Wayne State University

Biosafety Frequently Asked Questions

General questions

  1. What type of research requires the Institutional Biosafety Committee (IBC) approval?
  2. When and where must projects be submitted?
  3. Who will review my application?
  4. How does the IBC review process work?
  5. How long will it be until my protocol is approved?
  6. How long is my new IBC approval good for?
  7. Once I receive my IBC approval letter, am I through?
  8. Does work with human blood, cell lines, tissue or other human materials require IBC approval?
  9. Where do I find the IBC applications and SOP forms?

Specific questions

  1. Where can I find what is considered a  risk group 2 agent and other relevant biosafety definitions?
  2. Why is IBC approval required for the use of transgenic animals?
  3. I share a lab with an investigator whose research and lab has been IBC approved. Do I still need to apply to the IBC for approval of my project?
  4. I have a project that's been previously approved by the IBC. What if I have a new project that may need approval?
  5. To prepare for a BSL2 lab inspection what do I need to know?
  6. Why do I need and how do I prepare a biosafety Standard Operating Procedure (SOP) for my work?
  7. Who can be a Principal Investigator (PI) on a protocol?
  8. How do I get the required Biosafety training?

General questions

  1. What type of research requires the Institutional Biosafety Committee (IBC) approval?
    • Research at Wayne State University involving the use of biological materials, including; recombinant DNA, agents infectious to humans, animals or plants, CDC/USDA Select Agents (including listed biotoxins), and other genetically altered organisms and agents are reviewed by the IBC. The use of transgenic animals (knock-out, knock-in) or plants is also reviewed.
  2. When and where must projects be submitted?
    • You must submit a completed "IBC Biological Agent User Application Form" and laboratory specific biosafety Standard Operating Procedures (SOPs) to the IBC via the Office Environmental Health and Safety, 5425 Woodward Ave, Suite 300, for review and approval before beginning the project. The IBC meets every month. Meeting dates are posted online. Applications and SOPs must be submitted at least two weeks prior to the meeting date.
      • Note: You typically do not need IBC approval if you are using transgenic rodents that are able to be contained using ABSL-1 housing.  If the animals are being used in conjunction with rDNA, synthetic nucleic acid molecules, infectious agents, biotoxins, or require ABSL-2 housing, then an IBC will be required  
  3. Who will review my application?
    • Two Committee members with expertise in the type of activity you plan to pursue will review your application. The rest of the committee will have the opportunity to comment on your application during the IBC meeting.
  4. How does the IBC review process work?
  5. How long will it be until my protocol is approved?
    • Applications and SOPs must be submitted at least two weeks prior to the monthly IBC meeting in order to be reviewed that month. We will make every effort to review your protocol, and may ask you to provide any extra information the committee needs to make a decision. We appreciate your cooperation and patience during this process. Committee approval letters are typically forwarded to the PI within two weeks of the IBC meeting. 
  6. How long is my new IBC approval good for?
    • Your new registration will be valid for three years from the date of approval.
  7. Once I receive my IBC approval letter, am I through?
    • Not yet. If you have not had a biosafety level 2 (BSL2) inspection, prior to your IBC approval, you will be contacted by OEH&S to schedule one. This is typically done shortly before you receive your IBC approval letter. Once your lab has been BSL2 approved, the process will be complete.
  8. Does work with human blood, cell lines, tissue or other human materials require IBC approval?
    • Typically not, however, you do need OEH&S approval for this type of work, which includes record of attending the Biosafety training course and an on-site biosafety level 2 (BSL2) lab inspection conducted by a health and safety representative.
  9. Where do I find the IBC applications and SOP forms?

Specific questions

  1. Where can I find what is considered a risk group 2 agent and other relevant biosafety definitions?
  2. Why is IBC approval required for the use of transgenic animals?
    • The NIH Guidelines do not require approval for the use of transgenics rodents, but WSU does require registration of transgenic animals (knock-out, knock-in), or plants, in order to evaluate potential health or environmental hazards associated with these genetically modified materials. The questions posed on the IBC Transgenic Animal Form are meant to assess if these animals:
      • exhibit possible disease resistance (or are prone to infections more easily than normal);
      • contribute to the expansion of the host range of an infectious agent, or;
      • present any unexpected hazard to animal handlers or research staff, especially if they're exposed to a hazardous biological, chemical, or radioactive agent.
  3. I share a lab with an investigator who has been IBC approved and whose lab has been BSL2 approved. Do I still need to apply to the IBC for approval of my project?
    • Yes. If you work in a lab that is posted for BSL2 activities you must still go through the IBC approval process. One PI cannot "piggyback" on an existing IBC approval of another PI. You must also participate in a BSL2 lab inspection. A lab inspection initiated for one PI does not carry over to a second PI even if you use the same lab space.
  4. I have a project that's been previously approved by the IBC. What if I have a new project that needs approval?
    • All protocols that reach the end of their three year approval period must be updated and resubmitted to the IBC.  The protocol will be subject to the same procedures as a new protocol and will receive full committee review at the next scheduled IBC meeting.
  5. To prepare for a BSL2 lab inspection what do I need to know?
  6. Why do I need and how do I prepare a biosafety Standard Operating Procedure (SOP) for my BSL2 work?
    • A lab-specific biosafety manual (SOP) is prepared and adopted as policy per Section B.4. of the Biosafety Level 2 Criteria in the CDC/ NIH Biosafety in Microbiological and Biomedical Laboratories, 5th edition, Section IV.
    • The SOP can be prepared from past safety experience, using information obtained from the Biosafety training you've taken here at Wayne State or from the reference material on the OEHS Biosafety information and references webpage. The "Pathogen Safety Data Sheets and Risk Assessment" database from the Public Health Agency of Canada is very helpful.
    • You can use this SOP template form. To see a sample SOP, click here.
    • For further assistance, contact the Biosafety Officer at 313-993-7597.
  7. Who can be a Principal Investigator (PI) on an IBC protocol?
    • A Principal Investigator is a member of the academic staff or faculty who bears responsibility for the intellectual leadership of a project. The Principal Investigator accepts overall responsibility for directing the research, the financial oversight of the award's funding, as well as compliance with relevant University policies and sponsor terms and conditions of the award. If you do not fit this definition you will need to have a Responsible Faculty Advisor sign your application.
  8. How do I get the required Biosafety training?
    • Biosafety training is required for all researchers working with Risk Group 2 agents, including human (or primate) blood, tissue, cell lines or body fluids. Training is offered every month by OEH&S. For a schedule of upcoming classes: research.wayne.edu/oehs/training/lab.php
    • The OSHA Bloodborne Pathogen Standard is also covered in the training. Refresher training is required annually and can be completed on-line here.