Institutional Biosafety Committee

The Institutional Biosafety Committee is a federally regulated compliance body established under the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules.

Its primary purpose is to ensure that research involving recombinant or synthetic nucleic acids, biohazardous materials, or other biological agents at The University of Alabama is conducted safely, ethically, and in full compliance with applicable federal, state, and institutional standards.

At UA, the IBC operates under the authority of the Vice President for Research & Economic Development through the Office for Research Ethics & Compliance.

It functions independently of colleges, departments, and investigators, and its composition, scope, and authority are defined by the NIH Office of Science Policy (OSP).

IBC Independence and Decision-Making Authority

The IBC’s decisions are based on scientific risk assessment, regulatory standards, and biosafety best practices, not on convenience, workload, or funding considerations.

• The IBC’s authority is regulatory, not advisory to individual faculty.
• Faculty, staff, or administrators may not coerce, intimidate, retaliate, direct, pressure, or override IBC committee members or their determinations regarding research approvals, containment levels, or safety requirements.
• Any attempt to pressure, intimidate, or improperly influence IBC members or their decisions is strictly prohibited. Such actions may result in disciplinary review, suspension of research privileges, and, if warranted, referral to federal oversight agencies. Regulatory consequences to the University include:
• Suspension or revocation of the University’s IBC registration;
• Suspension of the University’s review of UA research involving recombinant or synthetic nucleic acids; or
• Restriction or termination of NIH funding for affected projects or the institution as a whole.

Roles and Responsibilities

• Investigators are responsible for providing accurate and complete descriptions of proposed research, including all biological materials and methods.
• The IBC evaluates those submissions to confirm that containment practices, training, and facilities meet required biosafety standards.
• EHS (Environmental Health & Safety) provides operational biosafety support and implements laboratory-level safety training and inspections.
• OREC (Office for Research Ethics & Compliance) administers the IBC, maintains official records, and ensures alignment with NIH reporting and documentation requirements.

Why the IBC’s Independence Matters

The IBC’s independent oversight protects:

• The safety of researchers, students, and staff working with biohazards;
• The integrity of The University of Alabama’s research programs; and
• The trust of funding agencies, regulatory partners, and the public.

The IBC’s role is not to inhibit research, but to ensure that all biological research at UA is conducted responsibly, transparently, and in compliance with national biosafety standards.

Faculty participation and collaboration with the IBC are encouraged and valued, but compliance determinations are not negotiable.

The Institutional Biosafety Committee (IBC) at The University of Alabama (UA) is charged by the Vice President for Research and Economic Development (VPRED) to review and approve all recombinant and synthetic nucleic acid molecule research conducted at or sponsored by UA, in accordance with the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (April 2024) and the Biosafety in Microbiological and Biomedical Laboratories, 6th Edition (BMBL).

In collaboration with the Biosafety Officer (BSO) and Environmental Health & Safety (EHS), the IBC also reviews research involving:

• Risk Group 1 (RG1) or Risk Group 2 (RG2) biohazardous materials;
• Microorganisms pathogenic to humans, plants, or animals;
• Biological Select Agents and Toxins (BSAT) subject to 42 CFR Part 73, 9 CFR Part 121, or 7 CFR Part 331;
• Bloodborne Pathogens (BBP); and
• Human or animal tissues, blood, or cell cultures.

The IBC ensures that all covered research is conducted safely and in compliance with the NIH Guidelines and applicable federal and institutional requirements. The committee coordinates review, as appropriate, with the Institutional Review Board (IRB) and the Institutional Animal Care and Use Committee (IACUC) when a protocol falls under multiple areas of oversight. Research requiring review by more than one committee may not begin until all relevant approvals have been obtained.

All faculty, staff and students working with biohazardous materials or recombinant/synthetic nucleic acids must complete the required biosafety training within 60 days of IBC registration and prior to initiating work.

Baseline IBC/Biosafety training is required for all investigators, staff, students, and visiting scientists listed on an approved IBC protocol. The training covers safe laboratory practices, regulatory responsibilities, risk assessment, and emergency procedures for work involving recombinant or synthetic nucleic acids and other biohazards. The initial course is delivered through the CITI Program. This training must be renewed every three (3) years and satisfies the Institutional Biosafety Committee’s (IBC) baseline training requirement.

Environmental Health & Safety (EHS), through its Biological Safety Program, monitors Biological inventory, conducts laboratory inspections, performs risk assessment, and advises on containment practices and personal protective equipment (PPE).

The Office for Research Ethics & Compliance (OREC) ensures that IBC training requirements are met for protocol approval and coordinates with EHS to confirm compliance with the NIH Guidelines. The Biological Safety Program, managed by EHS, provides additional biosafety and laboratory safety training through Skillsoft, conducts inspections, and assists researchers with operational safety practices.

Institutions that receive NIH funding for research involving recombinant or synthetic nucleic acid molecules must comply with the NIH Guidelines. Even if only one project benefits from NIH support, all similar research conducted at UA must follow the NIH Guidelines.

Training completion must be verified before the IBC grants final approval for any protocol.

References

• NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules:
• Centers for Disease Control and Prevention (CDC) – Biosafety in Microbiological and Biomedical Laboratories (BMBL)

The Institutional Biosafety Committee (IBC) operates as an independent oversight body appointed by the Institutional Official (IO), the Vice President for Research & Economic Development or their designee, in accordance with the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules.

The IBC must have no fewer than five (5) members with collective expertise in recombinant or synthetic nucleic acid technology, biosafety, and the capability to assess risks to public health and the environment. (Section IV‑B‑2‑a‑(1))

• At least two members must be unaffiliated with the institution (other than their IBC role) and represent the interests of the surrounding community with respect to health and environmental protection. (Section IV‑B‑2‑a‑(1))
• Include at least one individual with expertise in plant, plant pathogen, or plant pest containment principles when experiments requiring IBC prior approval under Appendix L are conducted. (Section IV‑B‑2‑a‑(1))
• Include at least one scientist with expertise in animal containment principles when experiments requiring IBC prior approval under Appendix M are conducted. (Section IV‑B‑2‑a‑(1))
• When the institution conducts research involving gene drive modified organisms, ensure the IBC has adequate expertise (e.g., species-specific containment, ecological/environmental risk assessment), using ad hoc consultants if necessary. (Section IV‑B‑2‑a‑(1))
• When the institution conducts recombinant or synthetic nucleic acid research at BL3, BL4, or at Large Scale (>10 liters), or research involving gene drive modified organisms: a Biological Safety Officer (BSO) is mandatory and must be a member of the IBC. (Sections IV‑B‑2‑a‑(1) and IV‑B‑3)
• When the institution participates in or sponsors recombinant or synthetic nucleic acid research involving human participants, ensure the IBC has adequate expertise and training (using ad hoc consultants if necessary). IBC approval must be obtained from the clinical trial site. (Section IV‑B‑1‑f)
• Conflict of interest: No IBC member may be involved (except to provide requested information) in the review or approval of a project in which they have been or expect to be engaged, or for which they have a direct financial interest. (Section IV‑B‑2‑a‑(4))

UA requires that faculty members appointed to the IBC hold tenure, ensuring experienced, objective, and stable governance in the review of biological research.



Members are appointed for staggered terms and must complete required biosafety and conflict-of-interest training prior to participating in reviews. Member biosketches and roster updates are filed annually with the NIH Office of Science Policy (OSP).



The IBC meets monthly, and members typically devote an average of 7–10 hours per month to committee service, including meeting attendance and review of research protocols. Additional ad hoc reviews may be requested between meetings for urgent amendments or time-sensitive projects.

Recommended Composition

Recommended composition to ensure competence: include persons with expertise in recombinant or synthetic nucleic acid technology, biological safety, and physical containment; include or have available consultants knowledgeable in institutional commitments and policies, applicable law, standards of professional conduct, community attitudes, and the environment; and include at least one member representing the laboratory technical staff. (Section IV‑B‑2‑a‑(2))

Through their service, IBC members play a critical role in supporting safe, compliant, and innovative research at The University of Alabama.

Who Can Serve

• The IBC must have at least five members with collective expertise to assess risks associated with recombinant or synthetic nucleic acid research.
• At least two members must be unaffiliated with The University of Alabama and represent community interests in health and environmental protection.
• The roster must include (or have ad hoc access to) relevant expertise (e.g., plant, animal, and human containment).
• A Biosafety Officer (BSO) must be a member if the institution conducts large-scale work, BL3/BL4 research, or work involving gene-drive modified organisms.
• Faculty members serving on the IBC must hold tenure to ensure an experienced, independent, and stable governance perspective in committee deliberations.
• (Source: NIH Office of Science Policy, NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules.)

How Members Are Appointed

• Members are appointed by the Institutional Official (IO), the Vice President for Research & Economic Development (or designee).
• UA files an annual roster and member biosketches with the NIH Office of Science Policy (OSP).
• Members do not review projects in which they are involved or have a direct financial interest, consistent with federal conflict-of-interest standards.

Time & Expectations

• Attend regular IBC meetings and participate in protocol review.
• Complete required biosafety, confidentiality, and conflict-of-interest attestations.
• Training and orientation are provided; ad hoc consultants may supplement expertise when needed.

Typical time commitment: IBC members generally attend a 90-minute monthly meeting and spend an additional 7–9 hours reviewing protocol materials in advance. The total annual time commitment averages approximately 7–10 hours per month, including meeting attendance, review preparation, and brief online compliance attestations.

Meeting Attendance and Quorum Requirements

Regular attendance is essential to the function of the Institutional Biosafety Committee (IBC).

Because the IBC operates under federal oversight (NIH Guidelines), each meeting must maintain a formal quorum of voting members in order to review and approve research protocols.

If quorum is not met, the committee cannot conduct official business, including review or approval of new or continuing research.

Consistent participation ensures:

• Compliance with NIH and institutional regulations;
• Timely review of research protocols; and
• Fair workload distribution among members.

IBC members are expected to:

• Attend monthly meetings (typically 60–90 minutes);
• Notify the IBC Administrator in advance if unable to attend; and
• Complete pre-meeting protocol reviews in a timely manner.

Repeated absences may require replacement of the member to preserve the committee’s ability to meet federal quorum and review requirements.

How to Volunteer for Consideration

• Email the IBC Administrator, Erika Chapin, at emchapin@ua.edu with:
  • A brief statement of interest and areas of expertise;
  • A current CV; and
  • Whether you are a community (unaffiliated) or UA-affiliated candidate.
• UA maintains a candidate pool and fills openings based on required expertise and NIH composition rules.
• Roster updates are posted and filed with the NIH OSP annually.

For more information, contact the Institutional Biosafety Committee (IBC) at ibc@ua.edu.

Office for Research Ethics & Compliance, The University of Alabama.

IBC Meetings are scheduled on the first Monday of the month unless otherwise arranged. 

• IBC Charter
• IBC Meeting Minutes
• IBC Committee Login

Other Biosafety Resources