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.

• Biological Use Authorization (BUA) Form | BUA Guidance
• Biosafety SOP Template | Instructions for SOP Template | Example SOP
• IBC Protocol Closure Form
• Waste Triage Flowchart

1. Why do I have to fill out a Biological Use Authorization (BUA) for my recombinant or synthetic nucleic acid (r/sNA) research?

The University of Alabama conducts research funded by the National Institutes of Health (NIH). It, therefore, must document the review of ALL recombinant or synthetic DNA research conducted by its research investigators. This requirement applies to all research activities, regardless of funding source. This includes research projects that are supported by departmental ‘Start-up funding’.

Section I-D-1. All NIH-funded projects involving recombinant or synthetic nucleic acid molecules must comply with the NIH Guidelines. Noncompliance may result in: (i) suspension, limitation, or termination of financial assistance for the noncompliant NIH-funded research project and of NIH funds for other recombinant or synthetic nucleic acid molecule research at the institution, or (ii) a requirement for prior NIH approval of any or all recombinant or synthetic nucleic acid molecule projects at the institution.

Section I-D-2. All non-NIH-funded projects involving recombinant or synthetic nucleic acid molecules conducted at or sponsored by an institution that receives NIH funds for projects involving such techniques must comply with the NIH Guidelines. Noncompliance may result in: (i) suspension, limitation, or termination of NIH funds for recombinant or synthetic nucleic acid molecule research at the institution, or (ii) a requirement for prior NIH approval of any or all recombinant or synthetic nucleic acid molecule projects at the institution.

BUA submissions are reviewed by the Biological Safety Officer (BSO) and the Institutional Biosafety Committee (IBC).

2. What research activities require project registration with the Biological Safety Program and IBC?

The University of Alabama requires project registration of any research activity that may pose risks to humans, animals, plants, the environment, and the community at large. Registration includes both teaching and research activities.

1. Recombinant and synthetic DNA/RNA research (including exempt work). (NIH Guidelines)
   • genetic engineering and/or modification in any organism
   • work with, or creation of, transgenic animals (vertebrates and invertebrates), or transgenic plants
   • synthetic biology
   • any clinical trials involving viral vectors or human gene therapy
2. The use of risk groups RG1 and Rg2 biohazardous agents
   • infectious agents: e.g., bacteria, viruses, prions, protozoa, fungi, etc.
   • biologically derived toxins or select agents
   • Human-derived materials: bloodborne pathogents (BBP) or other potentially infectious materials (OPIM)
   • work with human and animal cells or tissues in culture
3. Research with environmental ssampls, including soil and water.
4. Work with Animal-derived mat
   • Non-human primates
   • Ruminates or Swine
   • Chickens or other fowl
   • Any wild vertebrate animals

3. What is “Exempt” work?

Section III-F of the NIH Guidelines set forth eight categories of research that are exempt from the requirements of the NIH Guidelines; however, the University of Alabama still requires that Principal Investigators register these categories of work with the IBC by submitting an IBC application.

4. Does my BUA cover the use of human subjects, radioactive materials, or animals?

No. There are separate institutional committees that you must apply to when conducting research with human research participants (IRB), vertebrate laboratory animals (IACUC), or radioactive materials (RCAC).

5. Do I need to register for PCR work?

Yes, you need to register.

The IBC will need to review the work if you are cloning the PCR product prior to sequencing. Direct sequencing of PCR products does not need to be reviewed by the IBC, provided you are not cloning.

IF, no part of the registration rises to the level of review beyond the BSO and it is determined that the work does not qualify as biohazardous (>RG1), then you will receive a “NO determination” letter from the BSP indicating that finding.

6. What if I have never submitted my biological research (including DNA/RNA projects) for review?

The institution must review all recombinant or synthetic nucleic acid (r/sNA) research:

Section I-D. Compliance with the NIH Guidelines

“As a condition for NIH funding of recombinant or synthetic nucleic acid molecule research, institutions shall ensure that such research conducted at or sponsored by the institution, irrespective of the source of funding, shall comply with the NIH Guidelines.”

UA also requires that research with biological materials be registered. Biological materials include specimens from human, animal, plant, bacterial, viral, fungal, and parasitic sources. Therefore, if you have never submitted any biological research for review, you should contact the Biosafety Officer and submit a BUA as soon as possible.

7. What if I am working with an agent that is not a Risk Group 2 agent, such as Bacillus subtilis (Risk Group 1), and I am not generating recombinant molecules? Do I need a BUA?

You will still need a BUA. The process is somewhat abbreviated in that your protocols, SOPs, lab space, and risk assessments will be reviewed by the BSO first. Following review, the BSO may determine that the IBC should review the protocol. If the BSO determines that the BUA does not require formal review, the approval will be handled administratively. ALL approvals will be documented and reported to the IBC regardless of status.

Approved protocols will be kept on file so that the IBC can document that all research has been reviewed for applicability under the NIH Guidelines.

8. Aren’t BUAs only for regulated infectious agents like HIV?

No. As mentioned in Question 1, BUA stands for Biological Use Authorization. This includes r/sNA molecules or any pathogens which may not be harmful to humans but may have consequences if released into the environment. It includes all biological materials, infectious or potentially infectious agents, items subject to the Bloodborne Pathogen Standard, and environmental samples.

9. Do I need an IBC application for work involving potentially hazardous biological substances that is performed in my colleague’s lab?

If you are having work performed in another investigator's lab, you are responsible for ensuring that it is occurring in a laboratory that is registered with the IBC for that type of work and that it is conducted by individuals who have received training for the work they are performing.

10. Who in the lab fills out the BUA?

The UA IBC requires that an individual knowledgeable about the research project, risk assessment, and hazard control procedures complete the BUA. Preferably the PI or full-time lab staff member. If a graduate student will act as the PI on the BUA, that student’s mentor must be named the co-principal investigator and should be able to assume responsibility for the work covered by the application if the PI is unavailable. Co-PIs must accept their role on the IBC application.

11. The PI on our application is leaving UA, but the lab will still be active temporarily. What do we do?

If the principal investigator leaves UA for a position elsewhere or for retirement and laboratory members are still working on projects covered by the IBC application, a person must be designated who meets the requirements of principal investigator and who is available to serve in an oversight capacity in the lab for the duration of time while those projects are being completed. This change is made as a major amendment to the IBC application, and the committee will approve the change at a meeting.

12. Do I have to complete a BUA every time I receive funding for my research?

Yes, BUAs are required for:

• Projects that utilize Recombinant or Synthetic Nucleic acids.
  • Projects that generate or utilize genetically modified organisms, including transgenics and gene drives.
  • Projects utilizing potentially pathogenic materials/organisms, including those considered hazardous to humans, animals, agriculture, and the environment.
  • Projects that will import biological/botanical samples internationally.
  • Projects categorized as Risk Group 1 or 2. (BMBL 6th ed.)
  • Projects working with Bloodborne Pathogens or OPIM.
• Why is it necessary to review experiments so often?

The NIH Guidelines require the following: On behalf of the institution, the Institutional Biosafety Committee is responsible for:

Section IV-B-2-b-(5) Periodically reviewing recombinant or synthetic nucleic acid molecule research conducted at the institution to ensure compliance with the NIH Guidelines.

Triennial review of BUAs will verify that new laboratory personnel have received training, current lab demographics, and updated experimental procedures.

14. Who is responsible for maintaining all protocol submissions and associated paperwork?

It is the PIs responsibility to maintain all copies of approved BUAs and SOPs in addition to the expiration date of approved protocols. OREC will notify the PI that their project is suspended if a renewal of the existing BUA is not submitted by the expiration date.  Failure to renew a protocol in advance of the expiration date will put the BUA into an expired state and investigators must cease conducting experiments until a renewal is approved.

Expired protocols that are not renewed will be closed automatically after 60 days. Possession of and work involving unapproved materials by you and/or your staff constitutes a violation of UA policies, funding agency/sponsor requirements, and State and Federal laws.

15. Can I begin work immediately after I submit my BUA?

NO. Please contact the BSO with the details of your project if you seek to initiate work before or concurrent to notification from the IBC. 

16. What are the different types of submissions?

The IBC application process includes submissions of:

1. An initial application to obtain IBC approval for a three-year period.
   • NEW BUA:New projects must match the title on the funding award and any associated IRB or IACUC protocol titles. (#YR-000-IBC)
2. Amendment(s) to obtain approval for changes to the research
   • Minor amendment:If at any time during the year, you need to add or remove personnel, update demographics, or update additional funding sources, you may submit a MINOR amendment of that same protocol number. Most minor amendments can be administratively approved by the BSO and the Biological Safety Program (BSP).Major amendment:If you find it necessary to alter your research plans or SOPs for an approved BUA, you should submit a MAJOR amendment including updated items. Depending upon the risk assessment, major amendments will need to go before the IBC.
3. Renewal(s) to extend IBC approval for ongoing work for another three-year approval period.
   • Renewal-triennial: All protocols must be renewed every three years on the date of the initial protocol approval. Renewals should include a review of SOPs and risk assessments associated with the project. Approved renewals will be renamed as #YR-000-IBC_R1 (renewal cycle 1).

If you are unsure which category your amendment falls under, contact the BSO for guidance at biosafety@ua.edu.

17. When should I submit an amendment?

You must amend your approved IBC application if you are adding or changing:

1. genes studied or host/vector systems used in your rDNA work
2. infectious agents or biological toxins
3. work with substances from humans or certain vertebrate animals
4. transgenic animal work or transgenic plant work
5. administration of biological substances to animals
6. administration of biological substances to plants
7. anything else that may have an impact on the biosafety level of the work being performed
8. BSL2 laboratory space

18. When should I submit a renewal?

An approved IBC application is valid for three years. Amendments submitted within the 90-day period leading up to expiration are considered renewals. We recommend that you submit your renewal at least 60 days before the expiration date. Amendments (i.e., applications submitted outside of the 90-day renewal window) have no impact on the expiration date of a registration.

19. What forms are required to be submitted with a BUA?

Be sure to attach the following (if applicable) to your BUA under the “Hazard Control” section:

1. Standard operating procedures (SOP)
2. Shipping and Transport SOPs
3. Exposure Control Plans for your lab (BBP-contact EHS)
4. Emergency protocols and infection control policies for your lab
5. Vector maps
6. Materials certifications (i.e., certifications from the vendor that stem cells are disease free)
7. Materials Transfer Agreements (MTA)
8. Permits for collections, imports, exports (domestic or international)
9. Equipment decontamination SOPs from the manufacturer
10. Safety Data Sheets (if required)

20. What is the deadline for submitting BUAs to make the IBC meeting agenda?

The IBC meets monthly on the first Tuesday according to the posted schedule on the biosafety webpage under the ‘Committee’ tab.

Your submission must be received by the 1st of the month to be considered for the next IBC meeting. The BUA must be complete, including supporting documentation, permits, and SOPs. If the submission is complete and deemed fully eligible for IBC review by the BSO, it will be posted to the next meeting’s agenda.

Incomplete submissions will be returned to the applicant for revisions.

The IBC meeting schedule and submission deadlines are available as a downloadable pdf on the BSP webpage of the Office for Research Ethics & Compliance (OREC) website.

21. I have a BUA, but I need to add a postdoc. Do I have to fill out another BUA?

You may alter an existing BUA by submitting a “minor amendment” under the assigned protocol number and existing project title. The form for minor amendments can be found on the Biosafety website. Minor changes may be handled by the BSO administratively.

Changes involving the addition of a new biological agent or significantly modifying your experimental process require a major amendment and may require full committee review.

22. How can I find out what Risk Group my agent is?

Note that the following references are not all inclusive and all risk assessment outcomes are unique to the research.

• Section II-A Risk Assessment will assist the user in identifying the proper risk group (NIH Guidelines, 2024).
• Section II-B Containment supplies guidance on proper containment for your agent (NIH Guidelines, 2024).
• CDC: Biosafety in Microbiological and Biomedical Laboratories (BMBL) 6th Edition.

23. How can I find out what Section of the Guidelines describes my experiment?

Section III. Experiments Covered by the NIH Guidelines.

Please note, the descriptions are specific; if a description states that parts A, B, and C must apply, that means all stipulations must be met to qualify for that category or exemption.

Depending upon the scope of your work, Appendices A – M may also apply.

24. How can I determine the biosafety level of my experiment?

Your risk assessment determines biosafety levels as it relates to the proposed project. If multiple experiments of varying risk groups are performed in a lab that has been designated BSL2, then all experiments must follow the BSL2 best laboratory practices. BSL1 work may be performed in a BSL2 lab, but the reverse is not true. Precautions and training must be respected.

25. What is the difference between Biosafety Level 1 and Biosafety Level 2?

The table below gives a GENERAL comparison of BSL1 vs BSL2 requirements. Risk assessment is how we determine a project or lab’s containment procedural needs. Consult the BMBL 6^th Ed. for the full listing of requirements.

26. What is considered a Bloodborne Pathogen (BBP) or Other Potentially Infectious Material (OPIM)?

The Potentially Infectious Material/Bloodborne Pathogens Program affects a variety of areas on campus. Employees and students may perform tasks that involve much more than simply working with human blood. The Bloodborne Pathogens program is housed within EHS.

An employee or student is covered by this policy if they work with or are potentially exposed to any of the following materials:

• Human blood, human blood components, and products made from human blood.
• Human bodily fluids, including semen, vaginal secretions, cerebrospinal fluid, synovial fluid, plural fluid, pericardial fluid, peritoneal fluid, amniotic fluid, saliva in dental procedures, and any bodily fluid visibly contaminated with blood.
• Any unfixed tissue or organ (other than intact skin) from a human living or dead.
• Cell, tissue, or organ cultures from humans or animals unless certified free of bloodborne pathogens.
• Blood, organs, or other tissues from animals unless certified free of bloodborne pathogens.
• Culture medium unless certified free of bloodborne pathogens.

27. Is there a list of CDC/USDA Select Agents or Select Toxins?

Consult the Federal Select Agent Program page at https://www.selectagents.gov/sat/index.htm

28. I need a United States Department of Agriculture permit before submitting my BUA. How do I request a USDA permit to obtain my plant or animal specimen?

Go to the USDA Animal and Plant Health Inspection Service (APHIS) webpage for permitting specifics.

Please contact the Biosafety Officer if you need assistance in obtaining any permits. Allow several weeks for processing and expect an on-site inspection of your facility by the permitting authority.

29. What else is required to get my BUA approved?

The approval of any BUA will be predicated on the following:

• A compliance-based lab inspection during the past year.
• A facility inspection and risk assessment report from the Biosafety Officer submitted to the IBC for review.
• The Principal Investigator, students, and staff have completed all safety training.
• If appropriate, all at-risk staff and students have been offered the Hepatitis B vaccination and received Bloodborne Pathogens training.
• All sections of the BUA form have been satisfactorily completed. Incomplete submissions will be sent back.
• All permits and MTAs have been completed and attached to the BUA submission.

30. How do we get a biohazard sign for our door?

Labs designated BSL2 should post the orange sign with RG2 specifications for organisms or pathogens within the lab. The completed signage should be submitted to the BSO for approval and recordkeeping. The BSL2 signage is processed through the Biological Safety Program (OREC).

A PowerPoint template for this signage, with an example page, can be found on the biosafety webpage under Guidance & Tools. An emergency contact number for the PI shall be posted on the sign.

Please note: this signage must be printed in color or on orange paper (see OSHA Standard 1910.145 App A – Recommended color coding for biological hazard).