Frequently Asked Questions for Biological Use Authorization Application

These Frequently Asked Questions (FAQs) are designed to help you complete the Biological Use Authorization (BUA) applications. The below FAQs correspond to questions on the full BUA Application. The FAQs also pertain to the Request for Change to BUA Application; although, the numbering of the referenced questions differs. See the BUA webpage for information about the review process and to download the applications.


General Project Information

Q. I am a postdoctoral fellow/lab manager - can I serve as Principal Investigator (PI) for submission of the BUA application? Answer >>

Q. I am a postdoctoral fellow/lab manager and am listed as 'lab contact' on the BUA application. I have prepared this application, but I am not the PI of my laboratory. Am I responsible for the accuracy of this application and compliance with the applicable regulations? Answer >>

Q. Once I submit my BUA application, can I start my work right away? Answer >>

When should I provide the following?

  • Q. Institutional Animal Care and Use Committee (IACUC) protocol number? Answer >>

  • Q. Human Subjects Division number? Answer >>

Q. My project involves work with animals. Do I need approval for all my in vitro and in vivo work or just the work tied to my animal protocol? Answer >>

Q. I have not yet submitted my animal protocol to the Office of Animal Welfare (OAW). Can I still include the animal work on this BUA application? Answer >>

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Research Description

Q1. What information should I provide in question 1? Answer > >

Q2. What information should I provide in question 2? Answer >>

Q2. What information should I provide about my work involving recDNA in question 2? Answer >>

Q2. What information should I not include in question 2? Answer >>

Q3. What information should I include in question 3? Answer >>

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Human Research Participants

Q. My research involves recombinant DNA vaccine trials in human research participants. This work is exempt from the NIH Office of Science Policy, Recombinant DNA Advisory Committee (RAC) review. Do I need to submit a BUA application for my work even though it is exempt from RAC review? Answer >>

Q. I have already submitted my NIH Guidelines, Appendix M to the RAC for research involving human gene transfer, but I have not received their comments. How long will the IBC review take for my clinical trial? Answer >>

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Culture of Primary Cells or Cell Lines

Q16-18. Throughout the Culture of Primary Cells or Cell Lines section I am asked to list the 'type' and 'source' of my cells/cell lines. What do you mean by 'type' and 'source' of cells/cell lines? Answer >>

Q16b. I work with human induced pluripotent stem cells (iPSCs) that are purchased from an outside vendor, repository, or colleague. I will not be deriving them in my laboratory. Do I need to fill out the Recombinant and Synthetic DNA and RNA (questions 26-38) and the Gene Delivery Methods table (question 39) for this work? Answer >>

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Bloodborne Pathogens

Q19. I work only with established human cell lines obtained from a commercial vendor (e.g., ATCC) which is a very reliable and authentic source. I don't think the Washington State BBP rule applies to me. Please confirm. Answer >>

Q. What information should I provide if I work with human tissue, blood, or body fluids, or culture of human primary cells or cell lines? Answer >>

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Bacteria, Viruses, Yeasts, Fungi, Parasites, and Prions

Q20. My project involves work with non-recombinant microorganisms as well as recombinant microorganisms. In which sections of the BUA application should I list them? Answer >>

Q20. Can you provide some examples of non-recombinant and recombinant microorganisms? Answer >>

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Recombinant and Synthetic DNA and RNA

Q26. How do you define recDNA molecules? Answer >>

Q30. Which agents are exempt from the NIH Guidelines? Answer >>

Q31. I am asked to list my use of recombinant or synthetic DNA/RNA in non-exempt microorganisms. Since my work involves viral vectors, should I complete question 31? Answer >>

Q32. What types of experiments does question 32 cover? Answer >>

Q36. What types of experiments does question 36 cover? Answer >>

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Gene Delivery Methods

Q39B. I am asked to provide gene inserts and key regulatory elements. Can I use gene names other than RefSeq gene names in column B of the Gene Delivery Methods table? Answer >>

Q39C. My project involves in vitro work using viral vectors. How should I complete column C of the Gene Delivery Methods table? Answer >>

Q39D. My project involves administering viral vectors to animals. How should I complete column D of the Gene Delivery Methods table? Answer >>

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Gene Inserts

Q41. I have already listed the names of my genes in the Gene Delivery Methods table (question 39). Should I list them again here? Answer >>

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Oncogenes and Tumor Suppressor Genes

Q46-50. How do I complete questions 46-50? Answer >>

Q51. I believe my work with oncogenes or tumor-suppressor genes should not require an elevation in biocontainment, and I do not want to work at an elevated level of biocontainment. Can I petition the IBC to not increase the level of biocontainment for my work with these oncogenes or tumor-suppressor genes? Answer >>

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Transgenic Animals

Q52. What are the exemptions for transgenic rodents? Answer >>

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NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules

Q53. What levels of review are required for different sections of the NIH Guidelines? Can you help me identify sections of the NIH Guidelines that are applicable to my work? Answer >>

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Containment Requirements

Q54a. I am asked to identify the biosafety levels of my laboratory. I am not sure about the biocontainment levels for my laboratories. Can you explain the different biocontainment levels? Answer >>

Q54b. I am asked to identify the biosafety levels of my animal facilities. I am not sure about the biocontainment levels for my animal work. Can you explain the different animal biocontainment levels? Answer >>

Q. My research involves work with BSL-2 viral vectors with known oncogenes. What additional practices should I follow? Answer >>

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Training

Q93. Why should I take the biosafety training? Answer >>

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Statement of Responsibility

Q. I am a postdoctoral fellow/lab manager and have prepared this BUA application, but I am not the PI of my laboratory. Can I sign the Statement of Responsibility on behalf of the PI? Answer >>

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