories of experiments listed in Table 2, the IBC may require a risk/benefit analysis, risk mitigation plan, and other applicable documents as a condition of IBC approval.
Table 1. Agents and Toxins Covered by the US Government Policies on DURC
- Avian influenza virus (highly pathogenic)
- Bacillus anthracis
- Botulinum neurotoxin (any quantity)
- Burkholderia mallei
- Burkholderia pseudomallei
- Ebola virus
- Foot-and-mouth disease virus
- Francisella tularensis
- Marburg virus
- Reconstructed 1918 Influenza virus
- Rinderpest virus
- Toxin-producing strains of Clostridium botulinum
- Variola major virus
- Variola minor virus
- Yersinia pestis
Table 2. Categories of Experiments/DURC Effects
- Enhances the harmful consequences of the agent or toxin
- Disrupts immunity or the effectiveness of an immunization against the agent or toxin without clinical and/or agricultural justification
- Confers to the agent or toxin resistance to clinically and/or agriculturally useful prophylactic or therapeutic interventions against that agent or toxin or facilitates their ability to evade detection methodologies
- Increases the stability, transmissibility, or the ability to disseminate the agent or toxin
- Alters the host range or tropism of the agent or toxin
- Enhances the susceptibility of a host population to the agent or toxin
- Generates or reconstitutes an eradicated or extinct agent or toxin
If the research involves a non-attenuated form of one or more of the fifteen listed agents and toxins (Table 1), IBC membership will convene at a separate, stand-alone meeting as the Institutional Review Entity (IRE) to perform the following duties(based upon the USG Policy, Section 7.2):
- Assess whether the research produces, aims to produce, or is reasonably anticipated to produce one or more of the seven DURC effects (Table 2). Even if the PI does not self-identify DURC in the registration submission, the IRE will still perform this duty.
- If the conditions detailed in step 1 are met, the IRE will then assess whether the research fits the following definition of DURC: “Life sciences research that, based on current understanding, can be reasonably anticipated to provide knowledge, information, products, or technologies that could be directly misapplied to pose a significant threat with broad potential consequences to public health and safety, agricultural crops and other plants, animals, the environment, materiel, or national security.”
- Regardless of whether or not the IRE determines the definition is met, the Institutional Contact for Dual Use Research (ICDUR) will make the required notification to the U.S. Government (USG) funding agency or NIH within 30 days.
- Once the IRE identifies a registration as containing DURC using the criteria outlined above, the ICDUR will notify the CARO. The ICDUR will then notify the DURC Subcommittee of the IRE for their need to fulfill the remaining requirements of the USG Policy.
IRE Minutes: As per the 2015 OSP guidance document entitled “USG Policy for Institutional Oversight of Life Sciences DURC: Points to Consider when Using an IBC as an IRE,” the minutes of stand-alone IRE meetings must be distinct from those of IBC meetings and are not subject to the NIH Guidelines, Section IV-B-2-a-(7). IRE meeting minutes are public records of the State of Maryland which may be held confidential as executive advisory communications, or, may be subject to disclosure, depending on circumstances and as required by law. Minutes will be reviewed by the ICDUR before being considered final. Minutes will be made available on a confidential basis to IRE members for review, to the CARO and to UMB officials on a need to know basis.
Institutional Contact for Dual Use Research (ICDUR): The BSO will serve in this role. The ICDUR acts as liaison between the institution and the relevant program officers at the USG funding agencies, or for non-USG funded research, between the institution and the NIH (or the USG agency which NIH refers the institution). The CARO will be consulted during this process.
Appeal of Identification as DURC: The PI of a project may appeal the identification of a project as DURC in writing to the CARO. The CARO will then assure that the proper procedures were followed as outlined in the USG Policy. Upon consultation with the CARO, the chairperson and ICDUR will jointly rule on the appeal.
The appeals process will not prevent the ICDUR from communicating the IRE’s finding to the USG funding agency/NIH within 30 calendar days, as required by the USG Policy. If the USG funding agency (or NIH) classifies research as DURC, their decision supersedes the appeals process.
Annual Review and Changes to this Charter: This charter will be reviewed annually by the IBC. It may be modified or amended by approval of a majority of voting members of the IBC.
- BSAT — Biological Select Agents and Toxins
- BSO — Biological Safety Officer
- CARO — Chief Academic and Research Officer
- DURC — Dual Use Research of Concern
- EHS — Environmental Health and Safety
- IACUC — Institutional Animal Care and Use Committee
- IBC — Institutional Biosafety Committee
- ICDUR — Institutional Contact for Dual Use Research
- IRB — Institutional Review Board
- IRE — Institutional Review Entity
- NIH — National Institutes of Health
- OSP — Office of Science Policy
- RG — Risk Group
- UMB — University of Maryland, Baltimore
- USG — United States Government