Frequently Asked Questions
1. Why do I have to fill out a Biological Use Authorization (BUA) for my recombinant or synthetic DNA research?
The University of Alabama must be able to document that it has made an effort to review and monitor ALL recombinant or synthetic DNA research conducted by its faculty members. This is a condition of funding by the National Institutes of Health (NIH) for any institution that receives NIH funding and applies to all research activities, regardless of funding source. Even unfunded research is subject to these requirements. The BUA submissions are reviewed by the Institutional Biosafety Committee (IBC).
In addition to the review of recombinant and synthetic DNA molecule usage (which also includes the use of transgenic plants and animals, both vertebrate and invertebrate), the UA Institutional Biosafety Committee shall also review the following experiments at a convened meeting:
- Infectious biological agents for Humans, Animals and Plants
- Requests to use CDC and USDA Select Agents/Toxins
- Use of Human Cell Lines, blood and clinical specimens
- Human gene therapy clinical trials involving viral vectors
Contact the Biosafety Officer or Biosafety Manager if you have any questions.
2. Why so much attention to this now? When did the law change?
The “law” or the NIH Guidelines for Research Involving the Use of Recombinant DNA Molecules changed significantly in 2013. The NIH Guidelines now cover recombinant AND synthetic DNA research activities, with some very limited and defined exceptions. However, the outreach and surveillance efforts for compliance with the Guidelines has increased in the past years with the announcement of site visits conducted by the NIH to recipients of NIH funding. The NIH selects random institutions for audits and they are focusing on the process for the institutional review of recombinant DNA experiments. The University of Alabama was visited in 2013.
3. What if I have a previously approved recombinant DNA project?
If you have had a project approved since May, 2013, you will only need to update your BUA for personnel and other routine information. However, if you have an approval dating before May, 2013, you will need to submit an updated BUA. The information submitted on the new form will allow the university to meet requirements of the Guidelines that may not have been addressed on the earlier review of research.
4. What if I have never submitted any of my biological research (including DNA projects) for review?
The NIH Guidelines state that ANY recombinant DNA experiments must by reviewed by the institution:
Section I-D. Compliance with the NIH Guidelines
As a condition for NIH funding of recombinant DNA 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.
However, UA requires that all biological material be reviewed. Therefore, if you have never submitted any biological research for review, you should contact the Biosafety Manager or the Biosafety Officer and submit a BUA as soon as possible.
5. What are the institutional penalties for non-compliance to the Guidelines?
Please review the following sections of the NIH Guidelines:
Section I-D-1. All NIH-funded projects involving recombinant DNA techniques must comply with the NIH Guidelines. Non-compliance 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 DNA research at the institution, or (ii) a requirement for prior NIH approval of any or all recombinant DNA projects at the institution.
Section I-D-2. All non-NIH funded projects involving recombinant DNA techniques 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 DNA research at the institution, or (ii) a requirement for prior NIH approval of any or all recombinant DNA projects at the institution.
6. What is the deadline for the submission of BUA’s in order to make the IBC meeting agenda?
The IBC meeting schedule and submission deadlines are posted on the Biosafety Program page of the ORC website.
7. I have a BUA but I need to add a post doc. Do I have to fill out another BUA?
You may use a BUA form marked for “amendment” to request any changes in your BUA. Some changes such as adding a new agent or significantly modifying your process will require full committee review. Minor changes such as adding a new post doc may be reviewed by the Biosafety Officer or Biosafety Manager.
8. What if I am only working with an agent that is not a Risk Group 2 agent, such as Bacillus subtilis (which is a Risk Group 1 agent) and I am not generating recombinant molecules? Do I need a BUA?
You will still need a BUA that is reviewed by the IBC. Once approved, it will be kept on file so that the IBC can document that all experiments have been reviewed for applicability under the NIH Guidelines.
9. Aren’t BUA’s only for regulated infectious agents like HIV?
As mentioned in FAQ Question 1, BUA stands for Biological Use Authorization. The UA Biosafety Manual states that all biological materials require full committee review. This includes recombinant DNA molecules which may not be harmful to humans but may have consequences if released to the environment, not just regulated human pathogens. It also includes all biological materials, infectious or potentially infectious agents, items subject to the Bloodborne Pathogen standard, and environmental samples.
10. Who in the lab fills out the BUA?
The UA IBC requests that an individual who is knowledgable about the research project and hazard control procedures complete the BUA, preferably a faculty or full time lab staff member.
11. How can I find out what Risk Group my agent is?
12. How can I find out what Section of the Guidelines that describes my experiment?
13. How can I determine the biosafety level of my experiment?
14. Depending on the scope of your work, these other appendices may apply:
Over ten liters of culture
Large transgenic Animals
15. Is there a list of CDC/APHIS Select Agents or Select Toxins?
16. Do I have to fill out a BUA every time I fill out a grant?
ORC and EHS have to complete ‘Compliance Coordination Reviews’ to show that approved research projects have been reviewed by the appropriate committees. This includes the IBC review of the BUA.
17. What is a “current” BUA? How often must I reapply to the committee?
BUA’s shall be reviewed on an annual basis. Every year, the PI on the BUA will be sent a memo from ORC notifying them that it is time to submit an update. If a BUA is not submitted by the expiration date, the PI will be notified by ORC that their project is suspended.
18. Does my BUA cover the use of human subjects, radioactive materials or animals?
No, there are separate institutional committees that you must apply to in order to conduct research with human research participants (IRB), vertebrate laboratory animals (IACUC) or radioactive materials (RCAC).
20. I need a United States Department of Agriculture permit before I submit my BUA. How do I request a USDA permit to obtain my plant specimen?
This link will describe how to get a PPQ586:
This web site will also describe how to obtain an animal product permit:
Please contact the Biosafety Officer or Biosafety Manager if you need assistance in obtaining any permits. Allow several weeks for processing and expect an on site inspection of your facility.
21. How often does the committee meet?
The committee meets monthly according to the posted schedule.
22. Why is it necessary to review experiments so often?
The NIH Guidelines require the following:
Section IV-B-2-b: Functions
On behalf of the institution, the Institutional Biosafety Committee is responsible for:
Section IV-B-2-b-(5). Periodically reviewing recombinant DNA research conducted at the institution to ensure compliance with the NIH Guidelines.
An annual review of BUA’s will allow UA to verify that new laboratory personnel have received training and the location of the lab is current as well as any new experimental procedures have been accounted for.
23. What else is required to get an approved BUA?
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 or Biosafety Manager submitted to the IBC for review.
- All workers and the Principal Investigator have a record of completing the Basic Biosafety training course, refreshed annually.
- All at risk workers have been offered the Hepatitis B vaccination and received Bloodborne Pathogens training, if appropriate.
- All sections of the BUA form have been satisfactorily completed.
- All permits have been satisfactorily completed and obtained.
24. How do we get a biohazard sign for our door?
Biohazard door signs are issued after the IBC approves the submitted BUA application form. These signs are reviewed and updated annually. Every lab will have door sign specific to the biological materials used in the laboratory. Contact the Biosafety Officer or Biosafety Manager if you need a door sign.