• How are recombinant DNA (rDNA) or synthetic nucleic acids (sNA) defined? 
  • rDNA/sNA are made by joining DNA or RNA segments (natural or synthetic) to DNA or RNA molecules that can replicate within a living cell. They may also result from replication of previously constructed recombinant molecules.
  • According to NIH Guidelines, recombinant and synthetic nucleic acid molecules are defined as 
    • (1) molecules that 
      • a) are constructed by joining nucleic acid molecules and 
      • b) can replicate in a living cell, i.e. recombinant nucleic acids, or 
    • (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, or 
    • (3) molecules that result from the replication of those described in (1) or (2). 
  • The NIH Guidelines apply to both basic and clinical research studies. 
• I’m not sure if my rDNA/sNA is included or exempt, what do I do?
  • There are a variety of resources you can review, and you can always reach out to Biosafety if you still have questions. Resources include:
    • Table 1 and 2 in Chapter 3 of the Biosafety Manual
    • APB overview of non-exempt rDNA work
    • NIH Guidelines, section III-F
    • NIH FAQs about Experiments that are Exempt from the NIH Guidelines
    • Contact us: biosafetyeprotocol@lists.stanford.edu
• How do I know if my biological agent is under APB oversight?
  • APB oversight includes infectious agents classified as Risk Group 2 and above. Generally, classification by the NIH/CDC, as shown in the appendix of the CDC Biosafety in Microbiological and Biomedical Laboratories (BMBL) or  on the American Biological Safety Association Risk Group database, is acceptable to the APB. Classifications by commercial companies such as ATCC are NOT acceptable. 
  • You can also review the list of agents in the Biosafety Manual Appendix A; please note that this list may not contain all agents, and that some agents may be reclassified over time. It is always recommended to confirm with Biosafety if you are unsure.
• Should I check “Biological Agents” for work with Risk Group 1 agents?
  • Most Risk Group (RG) 1 agents are worked with at Biosafety Level 1, and are exempt from APB oversight. If this is the only work you are doing, you do not need an APB protocol. If you are doing work with non-exempt rDNA and a RG1 agent, you should list the RG1 agent under Biological agents, and to do so, you must click “yes” for Biological Agents.
• What is included in “Experimental Procedures: Humans”? What is not?
  • No APLAC protocol is needed for invertebrates (except cephalopods). At this time, you do not need to select “In Vivo (animals)”, which is mainly focused on vertebrate work requiring an APB. However, you must add your invertebrate work into your methods and overview, and include any applicable precautions. Examples would be work with C. elegans or arthropods such as mosquitos.
• What is included in “Experimental Procedures: Humans”? What is not?
  • If your work includes human samples that are obtained under an IRB (Institutional Review Board protocol), click this box. You will need to list the IRB number on your APB. 
  • If you are working with human material, such as an established cell line or any de-identified human material, that does not require an IRB, you do not need to check this box.
• Do I need an APB protocol if I work with radiological material but no rDNA/sNA or biological agent?
  • No, in this case you only need a protocol from the Administrative Panel on Radiological Safety. See the Controlled Radiation Authorization page for more information.
• How broad is field work or travel defined? 
  • Select this option if you are doing field work or travel directly related to the work described in your protocol for rDNA/sNA or biological agents. Examples might be traveling to an offsite location to collect samples, or doing work in a non-Stanford research lab, such as a collaborators’ lab (either in the US or internationally). 
  • If your field work or travel is related to other research and will not involve work with any rDNA/sNA or biological agents, you do not need to select this option.
  • If travel is related to a conference and will not involve lab work, do not select this option.

• Who should be listed on the protocol?
  • The PI must be listed, as should all personnel who will be doing work with rDNA/sNA or biological agents covered by the protocol. Additionally, if the PI delegates writing or maintaining the protocol to another person, even if that delegate will do no hands-on work, that person must also be listed on the protocol in order to view and edit the protocol. 
• What is the difference between the roles?
  • Principle Investigator: This is the faculty member [or individual with an official faculty waiver from the Dean of Research (DoR) or Stanford-affiliated institute] who is responsible for the work in the protocol, and the health and safety of the people on the protocol. This person CAN edit the protocol.
  • Admin Contact: This role is optional and does not need to be filled out. This person may be a lab manager or senior scientist (or any researcher in the lab) who is helping oversee the protocol and the work, or it may be an administrator who is doing no hands-on work but is helping maintain the written protocol. This person CAN edit the protocol.
    • If the Admin Contact is doing no hands-on work, this should be stated in the “Describe the researcher’s experience” section.
  • Research Coordinator: Similar to Admin Contact, an optional role that does not need to be filled out. As above, this may be an administrator or researcher who may or may not perform work listed on the protocol . This person CAN edit the protocol.
    • If the Research Coordinator is doing no hands-on work, this should be stated in the “Describe the researcher’s experience” section.
  • Project Personnel: These are all the people who are working on rDNA/sNA or biological agents that are covered by this protocol. These people can VIEW the protocol, but CANNOT edit it. It might also include collaborating PIs (see below on collaborating personnel).
• Who can be listed as the PI?
  • Any faculty member, or a person with an official faculty waiver from the Dean of Research (DoR). An example of this is a service center director who holds a protocol for their service center.
• How do I add people?
  • To add a person, enter their SUNetID, and most of the rest of their information should auto populate. Fill in remaining information, such as Highest Degree, and review all information for accuracy.
• Who can edit the protocol?
  • Only the people listed under Principle Investigator, Admin Contact or Research Coordinator CAN edit the protocol. 
  • People listed under Project Personnel can VIEW the protocol but CANNOT edit.
• I am collaborating, what does this mean for personnel?
  • If you are collaborating with another lab and providing them samples, it is always recommended to list the collaborating lab’s PI, and possibly their lab manager or research coordinator, on your APB so that the listed individuals have access to the information in the protocol, particularly regarding risks and hazards, as well as safety measures. The collaborating PI will also need their own protocol to continue work with samples they receive, if these samples continue to fall under the oversight of the APB.
  • Alternatively, one PI may choose to hold a protocol for all the work to be done with the samples. In this case, the collaborating PI and any members of the collaborating lab who work with those samples must be listed on the original protocol. Additionally, any work they will do must be listed under the protocol info. The PI whose name is the lead PI for the protocol will be ultimately responsible for the protocol and the work, and both PIs will be responsible for the safety and health of their individual lab groups.
• For “Describe the researcher’s experience”, do you have an example of what sort of experience or training I should list?
  • This section should provide the reviewer and the APB with a relevant overview of what the individual’s prior work involved, as it relates to the current proposed work and agents on the protocol. 
  • DO specifically state if the person will not be doing hands-on work, such as an administrator who is only helping manage the protocol.
  • DO provide information relating to previous work with similar rDNA/sNA or biological agents (e.g. “worked on influenza during their PhD” or “has spent several years working with rDNA, cloning, and creating viral vectors”) or with unrelated rDNA/sNA or biological agents, provided the work principles (such as BSL2 standards) are similar (e.g., “has worked with other Risk Group 2 bacteria in their postdoc and is familiar with working at biosafety level 2”).
  • Do NOT provide information unrelated to work in the protocol (e.g., “has 5 years experience with synthetic chemistry and making small molecules”).
  • DO provide a rough estimate of experience time, such as “several years” or “during their PhD”. Do NOT list highly specific amounts of time (e.g., “has 8.5 months of experience”), as you will then need to update this annually. It’s best to “evergreen” references to time if at all possible.
  • DO provide relevant training oversight if someone has no prior experience–such as “[Lab Manager] will train [New Researcher] on [relevant techniques], and [Lab Manager and PI] will assess proficiency prior to allowing [New Researcher] to perform work on their own.” It is suggested that you use specific names, not titles, as well as specifics on general techniques or work the training will cover. Ultimately, the PI is responsible for ensuring lab-specific training for all personnel working under their supervision or on their protocol.

• What funding do I have to list?
  • The APB does not require you to list funding for your project, but if you choose to do so, you should list only relevant funding. 
  • If you want the funding source to be listed in your approval letter, especially if you need this to provide to the funding agency, then you MUST list that funding source on your protocol.
• I don’t get NIH funding; why do I still have to follow the NIH Guidelines?
  • The NIH Guidelines apply to any institution that receives any NIH funding, and it applies to the full institution, even if the NIH funding is specific to certain individuals or projects. This means that if anyone anywhere at Stanford receives NIH funding, all of us are held to the standards set forth by the NIH Guidelines if we want our institution to be eligible for continued NIH funding.
• Does the project described on the protocol need to be listed in the funding sources?
  • Only list funding sources that include the project(s) listed in the protocol.
• Do private fundings need to be listed or only NIH fundings?
  • Either can be listed.
• What kind of fellowships do I need to list for funding?
  • Any that are relevant for the work described on the protocol.

• How do I list or link to another protocol?
  • Click the “Add” button next to the relevant section. Enter the correct protocol number, click save, and the protocol should be added as a hyperlink within this section.
• I have an APLAC/IRB/SCRO but I can’t list them here; what do I do?
  • The person adding the other panel protocols must be listed on those other protocols (and listed in a capacity that allows editing on that other protocol) in order to be able to add it to the APB protocol. For example, someone must be listed as the Admin (and therefore able to edit) both the APLAC and APB protocol in order to be able to add the APLAC protocol to the APB. This is a security measure within eProtocol to ensure that protocols can’t be accessed by those who are not doing the work.
  • Check the “Are You Using” page to ensure you have the relevant sections indicated. 
    • If Experimental Procedures: In Vivo (animals) is not selected, you won’t be able to list an APLAC protocol.
    • If Experimental Procedures: Humans (clinical studies, clinical samples) is not selected, you won’t be able to list an IRB protocol.
    • If Experimental Procedures: Radiological Materials is not selected, you won’t be able to list an APRS protocol.
  • Check that you are listing the protocol as the number only, which should then allow you to create a hyperlink to the listed protocol.
• What protocols do I have to list?
  • List all relevant protocols that will either involve work with samples from this APB protocol, or that are providing samples that will be worked with on this APB protocol. Examples include listing an APLAC protocol for animals receiving a viral vector or a biological agent, or an IRB protocol that is providing human tissue samples for screening for biological agents under the APB.
• Do I need to list exempt IRBs, e.g. when working with de-identified, infectious patient samples?
  • No, you don’t need to list them. In the methods section, provide information on these samples, and state that they are exempt from IRB oversight.

• What should I list under each section?
  • Experiment Location(s): List all locations where work described in the protocol will be done. This may include your main lab (including tissue culture rooms or procedure rooms), animal locations, shared facilities or collaborator’s spaces. 
  • If you are collaborating or providing samples to a shared facility, and the facility will be doing additional work under their own APB, you do not need to include that location if no one on your APB will be doing the work. However, state that the facility will be doing the work for you in your procedure information.
    • Example: You ask the Viral Vector core to produce a viral vector for you. They do this work themselves, and it is done under their own APB. You do NOT need to list the viral vector core under locations, but you do need to list them as the source for your viral vector. 
    • Example: You take biohazardous samples to a collaborator’s lab in order to use their equipment. The collaborator allows you to use this equipment, but does not have an APB and is not doing the work. You DO need to list this work and the location on your APB, given that your lab will be doing work in that location.
    • Example: You take samples to a collaborator’s lab but the collaborator has their own APB for this additional work. If you are doing the work, AND you are listed on the collaborator’s APB, AND the collaborator’s APB covers the work you are doing in that location, then you do NOT need to put this location on your own APB. Otherwise, the information should be in your APB. It is always best to reference the other APB in your methods section so it is clear that you have additional approvals.
• What do I list as the Biosafety Level?
  • Generally, the Biosafety Level is equivalent to the Risk Group for the agent being used. You can list this Biosafety Level, and it will be reviewed during protocol review. If necessary, the review process will have you update the level following a risk assessment.
  • Generally, Stanford laboratories are built to meet at minimum BSL2 facility standards.
• What does “shared room” mean?
  • A shared room is one that is routinely worked in by multiple lab groups. For example, a tissue culture room used by multiple members of the same lab is not a shared room, but an equipment room used by multiple members of multiple labs is a shared room.
• What if I don’t have a biosafety cabinet?
  • Not all work requires a biosafety cabinet (BSC), but it is a general requirement for certain agents or certain types of work. If you do not have a BSC, check the box to indicate this isn’t applicable, and the Biosafety team will work with you to review the procedures and agents and determine if one is necessary.
• What do I do if my biosafety cabinet is out of certification?
  • Your BSC should have a sticker on it indicating the last time it was certified. A BSC certification is valid for 365 days from the date of the last certification, even if the expiration date on the sticker only indicates the month of expiration. If the sticker indicates more than a year has passed, do not use the BSC. Put a sign on the glass sash saying “DO NOT USE, NOT CERTIFIED” and instruct personnel not to use the BSC. This is because a BSC out of certification cannot be guaranteed to provide adequate protection to you, the environment, or your samples if it is out of certification.
  • To get your BSC certified, Stanford currently contracts with TSS to provide services to campus. TSS contact information is available on the BSC services webpage. You will need to call and schedule an appointment, and the lab is responsible for the costs associated with certification and repairs, if needed. In some buildings, the facility manager takes care of BSC re-certifications and its associated costs.
• My lab is collaborating; what locations and BSCs do I need to list?
  • If the work being done is covered by this APB, then the locations, including any collaboration locations, need to be listed on this APB.
  • If the work in a collaborating space is being covered by another APB, it does not need to be listed on this APB–instead, it must be listed on the APB covering the specific work.
• My lab is using a shared facility; what locations and BSCs do I need to list?
  • If you will be doing work in the shared facility and that work is covered in your APB, you will need to list the location, including any BSCs, that you will use in this APB.
  • If you will be doing work in a shared facility and that work is covered under another APB–for example, one held by the shared facility–then you do not need to list the shared facility or the location on your APB. However, you should make note in your methods that the work is done at the facility under a separate APB (be “evergreen”, list the shared facility instead of the APB number), especially if samples will be returned to your lab for future processing.
  • If the shared facility itself is doing the work for you, then they need to hold an APB that includes the work and the locations. It does not need to include you or your lab’s locations, but should cover what sorts of general samples are received and worked with.
• How do I find the manufacturer, model, serial number and certification date of my biosafety cabinet?
  • This information is  listed on the BSC itself, typically  on the certification sticker.
• How do I get my BSC certified if it is expired?
  • Stanford has a contract with TSS; you will need to call and schedule an appointment, and the lab is responsible for the costs associated with certification and repairs, if needed. In some buildings the facility manager takes care of BSC re-certifications and its associated costs.
• Do I need to list BSCs used in animal facilities?
  • Yes, if you will be doing relevant biohazard/rDNA/sNA work in the animal facility and utilizing the BSC.
• Do I need to list animal housing rooms in this section?
  • For animals previously administered rDNA/sNA or biological agents that are covered by the protocol, yes. However, you do not need to list other housing locations–such as breeding suites, or the room your animals are housed in prior to moving them to a biohazard housing suite. 
• How do I know which rooms in the animal facility to list?
  • If you already have assigned rooms, great! List those!
  • If this work is new and you haven’t been assigned an animal BSL2 (ABSL2) room, then you can list “TBD” on the rooms. Once you have an approved APB and APLAC protocol, you will need to take VSC-0004 training for working with biohazards in animals, and your housing room will be assigned during or shortly after this training. At that point, you can do a quick revision to your protocol to update “TBD” to the given room, and add the relevant BSC. The Biosafety team is able to approve these sorts of revisions on a very quick turnaround.
• My lab does not have an autoclave; is it mandatory to list one? Which one should I list?
  • This question is most important for certain higher hazard work or if you will be autoclaving any waste, which is strongly discouraged. If you intend to autoclave waste, please reach out to Biosafety for discussion, as there are regulatory requirements for this that we all must comply with. It is not necessary if you won’t be treating waste or inactivating agents, but you can list the autoclave that is generally used by your lab for items such as clean glassware or to sterilize solids or liquids. In most cases, the autoclave does not have to be within your lab. 
• My lab’s agents are stored in many freezers across campus. Do I need to list them all?
  • Yes, list all relevant storage locations.

• I can’t check the “continuation of an expiring protocol” box; what do I do?
  • This box can only be checked when you initially clone a protocol, and this is done as a part of the cloning process. If you didn’t do it at the time the protocol was cloned, don’t worry about it now.

• What should my short summary cover?
  • Your short summary should provide a high-level overview of the work you are doing in lay language (be sure to define acronyms), including your basic research goal or question, how you aim to tackle this goal, what relevant rDNA/sNA or biological agents this will include, and what outcomes are expected. This summary can be up to a paragraph long, but shouldn’t be a novel! This summary may be used in communications to the APB panel to describe your overall protocol. Some brief examples follow:
    • Example: My work aims to trace neuronal pathways related to optogenetics and light. We use AAV and modified rabies viral vectors to transduce neurons in vitro and in mouse models, and then perform genomic and proteomic screening to assess changes in cells or tissues in response to light stimuli.
    • Example: My work focuses on viral genetics related to entry into cells. We work with human cytomegalovirus and low-pathogenicity strains of influenza and make targeted mutations in the virus surface proteins, then assess changes in virus-cell binding, entry, replication and pathogenicity in tissue culture and in mouse models. We also use small molecule inhibitors to test their ability to block virus entry, with the goal of identifying potential drug candidates to block infection.
• What technical description sections do I need to fill out?
  • The technical description should cover sections (A) goals of the project, (B) methods, assays, and experimental procedures, and (C) precautions. Animal work in section (D) can only be filled out if you have selected animal work under Are You Using, Experimental Procedures: In Vivo (animals). Be sure to fill out all sections that apply. 
• What is covered under Technical Description: Goals?
  • This section should provide an overview of the work you are doing, and may be similar to your short summary. It can be more technically worded, as needed. It should convey your experimental questions, basic research aims, and what you hope to accomplish or discover with this work. If you work on multiple projects with multiple agents, be sure it is clear in this section what experimental projects are done with which agents.
• How detailed should my methods, assays and experimental procedures be?
  • This section should allow your reviewer and the APB to understand the basic steps your lab will be doing with the agents, from start to finish. For example, this section should be detailed enough that your reviewer and the APB have a good idea of the work to be done and therefore can assist you with risk assessment during the review process, but does not have to be detailed enough that your reviewer or the APB could replicate the methodology!
  • DO assume the reader has a basic understanding of biology and the work you are proposing (e.g., don’t explain what a miniprep is, or how you use lipofectamine to transfect cells).
  • DO cover all the rDNA/sNA or biological agents listed in your protocol. If the work is slightly different for each, you may choose to write a short section for each agent. If the work is all similar, you may choose to state broadly what you do, and include a statement that it is done with all of the biological agents listed. 
  • DO cover your work start to finish (e.g., plasmids made and used to transfect cells that produce viral vectors, harvesting of viral vector and any subsequent concentration steps, how the viral vector will then be used, what the transgene in the viral vector is expected to do, and basic assays you will use to test this). 
  • Do NOT just cut and paste from your grants. This may be a good starting point, but be sure to review the work to ensure it covers an adequate level of detail. If your grant simply states you will assess pathogenicity, then add to your APB how you will do this (e.g., plaque assays, LD50 assays, etc.).
  • Especially do NOT cut and paste from the methods sections of papers! This is far more detail than is needed, and makes the APB review process more difficult for your reviewer–it’s also unnecessary work for you!
  • Do NOT cut and paste from kit protocols, such as Qiagen. Your reviewer can look up the kit if needed, and generally the reviewers and the APB all have relevant scientific backgrounds and are familiar with kits. If they aren’t, your reviewer will ask!
  • Lab standard operating procedures (SOPs) are often too detailed and unnecessary for this section. Please feel free to attach SOPs in the attachment section if desired.
• What should my precautions section cover?
  • This section should include the basic precautions your lab takes when working with rDNA/sNA or biological agents. This should follow the standard relevant Biosafety Level requirements in Biosafety in Microbiological and Biomedical Laboratories by the CDC. 
  • In particular, you should note: 
    • What engineering controls are used and when–this can be as simple as “all work is done in a BSC”, or may need to be more detailed if some work is done in a BSC and some is done on the bench top, fume hood, or other work area.
    • Any procedures with a high risk of aerosolization
    • Use of  sharps, and specifically include if you are using engineered safety sharps or not
    • Work with other hazards, such as radiation or higher-hazard chemicals, during biological work processes
    • The appropriate disinfectant for each agent listed on the protocol, including name, final concentration, and contact time.
  • After reviewing your work, Biosafety may require you to work with enhanced precautions. These are BSL3 practices that are employed while working at BSL2 in order to provide additional safety measures. If asked, please add these enhanced precautions to your work, specifically noting (as needed) what work and what agents they relate to.
• What should my animal work description cover? What if I already put this work in the methods?
  • If you already put this in your methods, be sure it includes all the information asked for (i.e., model, procedures, timeline, etc.)–or better yet, cut and paste into this section! This can really help your reviewer focus on the relevant information in each section.
  • This section should cover work from the time an animal is administered a rDNA/sNA or inoculated with a biological agent through the time at which final samples are taken. Include methods of delivery, samples and time points along the way, and any final samples taken. Also include any additional experimental work to be done, such as animal imaging or behavioral analysis.
  • Describe which procedures will be performed at ABSL2 and if animals are allowed to be transferred to ABSL1; be sure to include the time frames for each housing location, e.g. animals administered with lentivirus will be kept at ABSL2 for 48 hours and then transferred to ABSL1 until euthanasia.
  • Describe the potential shedding of the agent with references to the literature, if available.
  • Describe the disposal route of animals housed at ABSL2, e.g. carcasses of infected animals will be collected in red biohazardous bags and placed in carcass collection fridges within the Veterinary Service Center.

• What should I include in my rDNA description?
  • Provide a brief description of the sorts of non-exempt rDNA you are using, including the source you obtained it from. This can be a company or a collaborator–if a collaborator, please provide their institution. An example might be “We use third-generation lentivirus and Adeno viral vector constructs to express channel rhodopsin genes. We purchased the Lentivirus from Addgene and the Adeno viral vector was gifted to our lab by Dr. Jane Stanford at Stanford University.”
• What is the difference between rDNA and sNA? (Or, Where do I list my plasmids that are not viral vectors?)
  • If you’re not sure, list it all under rDNA.
  • The Biosafety team is working toward streamlining these pages within the APB eProtocol template. While this work is going on behind the scenes, we suggest you differentiate these two categories based on the following:
    • rDNA: vector systems, such as viral vectors, and the helper plasmids used to produce the vector systems, or plasmids used for germline editing, such as those expressing CRISPR/Cas9 or containing a transposon.
    • sNA: nucleic acid sequences synthesized but not contained within a vector system or plasmid, and which are non-exempt under the NIH Guidelines.
• Do I need to list all rDNA or plasmids my lab uses?
  • You need to list all non-exempt rDNA. So, for example, list all viral vectors or plasmids to generate transgenic animals. It is very helpful to list the generation for lentivirus, as later generations have additional safety features, such as self-inactivating sequences.
  • You do NOT need to list all rDNA/sNA that is exempt from the NIH Guidelines; for example, if you have a plasmid you are using to express GFP, it does not need to be listed under either rDNA or sNA, UNLESS it is used as part of a vector system to insert the GFP gene into the germline of a living organism. For example, if the plasmid is simply transiently transfected in cells to express GFP, it does not need to be included, but if it is transduced into cells via a lentivirus, then it does need to be included.
• Where can I find more information on viral vectors?
  • Recombinant Viral Vector Biosafety Levels
  • Adeno-associated Virus Vector Fact Sheet 
  • Adenovirus Vector Fact Sheet
  • Epstein-Barr Virus Vector Fact Sheet
  • Herpesvirus Vector Fact Sheet
  • Lentivirus Vector Fact Sheet
  • Moloney Murine Leukemia Virus Vector Fact Sheet
  • Rabies Virus Vector Fact Sheet
  • Sendai Virus Vector Fact Sheet
• How do I add maps of my viral vectors? Where?
  • Maps should be added under the Attachments section. You can provide a company brochure if you purchased a viral vector plasmid kit, or you can paste maps into a word doc or PDF. Maps should show ORFs and other sequences of relevance (e.g., origin of replication, promotor, etc.) and be big enough to be read by your reviewer. 
  • Note: please do not upload entire sequence files but instead graphic maps.
• How do I know what “generation” my viral vector is?
  • If you purchased a viral vector, the company should provide this information. If you got it from a collaborator, they should be able to provide you this.
  • Addgene gives a good overview of lentivirus generation.
  • As a general rule of thumb, second generation lentivirus is made from 3 plasmids, while third and higher generation lentivirus is made from at least 4 plasmids.
• My lab uses multiple constructs of the same viral vector; how should I list these?
  • If the constructs are similar, then you can list all of them under “Vector Backbone” and fill out one section of the viral vector table. Example: you have multiple lentivirus vectors where the vector backbone is the same but the transgene or insert is different.
  • If the constructs differ, for example, in terms of the wild type deletions, list them separately. Example: you have multiple lentivirus vectors made from different backbones/plasmids, and which may have different deletions, promotors, etc.
• What is meant by vector and backbone?
  • Vector is the original name of your viral vector, such as “Lentivirus” or “Adeno-associated virus”. Backbone is the more specific name of that particular vector, such as “pLKO”. If you have multiple transgenes or inserts in the same backbone, you can list them all under a single entry, provided that you include a full list of inserts.
• What is meant by wild type deletions?
  • These are the genes present in the original wild-type virus that are not present in the viral vector or any of the helper plasmids used to produce it. For example, lentivirus is based on HIV, so any genes present in HIV that are not present in the lentivirus are deleted.
• What is meant by replication status?
  • Once produced, can your viral vector replicate itself? If yes, it is replication competent. If not, it is replication incompetent.
  • It is important to understand that in general, viral vectors are capable of a single round of entry into a given cell–meaning they may enter any cell they come in contact with. However, once in that cell, the viral vector does not contain the full replication machinery and should not be able to produce additional copies of itself, unless the missing machinery is provided through another method, such as a plasmid or a co-infection. 
• What is meant by helper plasmids? Do I need to list all of them?
  • These are the plasmids that supply the machinery to construct the viral vector, but are not actually packaged into the viral vector, rendering it replication incompetent after production. Often, this is the envelope and packaging plasmids. Yes, list them all.
• What is meant by source of vector?
  • Source is who you purchased or received the vector from. If purchased from commercial vendors, please list the company. The catalog number may also be helpful to include.
• Do I need to list all cell lines we use with the viral vectors?
  • List the cell line(s) used to produce the viral vector here. Other cell lines that you transduce with the viral vector should be listed in the methods or in the cells section.
• My lab expresses many inserts; how should we list these?
  • List all inserts–if this is a lot, you can list genes or gene families, such as “channel rhodopsins” instead of each individual channel rhodopsin gene.
• My lab uses CRISPR and/or Cas9, or similar systems. Do I add the vectors here? If yes, how?
  • If your CRISPR or Cas9 or similar systems are expressed on a viral vector or a plasmid, then list them in the rDNA section, and be sure the viral vector is listed in the table.

• What should be included in my sNA description?
  • Provide a brief description of the sorts of non-exempt sNA you are using, including the source you obtained it from. This can be a company or a collaborator–if a collaborator, please provide their institution as well. An example might be “We use microRNAs, which were gifted to our lab by Dr. Jane Stanford at Stanford University.”
• How is this different from what I list in my rDNA section? Do I need to list all my rDNA if it is assembled in the lab?
  • rDNA should primarily focus on your viral vectors and the helper plasmids used to produce those viral vectors. 
  • sNA should primarily focus on non-vector/plasmid pieces of rDNA/sNA used in your research. 
  • You only need to list the non-exempt items, not all items in your lab.
• Do I need to list all primers/PCR oligos or other nucleic acids that the lab has synthesized or purchased synthesized?
  • No, if they are exempt from the NIH Guidelines, you do not need to list them. 
• What is meant by conjugates present?
  • If your sNA molecule is linked to another molecule, such as a peptide, small molecule, or lipid, include that here.
• What should I list as sequence origin?
  • This should provide what the sequence originates from, or what it was modeled on. For example, if you’re expressing part of a gene, what is the gene and what organism is it from? Or, perhaps you designed a new gene–is it modeled on something found in nature?
• What is meant by replication status?
  • Does the sNA contain any sequences that might allow it to replicate? If yes, state that here.
• How do I know if my sNA can integrate into dNA?
  • Does it contain any integration sequences? Transposable elements? Splice acceptors/donors? If yes, list those here. 

• What agents do I have to list?
  • List all agents Risk Group 2 or higher that you are using in your work. 
  • List any Risk Group 1 agents that have been modified using non-exempt rDNA/sNA. 
  • Do not list unmodified Risk Group 1 agents, or exempt model systems such as cloning strains of E. coli or Saccharomyces cerevisiae.
  • List agents that may qualify as non-exempt under certain conditions, such as Adeno-associated viral vectors, and animal pathogens that qualify as Animal Biosecurity for purposes of housing and handling animals, such as Citrobacter rodentium or Plasmodium berghei. However, if these are the only agents listed, you may not need an APB protocol–confirm with Biosafety.
• What if I don’t see my agent listed on the drop down list?
  • Contact biosafetyeprotocol@lists.stanford.edu and we will add it to the drop down list. This change may take several business days to complete.
• What if I have a lot of agents?
  • Contact Biosafety first! For labs with an excessive number of agents, such as microbiome labs working with tens or hundreds of agents, but you may be able to list each genus in the Agent section, and then attach a full list of agents to the Attachments section of the protocol rather than adding all the individual agents as separate strains within the Agents section.
• What if I want to work with a Select Agents or Risk Group 3 or 4 agent?
  • Please reach out to Biosafety and the Biosafety Officer as soon as you begin to think about this work. At this time, Stanford does not have facilities to support Select Agent or Risk Group 4 work. However, Biosafety will be happy to guide you on creating a Risk Group 3 protocol and the requirements for this work.
• How do I know the Biosafety Level for my agent? What does “+” mean and how do I know if it applies?
  • Start by looking up the Risk Group for your agent, and listing that on the protocol. If your agent is a Risk Group 3 or 4, reach out to Biosafety before creating the protocol–we will help you with a risk assessment to determine if the work can be done at Stanford and at what Biosafety Level. 
  • Most work at Stanford is Biosafety Level 2. Start by listing your work as BSL2 unless otherwise instructed by Biosafety.
  • You should generally default to listing agents as BSL2 and not BSL2+. The “+” is used to denote enhanced precautions. So, BSL2+ means working in a BSL2 facility with BSL3 practices. These enhanced precautions add additional layers of safety to help mitigate potential risks. Biosafety will work with you on this designation if needed, and the enhanced precautions will need to be detailed in your protocol.
• What do I need to provide for strain and source information?
  • Strain names provide additional identifying information for your agent. For example, if you listed Pseudorabies Virus as your agent, you might list Bartha as the strain. Or, if you listed Salmonella typhimurium, the strain might be SL1344. This can be an important piece of information–some strains may be different Risk Groups from others, possibly even a Select Agent! 
  • Source also provides an important piece of information. Source can be a collaborator (Dr. Jane Stanford at Stanford University) or a commercial vendor. For collaborators, provide also their home institution. For commercial vendors, a catalog number is helpful but not required.
• I already listed my viral vector under rDNA; do I need to list it under agent?
  • Yes, list the general vector, but you don’t need to list all the plasmids. This should align with what you put for “vector” on the rDNA page, such as “lentivirus” or “adenovirus vector”. However, if you have multiple types of Lentivirus, you only need to list it once under Agents.
• What should I not list under agents?
  • Don’t list things that aren’t biological agents. This includes proteins, antibodies, chemicals, small molecules, etc.
  • Don’t list Risk Group 1 agents that are not modified with non-exempt rDNA/sNA. This is important to allow broader classification and tracking of the higher level agents on Stanford’s campus under APB oversight.
  • Important: If you are NOT working with any infectious agent but you are working with non-exempt rDNA/sNA, select this option under the Agents tab in order to ensure your protocol is approved for 3 years instead of 1. If you are working with infectious agents as well as non-exempt rDNa/sNA, there is no need to list the rDNA/sNA, just the agents.
• How do I know what antibiotic/antiviral drugs my agent is resistant or susceptible to?
  • First, check with the supplier–a collaborator or a commercial vendor–and determine what information they can provide on potential resistance. 
  • Next, the APB requires a biogram, or a test for antibiotic sensitivity and resistance, for almost all bacteria used on protocols. This test looks at clinically relevant antibiotics–not the ones generally used in labs for selection. This information is used if there is a potential lab exposure–EHS and the lab will be able to provide this information to the treating physician to assist with the correct choice of treatments. 
  • Additionally, in rare instances, testing sometimes identifies that you don’t have what you think you have! In these cases, the agent may be related or different, and it’s good for a lab to know this information! 
  • Stanford offers testing services through a contract with the VA. Generally your reviewer will send information on how to request testing during protocol review, once it has been determined that testing is needed. If you haven’t received this information during review, please contact Biosafety for how to engage this service.
• How specific do I need to be for concentration and volumes of agents generated?
  • Provide at least close ballpark numbers. What is the rough anticipated concentration of any agent in the supernatant or in the cells? Will you then further concentrate the agent, and if so, what do you anticipate the expected concentration to be?  For example, you don’t need to report exactly 1.26×10^6, roughly 10^6 is fine.  Or perhaps you will grow it to 10^6 and then concentrate it through centrifugation to 10^8.
  • For volume, think about how you will grow the agent–standard tissue culture amounts, generally in T150s? Larger? Smaller? How many flasks do you anticipate growing at any one time?
• What if I will generate close to 10 liters but promise not to go over 9.99 liters?
  • NIH Guidelines cover large-scale work, defined as 10L or above. To avoid errors that may lead to usages over this amount, any volume growth is capped at 9L. Keep in mind, this is 9L in a given container, not 9L across multiple containers, or across time! 
  • For any anticipated growth over 9L, you must include Large Scale guidance–if you plan to do work above 9L, please reach out to Biosafety during the experiment planning stages so we can help address how Large Scale Guidance should be implemented for your work. 
• Projects change in our lab; what does it mean if I select one agent for one personnel, but they want to work on another agent? Do I have to submit a revision?
  • Yes, please submit a revision to indicate the person is working with a new agent by checking the appropriate box on the personnel-agent table. This is important to know in case there are medical surveillance requirements for certain agents. You’ll also need to ensure the person is trained on the new agent.
• What is done with the agents and personnel information?
  • This information may be conveyed to Occupational Health for review and recommendations on medical surveillance. 
• We are currently not working with one agent but still have an active grant. Can I leave it on the protocol without assigned personnel?
  • Yes! Simply leave the row blank with no checked boxes.
• I only buy a few uL of virus from a vendor for one experiment. Do I still need to list it here even though we don’t produce or culture in the lab?
  • Yes, all agents that fall under APB purview must be listed on a protocol, and you must be approved to work with that agent prior to starting the work, no matter how big or how small.
• Where do I attach the biogram for the bacteria I am working with? 
  • Text of this section should provide an overview of the biogram results
  • Upload the biogram in the attachments section, which is at the end of the Protocol Information section. We suggest you make a heading of “Biogram” or similar, and put all relevant biograms under that heading. Be sure each biogram file is labeled with the agent name, and ideally, the date of testing.
• My PI is not working in the lab. Which box do I check in the biological agents/ personnel table?
  • If they are not working with any agents, check the “N/A (No work) box”.

• How specific do I need to be on listing cell lines?
  • Please list all cell lines that are used with an infectious agent, transfected to produce a viral vector, or transduced with a viral vector. If you use other cell lines in your lab, but separately from your APB work, these do not need to be listed on your APB.
• My lab has had these cells forever; what should I list as a source?
  • Do your best to list previous sources, such as the company or your collaborating lab/institute. If you truly don’t know, it’s okay to say so.
• How are the cell precautions different from the description section precautions? What do I need to include in this section?
  • If you list any human cell lines, you can list Bloodborne Pathogens/Universal Precautions; be sure everyone who works with them, and the PI overseeing the work, are aware of Bloodborne Pathogens requirements and working under Universal Precautions, including training and best practices. 
  • If any cell lines listed meet the following criteria, please follow the directions here:
    • Cell lines transformed by EBV–list EBV as an agent, and state in cell biosafety precautions that these cells will be worked with at BSL2. An example is Raji cells.
    • Cell lines containing Hepatitis viruses–list the virus as an agent, and state in cell biosafety precautions that these cells will be worked with at BSL2. An example is Huh7 cells with Hepatitis C virus.
    • Primary cell lines from cancers that are highly associated with infectious agents, such as hepatocellular carcinoma and Hepatitis viruses, or cervical carcinomas and Human Papillomavirus. List the virus as an agent and state that these cells will be worked with at BSL2. 
• I can’t enter an animal species; what do I do?
  • Check to make sure you selected “In Vivo” work on the “Are You Using” page. If you have, and you still can’t enter an animal species, contact Biosafety.
  • If you’re working with an invertebrate such as an arthropod, state that in your Methods, but you don’t need to list the animal here.
• I don’t see my species listed; what do I do?
  • Select Other, and type in the species in the description box.
• What is meant by description for animals?
  • Provide the strain or exact species, such as mouse strain or bird species. For Sheep, specify if you are working with male sheep, or female/neonatal sheep–neonatal sheep are those 12 weeks of age and younger. For primates, specify species. 
• How are the animal precautions different from the description section precautions? What do I need to include in this section?
  • Specify exactly which agents will be administered to animals. For viral vectors, specify if viral vector will be directly administered, or if only transduced cells will be administered–and if only transduced cells, confirm the cells will be grown a minimum of 48h post transduction in vitro, followed by washing of cells, prior to administration of animals. It is also helpful to include if animals will only be handled within animal facilities, or if they will be transported to your lab or other facilities for procedures or sampling. 
  • Precautions should include general animal biosafety precautions, such as those found in the CDC BMBL or included in the Veterinary Service Center’s SOP for ABSL2 and ABSL1+ animal work. Review the Biosafety Animal Housing requirements, and confirm you will adhere to appropriate cage card labeling, Animal Biosafety Level practices, and PPE, and specify housing, such as 
    • ABSL2 permanent housing
    • ABSL2 for defined shedding period followed by transfer to a clean cage, updating of cage signage, and transfer to ABSL1 (regular animal housing)
    • ABSL1 (or regular animal housing)

If you or your lab need more information on ABSL2 precautions, reach out to the VSC for their ABSL2 or ABSL1+ SOPs by contacting vsc_training@stanford.edu, or reach out to Biosafety.

• How do I know what Stanford’s recommended procedures are so I can confirm I’m following them?
  • Review the Biosafety Manual, particularly Chapter 9, for an overview of Safety. You will likely check Yes for all of these safety procedures–if there is one you intend to check “no” on, describe in question 1e what the alternate precautions you take are. An example would be work with prion-like proteins, which requires more stringent decontamination than use of 0.5% sodium hypochlorite. Therefore, you would check no to 1d and provide information in 1e on what decontamination procedures you would use.
• What qualifies as secondary containment?
  • Secondary containment is defined as a hard-walled container that is leak-proof and has a tight fitting lid. It should be labeled with the biohazard symbol on the lid and at least one side, as well as the name and contact information for the responsible person, and the agent and biosafety level. Please note: Styrofoam boxes are NOT leak-proof and are NOT appropriate secondary containment. Zip lock bags can be used if desired but do not replace hard-walled secondary containment.
• How do I get biohazard stickers to label my equipment? Why does all equipment used with biohazards need a sticker?
  • Biohazard stickers can be requested from the safety store and picked up at the EHS front desk.
  • All equipment used with biohazards needs a sticker to indicate that it may have been exposed. This informs other users of the equipment to be aware and take appropriate precautions. It also indicates that the equipment should be appropriately decontaminated before disposal. 
• What are the transport requirements for Risk Group 2? Do they differ if I’m walking or driving? Staying on campus or going to an off-campus location?
  • Transport within the lab: Wear appropriate PPE (e.g., lab coat, gloves, eye protection).
  • Walking on campus between buildings or through public areas: Place the material in secondary containment and wipe the outside of the secondary containment with appropriate disinfectant. Be sure you have proper PPE (lab coat, gloves, eye protection) with you in case of a spill or other emergency, but do not use a gloved hand on any common surfaces such as door handles, elevator buttons, or stair railings.
  • When driving off campus, use a private vehicle (no bikes or scooters) and not public transportation (Margarite, ride share, etc.). Place the material in tertiary containment, labeled as you would for secondary containment. Take a spill kit and appropriate disinfectant in case of emergency.  Drive directly to your destination, without running errands or making other stops along the way.
• What if I need to transport Risk Group 3 agents?
  • Contact Biosafety for the appropriate SOPs and precautions.
• Decontamination says bleach, but my agent is susceptible to other disinfectants; should I still say yes to using bleach?
  • Good question! While biosafety is planning on updating this question, please only answer yes if you will use bleach. Otherwise, in question “e”, include the disinfectant, concentration, and contact time you will use.
• There is no selection for 50% bleach to decon PLP. How do I add other concentrations of bleach or disinfectants?
  • In question “e”, provide an overview of the decontamination and disposal methods that you will use for prion–like proteins (PLP). For more information on these, contact Biosafety.
• What is PPE? Is a BSC PPE?
  • PPE is personal protective equipment, generally a lab coat, gloves and eye protection. Indicate any additional required PPE.
  • NOTE: As of May 2024, eye protection is required by the APB for all BSL2 and higher work or work done in BSL2 spaces.
  • Do not indicate optional PPE, such as voluntary use of face masks. 
  • No, a Biosafety Cabinet is an Engineering Control Device, not PPE.
• What is the required PPE for my work? How do I know when to use additional PPE and when is it required?
  • At a minimum, you should be using a lab coat, gloves, and safety glasses (eye protection) when working with BSL2 agents. If additional PPE is required, you and your protocol reviewer will discuss this during the review process and update this section. The PPE Assessment Tool can help guide your PPE choices.
  • If you go to areas where additional PPE is always required, such as ABSL2 vivarium spaces, you must wear the PPE required in the space.
• PPE levels differ in my lab versus other places, like vivariums; what PPE should I indicate?
  • You do not need to indicate PPE used in vivariums unless this PPE is also used in your lab–for example, don’t select “shoe covers” if you only wear them in the ABSL2 rooms, but never in your lab.
  • Indicate the minimum requirement generally for your work–for example, what you wear in the lab to do most of your BSL2 work.
• What is needed if I indicate respirator use?
  • Only indicate a respirator if this is required for work on your protocol. If it is required, indicate the type that is required, such as a face mask, N95, PAPR, CAPR, etc. 
  • Some respirators will require enrollment in the Respiratory Protection Program, with annual medical clearance, training, and fit testing. It is the PI’s responsibility to ensure all lab personnel are adhering to the requirements of this program.
  • Do NOT select respirator use if you are voluntarily wearing a face mask or N95.
• What sort of eye protection is appropriate?
  • At minimum, wear ANSI Z87.1-approved safety glasses to protect your eyes, either regular or over-the-glasses ones that fit over your eye glasses. Normal eye glasses are not sufficient,  unless you have ordered safety glasses with prescription lenses. For more on prescription glasses, see the appropriate section on the Lab Safety PPE page.
  • For certain tasks with higher spill or splash hazard, goggles or a face shield and eye protection may be more appropriate. 
  • Regular and over-the-glasses safety glasses can be provided by EHS through the safety store, but for ongoing operational needs, they are the responsibility of the PI to provide.
• Is there other PPE I should consider?
  • Other PPE might include cut-resistant gloves for use with microtomes/cryostats/vibrotomes or other sharp blades, hearing protection, or other protective clothing. Be sure to list any additional required PPE in the precautions section. If you’re not sure what you might need, ask your reviewer or reach out to Biosafety.

Visit the Lab Safety PPE page for more information, and review your lab’s PPE Assessment Tool.

• What do I need to include in the Risk section?
  • For each infectious agent, include a brief answer that addresses common routes of infection (especially those potentially present in the lab), clinical signs and symptoms of infection, if immunization and treatment are available, and any risks infection could lead to. Specifically include if there are any reproductive or developmental risks, increased risk to those who are not immunocompetent, or any long-term risks. 
    • For bacteria, specifically list any known antibiotic resistance for each specific strain. This is important information in case an exposure needs to be treated.
  • For each viral vector, include a brief answer that addresses potential routes of exposure in the lab and risks of exposure, including transgene expression risks, particularly if the transgene is a toxin, oncogene, or PLP. If the viral vector cargo is not a transgene but a rDNa/sNA that may affect other nucleic acids or proteins, include possible downstream risks for exposure. 
  • For any work with human blood, blood products, cells, cell lines, or other potentially infectious material, include the risk of Bloodborne Pathogens.
  • Specifically include risks for needlestick if any work will include use of needles or sharps, or risk from animal bites if in vivo work is performed.
• How do I know what medical surveillance practices should be included?
  • Medical surveillance requirements are determined by the Stanford University Occupational Health Center Medical Director. If a vaccine is available for one of your agents,  reach out to Biosafety and/or the Occupational Health Center.
  • Other medical surveillance steps may include baseline testing upon starting in a lab, testing prior to leaving a lab, testing for previous exposures, or testing to confirm adequate immune response to a given agent. If you have any questions about this, reach out to Biosafety and/or the Occupational Health Center.
• We have a lot of agents; do I need to list the risks for all of them? 
  • Yes. As the PI, you are responsible for ensuring all your people are trained on the agent information and risks. Use this section as a training document for your lab. 
• What if our exposure policies are different from those listed here?
  • Select No on the applicable policy, and clarify in section (g) what practice or policy your lab adheres to. This will be reviewed by Biosafety and possibly an Occupational Health Center provider.
• How do I find out what clinical symptoms are associated with the biological agent(s) in my lab?
  • Look up your agent on the CDC website–this is a great resource for general information on many agents, and will provide information for the general public and for medical caregivers.
  • Another resource is the Public Health Agency of Canada’s Pathogen Safety Data Sheets. Some of the applicable information on classification may differ between the US and Canada, but in general, these sheets provide almost all the information needed to train your staff on an agent.
• Can I get immunizations from OHC for (an) agent(s) I am working with? If yes, is this service covered or do I need to pay for it?
  • If determined that this is appropriate by an OHC provider, then yes, you can receive this immunization from the OHC. Direct payment questions to the OHC.

• What training is required?
  • Everyone on a protocol who is doing active work with agents or rDNmust take EHS-1500 Biosafety. Other general lab trainings that are likely to be required for everyone include EHS-1900 Chemical Safety and EHS-2200 Compressed Gas Safety.
  • Other trainings that are required:
    • EHS 1600 is required if you work with material under the Bloodborne Pathogens Standard (human blood, blood products, cells, cell lines, or OPIM; at Stanford, this also includes NHP material), or oversee someone who works with Bloodborne Pathogens material. This training is required annually by OSHA. Please note: EHS-1600 and EHS-1601 have the same content.  No protocol will be approved without all personnel having completed this as required–the only exception will be an extended medical leave or other absence, and the PI must state they will ensure the person is trained upon their return to the lab and prior to engaging in any applicable work.
    • EHS 1090 is required you work with any agent on the Aerosol Transmissible Disease Standard Appendix D list, or oversee someone who works with an agent on this list: EHS-1090. No protocol will be approved without all personnel having completed this as required–the only exception will be an extended medical leave or other absence, and the PI must state they will ensure the person is trained upon their return to the lab and prior to engaging in any applicable work.
    • If you work with cryogens such as liquid nitrogen: EHS-2480.
    • If you are in charge of shipping any biologicals OR dry ice: EHS-2700. NOTE: You only need to take this training to ship items, not receive. This training is good for 2 years. If, after 2 years, you do not ship items, you do not need to renew this training.
• What training is recommended?
  • We highly recommend both Computer Ergonomics (EHS-3400) and Lab Ergonomics (EHS-4800).
• Do people on the protocol who do not work with agents and don’t sit in the lab (example, an office admin) need to take training? Does my PI need to take training if (s)he doesn’t work in the lab?
  • An admin who does not do any work and does not routinely enter the lab space does not need to take these trainings.
  • A PI or supervisor who does not do any direct work, but does oversee personnel required to take either BBP EHS1-1600 or ATD EHS-1090, MUST take these trainings. There will be no exceptions to this requirement. The PI does not need to take other lab-specific trainings.
• My PI doesn’t do work and doesn’t sit in the lab; are you sure they need to take training?
  • Yes. No exceptions will be made. This requirement has been supported by the Dean of Research for over a decade.
• Where can I find the Agent Education Acknowledgement form? What training is required before people sign the form? How do people complete this and what needs to be done with it? Does the PI have to sign the AEA form?
  • If you are creating a brand new protocol, you can email Biosafety for this form. Once a protocol has been submitted, your reviewer will attach a blank AEA form to your protocol for future use. 
  • All people who work with agents must review the appropriate agent information, as listed on the form. Training materials may be supplied by Biosafety, attached to the protocol, or they may be available online, such as through the CDC or Public Health Agency of Canada Pathogen Safety Data Sheets.
• On the training list, what does the blue and red highlighting mean?
  • BLUE means the training has expired and MUST be retaken before the protocol can be approved.
  • RED means the training may not be required or has never been taken before. Training dates will auto populate within 1 full day.
• How often do I need to re-take EHS-1600, EHS-2700, and EHS-1090?
  • EHS-1600 and EHS-1090 must be taken annually if you are doing work relating to the Bloodborne Pathogen Standard or Aerosol Transmissible Disease Standard, or overseeing someone who does work under these standards.
  • EHS-2700 must be taken every two years if you are shipping biologicals or dry ice.
• A lab member is on leave and cannot complete the training. How can we get our protocol approved without removing the person?
  • The only exceptions to training will be an extended medical leave or other absence, and the PI must state they will ensure the person is trained upon their return to the lab and prior to engaging in any applicable work. 
• I completed my training today but my new expiration date did not update. Can you help?
  • Training updates within 1 full day–the records are pulled from STARS, the training system, into eProtocol, each night. If it does not update within 1 full day, contact Biosafety.
• I completed the training but at the end I could not exit and my training records don’t show up as completed in STARS. How do I proceed?
  • Contact STARS for further assistance.
• STARS does not show EHS-1600 or EHS-1090 assigned to me. Does that mean I don’t need to complete it?
  • If you work with any human blood, blood products, cells, cell lines, or OPIM as per the Bloodborne Pathogen Standard, you must take EHS-1600 annually. You can search and enroll in STARS if it is not assigned. NOTE: Stanford also includes all NHP blood, blood products, cells, cell lines or OPIM in the category of BBP.
  • If you work with an agent listed in the Aerosol Transmissible Disease Standard Appendix D, you must take EHS-1090 annually. You can search and enroll in sTRS if it is not assigned.
• I am receiving a lot of dry ice packages in my lab but only the lab manager sends dry ice shipments. Do I need to complete EHS-2700?
  • Only those shipping biologicals or dry ice need to take this training. It is not necessary to take this training to receive packages.

• What do I have to attach? Are there attachments that are recommended?
  • You must attach anything that you make reference to in a protocol, such as viral vector or plasmid  maps, a biogram (antibiotic sensitivity and resistance testing for bacteria), previous publications you are providing as proof of methodology/inactivation/safety information, the Agent Education Acknowledgement form signed by all lab members, or for protocols on microbiome agents with extensive agent lists, the full agent list (you must get permission from Biosafety in order to do this, as at a minimum the genus must be listed in the Agent section). 
  • Recommended attachments would include Standard Operating Procedures or other documents that are useful to your reviewer, or that you want to ensure your lab members review when they review the protocol as part of their training.
• What should I label the attachment section names? How can I update the attachment section names?
  • Use generic labels such as “Agent Education Acknowledgement form”. You cannot edit these once they have been created, so don’t get too specific!
• My protocol has a lot of old attachments that are no longer relevant; what should I do?
  • If the attachments are not relevant to the current iteration of the protocol and are more than 3 years old, you may delete them from the protocol.
  • Do not delete training records such as the AEA form if they are less than 3 years old.
• Do I need to upload all training certificates for all personnel? What should not be attached? 
  • No, training information pulls automatically from STARS. You only need to attach the AEA form for training.
  • Documentation about BSC certifications does not need to be attached.
  • BBP local exposure plans no longer need to be attached.
• What formats are accepted for uploading documents?
  • Word, Powerpoint, JPEG images, and PDF documents can be attached.
• Should I attach a PDF of my APLAC, IRB, SCRO?
  • If your protocol is a Stanford protocol and you’ve listed it in the “Other Panels” section, a hyperlink to the protocol will be automatically created and you do not need to attach a PDF.
  • If you are at the VA and utilize a VA protocol, such as an animal ACORP protocol, then you will need to attach it as a PDF.
• I don’t recognize an attachment or the name of the person who attached it. Should I delete the attachment?
  • It may have been attached by a previous lab member or a member of Biosafety, so don’t worry about the name of the person. 
  • However, if the document is not relevant to your current protocol, or is more than 3 years out of date, such as an old AEA form, then you may remove it from the protocol.

• Does my PI have to be the one to check these boxes?
  • Yes, they are responsible for the protocol itself and the safety in the lab, and need to complete the certifications on this page.

• How can I print a PDF of my protocol?
  • Click on print view and select what you want to print. It will download a PDF of the protocol that you can then print.

• Where do I see previous BVs conducted in my lab?
  • These are attached under Event History in the Protocol History section of your protocol. Biovisits should be attached within 1 month of completion, so don’t worry if they don’t appear right away.
• Where can I download the Approval Letter of my protocol?
  • Under Protocol History, find the most recent approval (likely at the bottom of the list), and click on the link under the “Letter” column. This will download your approval letter.