FAQs
- What is the role of the Institutional Biosafety Committee (IBC)?
- Why do I need IBC Oversight?
- What type of research might be registered with the IBC?
- How do I Determine Risk Group and Biosafety Level Containment?
- How do I register my protocol?
- I only work with BL-1 agents, how do I register my protocols?
- What trainings do I need to complete?
- What trainings do students in my lab need to complete?
- If I am working only with biohazardous materials and not with recombinant DNA, do I need to register my project with the IBC?
- Do my materials require IBC review?
- Do I need to register my project with the IBC if I will be conducting all my research at another institution or in another country?
- If I am modifying an already approved IBC protocol, what forms do I need to complete?
- What do I do if my protocol has been completed?
- I share a lab with an investigator who is registered with the IBC. Doesn’t that registration apply to my work in the shared lab?
- Does my lab have to be approved for biosafety work?
- I am moving my lab to another building. What do I have to do?
- Will my laboratory be audited or inspected?
- Who do I call to get my biosafety cabinet serviced?
- I receive no external/NIH funding. Do I have to register my protocol?
- I have a fellowship grant to conduct recombinant DNA research. Do I have to register my grant?
- Is medical surveillance available?
What is the role of the Institutional Biosafety Committee (IBC)?
The IBC is responsible for monitoring and ensuring compliance approval of all research projects that involve biological material including recombinant DNA materials and human gene therapy/gene transfer protocols. IBCs were established under the NIH Guidelines to provide local review and oversight of nearly all forms of research utilizing recombinant DNA. Villanova University’s biosafety charter mandates IBC review of all potential biohazardous agents and recombinant DNA research.
VU's IBC is charged with the following responsibilities:
- Setting biosafety containment levels (Section III-D-2-b, III-D-5; NIH Guidelines).
- Overseeing biosafety training practices.
- Approving of safety practices.
- Review and approval of ALL research proposals that include biological agents and recombinant DNA.
- Reporting significant problems or violations of the NIH Guidelines.
- Performance of such other functions as deemed necessary by the institution (Section IV-B-2; NIH Guidelines).
- Conducting periodic review to ensure compliance–lab inspections are conducted on an annual basis.
The IBC review process considers the following points:
- Independent determination of the biosafety level for the location appropriate to the research proposal by review of the following:
- Vectors and host systems proposed for use in the research
- Employee exposure, safety and risk potential
- Environmental considerations
- Evaluation of facilities, procedures, practices, and training of personnel
- Ensuring compliance with Appendix M of the NIH Guidelines (if applicable to the proposal).
- Ensuring compliance with data reporting, adverse event reporting and surveillance.
Why do I need IBC Oversight?
Per federal and state regulations Villanova University, through Villanova’s Institutional Biosafety Committee (IBC), is required to review, approve and maintain documentation on all protocols involving recombinant DNA.
What type of research might be registered with the IBC?
Experiments involving the following must be registered with the IBC:
- Pathogens affecting humans, animals or plants;
- Materials potentially containing human pathogens (e.g. unfixed human specimens, human blood);
- Recombinant DNA molecules including viral vectors;
- All cell and organ cultures of human origin, including well established cell lines and pluripotent cells and their derivatives
- De novo generation of transgenic animals (using recombinant DNA technology to add foreign DNA or subtract a portion of the animal’s genome);
- Generation of de novo transgenic animals: Defined as the addition of foreign DNA or subtraction of a portion of the animal genome using recombinant DNA technology. Examples of recombinant DNA technology include
(1) Direct microinjection of a chosen gene construct from another member of the same species or a different species into the pronucleus of a fertilized ovum;
(2) Insertion of the desired DNA sequence by homologous recombination into an in vitro culture of embryonic stems and cells;
(3) Use of a plasmid or virus to transfer the genetic material into germ cells. Breeding animals to generate transgenics need not be registered with the IBC. Those transgenics that already exist or which have been purchased are not subject to IBC registration.
- Generation of de novo transgenic animals: Defined as the addition of foreign DNA or subtraction of a portion of the animal genome using recombinant DNA technology. Examples of recombinant DNA technology include
- De novo generation of transgenic plants;
- Introduction of recombinant DNA (plasmids) or gene transfer vectors (including viral vectors) into human subjects;
- Introduction of genetically engineered micro-organisms or infectious agents into human subjects (including live vaccines if they are experimental in nature and/or not FDA approved for use in the specific study population.
- As of May 2018, NIH regulations require institutions to maintain transgenic animal registration.
How do I Determine Risk Group and Biosafety Level Containment?
For more detailed information, refer to the Biosafety in Microbiological and Biomedical Laboratories (BMBL) or the NIH Guidelines.
Visit the Biosafety Level Practices website for additional information.
What trainings do students in my lab need to complete?
Use a personnel addition form to send list of current students to ORP. Contact the IBC to obtain the appropriate form. Students working in BL1 and BL2 labs need to complete a course on Blackboard titled, “Student Biosafety Training”, instructions here.
If I am working only with biohazardous materials and not with recombinant DNA, do I need to register my project with the IBC?
Yes, VU IBC reviews and approves all research involving biohazardous materials, as defined below. IBC registration and approval of research involving these biohazards is required.
- Naturally occurring or engineered micro-organisms or viruses capable of causing disease in humans and/or animals. These are Risk Group (RG) 2, 3 or 4 pathogens as defined by NIH (Note: this list is not all inclusive). Those agents not listed in RG 2, 3 and 4 are not automatically or implicitly classified as non-pathogens or in RG
- A risk assessment must be conducted based on the known and potential properties of the agents and their relationship to agents that are listed. Consult the following websites for guidance.
- Human or mammalian cell lines (including embryonic and established), human tissue or blood. IRB approval may be required for this research. Please contact ORP for details.
- Toxins derived from plants, animals or micro-organisms that will have adverse effects in humans or animals.
- Plant pathogens or pests (arthropods, nematodes, weeds) that are regulated by state or federal policy or law. Consult the following website for up to date lists of regulated organisms.
- Select biological agents that may adversely affect public health, animal or plant health, or animal or plant products. Note: all possession and use of Select biological agents requires special registration through the Biological Safety Officer.
Do my materials require IBC review?
- Transgenic Plants and/or Agrobacterium
- You must register with the IBC and comply with the USDA guidelines and regulations for containment of transgenic plant and plant materials. If your research involves infectious agents, potentially infectious material, or recombinant nucleic acids; you must register with the Villanova Institutional Biosafety Committee. Since the University receives funding from NIH grants, ALL research conducted at VU must comply with the NIH Guidelines and University policies. Please complete and submit an IBC form.
- Transgenic Drosophila
- If creating mutants with P element-mediated transformation, you must register with the IBC. Whether this research has to have full IBC review and approval depends upon the genes being introduced back into the Drosophila. The Biosafety Officer and/or the IBC Chair will determine whether full review and approval are required.
- Mouse Tissue and Mouse Gene Transfections
- Villanova University Institutional Biosafety Committee is now charged with registering ALL recombinant DNA research on VU. Whether this research has to have full IBC review and approval depends upon the genes being introduced into the host cell. The Biosafety Officer and/or the IBC Chair will make this determination.
- Human Tissue/ Cell Lines/ Gene Transfer
- Human cells or tissue cultures, even commercially derived (e.g. ATCC), are considered "other potentially infectious material" (OPIM) unless the investigator or commercial source characterizes and documents the material to be free of contamination from human hepatitis viruses, human immunodeficiency viruses, and other recognized or latent bloodborne pathogens. This is the OSHA interpretation of the Bloodborne Pathogens Standard (29 CFR 1910.1030).
- Human cell tissue work may also require IRB approval. Please contact
- Saliva samples from Outpatient Clinics
- You must register with the IBC. This is research conducted in a research laboratory and by culturing the viruses, the number of infectious particles is increasing; therefore, increasing the theoretical risk to workers.
- E. coli K12, plasmids, and Saccharomyces
- You must register with the IBC. Depending upon the types of genetic material being manipulated, this may be a simple registration with the Biosafety Officer or it may require full review and approval by the IBC. Please contact the
- You must register with the IBC. Depending upon the types of genetic material being manipulated, this may be a simple registration with the Biosafety Officer or it may require full review and approval by the IBC. Please contact the
- Viral Vectors
- All vectors are not the same. More importantly, the class of gene insert can change the biosafety level of the construct. Go to Gene Vector Biosafety Levels for many common vectors and insert classifications. Please contact
- All vectors are not the same. More importantly, the class of gene insert can change the biosafety level of the construct. Go to Gene Vector Biosafety Levels for many common vectors and insert classifications. Please contact
Do I need to register my project with the IBC if I will be conducting all my research at another institution or in another country?
Yes, contact IBC so that we may guide you on the next steps.
If I am modifying an already approved IBC protocol, what forms do I need to complete?
Contact the IBC to obtain an amendment request form.
What do I do if my protocol has been completed?
Contact ORP regarding decommissioning procedures and to obtain a Closure Form.
I share a lab with an investigator who is registered with the IBC. Doesn’t that registration apply to my work in the shared lab?
No, at Villanova each principal investigator is responsible for full compliance with the NIH Guidelines in the conduct of recombinant DNA research and with University biosafety requirements. Investigators may not apply an existing IBC protocol of other investigators to themselves. Therefore, a separate IBC form must be completed for each grant, project or set of experiments.
Does my lab have to be approved for biosafety work?
Yes, please fill out the appropriate inspection checklist (link to resources webpage). Contact the Biosafety Officer to inspect the room. Contact Environmental Health & Safety (EH&S) to check biosafety cabinet. Then, inform the IBC once these action items have been completed.
I am moving my lab to another building. What do I have to do?
The BSL2 inspection checklist needs to be filled out contact the IBC office to assist in coordinating with the Biosafety Officer to inspect the room. Contact EH&S to check biosafety cabinet. Then, inform the IBC once these action items have been completed.
Will my laboratory be audited or inspected?
Yes. The EH&S director visits each laboratory annually to verify compliance. In addition, University laboratories are subject to inspection by federal, state and local regulatory agencies as well as funding and accrediting agencies.
I receive no external/NIH funding. Do I have to register my protocol?
As Villanova University receives funding from NIH grants, ALL recombinant DNA research conducted at the University has to comply with the NIH Guidelines and University policies. Therefore, irrespective of funding source, all recombinant DNA research must be reviewed by the IBC.
I have a fellowship grant to conduct recombinant DNA research. Do I have to register my grant?
Check if your advisor is a principal investigator on an approved IBC protocol. If so, your PI must submit a personnel amendment. If not, contact ORP for further guidance.
Is medical surveillance available?
Students can visit the Student Health Center. Staff and faculty are eligible for medical surveillance. Contact ORP for more details.