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.
     • 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 may be required.  Please read the information below regarding transgenic animals.
2. When and where must projects be submitted?
   • You must submit a completed e-Protocol submission, including the appropriate laboratory specific biosafety Standard Operating Procedures (SOPs), to the IBC for review and approval before beginning the project. The IBC meets every month. Meeting dates are posted online. Applications and SOPs must be submitted by the 1st of each month for inclusion in that months IBC meeting.
3. Who will review my application?
   • You protocol will be pre-reviewed by the WSU Biosafety Officer.  Once any recommended changes have been completed, two Committee members with expertise in the type of activity you plan to pursue will review your application. These reviewers will present your application at the IBC meeting and provide recommendations.  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?
   • Please see the WSU IBC Charter for detailed information.
5. How long will it be until my protocol is approved?
   • Applications and SOPs must be submitted by the 1st of the month for inclusion in the monthly IBC meeting. 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 prior to the IBC meeting at which your protocol is being reviewed. 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.  If the human blood, cell lines, tissues, etc are known or can be reasonably expected to harbor a specific pathogen, then IBC approval is required prior to initiating work.  If you identify a specific pathogen during the course of your work on these materials, then an IBC application for continued work with this material must be submitted.
9. Where do I find the IBC applications and SOP forms?
   • IBC application information
   • Step-by-step guide to the IBC protocol reveiw and approval process
   • IBC protocol attachment forms (e.g., SOP forms)

Specific questions

1. Where can I find what is considered a risk group 2 agent and other relevant biosafety definitions?
   • Go to the OEH&S website Biosafety page for lists and a definition of Risk Group 2 agents.  The American Biological Safety Association has a useful tool for looking up the risk group assigned to specific microorganisms.  Please also visit the CDC/USDA website for a list of Select Agents and toxins.  Another helpful web link is the NIH Guidelines.
2. Why is IBC approval required for the use of transgenic animals?
   • Work with transgenic animals is covered by Section III-D 4 of the NIH Guidelines.  There are exemptions for work with transgenics rodents that are either purchased, bred, or obtained from a collaborator, as long as these animals can be housed at ABSL-1.  For more detailed information on working with transgenic animals, please visit the NIH OSP website or contact the WSU Biosafety Officer.
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?
   • The BSL2 checklist used by the WSU Office of Environmental Health & Safety (OEH&S) for your lab inspection comes directly from the CDC/ NIH Biosafety in Microbiological and Biomedical Laboratories, 6th edition, Section IV, Laboratory Biosafety Level Criteria - Biosafety Level 2. Reviewing and understanding the safety policies, practices and procedures in this section will help you prepare for the inspection.  The WSU BSL-2 Inspection Form is also available on-line and can be helpful in preparing your laboratory for the visit from OEHS.
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. The "Pathogen Safety Data Sheets and Risk Assessment" database from the Public Health Agency of Canada is very helpful.
   • Guidance from the IBC for preparing a biosafety laboratory SOP.
   • 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. Biosafety/Bloodborne Pathogens for Laboratory Workers is required annually and is available online. See the Laboratory Safety Training page for information on how to complete this course and quiz.