These frequently asked questions (FAQs) are designed to help you complete the BUA application. The below FAQs correspond to the full BUA application. The FAQs also pertain to the Change to BUA application, but the numbering of the referenced questions may differ. See Biological Research Approval for information about the review process.

General Project Information

I am a postdoctoral fellow/lab manager. Can I serve as Principal Investigator (PI) for submission of the BUA application?

No, it is the PI who is solely responsible for the accuracy of the BUA application and compliance with the applicable regulations. The lab contact section of the application is meant only for contact purposes, to request additional information, and to schedule laboratory inspections. See the FAQ for the Statement of Responsibility.

Once I submit my BUA application, can I start my work right away?

Even though the National Institutes of Health (NIH) categorize certain types of experiments that can be initiated simultaneously with submission of the BUA application, institutional policy requires that you wait for approval from the IBC and/or EH&S.

  • For reviews covered under NIH Guidelines, Sections III-A through III-C, contact EH&S for specific instructions.
  • For reviews covered under NIH Guidelines, Section III-D, an IBC member and an EH&S biosafety officer will be assigned to your project as primary reviewers and will work with you to obtain approval. All IBC members will also have the opportunity to review your BUA application. You can proceed with your Section III-D research project once you have received your BUA letter.
  • For reviews covered under NIH Guidelines, Section III-E, an EH&S biosafety officer will review the application and provide a preliminary approval on behalf of the IBC. The application is then reviewed at the next convened IBC meeting for final approval. You can proceed with your Section III-E research project once you have received your BUA letter.
  • Reviews falling under NIH Guidelines, Section III-F are exempt from the NIH Guidelines (e.g., work with E. coli K12 and its derivatives). However, to ensure compliance, the IBC recommends registering the research by submitting a BUA application to EH&S.
  • Research with biohazardous agents that are not recombinant (e.g., human cell lines) must be reviewed by EH&S by submitting a BUA application.

The IBC review process includes a biosafety laboratory inspection that is conducted by an EH&S biosafety officer to evaluate lab space, containment practices, training, work procedures, and personal protective equipment (PPE). Once your research has been approved, you will receive a BUA letter from the IBC. If your research is not approved, an EH&S biosafety officer will work with you to address outstanding issues; approval is issued upon resolution.

When should I provide an IACUC (Institutional Animal Care and Use Committee) protocol number?

Provide an IACUC protocol number only when applicable to the research proposed in the BUA application; otherwise, leave the field blank. Specifically, if your research involves any work with transgenic animals or administration of biohazardous agents including recDNA, you must provide the IACUC protocol number. Please note that only one IACUC protocol may be associated with a single BUA application.

When should I provide a Human Subjects Division number?

Provide a Human Subjects Division number only when applicable to the research proposed in the BUA application; otherwise, leave the field blank. Specifically, if your research involves use of human source materials that require Institutional Review Board (IRB) approval or administration of biohazardous materials to human subjects (e.g., recombinant DNA vaccine), you must provide your Human Subjects Division number.

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?

You need approval for all your in vitro and in vivo work on a BUA. Each animal protocol involving biohazardous agents must have a separate BUA. If you have work with biohazardous agents unrelated to your animal protocol(s), then you may either:

  1. Submit a separate BUA application for the in vitro work; or
  2. Include in vitro work on the BUA application associated with one of your animal protocols.

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?

Yes, you may include the animal work on the BUA application, but the risk assessment and IBC review cannot be completed until the IACUC protocol is submitted and reviewed by EH&S. It is best to submit the BUA application at the same time you submit your animal protocol to OAW. If you are not planning to start the animal work right away, you may want to submit your initial BUA application for in vitro work only. Later, you can submit a Change to BUA application to add the in vivo work when you submit the animal protocol. IBC approval always precedes IACUC approval.

Research Description

Q1. What information should I provide in Question 1?

Provide only a brief and general description of the overall goals of the proposed research (one or two sentences). This information is used to help assign your project to reviewers with relevant expertise and to help them understand the background of your research. Provide your description in laymen's terms so that it can be understood by all members of the IBC, which includes professional staff, faculty from a variety of disciplines, and members of the general public. The review process does not assess the scientific merit of the proposed research.

Q2. What information should I provide in Question 2?

Provide a brief, yet complete, description of the actual experimental procedures and biohazardous agents, including recDNA that will be used for the proposed research. You are strongly encouraged to use general terms for common laboratory procedures such as the following:

  • Engineering of plasmids in laboratory strain E. coli
  • Culture of human cell lines
  • Sorting human cells by flow cytometry

However, also be specific about which biohazards will be associated with which procedures. Some examples include the following.

  • Breeding mice containing the transgene for GFP
  • Transducing human cell lines with an adenoviral vector expressing the gene MYC
  • Working with a lentiviral vector expressing a GFP reporter gene

Be sure to specifically mention procedures that preclude the use of physical containment that would otherwise be required (e.g., stereotactic injections if Risk Group 2 viral vectors to animals, imaging of animals exposed to human cells when the imaging equipment cannot fit inside a biosafety cabinet). You may want to complete this question after you have filled out the rest of the application in order to assure that all relevant procedures and biohazardous materials/agents are included. Be aware that your application may be returned to you as incomplete if this question is not consistent with the rest of your application.

Q2. What information should I provide about my work involving recDNA in Question 2?

If your research includes recDNA from any portion of one or a few genes, explicitly list the genes as well as the context in which the DNA or RNA will be used. If your research involves a large number of genes, then describe the functional categories of the proteins encoded by these genes, such as 'cytokine receptors' or 'cell signaling', as well as the context in which they will be used. If your research includes the discovery of new genes that will then be used in your research, describe the functional properties of the proteins encoded by the target genes (if known), how they will be identified (using general terms), and what you will do with them once they are identified.

You MUST use RefSeq gene names when listing specific genes. This is essential for reviewers to carry out a risk assessment of your proposed research. Be aware that your application may be returned to you as incomplete if you do not use RefSeq gene names. Instructions for verifying correct RefSeq gene names are included in the FAQ for question 35B.

Q2. What information should I not include in Question 2?

Do not provide experimental protocols or details such as dosing regimens or specific concentrations. Do not cut and paste procedures from animal protocols, grant proposals, or standard operating procedures. Do not provide the scientific justification, rational, or hypotheses associated with the proposed research.

Q3. What information should I include in Question 3?

Please describe what you believe, in your professional opinion, constitutes the greatest biohazardous risk associated with your research. Be aware that a formal review of your application may lead to the identification of other biohazards associated with the proposed research which, in the opinion of biosafety professionals or members of the IBC, may constitute an even greater hazard. If this is the case, you may be contacted for further discussion on the topic. Be aware that your application may be returned to you as incomplete if you fail to identify what you believe to be the greatest biohazard associated with your proposed research.

Culture of Primary Cells or Cell Lines

Q14-16. 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?

'Type' of primary cells means human or animal primary cells taken directly from blood or living tissue (e.g., peripheral blood mononuclear cells, T cells, dendritic cells, etc.).

'Type' of cell lines means human or animal cell lines that may or may not be well characterized [e.g., human derived HEK293 cell lines, Epstein-Barr Virus (EBV)-transformed lymphoblastoid cell lines, embryonic stem cell (ESC) lines, induced pluripotent stem cell (iPSC) lines, etc.].

If your cell lines contain recDNA, be sure to include them in the Gene Delivery Methods table (question 35), even if they were engineered prior to the application.

By 'Source,' we mean the source from where you obtained the primary cells/cell lines (e.g., cells were isolated in my laboratory; cells were obtained from another UW PI; cells were obtained from a collaborator at Fred Hutchinson Cancer Research Center (FHCRC); cells were purchased them from a commercial vendor). 

Q14. 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 and the Gene Delivery Methods table for this work?

For research involving human iPSCs, you must fill out relevant questions of the Recombinant and Synthetic DNA and RNA section and the Gene Delivery Methods table regardless of whether you will derive iPSCs in your laboratory or use iPSCs that already exist. Additionally, explain what you will be doing with these cells in your answer to Question 2.

Bloodborne Pathogens

Q17. 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.

The Washington State BBP Rule applies to all work done with human blood, tissue, body fluids visibly contaminated with blood or other potentially infectious materials (OPIM), as well as human cells and cell lines. All human cell lines, whether established or from authentic sources, are covered under the Washington State BBP Rule due to their potential to harbor BBPs. For a list of OPIM and information about the BBP program, see EH&S Bloodborne Pathogens (BBP) Program

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?

If you answered 'Yes' to questions 10 and/or 14 for work with human blood, tissue, or body fluids, or culture of human primary cells or cell lines, the Washington State BBP Rule applies. As part of the BBP program, you will need to submit a site-specific BBP Exposure Control Plan. Initial and annual BBP training is also required. For information, see Bloodborne Pathogens (BBP) Program.

Bacteria, Viruses, Yeasts, Fungi, Parasites and Prions

Q18. My project involves work with non-recombinant microorganisms as well as recombinant microorganisms. In which sections of the BUA application should I list them?

For work involving non-recombinant microorganisms, to include wild-type and naturally occurring mutant species, complete Question 18 and fill out the Microorganism Table.

In the table, provide the genus and species of the microorganisms you will be using. If you are working with naturally occurring mutant species, you must also provide information about the naturally occurring mutations and their effects on the microorganisms. For examples of non-recombinant microorganisms, see the next FAQ.

For work involving recombinant microorganisms, complete all applicable questions of the Recombinant and Synthetic DNA and RNA section and the Gene Delivery Methods table. For the definition and examples of recombinant microorganisms, see the next FAQ

Q19. Can you provide some examples of non-recombinant microorganisms?

Non-recombinant microorganisms include:

  • Wild-type, naturally occurring species of bacteria, viruses, yeasts, fungi, parasites and prions (e.g., Pseudomonas aeruginosaBacillus cereusTreponema pallidum)
  • Naturally occurring mutant species of bacteria, viruses, yeasts, fungi, parasites and prions (e.g., Bacillus Calmette-GuerinChlamydia trachomatis LGV strains)

Recombinant microorganisms include:

  • Bacteria, viruses, yeasts, fungi or parasites whose genetic materials has been altered using recDNA technology. Examples include Listeria monocytogenes expressing ovalbumin, Toxoplasma gondii luciferase expressing PRU-Luc-GFP type II strain, and gene cloning done in E. coli K12.

Recombinant and Synthetic DNA

Q23. How do you define recDNA molecules?

Recombinant and synthetic nucleic acid molecules or "recDNA" molecules, including those that are chemically or otherwise modified analogs of nucleotides (e.g., morpholinos) or both, are defined in the context of the NIH Guidelines as follows.

  1. Molecules that (a) are constructed by joining nucleic acid molecules and (b) can replicate in a living cell (i.e., recombinant nucleic acids).
  2. Nucleic acid molecules that are chemically or by other means synthesized or amplified, including those that are chemically or otherwise modified but can base pair with naturally occurring nucleic acid molecules (i.e., synthetic nucleic acids).
  3. Molecules that result from the replication of those described in (i) or (ii) above.

The above definition reflects the March 2013 amendment to the NIH Guidelines and the definition of recDNA stipulated in UW Administrative Policy Statement 12.3.

Examples of recDNA molecules outside of living cells that fall under the above definition include the following.

  • Cloning DNA in bacterial plasmids
  • siRNA
  • Oligonucleotide primers
  • naked DNA from PCR or DNA sequencing
  • base-pair analogs
  • Note that naked DNA molecules in test-tubes are exempt from the NIH Guidelines; however, when in an organism, naked DNA molecules are not exempt.

All forms of recDNA are treated as biohazards regardless of whether the recDNA molecules are (a) purchased from a vendor (e.g., purchase a human cell line containing a plasmid), (b) constructed in your laboratory, or (c) used to transfect cells. All recDNA, irrespective of exemption from the NIH Guidelines, must be treated as a biohazard. See the Biological Research Approval for the IBC's working definition of a biohazard. Containment practices for work with recDNA in BSL-1 or higher laboratories are as stipulated in the UW Biosafety Manual. See Biohazardous Waste for information on how to properly identify, package, decontaminate, and dispose of biohazardous waste, including recDNA waste. 

Q27. I am asked to list my use of recombinant or synthetic DNA/RNA in microorganisms. Since my work involves viral vectors, should I complete Question 27?

Yes, list all viral vector work in Question 27. You must also list all other work with microorganisms. In your answer, include the genus, species, and strains for the viral vectors and other recombinant microorganisms.

  • If working with lentiviral vectors, clarify if they are non-HIV pseudotyped, replication deficient.
  • If working with gammaretroviral vectors, describe the vector pseudotype (e.g., ecotropic, amphotropic, VSV-G).
  • For uncommon pseudotype systems, also indicate the host range of that pseudotype, especially if able to infect human cells.

In addition to Question 27, the Gene Delivery Methods table must also be completed for work involving gene delivery via viral vectors and other recombinant microorganisms. You must use RefSeq gene names when listing specific genes.

Q28. What types of experiments does Question 28 cover?

If your project involves recDNA in animals (somatic cells or germ-line transgenics), mark 'yes' to Question 28. Use of recDNA in animals includes use of viral vectors, plasmids, siRNA, recombinant microorganisms, cells containing recDNA (e.g., cells modified with viral vectors or siRNA), and all other forms of recDNA. Question 28 applies to the genetic engineering of somatic cells and to the generation and use of germ-line transgenic animals. 'Animals' are defined broadly to include rodents and other mammals, zebrafish, oysters, insects, and nematodes. Question 28 applies to animals who you propose to treat with recDNA (on your own IACUC protocol) and animals obtained from other sources who have been treated with recDNA.

In your answer, list the species and the nature of the recDNA work (e.g., delivering recombinant AAV expressing GFP to mice, delivering differentiated iPSCs containing lentiviral reprogramming genes into rat hearts).

In addition to Question 28, the Gene Delivery Methods table must be completed for work involving gene delivery to animals. You must use RefSeq gene names when listing specific genes.

Q32. What tyes of experiments does Question 32 cover?

If your project involves potential production/release of infectious agents from recombinant cells, animals, or plants (common examples include bacteria and viruses), mark 'yes' to Question 32. In your answer, explain why you believe infectious agents may be produced/released. Be aware that essentially all forms of commonly used viral vectors, and transgenic mice when the transgene is introduced by viral vectors or contains LTR sequences from gammaretroviral vectors have the potential to produce/release infectious agents.

Gene Delivery Methods

Q35B. I am asked to provide gene inserts. Can I use gene names other than RefSeq gene names in column B of the Gene Delivery Methods table?

No, gene names other than RefSeq gene names may not be used in this column. The IBC requires that you provide only RefSeq gene names. Some examples of RefSeq gene names include 'GFP', 'MYC', and 'COP4'. To verify that your gene names are correct follow the instructions below.

  1. Access the National Center for Biotechnology Information (NCBI) RefSeqGene website.
  2. Enter your gene name. Select 'Search' to search the RefSeq database.
  3. The search results for your gene will display. If your gene name appears as blue linked text, you have entered a correct RefSeq gene name.

If your gene name does not appear in the search results or appears under aliases, you have not entered a RefSeq gene name. You must determine the correct RefSeq gene name before entering the gene name into Column B or elsewhere on your application.

If your research involves more genes than can be easily listed in column B, list the functional categories or the categories of the encoded proteins in Question 37. 

Q35C. My project involves in vitro work using viral vectors. How should I complete column C of the Gene Delivery Methods table?

If your project involves in vitro work, mark 'yes' to column C. In your answer, specify the cell types in which the viral vectors (or other agent) will be grown and explain the activities for which they will be used. See the example of adeno-associated viral vectors provided on the Gene Delivery Methods table.

Q35D. My project involves administering viral vectors to animals. How should I complete column D of the Gene Delivery Methods table?

If your project involves in vivo work, mark 'yes' to column D. In your answer, specify the animal species and explain the activities for which the viral vectors (or other agent) will be used.

Gene Inserts

Q37. I have already listed the names of my genes in the Gene Delivery Methods table. Should I list them here again?

No, you do not need to list your genes again in Question 37. 

If your research involves more genes than can be easily listed in column B, list the functional categories or the categories of the encoded proteins in Question 37. Examples include cytokine receptors, cell signaling, cloning transcription factors, and HLA/MHC genes.

Oncogenes and Tumor Suppressor Genes

Q42-47. How do I complete Questions 42-47?

You must disclose the use of all oncogenes and tumor suppressor genes in this section. Follow the below instructions to complete this section.

  1. Verify that you are using correct RefSeq gene names. Instructions for verifying correct RefSeq gene names are included in FAQ for Q35B.
  2. Using RefSeq gene names, check the Cancer Gene Census database to see if any of your genes are listed. Search using the search box in the Census table, not the search box on the site's toolbar.
  3. If any of your genes appear in the database, mark 'yes' to Question 42 and list the gene names.
  4. Certify that you have checked the database and have reported any and all genes that appear. You must initial the Certification regardless of whether your genes appeared in the database.
  5. If your genes do not appear in the database but are well described in the scientific literature as oncogenes, mark 'yes' to Question 44. In your answer, list the gene names, briefly describe why they are considered oncogenes, and provide references.
  6. If your genes do not appear in the database, but you have reasons to believe they are oncogenes, mark 'yes' to Question 45. In your answer, list the gene names, briefly describe why you consider them to be oncogenes, and provide references.
  7. If you are silencing or knocking out a tumor suppressor genes, mark 'yes' to Question 46. In your answer, list the genes names and describe, noting if work is done in animals.

Q47. 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? 

It is the IBC's policy that the addition of oncogenes or tumor suppressor genes to certain classes of viral vectors necessitates that work with these vectors is carried out at higher levels of biocontainment. This includes work with oncogenes or tumor suppressor genes in all classes of vectors based on retroviruses, adeno-associated viruses, and any other virus-based vectors that have a reasonable capacity for genomic integration.

If your work involves the use of oncogenes or tumor suppressor genes in these classes of recombinant viral vectors, and you would like to petition the IBC to not increase the level of biocontainment for your work with these vector/gene combinations, then please describe your rationale in the space provided on Question 47.

Examples of acceptable rationales include:

  1. I am working with a tumor-suppressor gene, but am over-expressing this gene.
  2. I am working with an oncogene, but am knocking down the expression of this gene.
  3. I am working with an oncogene, but have deleted a functional domain known to be necessary for the oncogenic potential of the corresponding protein.
  4. I am working with an oncogene that appears in one of the oncogene databases, but there is scientific evidence that this gene is not a driver of oncogenesis.

Please be sure to provide references from the scientific literature supporting your rationale.

Transgenic Animals

48. What are the exemptions for transgenic rodents?

The following are exempt as stipulated in the NIH Guidelines, Section III-F.

  1. The purchase or transfer of transgenic rodents.
  2. Generation of BSL-1 transgenic rodents via breeding, with the following exceptions. Exceptions are as stipulated in NIH Guidelines, Appendix C.
    • Breeding of rodents that have a gene encoding more than fifty percent of an exogenous eukaryotic virus
    • Breeding of rodents in which the transgene is under the control of a gammaretroviral long terminal repeat (LTR)

See the reference table from the NIH Office of Science Policy for a listing of animal experiments covered under the NIH Guidelines with references to the corresponding NIH Guidelines sections and biosafety levels.

The PI is responsible for assuring that the transgenes do not include gammaretroviral LTRs of more than one-half of a viral genome. There are a growing number of examples in which PIs have not reported this correctly. PIs are obligated to review the primary literature associated with the transgenic rodents that they wish to use in order to verify this.

NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules

Q49. 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?

PIs are required to identify the sections of the NIH Guidelines that apply to their work. If you misidentify the sections of the NIH Guidelines that apply, a biosafety officer will notify you and help you to determine the correct sections. Also, please note that the EH&S Biosafety training includes an introduction to the NIH Guidelines sections.

Experiments Covered by the NIH Guidelines describes the levels of review necessary for certain types of experiments involving recDNA. The six categories of review reflect the risks associated with the research, with more stringent review required for higher risk experiments.

Section III-A: Experiments covered under this section involve the deliberate transfer of a drug resistance trait to microorganisms that are not known to acquire the trait naturally, if such acquisition could compromise the ability to control disease agents in humans, animals or agriculture.

Be aware that research covered under Section III-A also requires approval from the NIH RAC and the NIH Director. For more information see Major Actions under Section III-A of the NIH Guidelines.

Section III-B: Experiments covered under this section involve the deliberate formation of recDNA containing genes for the biosynthesis of toxin molecules lethal for vertebrates at an LD50 of less than 100 nanograms per kilogram body weight (e.g., cloning in E. coli K12 of DNA containing genes coding for the biosynthesis of toxic molecules such as botulinum toxins, tetanus toxin, diphtheria toxin, Shigella dysenteriae neurotoxin).

Section III-C: Experiments covered under this section involve the deliberate transfer of recDNA or DNA/RNA derived from recDNA, into one or more human research participants. For more information on research involving recDNA in humans see Clinical Trials.

Section III-D: Experiments covered under this section include use of recDNA in pathogenic microorganisms, animals, plants, viral vectors for gene transfer, gene transfer in Risk Group 2 and 3 agents, and restricted agents. Examples include the following.

  • All viral vectors
  • All recDNA experiments in whole animals (e.g., mice injected with plasmids, replication deficient lentivirus, gammaretrovirus, adeno-associated virus, etc.)
  • Research involving more than ten liters of recDNA culture
  • Research with influenza viruses containing genes or segments from 1918 H1N1, human H2N2 (1957-1968), and highly pathogenic avian influenza H5N1 strains

Section III-E: Experiments covered under this section include use of recDNA in Risk Group 1 microorganisms or formulated into synthetic or natural vehicles, and research with whole plants at biosafety level P1 (Plants-1). Examples include the following.

  • E. coli, non-pathogenic strains [which are not exempt under Section III-F]
  • Pseudomonas graminis, rhizobium tropici plant pathogens used in plants at P1
  • All recDNA experiments in plants (e.g., plants infected with recombinant Amycolata autotrophica, Sphaerophorus necrophorus)

Section III-F: Experiments covered under this section are exempt from the NIH Guidelines. See NIH Guidelines Exempt Experiments.

Containment Requirements

Q50a. 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?

Each Principal Investigator (PI) is responsible for performing a risk assessment of his or her work to identify hazards. The risk assessment helps determine which biohazard containment and laboratory practices are appropriate. See Biological Risk Assessment for more information, including Risk Groups and Biological Safety Levels and the associated references.

As mandated by the NIH Guidelines, PIs must complete the EH&S Biosafety Training prior to their initiation of work with biohazardous agents and every three years thereafter. The training provides relevant information about laboratory biosafety levels. It is recommended that you take the training before completing this application. Be aware that your application cannot be approved until completion of training is verified.

If this question is completed incorrectly, a biosafety officer will notify you and help you to determine the correct biosafety levels for your laboratory.

Q50b. 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?

Animal Biosafety Level (ABSL) classification refers to facilities, practices, and operational requirements applicable to work with animals that have been exposed to biohazardous agents. Animals exposed to biohazardous agents assigned to BSLs 1-4 are generally assigned into ABSLs 1-4, respectively. ABSLs correspond to increased levels of protection for research staff and the environment, and are recommended as the minimal standard for activities involving laboratory animals exposed to biohazardous agents. Note that no ABSL-4 research is conducted at the UW. See the reference table from NIH Office of Science Policy for a listing of animal experiments covered under the NIH Guidelines with references to the corresponding NIH Guidelines sections and biosafety levels.

Practices and facility requirements for biosafety laboratories apply to research with animals as well. The animal care and use environment can present unique hazards not found in standard microbiological research laboratories (e.g., animals may generate aerosols, bite and scratch, be infected with a zoonotic agent, etc.) Keeping this in mind, all additional animal facility standard operating procedures must be followed.

If this question is completed incorrectly, a biosafety officer will notify you and help you to determine the correct animal biosafety levels for your laboratory.

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

The presence of oncogenes in viral vectors that ordinarily require BSL-2 containment may necessitate enhanced safety precautions. Such vectors may be required to be handled in a BSL-2 laboratory with additional BSL-3 practices. The PI is responsible for the enforcement of these practices. The UW Biosafety Manual, Section 4-A-3, provides details on the additional BSL-3 practices that are required for working with these agents in a BSL-2 laboratory.

Use of oncogenes must be reported in the oncogene section of the application. See IBC Policies for more information.

Training

Q89. Why should I take the biosafety training?

As mandated by the NIH Guidelines, PIs must complete the EH&S Biosafety Training prior to their initiation of work with biohazardous agents and every three years thereafter. The training is also required for students, fellows, laboratory managers, research staff, and other staff with potential for exposure to biohazardous agents, including recDNA, at the UW.

The training covers roles and responsibilities when conducting research with biohazardous agents, including recDNA. The course also covers the review and approval process for biohazardous agents at the UW and the requirements governing their use (e.g., facilities, equipment, practices).

It is recommended that you take the training before completing this application. Be aware that your application cannot be approved until completion of training is verified. 

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?

NIH Guidelines, Section IV-B-7 states that the PI is the sole person responsible for the conditions set forth in the application, regardless of who prepared it. If the application was prepared by someone other than the PI, then the PI should take care to review the entire application in detail before signing the Statement of Responsibility.

Contact

EH&S Research and Occupational Safety

(206) 221-7770