Environmental Health & Safety
Frequently Asked Questions
(FAQs)
- Why do I have to register my protocol?
Per federal and state regulations, the University of Rochester’s Institutional Biosafety Committee (IBC) is required to review, approve, and maintain documentation on all protocols involving recombinant DNA or requiring at least BSL-2 precautions.If you are intending to use certain biological agents and toxins known as “Select Agents,” you must notify Sonia Rosenberger, Biosafety Officer, directly, as soon as possible (X53014 or srosen22@safety.rochester.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. Examples of Select Agents include Francisella Tularensis, Bacillus Anthracis, Yersinia pestis, staphylococcal enterotoxins and Tetrodotoxin. For more information, visit the Select Agent Reference
(Return to FAQs) - I receive no external funding. Do I have to register my protocol?
Yes. Registration with the IBC is based on the biologicals used in your experiments, not on funding.
(Return to FAQs) - 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 and synthetic nucleic acid molecule research conducted at the University must comply with NIH Guidelines and University policies.
(Return to FAQs) - 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 must register your project with the IBC. Use the Grant/Project Registration Form Word Version and PDF version.
(Return to FAQs) - 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, human tissue, tissue/fluids from experimental animals).
- Recombinant and synthetic nucleic acid molecules including viral systems.
- Mammalian cells and cell lines (refer to Extended Help for Registering Mammalian Cells, Mammalian Cell Lines and Unfixed Mammalian Tissues/Fluids)
- De novo generation of transgenic animals (Animal's genome has been altered by the stable introduction of recombinant or synthetic nucleic acid molecules, or nucleic acids derived there from, into the germ-line).
Examples include: - Direct microinjection of a chosen gene construct from another member of the same species or from a different species into a protoneucleus of a fertilized ovum;
- Insertion of the desired DNA sequence by homologous recombination into a culture of embryonic stem cells;
- Use of a plasmid of virus to transfer genetic material into germ cells.
- Breeding or crossbreeding of animals which were originally created using recombinant DNA technology AND which are genetically different from each other.
- Backcrossing transgenic animals that were originally created using recombinant DNA with wild type animals.
- Human Subject Studies
- Clinical studies involving the introduction of Recombinant or Synthetic nucleic acid molecules (plasmids), or gene transfer vectors (including viral vectors) into human subjects with or without specimen analysis.
- Clinical studies involving introduction of genetically engineered microorganisms 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) with or without specimen analysis.
- Clinical studies which involve no introduction of the above mentioned agents to human subjects. However, sera, blood products or other specimens collected from the study participants will be process for shipment, analyzed or experimented within UR research labs or in areas not considered clinical lab space.
- Generation of transgenic plants. Contact the Biosafety Officer, Sonia Rosenberger, at srosen22@safety.rochester.edu.
NOTE: Animals are defined as belonging to the Kingdom Animalia and include more than animals approved under UCAR protocols.Refer to NIH Transgenic Animals FAQs for additional information
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- If I am registering a new grant or project (set of experiments) or a 5-year update, what forms do I need to complete?
- Grant/Project Registration Form (Form G)
- New or updated Viral Vector Registration Form (Form VV) – if applicable
- If you DO NOT have a viral vector registration for the viral system associated with the project on file with the IBC, use the following link to access the form:
- If you DO have a viral vector registration for the viral system associated with the project on file with the IBC and you need a copy of it, please email Sonia Rosenberger and she can email it to you. srosen22@safety.rochester.edu
- Laboratory Registration (Form L)
- If you DO NOT currently have one on file with the IBC, use the following link to access the form:
- If you DO have one on file with the IBC, please make sure it is up to date, including current laboratory personnel. If you need a copy of the latest version of your laboratory registration, please email Sonia Rosenberger and she can email it to you. srosen22@safety.rochester.edu.
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- If I am modifying an already-approved grant or project (set of experiments), what forms do I need to complete?
- Modify the applicable G form to include all the changes you wish to make. Make the changes (and only those changes) in RED font. Submit with supporting documents, as applicable, (Form VV; Lab Registration) to the IBC Program Coordinator.
- New or Updated Viral Vector Registration Form (Form VV) – if applicable
- If you DO NOT have a viral vector registration for the viral system associated with the project on file with the IBC, use the following link to access the form:
- If you DO have a viral vector registration for the viral system associated with the project on file with the IBC and you need a copy of it, please email Sonia Rosenberger and she can email it to you. srosen22@safety.rochester.edu
- Laboratory Registration (Form L)
- Please make sure your laboratory registration is up to date, including current laboratory personnel and biosafety cabinet certification dates. If you need a copy of the latest version of your laboratory registration, please email Sonia Rosenberger and she can email it to you. srosen22@safety.rochester.edu
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- If I am submitting a UCAR (new or 36 month review), what forms do I need to complete?
- Grant/Project Registration Form (Form G)
- Viral Vector Registration Form (Form VV) – if applicable
- If you DO NOT have a viral vector registration for the viral system associated with the project on file with the IBC, use the following link to access the form:
- If you DO have a viral vector registration for the viral system associated with the project on file with the IBC and you need a copy of it, please email Sonia Rosenberger and she can email it to you. srosen22@safety.rochester.edu
- Laboratory Registration (Form L)
- If you DO NOT currently have one on file with the IBC, use the following link to access the form:
- If you DO have one on file with the IBC, please make sure it is up to date, including current laboratory personnel. If you need a copy of the latest version of your laboratory registration, please email Sonia Rosenberger and she can email it to you. (srosen22@safety.rochester.edu).
- If I am modifying a UCAR protocol, what forms do I need to complete?
- Modify the applicable G form to include all the changes you wish to make. Make the changes (and only those changes) in RED font. Submit with supporting documents, as applicable, (Form VV; Lab Registration) to the IBC Program Coordinator.
- New or Updated Viral Vector Registration Form (Form VV) – if applicable
- If you DO NOT have a viral vector registration for the viral system associated with the project on file with the IBC, use the following link to access the form:
- If you DO have a viral vector registration for the viral system associated with the project on file with the IBC and you need a copy of it, please email Sonia Rosenberger and she can email it to you. srosen22@safety.rochester.edu
- Laboratory Registration (Form L)
- Please make sure your laboratory registration is up to date, including current laboratory personnel. If you need a copy of the latest version of your laboratory registration, please email Sonia Rosenberger and she can email it to you. srosen22@safety.rochester.edu
- What do I do if my protocol has been completed or terminated?
Please contact the IBC with this information by emailing Sonia Rosenberger at srosen22@safety.rochester.edu.
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- Where should I send my completed IBC registration forms?
All forms must submitted electronically, via email to IBC Program Coordinator at srosen22@safety.rochester.edu. These are needed for committee review. If not signed digitally - signed, hard copies should then be sent through intramural mail to RC Box 278878 or faxed at 274-0001.
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- 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, which falls approximately 10 days after the deadline. After committee review, the Principal Investigator will receive notice of the meeting results approximately 2-7 days after the meeting, after ensuring all signed hard copies have been received and lab safety training is up to date. That notice may be in the form of an approval letter or an email from Sonia Rosenberger, Biosafety Officer, with additional questions from the committee. Final approval will then depend on how quickly the questions are resolved.
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- How should I respond to the additional questions from the IBC?
Responses to the additional questions from the IBC should be submitted electronically to Sonia Rosenberger at srosen22@safety.rochester.edu or per her email directions.
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- Should I submit a revised IBC registration form with my response to the additional questions?
The IBC prefers you DO NOT submit a revised application with your responses to the additional questions unless a revised registration form is explicitly requested.
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- I share a lab with an investigator who is already registered with the IBC. Doesn't that grant/project 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 grant/project registrations of other investigators. Therefore, a separate grant/project registration form must be completed for each Principal Investigator. However, Laboratory registration forms of senior Principal Investigators may be used by junior Principal Investigators of the same laboratory.
Investigator responsibilities under the NIH Guidelines
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- 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 Sonia Rosenberger, Biosafety Officer, for advice. (X53014 or srosen22@safety.rochester.edu):
- Biosafety in Microbiological and Biomedical Laboratories (BMBL)
- NIH Guidelines
- Health Canada
- American Biological Safety Association Risk Groups
- UR Extended Help for Registering Mammalian and Plant Pathogens
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- I am moving my lab to another building. What do I have to do?
First, the PI or the department must notify EH&S four weeks in advance of moving. Second, follow the lab decommissioning process outlined in the Lab Decommissioning Reference. If you have addition questions, contact EH&S at 275-3241 or e-mail EH&S Question. Once you are set up in your new space, please contact Sonia Rosenberger (X53014 or srosen22@safety.rochester.edu) for your biosafety inspection.
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- Why do I need to have my laboratory inspected and who do I contact to have it done?
The University of Rochester provides compliance assurances to the National Institutes of Health and other funding sponsors. Contact Sonia Rosenberger to set up an inspection date at 275-3040 or srosen22@safety.rochester.edu.
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- May I become a member of the Institutional Biosafety Committee?
The IBC welcomes interest in committee membership. If you would like additional information about the committee, please contact Sonia Rosenberger at 585-275-3014 or srosen22@safety.rochester.edu.
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- Do all my mammalian cells and cell lines have to be registered with the IBC?
Please refer to this guidance document (Extended Help for Registering Mammalian Cells, Mammalian Cell Lines and Unfixed Mammalian Tissues/Fluids) for more information or contact Sonia Rosenberger, Biosafety Officer, for advice (X53014 or srosen22@safety.rochester.edu).
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- Where can I find information about registering my transgenic mice?
NIH has put together a specific set for FAQs for Transgenic Animals.
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- Can I delegate the completion of IBC registration documents to my staff?
Yes. However, since the information required by the IBC is scientifically detailed and must accurately reflect the specific biologicals used on a per project/grant basis, registration documents should be completed by staff having a background in a scientific discipline. Also, in addition to the Principal Investigator, an identified lab employee must be named as a secondary contact for all IBC and biological safety matters (unless the PI is the only individual in the lab who is working with biohazards). This secondary contact must be scientifically qualified for the role in order to provide accurate answers to committee questions. Lastly, and as a reminder, the Principal Investigator is ultimately responsible for the accuracy of the information provided to the IBC.
Investigator responsibilities under the NIH Guidelines
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QUESTIONS or COMMENTS?
Contact EH&S at (585) 275-3241 or e-mail EH&S Questions.
This page last updated 3/6/2014. Disclaimer.
