Institutional Biosafety Committee

University of Maryland, Baltimore

April 2025

Use these anchor links below to get to an IBC Charter section:

Purpose | Institutional Official | Membership | Chairperson | Vice Chairperson | Responsibilities | Procedures | Meetings | Quorum and Voting | IBC Minutes | Confidentiality | Conflict of Interest | Subcommittees | Dual Use Research | Institutional Contact for Dual Use Research (ICDUR) | IRE Minutes | Appeal of Identification as DURC | Annual Review and Changes to this Charter | Abbreviation Index

Purpose: 

The University of Maryland, Baltimore (UMB) President has charged 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 6th 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 UMB administration for the development of University policies and procedures that will promote safe conduct of biomedical research and compliance with local, state and federal regulations.

Institutional Official: 

The Institutional Official (IO) is the individual who, as a representative of senior administration, bears ultimate responsibility for the IBC and can act on the University’s behalf. The IO of the UMB IBC is Dr. Bruce Jarrell, President of the University.

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 Chairperson, 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: 

1. The BSO is a permanent voting member and serves as an administrative resource.
2. 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. 
3. At least one member will be a person with expertise in animal containment principles.
4. 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 IO 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 IO 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 Oversight of Dual Use Research of Concern and Pathogens with Enhanced Pandemic Potential” (“USG Policy”).

The IBC will:

1. 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.
2. Notify the Principal Investigator (PI) of the results of the IBC’s review and approval or disapproval.
3. Lower containment levels for certain experiments as specified in Section III-D-2-a of the NIH Guidelines.
4. Set containment levels for experiments specified in Section III-D-4-b or for other experiments that are not set by the NIH Guidelines.
5. Periodically (typically annually) review recombinant or synthetic nucleic acid molecule research conducted at UMB for compliance with the NIH Guidelines.
6. Adopt emergency plans covering accidental spills and personnel contamination resulting from recombinant or synthetic nucleic acid molecule research.
7. Report any significant problems with or violations of the NIH Guidelines and any significant research-related accidents or illnesses to the President 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.
8. 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).
9. Review research with infectious agents and Select Toxins conducted at or sponsored by UMB for applicability of the USG Policy (see the 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 Department 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 molecules 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 Select Toxins at exempt quantities (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:

• Experiments that require NIH and IBC approval prior to initiation (Sections III-A and III-B).
  • Biosafety staff 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.
• Experiments that require IBC and IRB approval prior to research participant enrollment (Section III-C).
  • Biosafety staff 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.
• Experiments that require IBC approval before initiation (Section III-D).
  • Biosafety staff 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.
• Experiments that require IBC notice simultaneous with initiation (Section III-E).
  • Biosafety staff 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. 
• Experiments that are exempt from the NIH Guidelines (Section III-F).
  • Biosafety staff 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: 

• Risk Group 2
  • Biosafety staff will review registrations involving non-recombinant Risk Group (RG) 2 pathogens and notify the PI of the containment level required. All protocols involving non-recombinant SARS-CoV-2 stocks and/or propagation will be reviewed by the IBC at a convened meeting.

• 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. 

• Risk Group 4
  • Research with RG 4 pathogens is currently not permitted at UMB. 

• 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 Select 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 Biosafety staff, 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 the 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 five 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 IO 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 IO 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. As with the IBC, a minimum of five members must be present at any subcommittee meeting in order to do business. The BSO will serve as a member of all IBC subcommittees ex officio. The chairperson of each subcommittee will be appointed as needed, but the IBC IO will retain oversight.

Dual Use Research:

The IBC screens all registrations involving infectious agents for potential Dual Use Research, Dual Use Research of Concern (DURC; also referred to as Category 1 Research), and the involvement of Pathogens with Enhanced Pandemic Potential (PEPP; also referred to as Category 2 Research). 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. 

The IBC at its convened meetings will assess all protocols under review for involvement of agents and/or toxins listed in Table 1, including making a determination if a pathogen will be classified as a PPP. If a protocol does include an agent and/or toxin from Table 1, IBC membership will convene a separate, stand-alone meeting as the Institutional Review Entity (IRE) to perform the following duties (based upon section 5.2 of the USG Policy):

1. Assess whether the research produces, aims to produce, or is reasonably anticipated to produce one or more of the experimental outcomes listed in Table 2. Even if the PI does not self-identify one of the outcomes in the registration submission, the IRE will still perform this duty.
2. If the conditions detailed in step 1 are met, the IRE will then assess whether the research meets either of the following definitions:

a. Category 1 Research: "Based on current understanding, the research can be reasonably anticipated to provide, or does provide, knowledge, information, products, or technologies that could be misapplied to do harm with no — or only minor — modification to pose a significant threat with potential consequences to public health and safety, agricultural crops and other plants, animals, the environment, materiel, or national security."

b. Category 2 Research: "The research can be reasonably anticipated to result in the development, use, or transfer of a PEPP or an eradicated or extinct PPP that may pose a significant threat to public health, the capacity of health systems to function, or national security."

When the IRE identifies a registration as containing Category 1 and/or Category 2 Research using the criteria outlined above, the Institutional Contact for Dual Use Research (ICDUR) will notify the IO and organize a DURC/PEPP Subcommittee to fulfill the remaining requirements of the USG Policy, including semi-annual review of approved Category 1 and/or 2 projects. 

Institutional Contact for Dual Use Research (ICDUR):

The ICDUR is appointed by the IO as UMB's authority for application of the USG Policy. The ICDUR acts as liaison between the institution and the relevant USG funding agencies. The ICDUR may appoint one or more Authorized Organizational Representatives (AOR's) that may also communicate directly with the funding agencies on the ICDUR's behalf.

IRE Minutes:

Actions of the IRE performed outside of IBC meetings, including those performed by a DURC/PEPP subcommittee, will be documented in separate minutes that will not be subject to NIH Guidelines, Section IV-B-2-a-(7). IRE 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 IO and to UMB officials on a need-to-know basis.   

Appeal of Identification as Category 1 or Category 2 Research:

The PI of a project may appeal the identification of a project as Category 1 or 2 in writing to the IO. The IO will then assure that the proper procedures were followed as outlined in the USG Policy. Upon consultation with the IO, the chairperson and BSO 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 within 30 calendar days, as required by the USG Policy. If the USG funding agency classifies research as Category 1 or 2 Research, their decision supersedes the institutional appeals process.

Annual Review and Changes to this Charter:

This charter will be reviewed at least annually by the IBC. It may be modified or amended by approval of a majority of voting members of the IBC. 

Abbreviation Index:

• AOR — Authorized Organizational Representative
• BSAT — Biological Select Agents and Toxins
• BSO — Biological Safety 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
• PEPP — Pathogen with Enhanced Pandemic Potential
• PPP — Pathogen with Pandemic Potential
• RG — Risk Group
• UMB — University of Maryland, Baltimore
• USG — United States Government