Extended Help for Registration
Biosafety Requirements & Resources
IBC Review/Approval & Meetings
Containment categories for commonly used agents
Human Subject Studies that Require IBC Approval
Frequently Asked Questions (FAQs)
Q. 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 Janet Ives, Biosafety Officer, directly, as soon as possible (X53014 or jives@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. Common examples of Select Agents include Francisella Tularensis, Bacillus Anthracis, Yersinia pestis, staphylococcal enterotoxins and Tetrodotoxin. For more information, visit the Select Agent Reference.
Q. 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.
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 NIH Guidelines and University policies.
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 on the Mentored Project IBC Registration Form (Word Version and PDF version).
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;
- Human cell lines that are not well-characterized or require Biosafety Level 2 containment;
- 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.
- 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);
- The analysis of, or experimentation, with sera, blood products, or other human specimens in UR research laboratories or those UR labs that are NOT accredited with the College of American Pathologists (CAP) or with the Joint Commission on Accreditation of Healthcare Organizations (JCAHO).
Q. 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 Patty Bardeen and she can email it to you. pbardeen@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 Patty Bardeen and she can email it to you. pbardeen@safety.rochester.edu
Q. If I am modifying an already-approved grant or project (set of experiments), what forms do I l need to complete?
- Request to Amend/Modify an Existing IBC Approval Form (Form AM)
- Please contact Patty Bardeen at pbardeen@safety.rochester.edu to request a modification form. She will email it to you. Please be sure to provide her with the IBC Registration number, which begins with GNT.
- 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 Patty Bardeen and she can email it to you. pbardeen@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 Patty Bardeen and she can email it to you. pbardeen@safety.rochester.edu
Q. If I am submitting a UCAR (new or 36 month review), what forms do I need to complete?
- Submit a copy of your UCAR protocol.
- 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 Patty Bardeen and she can email it to you. pbardeen@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 Patty Bardeen and she can email it to you. pbardeen@safety.rochester.edu.
Q. If I am modifying a UCAR protocol, what forms do I l need to complete?
- Request to Amend/Modify an Existing IBC Approval Form (Form AM)
- Please contact Patty Bardeen at pbardeen@safety.rochester.edu to request a modification form. She will email it to you. Please be sure to provide her with the IBC Registration number, which begins with GNT.
- 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 Patty Bardeen and she can email it to you. pbardeen@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 Patty Bardeen and she can email it to you. pbardeen@safety.rochester.edu
- Please email Patty Bardeen a copy of the UCAR modification, which you submitted to the UCAR office.
Q. Why is the amendment/modification form the same as the annual review form?
The IBC annual review form is simply a verification that no changes have been made to the project, and serves as a reminder for investigators to submit any changes that were not approved or any upcoming changes for the next year of the project. However, if an investigator makes a change to the project during the year and submits the modification form, this also serves to assure the IBC that all changes have been submitted for approval up to the date of the modification. Therefore, submitting a modification may re-set the annual renewal date to one year following the date of the modification submission.
Q. What do I do if my protocol has been completed or terminated?
Please contact the IBC with this information by emailing Patty Bardeen at pbardeen@safety.rochester.edu.
Q. Where should I send my completed IBC registration forms?
All forms must submitted electronically, via email to Patty Bardeen, IBC Program Coordinator at pbardeen@safety.rochester.edu. These are needed for committee review. If not signed digitally - signed, hard copies should then be sent to Patty through intramural mail to RC Box 278878 or faxed to her at 274-0001.
Q. How long with 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 Janet Ives, Biosafety Officer, with additional questions from the committee. Final approval will then depend on how quickly the questions are resolved.
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 Janet Ives at jives@safety.rochester.edu or per her email directions.
Q. 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.
Q. I share a lab with an investigator who is 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 grant, project or set of experiments.
However, Laboratory registration forms of senior Principal Investigators may be used by junior Principal Investigators of the same laboratory.
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 Janet Ives, Biosafety Officer, for advice. (X53014 or jives@safety.rochester.edu)
Q. 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 at the Lab Decommissioning Reference. If you have addition questions, contact EH&S at 275-3241 or e-mail EH&S Questions. Once you are set up in your new space, please contact Lisa Denmark (X53040 or ldenmark@safety.rochester.edu) for your biosafety inspection.
Q. 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. One of these assurances is laboratory inspections will be conducted annually for all research involving recombinant DNA and/or biohazards. Contact Lisa Denmark, IBC Technical Associate, to set up an inspection date at
275-3040 or ldenmark@safety.rochester.edu
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 Program Coordinator, Patty Bardeen at 585-275-2402 or pbardeen@safety.rochester.edu.
This page last updated 2/5/08. Disclaimer
