Project Registration

BUA Timeline

Total turnaround is approximately 4-6 weeks (barring revisions):

• PI Submits BUA: 1-2 weeks prep time
• BSP reviews application: 1-2 weeks
• BSO/IBC reviews pre-meeting: 1 week
• IBC deliberations: 1 day
• OREC document turnaround: 1-2 weeks

A Project Registration via BUA is required for 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 materials from:
   • Non-human primates
   • Ruminates or Swine
   • Chickens or other fowl
   • Any wild vertebrate animals

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.

Each Submission

IBC meetings are scheduled on the first Tuesday of the month unless otherwise stated. Your submission must be received by the 1st of the month to be considered for the next IBC meeting. 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.  

View IBC meeting schedule and submission deadlines

Pre-Review: The BSP reviews applications for the following:

• The title of the project must match titles of associated funding and any corresponding IRB or IACUC protocols. 
• SOPs attached are current and complete. 
• The project abstract is written in plain language. It should be clear, concise, organized, and appropriate for the intended audience. (Non-scientific community members also sit on the IBC) 
• Exposure Control Plan is attached (work with Bloodborne Pathogens). 
• Proper waste disposal procedures throughout the SOP and BUA 
• Permits/MTAs attached 

Incomplete submissions will be returned to the applicant. Questions and clarifications will be addressed with the PI during this 2-week pre-review period. 

Timeline

Preliminary application review will take approximately 1-2 weeks. 

The PI is responsible for performing a full project risk assessment. Following the BUA submission, the BSO will review the Risk Assessment for: 

• Appropriate Risk Group (RG) and containment level (BSL).  
• Are additional containment practices needed? 
• Perform a full inspection of lab space and equipment. 
• Evaluate the experience and training of all researchers listed on BUA. (training certificates) 

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.

The BSO then determines the path of review.

BSO/IBC Review Flowchart 

Timeline

• BSP Pre-review phase – 1-2 weeks 
• BSO/IBC reviews pre-meeting – 1 week 
• IBC deliberations – 1 day 
• OREC document turnaround – 1-2 weeks 

Post-Approval Monitoring (PI, BSO, EHS, OREC) 

1. PI is responsible for submitting an updated inventory and self-audit of the lab annually. 
2. Once the IBC protocol is approved, the lab becomes eligible for random compliance inspections by the BSP. 
3. BSO performs and documents random inspections of labs with approved BUAs yearly. 
4. BSO investigates lab accidents and ‘near-miss’ incidents.  

Reporting is Ongoing for the Life of the Authorization

1. IBC receives written results of lab inspections at regularly scheduled meetings. 
2. PI receives written notification of results of lab inspection and submits responses to corrective actions requested. 
3. OREC submits NIH OSP notification if required. 
4. OREC submits an annual report to NIH OSP. 

The Biological Safety Program (BSP) at The University of Alabama was established to ensure that all research, testing, and teaching activities involving biohazardous materials and the facilities used to conduct such work comply with all federal regulations, best practices, and university policies. 

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 materials from:
   • Non-human primates
   • Ruminants or Swine
   • Chickens or other fowl
   • Any wild vertebrate animals

Committee Responsibilities

The Institutional Biological Safety Committee (IBC) was established to conform to NIH Guidelines (2024). All committee proceedings are confidential. The IBC is charged with the oversight of all projects involving: 

1. To review the use of Risk Group 1 (RG1) and RG2 biohazardous agents; 
2. To review and approve the use of select agents and recombinant and synthetic nucleic acids (NIH Guidelines); 
3. To review the Biological Safety Program (BSP) annually to determine if the program is effective and compliant with regulations; 
4. To advise the Biological Safety Officer (IBSO) and support the biological safety program; 
5. To assist the IBSO with the enforcement of regulations and guidelines; and 
6. To advise the Vice President for Research. 

IBC Meetingsare scheduled on the first Tuesday of the month unless otherwise arranged. 

The Office of Environmental Health & Safety (EHS) provides proper disposal of both biologically hazardous and regulated medical wastes through a contracted disposal service. Information about the disposal of biological materials can be found on the EHS websites:

• Waste Triage Flowchart
• Waste Disposal Request
• Formaldehyde Program
• Medical Waste Manual
• Autoclave Safety Policy

Additional information on infection control including sterilization guidance:

• CDC Infection Control Guidelines and Guidance Library

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).