IBC Project Registration Process

The Institutional Biosafety Committee (IBC) serves as the University’s regulatory oversight body for research, teaching, or service activities that involve biohazardous materials, recombinant or synthetic nucleic acids, or other biological hazards.

Its responsibility is to ensure that such work is conducted in accordance with the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules, the CDC’s Biosafety in Microbiological and Biomedical Laboratories (BMBL), and University of Alabama policy.

The IBC’s scope of authority focuses on risk assessment, compliance verification, and institutional approval—not the day-to-day operational management of laboratory safety (which is the responsibility of EHS through the Biosafety Officer (BSO)).

Key IBC Responsibilities

• Report to federal agencies: Through the Office for Research Ethics & Compliance (ORED), file annual rosters and incident reports with the NIH Office of Science Policy (OSP) when required.
• Determine applicability: Decide whether proposed work requires IBC registration, exemption, or modification under the NIH Guidelines.
• Assess and classify risk: Review each Biological Use Authorization (BUA) submission to determine the appropriate Risk Group (RG1–RG2) and biosafety containment level (BSL-1 or BSL-2 at UA).
• Review and approve protocols: Evaluate submitted projects for compliance with NIH, CDC, and institutional standards, and approve, modify, or disapprove as appropriate.
• Verify training and documentation: Ensure that all personnel engaged in the work have completed required biosafety training and that appropriate facilities and equipment are in place.
• Monitor continuing compliance: Review amendments, annual renewals, inspection reports, and incident summaries to confirm ongoing adherence to regulatory standards.

Division of Responsibilities

The Institutional Biosafety Committee (IBC) operates through a collaborative structure that includes both ORED and EHS, each with clearly defined responsibilities that support the safe and compliant conduct of biological research at The University of Alabama. While the two offices work closely, their functions are distinct:

IBC Administrator – Office for Research Ethics & Compliance (OREC)

Primary Focus: Regulatory compliance, committee administration, and official documentation.

The IBC Administrator manages the regulatory and administrative operations of the IBC on behalf of ORED. They ensure that the University’s biosafety oversight processes meet federal standards under the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules.

Key Responsibilities include:

• Managing IBC membership, rosters, meetings, and records
• Receiving, logging, and tracking Biological Use Authorization (BUA) submissions
• Preparing agendas and meeting materials, ensuring quorum, and maintaining conflict-of-interest documentation
• Issuing official IBC determination letters (approvals, deferrals, etc.)
• Verifying that all listed personnel have completed required biosafety training before approval
• Maintaining the IBC’s federal registration with the NIH Office of Science Policy (OSP)
• Filing annual reports and supporting institutional compliance audits

Biosafety Officer (BSO) – Environmental Health & Safety (EHS)

Primary Focus: Operational biosafety, laboratory safety, and risk assessment and mitigation.

The Biosafety Officer (BSO), housed within EHS, provides hands-on technical oversight of laboratory biosafety practices. The BSO ensures that approved research is conducted safely and that laboratories meet the physical and procedural standards required for their containment level.

Key Responsibilities include:

• Conducting risk assessments and biosafety inspections of research laboratories
• Evaluating containment facilities, biosafety cabinets, and personal protective equipment (PPE)
• Advising on laboratory signage, decontamination, and waste management procedures
• Assisting with incident response and investigation for biological spills or exposures
• Delivering biosafety training through EHS systems (e.g., Skillsoft)
• Collaborating with the IBC Administrator to verify that laboratory operations align with IBC-approved containment requirements

How They Work Together

Together, these roles form UA’s biosafety compliance framework: ORED ensures the research is approved appropriately, and EHS ensures it is conducted safely in practice.

1. Submit Project Information: Investigators complete a Biological Use Authorization (BUA) form and submit it to the IBC Administrator (ORED). Include details on biological materials, recombinant DNA, procedures, and personnel involved.
2. Containment and Risk Assessment: The BSO reviews the project for containment requirements, performs a risk assessment, and confirms that facilities and safety measures align with proposed activities.
3. Prep Meeting: The Prep Committee conducts an initial review of the protocol prior to the full IBC meeting. The purpose of this review is to identify potential issues, inconsistencies, or questions that could arise during formal committee evaluation and to provide constructive feedback to the PI. This process helps ensure the protocol is thorough and well-prepared, supporting a more efficient and effective review by the full committee.
4. IBC Review and Determination: The IBC conducts a formal review during its monthly meeting. Projects may be approved, conditionally approved pending modifications, tabled for clarification, or denied if not compliant.
5. Notification and Documentation: The IBC Administrator issues an official approval or determination letter to the PI, maintains records, and ensures all training and documentation are complete before research begins.
6. Renewals and Amendments: Approved projects must be renewed annually or amended when new agents, personnel, or procedures are added. Substantial changes require new IBC review prior to implementation.

All personnel listed on a BUA must complete:

• The CITI Biosafety and IBC Training course; and
• Any additional laboratory-specific training required by EHS, such as bloodborne pathogens, viral vectors, or shipping of biological materials.

Training completion is verified by ORED before IBC approval is granted.

IBC meetings are held on the first Tuesday of each month.

To be considered for review, complete Biological Use Authorization (BUA) applications — including all required documentation and attachments — must be submitted to the IBC Administrator (OREC) by the 1st of the month preceding the meeting.

Late or incomplete submissions will be deferred to the following month’s agenda.

The University of Alabama follows a structured, collaborative review process to ensure that all biological research is conducted safely and in full compliance with federal and institutional standards.

The steps below clarify the current roles of the Office for Research Ethics & Compliance (OREC) IBC Administrator and Environmental Health & Safety (EHS) within the IBC review cycle.

1. Submission and Deadlines

Investigators must submit a complete Biological Use Authorization (BUA) form and all required documentation to the IBC Administrator (ORED) by the first of each month to be considered for the next scheduled IBC meeting.

IBC meetings are typically held on the first Tuesday of each month.

A submission is considered complete when it includes:

• A current and signed BUA form
• Standard Operating Procedures (SOPs) for all proposed work
• Required permits, Material Transfer Agreements (MTAs), and supporting documentation
• Updated training certificates for all personnel listed on the BUA

2. Pre-Review

Each submission undergoes a two-step pre-review prior to IBC consideration.

Step 1 – Administrative Review (OREC – IBC Administrator)

The IBC Administrator performs an initial screening to ensure:

• The project title matches associated funding, IRB, or IACUC protocols;
• SOPs and attachments are current and complete;
• The project abstract is written in plain language (so non-scientist IBC members can understand it);
• Required training documentation and permits are attached;
• All elements meet NIH submission standards.

Step 2 – Technical Review (EHS – Biosafety Officer)

The Biosafety Officer (BSO) conducts the technical biosafety evaluation, including:

• A risk assessment to determine the appropriate Risk Group (RG) and containment level (BSL);
• Review of containment facilities, equipment, and procedures;
• Verification that laboratory practices meet the required safety standards;
• Review of personnel experience and biosafety qualifications;
• Identification of any additional containment or procedural safeguards required.

3. Prep Meeting (IBC Prep Committee)

The Prep Committee conducts an initial review of the protocol prior to the full IBC meeting, including:

• Identifying potential issues, inconsistencies, or missing information;
• Highlighting questions that may arise during formal committee review;
• Providing feedback to the PI to strengthen the submission;
• Ensuring the protocol is thorough and well-prepared for full committee evaluation.

4. IBC Review and Determination

The Institutional Biosafety Committee (IBC) reviews each complete Biological Use Authorization (BUA) submission during a convened monthly meeting.

The committee may:

• Approve the protocol as submitted;
• Approve with conditions, pending specific modifications or clarifications;
• Resubmit with revisions, pending additional information or changes; or
• Deny the protocol if it does not meet applicable compliance standards.

All IBC reviews—whether a project is approved, deferred, denied, or determined to be exempt—must be formally documented.

Even when an activity is determined to be exempt from IBC approval under the NIH Guidelines, the IBC Administrator (OREC) must maintain written evidence that the project was reviewed and the exemption determination was made by or under the authority of the IBC.

The IBC Administrator (OREC) issues official correspondence to the Principal Investigator (PI) reflecting the committee’s decision or exemption determination and maintains the institutional record of all IBC reviews and determinations, as required by the NIH Office of Science Policy (OSP).

Incomplete or non-compliant submissions are returned to the PI for revision before being placed on the IBC agenda.

4. Post-Approval Monitoring

Once a BUA is approved, oversight continues throughout the life of the project.

5. Ongoing Reporting and Compliance

• The IBC receives inspection summaries and compliance reports during regularly scheduled meetings.
• PIs receive written inspection outcomes and must submit timely responses to any corrective actions.
• OREC submits annual IBC reports and membership rosters to the NIH Office of Science Policy (OSP).
• Reportable incidents or laboratory events are promptly communicated to NIH OSP as required by the NIH Guidelines.