Protocol Submission
IBC Process
Funding
Committee Membership
Miscellaneous

PROTOCOL SUBMISSION

Q. Why do I have to register my protocol?

Per federal and state regulations, the University of California , Irvine 's Institutional Biosafety Committee (IBC) is required to review, approve, and maintain documentation on all protocols involving recombinant DNA.

If you are intending to use certain biological agents and toxins known as “Select Agents,” you must notify Sheila Hedayati, the Biosafety Officer, directly as soon as possible (X49888 or shedayati@uci.edu ).  Select agents are those agents and toxins that have been determined by the federal government to have the potential to pose a severe threat to public health and safety and are under special restrictions . For a list of all these agents, please go to: http://www.cdc.gov/od/sap/docs/salist.pdf

Q. What type of research must 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 (human embryonic stem cells, 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.
• 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);

Q.        If I am working only with biohazardous materials and not with recombinant DNA, do I need to register my project with the IBC?

Yes*

*UCI 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 RG2, 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 web sites for guidance.
• NIH list - http://www4.od.nih.gov/oba/rac/guidelines_02/APPENDIX_B.htm
• CDC list - http://www.cdc.gov/od/ohs/biosfty/bmbl4/bmbl4toc.htm

• Human or mammalian cell lines (including embryonic & established), human tissue or blood.

• 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 web sites for up to date lists of regulated organisms.
• USDA/APHIS - http://www.aphis.usda.gov/ppq/regpestlist

• 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
• CDC program - http://www.cdc.gov/od/sap/index.htm
• USDA/APHIS program -http://www.aphis.usda.gov/programs/ag_selectagent/index.html

Q.  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?

You must notify the IBC with regard to your proposed work. If your research is being “conducted entirely outside of UCI and/or the U.S”, and no work will be done on the UCI campus, review by UCI's IBC may not be needed.  However, institutional approval must be obtained from the collaborating institution. This has to be submitted to ibc@uci.edu or faxed at 949-824-1325.

Q. I need expedited review for my IBC application what do I do?

Q. If I am registering an IBC protocol or a 3-year renewal, what forms do I need to complete?

IBC protocol application

Q. If I am modifying an already approved IBC protocol, what forms do I need to complete?

IBC protocol modification request

Q. What do I do if my protocol has been completed or terminated?

Please complete the IBC protocol closeout form.

Q. Where should I send my completed IBC registration forms?

All forms must submitted electronically via e-mail to Alice Lee, IBC Administrator at ibc@uci.edu . These are needed for committee review.  A signed, hard copy should also be sent to the IBC Administrator through inter-campus mail to EH&S Zot 2725 or faxed to (949) 824-1325.

Q. When is the deadline for my protocol submission?

For more information, please go to: http://www.ehs.uci.edu/programs/biosafety/ibc/index.html

All posted dates are listed in the IBC website.

Q. 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 – 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 “piggy-back” on the existing IBC protocols of other investigators.  Therefore, a separate IBC form must be completed for each grant, project, or set of experiments.

Q. I am moving my lab to another building.  What do I have to do?

1. The PI or the department must notify EH&S. For more information, please visit the Lab Relocation Guidelines. If you have additional questions, contact EH&S at (949) 824-6200 or e-mail safety@uci.edu .

2. Complete the Biosafety Modification Form and e-mail to ibc@uci.edu . Once you are set up in your new space, please contact the Biosafety Officer (X49888 or shedayat@uci.edu ) for your biosafety inspection . The BSO will also inspect the laboratory after the biological safety cabinet has been recertified to ensure compliance with recommendations stipulated by the IBC.

Q. Who do I call to get my biosafety cabinet serviced?

Call TSS , Inc. at 1-800-877-7742 as the University of California , Irvine has a service contract set up with them.

Q. I only work with plants and Agrobacterium. Do I have to register?

Yes , 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 University of California , Irvine Institutional Biosafety Committee. Since the University receives funding from NIH grants, ALL research conducted at UCI must comply with the NIH Guidelines and University policies. Please complete and submit an IBC form.

Q. I work with Drosophila and create mutants of Drosophila with P element-mediated transformation. Do I have to complete the IBC form?

Yes , 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.

Q. I work with mouse tissue culture and mouse gene transfections. Sometimes I use human tissue cultures. I have never registered with the IBC because I am exempt from the NIH Guidelines. Why do I have to fill out forms now and why am I considered to be doing BSL-2 research now?

The University of California , Irvine Institutional Biosafety Committee is now charged with registering ALL recombinant DNA research on UCI. 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. Any work with human cells or tissue cultures, even commercially derived (e.g. ATCC ), is considered to be "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, http://www.osha-slc.gov/SLTC/bloodbornepathogens/ ).

The other implications include the requirement that all personnel complete the Bloodborne Pathogen training offered on-line by Environmental Health and Safety at https://www.ted.uci.edu/kc/main/kc_frame.asp . The Biosafety Manual and Exposure Control Plan can be reviewed at http://www.ehs.uci.edu/programs/biosafety/bioSafety_handBook . This manual incorporates the required elements of the BBP "Exposure Control Plan." http://www.ehs.uci.edu/programs/biosafety/UCIBBPExposureControlPlan.doc . Use this template to write the laboratory specific procedure and place a copy in your laboratory safety manual.

More information on this designation is available from the Biosafety Officer or on the IBC website.

Q. I only work with BSL-1 agents so I am exempt from any registration. Why are you bothering me?

The compliance required of you depends upon what exactly you are doing and with which agents. It may be that the wildlife you have been working with for ten years is now infected with a zoonotic, infectious agent. Or it may be that the NIH Guidelines and interpretations of those Guidelines have changed. The BSO can determine whether you must simply register (which involves completing the forms for BSO review) or whether the IBC must review and approve your work. Contact Sheila Hedayati, the Biosafety Officer, as soon as possible (X49888 or shedayati@uci.edu )  to discuss what you are doing in your research, present documentation of the biosafety level for the agents, and determine whether full review and approval are required.

Q. How do I know what I need for Biosafety Level 2 research?

The standards for research and clinical laboratories are published by the Centers for Disease Control, the Biosafety in Microbiological and Biomedical Laboratories (BMBL), at http://www.cdc.gov/od/ohs/biosfty/bmbl5/bmbl5toc.htm .

Q. My research involves collecting saliva samples from patients in an outpatient clinic and then culturing for viruses in the research laboratory. Do I have to register with the IBC ?

Yes , you must register with the IBC . This is research conducted in a research laboratory and by culturing the viruses, the number of infectious particles are increasing; therefore, increasing the theoretical risk to workers.

Q. I am working with E. coli K12, plasmids, and Saccharomyces. Do I have to register with the IBC ?

Yes . 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 submit an IBC application.

Q. I have an active IBC approval for recombinant work in my lab. Recently I submitted a new research proposal. Do I have to submit a new registration with the IBC or can I just modify the current protocol?

You will need to submit a new application with the IBC if the research project involves a substantial change to the currently approved protocol, such as an increase in the biosafety containment level. A modification may be submitted for IBC review when changes are not considered to be substantial.

The IBC reserves the right to request a full renewal or a new application for any submitted modifications that are deemed to be substantial in nature.

Q. I have a human gene transfer (clinical trial) proposal. What will the IBC review?

For clinical trials, the IBC will review the application and supporting documents for the following:

• Compliance with Appendix M of the NIH Guidelines
• Consideration of issues and recommendations made by RAC
• Investigator's or sponsor's response to RAC 's recommendations (when applicable)
• Withholding IBC approval of the proposal until after RAC review
• Ensuring compliance with data reporting, adverse event reporting, and surveillance.

Q. Will my laboratory be audited or inspected?

Yes. The BSO is responsible for conducting periodic laboratory inspections. The BSO or designee visits each laboratory each time a protocol is submitted 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.

Q. In what order should I submit my IACUC and IBC applications?

There is no prescribed requirement for the order in which IACUC and IBC applications are submitted; however, IACUC final approval will not be granted until IBC approval has been received. It is advisable to submit your IBC proposal either before or at the same time as when you submit your IACUC proposal to avoid delays.

Q. What is the RAC?

The RAC is the Recombinant DNA Advisory Committee which issues recommendations to the NIH director regarding recombinant DNA activities. The recommendations are conveyed through the NIH Office of Biotechnology Activities (OBA), which is responsible for the NIH oversight system of recombinant DNA research.

More information about the RAC may be located at: http://www4.od.nih.gov/oba/rac/aboutrdagt.htm

Q. How long will the IBC approval process take?

If registration forms are received before a submission deadline, it will be reviewed at the next IBC meeting.  After committee review, the Principal Investigator will receive notice of the meeting results approximately 2-7 days after the meeting.  This notice will be in the form of an approval letter or a memo, with additional questions from the committee.  Final approval will then depend on how quickly the questions are resolved.

If this is a renewal, you should submit your protocol 60 days before the expiration date. Notifications are sent to the PI via e-mail 90, 60, and 30 days in advance.

Q. How long does it take to get a review and notification of the results?

The committee meets monthly to review and approve protocols. Protocols which are received 2 weeks in advance of a meeting will be on the agenda, so 4–6 weeks, depending on when a protocol is submitted. Most protocols are completed with one review; however, if follow-up with a PI is needed, a protocol may be deferred to the next meeting which would delay the protocol for approximately 4 more weeks. The PI is notified of the result following any IBC meeting in which the protocol is discussed.

Q. How should I respond to the additional questions from the IBC?

Responses to the additional questions from the IBC should be submitted electronically to the IBC Administrator at ibc@uci.edu or per IBC administrator e-mail directions.

Q. Should I submit a revised IBC registration form with my response to the additional questions?

The IBC prefers you to submit a revised application with your responses to the additional questions unless a revised registration form is explicitly requested.

Q. What is reviewed by the committee?

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)
• Assurance that no clinical trial participants are enrolled until the RAC (Recombinant Activities Committee, through OBA) review process is complete (when applicable).
• Consideration of issues and recommendations made by RAC for clinical trial proposals and the Investigator's response to RAC 's recommendations (when applicable).
• Withholding institutional approval of the proposal until after the RAC review process has been completed and the appropriate documentation has been received by both the Principal Investigator and the IBC (when applicable).
• Ensuring compliance with data reporting, adverse event reporting, and surveillance.

Q. I receive no external funding.  Do I have to register my protocol?

Yes.  Registration with the IBC is based on the biological materials used in your experiments, not on funding.

Q. I receive no funding from NIH.  Do I have to register my recombinant DNA protocol?

Yes.   Since the University receives funding from NIH grants, ALL recombinant DNA research conducted at the University has to comply with the NIH Guidelines and University policies.  All recombinant DNA research must be reviewed by the IBC.

Q. I have a fellowship grant to conduct recombinant DNA research.  Do I have to register my grant?

Probably not.  Check with the Principal Investigator of your fellowship position.  If that person is registered with the IBC and your research is part of his/her research, then you do not have to register again.  However, if your research will be quite different from the protocol that received IBC approval (e.g., uses different recombinant DNA constructs or different biohazards), then you and the Principal Investigator need to register your project with the IBC.

Q. Can I become a member of the Institutional Biosafety Committee?

The IBC welcomes anyone interested in committee membership.  If you would like additional information about the Committee, please contact the IBC Administrator at (949) 824-8024 or ibc@uci.edu .

Q. What is the role of the Institutional Biosafety Committee ( IBC )?

The IBC is responsible for monitoring and ensuring compliance as well as review and approval of all research projects that involve biological material including recombinant DNA materials and human gene therapy/gene transfer protocols. IBC's were established under the NIH Guidelines for Research Involving Recombinant DNA Molecules to provide local review and oversight of nearly all forms of research utilizing recombinant DNA .  Over time, many institutions have chosen to assign their IBC's the responsibility of reviewing a variety of experimentation that involves biological materials (e.g., infectious agents) and other potentially hazardous agents (e.g., carcinogens). This additional responsibility is assigned entirely at the discretion of the institution. The University of California , Irvine 's biosafety policy mandates review of all potential biohazardous agents and recombinant DNA research.

UCI's IBC is charged with the following responsibilities:

1. Review and approval of ALL research proposals that include biological agents and recombinant DNA.
2. Approval of safety practices
3. Setting biosafety containment levels (Section III-D-2-b, III-D-5; NIH Guidelines)
4. Conducting periodic review to ensure compliance – lab inspections are conducted on a annual basis
5. Oversee biosafety training practices
6. Reporting significant problems or violations of the NIH Guidelines
7. Performance of such other functions as deemed necessary by the institution (Section IV-B-2; NIH Guidelines)

Q. How often does the IBC meet?

The frequency of IBC meetings is commensurate with the volume of protocols needing review, the nature and risks of the research, and the need for continuing oversight. The committee meets as needed (typically every month) and follows the guidelines provided by the NIH Office of Biotechnology Activities (OBA) involving research with recombinant DNA.

Q. How do I find out what biosafety level I am supposed to use for the infectious agents I work with?

The IBC uses many of the following for guidance or you may contact the Biosafety Officer for advice (X49888 or shedayat@uci.edu ):

• Biosafety in Microbiological and Biomedical Laboratories (BMBL)
• NIH Guidelines
• American Type Culture Collection (ATCC)
• Health Canada

Q. How to Determine Risk Group and Biosafety Level Containment

Risk groups are a classification system for etiological agents; the lower the risk – the lower the risk group class. The Biosafety Level refers to the physical and procedural barriers used to contain an etiological agent. Risk groups and biosafety containment levels are not proportional determinations.

The IBC application provides additional information regarding risk groups and biosafety levels . If you are unsure of the proper determinations after reviewing the information in the application, please contact the IBC Administrator at (949) 824-3757 or by email at ibc@uci.edu .

The tables below give a brief summary of Risk Groups (RG) and Biosafety Levels (BSL). For more detailed information, refer to the Biosafety in Microbiological and Biomedical Laboratories (BMBL) or the NIH Guidelines: NIH Guidelines for Research Involving Recombinant DNA Molecules .

** Special requirements – needle protective devices should be used for injection procedures when possible, sealed rotor heads and/or canisters should be used for centrifugation and opened only in a biosafety cabinet, and use only ultracentrifuges fitted with HEPA filters.

Screening for Replication Competent Virus - Recombination events or contamination from wildtype virus can result in the presence of replication competent virus (RCV) in a population of replication deficient viral vectors. The IBC recommends testing for the presence of RCV in viral stocks to be used for in vivo experiments.

Q. Are all viral vectors the same? Why does the gene insert make a difference?

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.

Q. How can I get a Biosafety Approval letter for a Fellowship Grant?

You can request a copy at ibc@uci.edu or you can ask your PI for a copy. All approval letters are sent to the responsible principal investigator.

Q. How do I get a Hepatitis B vaccination?

For the latest Hepatitis B information, please visit the EH&S Occupational Health website at: http://www.ehs.uci.edu/occhlth.html

Q. How do I find out what biosafety level I am supposed to use for the infectious agents I work with?

Revision 6/2008