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Institutional Biosafety Committee (IBC)


REGISTER YOUR rDNA WORK

To complete a registration, please go to: http://www.eresearch.umich.edu

Please allow three to four weeks for review and approval of your IBC registration, whether it is an initial registration, an amendment, or a renewal. Remember that project award accounts may be held until rDNA projects are properly registered.

NON-UM INVESTIGATORS
Investigators from other institutions who are having recombinant DNA work performed for them at a UM facility such as the Vector Core Laboratory (VCORE-UM) must complete a special IBC registration form. Please e-mail the IBC Coordinator or call (734) 936-3934 to receive a copy of the registration form you will need to complete. Please contact the Vector Core Laboratory directly at (734) 936-5843 for additional information on use of that facility.


INTRODUCTION TO THE IBC
The Institutional Biosafety Committee oversees recombinant DNA research at the University of Michigan. The UM adheres to the NIH Guidelines for Research Involving Recombinant DNA Molecules with regard to all uses of recombinant DNA at the University. The UM requires that all use of recombinant DNA at the University be registered with the Institutional Biosafety Committee even if such use is exempt from the requirements of the NIH Guidelines. The IBC also has oversight responsibility for Select Agents and for "experiments of concern."

View the IBC Charge

The IBC Standard Operating Procedures are being revised. Please view the IBC Basic rDNA Registration Process Flowchart for an overview of our current process. Additional detail is provided below for specific topics.

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PI RESPONSIBILITIES
Registration
The principal investigator or project director at UM is responsible for registering rDNA work and for ensuring the use of proper microbiological practices and laboratory techniques at the approved biosafety level. Additional PI/PD responsibilities are detailed in Section IV-B-7 of the NIH Guidelines.

Laboratory Inspections
The principal investigator or project director of a BL2, BL2+, or BL3 laboratory must ensure that a working Biosafety Manual is available for the research project and that all staff have attended the OSEH Comprehensive Laboratory Safety Training course. Laboratories planning BL2, BL2+, or BL3 work must be inspected by OSEH and all corrective action items completed before the IBC will issue approval for the associated registration. A checklist of items required in addition to a Biosafety Manual and personnel training is located at http://www.oseh.umich.edu/pdf/BL2checklist.pdf.

Personnel Training
All laboratory personnel must attend the OSEH Comprehensive Laboratory Safety Training course (#BLS009). Free. Pre-registration required through My LINC.

Individuals planning to work with viral vectors are highly recommended to enroll in the course "Working Safely with Viral Vectors" (course #BLS008) which is offered quarterly by the Vector Core and OSEH (February, May, August, November). Free. Pre-registration required through My LINC.

Approval for Human Gene Transfer Research
Principal investigators performing human gene transfer work have special responsibilities and reporting requirements that are detailed in Appendix M of the NIH Guidelines, and in the section below on human gene transfer.

Approval for Select Agents Research
Investigators planning work with Select Agents should read the Introductory Guide and contact Janet Follo, the University's Responsible Official, at 734-647-3133, to initiate the required review processes.


CONTAINMENT LEVELS: BL1, BL2, BL2+, BL3
Please note that at least BL1 lab practices should be used with all recombinant DNA work, even if the work is exempt from NIH Guidelines.

Recombinant DNA work at BL2, BL2+, or BL3 requires an OSEH laboratory inspection as well as registration with the IBC. It is recommended that you contact OSEH (7-9213) at the same as you are preparing your IBC Registration in order to arrange for a lab inspection. Your inspection must be completed and all action items corrected before the IBC will issue approval. In addition to a completed Biosafety Manual and appropriate training for personnel involved with the project, the OSEH staff will cover items on the BL2 checklist.

An outline of BL1, BL2, and BL3 lab practices can be found in Appendix G of the NIH Guidelines, and the CDC/NIH Biosafety Guideline contains a chart of biosafety practices for work with infectious agents.

Work requiring BL3 containment must be approved on a case-by-case basis by the IBC.

Experiments requiring containment ABOVE BL3 will not be permitted without the prior approval of the Regents.


TRAINING
All laboratory personnel must attend the OSEH Comprehensive Laboratory Safety Training course (#BLS009). Free. Pre-registration required through My LINC.

Individuals planning to work with viral vectors are highly recommended to enroll in the course "Working Safely with Viral Vectors" (course #BLS008) which is offered quarterly by the Vector Core and OSEH (February, May, August, November). Free. Pre-registration required through My LINC.


VIRAL VECTOR STANDARD OPERATING PROCEDURES & GUIDANCE
OSEH has developed SOPs for commonly used viral vectors:

View the OSEH Adenoviral Vector SOP

View the OSEH Retroviral Vector SOP

See also the NIH OBA (RAC) guidance on biosafety with Lentiviral Vectors


REPORTING LAB ACCIDENTS AND ILLNESSES WITH rDNA
For immediate response procedures refer to the Spill & Exposure Response Procedures for Etiologic Agents & Recombinant DNA.

IMPORTANT: All spills and exposures involving recombinant DNA must be reported to the following:


ANIMALS AND rDNA
IBC registrations include questions about your use of animals and recombinant DNA. Based upon your responses, the IBC will assign a containment level for your work with (housing of) the animals. It is usually denoted as "BL1N" or "BL2N," etc., and corresponds to the commonly used "ABSL1," "ABSL2," etc. The animal containment level may be different from the containment level approved for handling your recombinant construct in the lab. The IBC has developed a virus-specific containment reference for the housing of animals injected with recombinant virus.

The containment conditions for animal work involving viral vectors are conditioned on proof that each batch of virus used is substantially free of replication competent virus. ULAM may require such proof prior to commencement of animal experimentation.

All work with animals must be approved by the University Committee for the Use and Care of Animals (UCUCA). Contact UCUCA and the Unit for Laboratory Animal Medicine (ULAM) for additional guidance on work with animals.

Investigators planning to administer recombinant DNA to animals should refer to Appendix Q and Section III-D-4 of the NIH Guidelines for information on biological and physical containment practices.

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SYNTHETIC NUCLEIC ACID MOLECULES
In March 2013 the NIH Guidelines were revised and renamed to include work with synthetic nucleic acid molecules. NIH OBA has published an FAQ on what type of work with synthetic nucleic acid molecules is covered by the Guidelines. IBC registration is required for research meeting this criteria (click here for announcement/criteria) Please note that small DNA molecules such as oligonucleotides and PCR primers are not included in these categories of synthetic nucleic acids. Email the IBC at IBCSyntheticDNA@umich.edu with questions, or call 734-936-3934.

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HUMAN GENE TRANSFER PROPOSALS: PROCEDURES FOR SUBMISSION AND APPROVAL
If you are planning a human gene transfer proposal please note there is a special review process for this type of work:

1) NIH OBA Recombinant DNA Advisory Committee Review Process
All human gene transfer research proposals must undergo review by the Recombinant DNA Advisory Committee (RAC) of the NIH Office of Biotechnology Activities (NIH/OBA). The RAC determination on the proposal must be obtained PRIOR TO the proposal receiving local Institutional Biosafety Committee (IBC) approval.

NIH OBA has an excellent set of FAQs about human gene transfer and the RAC review process.

NIH OBA also provides guidance on informed consent for gene transfer research.

Please refer to Appendix M of the NIH Guidelines for complete information on NIH/OBA/RAC requirements for submission, review and reporting in connection with human gene transfer clinical trials.

Please keep in mind that the IBC cannot formally approve a human gene transfer proposal until review by NIH OBA/RAC has been completed and a letter has been received with the outcome of the NIH OBA/RAC review. The schedule of RAC meetings and corresponding RAC deadlines is displayed at the NIH OBA website.

No research participant may be enrolled in a human gene transfer clinical study until the RAC review process is completed AND IBC and IRB approvals and applicable regulatory authorizations are obtained. Furthermore, investigators are required to submit specific additional materials to NIH OBA prior to the enrollment of any research participant (for additional clinical trial sites being added to multi-center trials) OR no later than 20 working days after the enrollment of the first research participant (for the primary site identified with a clinical trial).

2) Local Review Process
Please inform the IBC as early as possible when you are considering submission of a human gene transfer proposal to the RAC. The IBC will attempt to conduct reviews simultaneous with RAC reviews though no IBC determination may be made until the RAC outcome is known. The IBC meets on a monthly basis and needs two to three weeks prior to a meeting for review of human gene transfer proposals. The upcoming IBC meeting schedule is below.

All human gene transfer clinical trials require IRB approval in addition to IBC approval, and there is a section of the IRB application in eResearch which is devoted to human gene transfer. When you complete that section of your IRB application, the IBC will be notified automatically. The IBC functions as an "Ancillary Committee" to the IRB's review of human gene transfer clinical trials.

The IBC requires submission of the same materials required by NIH OBA/RAC: 1) scientific abstract, 2) non-technical abstract, 3) clinical protocol including tables, figures and relevant manuscripts, 4) responses to NIH Guidelines Appendices M-II through M-V, 5) informed consent draft, and 6) curriculum vitaes for all key personnel. Submission of these materials to the IBC can be made through the eResearch system as part of your IRB application for the human gene transfer clinical trial.

Please contact the IRBMED (763-4768) regarding the full process for human subjects review and approval.


SAFETY REPORTING: SERIOUS ADVERSE EVENTS IN HUMAN GENE TRANSFER
Please see Appendix M-I-C-4 of the NIH Guidelines for safety reporting requirements, including serious adverse event reporting and the reporting of findings from tests in laboratory animals suggesting risk for human research participants.

Please see Appendix M-I-C-3 regarding annual reporting requirements for human gene transfer projects.

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EXPERIMENTS OF CONCERN: An important notice from the IBC


SELECT AGENTS
If you are planning work with select agents, please read the Select Agents Introductory Guide and note that the IBC will accept hard copy, hand-delivered submissions only regarding rDNA work that involves select agents (please do not submit online rDNA registrations for work that involves select agents).


IBC MEETINGS and SUBMISSION DEADLINES FOR 2014
All of the meetings listed below are on the third Friday of the month and start at 1:15 p.m. Please call the IBC at 734-936-3934 or e-mail the IBC Coordinator for more information regarding meetings.

2014 IBC Meetings:

January 17, 2014 (December 27 deadline)

February 21, 2014 (January 31 deadline)

March 21, 2014 (February 28 deadline)

April 18, 2014 (March 28 deadline)

May 16, 2014 (April 25 deadline)

June 20, 2014 (May 30 deadline)

July 18, 2014 (June 27 deadline)

August 15, 2014 (July 25 deadline)

September 19, 2014 (August 29 deadline)

October 17, 2014 (September 26 deadline)

November 21, 2014 (October 31 deadline)

December 19, 2014 (November 28 deadline)

The IBC reserves the right to change meeting dates and deadlines. Changes will be posted here as far in advance as possible.

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FREQUENTLY ASKED QUESTIONS

Q: I would like more information about the IBC registration system.

A: Please see the attached information and FAQs. If your questions are not answered there, please feel free to email the IBC Coordinator.

Q: I am already registered with the IBC for some recombinant DNA work. When do I need to fill out another recombinant DNA registration form?

A: Once you have completed an IBC registration in eResearch, that registration is valid for three years from the approval date. You will need to amend that registration, however, if changes in your rDNA work involve any of the following: the cloning of genes onto a viral chromosome,* or if your recombinant DNA work involves a CHANGE in organism studied, host-vector system, animal model, or biosafety level.

Please note that all human gene transfer clinical protocols must go through a separate, specialized registration and approval process. See information above regarding human gene transfer work.

*Please note that ALL GENES to be cloned onto a viral chromosome must be represented on a IBC registration.

If you are unsure what is contained in your existing IBC registrations, please email the IBC Coordinator or call us at 936-3934.

Q: I have been registered with the IBC, why do I need to complete a new form in eResearch?

A: All investigators registered with the IBC in our old registration system will be required to eventually convert their recombinant DNA registration to eResearch. The questions in the new form are different than those in the older registration forms. We will notify you of a three-month window of time when you can convert your old registration data to the new IBC registration in eResearch. Your old system registration will remain in effect until your process of converting to eResearch has been completed.

If you would like to receive a copy of your old rDNA registrations to assist you in converting your registration to eResearch, please contact the IBC Coordinator.

Q: Do I have to register for PCR work?

A: You need to register the work with the IBC if you are cloning the PCR product first, prior to sequencing. The direct sequencing of PCR products does not need to be registered with the IBC - as long as there is no cloning involved.

Q: My lab partner is registered for recombinant DNA work. Doesn't that registration also cover what I do in our shared lab?

A: In some cases it might. Investigators sharing laboratory space also share registration and training obligations. Recombinant DNA work may be registered either under the investigator in whose lab the work is occurring or under the principal investigator of a project.

For example, investigators in charge of labs where recombinant DNA work occurs are responsible for ensuring that there is a registration with the IBC for all the recombinant DNA work occurring in their lab space. In addition, they must maintain documentation of the training status for all the individuals working in the lab with recombinant DNA at BL2 or BL2+ containment.

View the IBC's position on lab collaborations.

Q: Is it alright for the BL2 portion of my rDNA work to be performed in my colleague's BL2 lab? Who needs to be registered for the work?

A: Principal investigators who are not themselves registered for BL2 or BL2+ recombinant DNA work, and who are having this work performed in another investigator's lab, are responsible for ensuring that it is occurring in a laboratory that is registered with the IBC for that type of work and that it is conducted by individuals who have received training for the work they are performing.

View the IBC's position on lab collaborations.

Q: What items will OSEH review when they inspect my lab before I can begin my BL2 or BL3 rDNA work?

A: OSEH will be looking at the items on the BL2 Recombinant Laboratory checklist and reviewing the laboratory's completed Biosafety Manual to ensure the lab has the proper training, and written procedures in place to safely conduct the work.

More frequently asked questions will be posted here in the future.

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LINKS TO RESOURCES

  • External Resources
  • Internal Resources


    CURRENT MEMBERSHIP OF THE IBC

    Philip Hanna, Chair
    Microbiology & Immunology
    Medical School

    Carl Marrs, Associate Chair
    Epidemiology
    School of Public Health

    Janice Berry
    Periodontics/Prevention and Geriatrics
    School of Dentistry

    Lois Brako
    UM Office of Research

    J. Christopher Fenno
    Biologic & Materials Science
    Dental School

    Janet Follo, Biological Safety Officer (ex officio, voting)
    Responsible Official
    Occupational Safety and Environmental Health

    Renny Franceschi
    Periodontics & Oral Medicine
    Dental School

    Michael Imperiale
    Microbiology & Immunology
    Medical School

    Joyce Lai, Community Representative
    Michigan Department of Community Health

    Pedro Lowenstein
    Neurosurgery; Cell and Developmental Biology
    Medical School

    David Miller
    Internal Medicine and Microbiology & Immunology
    Medical School

    Harry Mobley, IBC BSL3 Subcommittee Chair (ex officio, non-voting)
    Microbiology & Immunology
    Medical School

    Stephen Rapundalo, Community Representative
    MichBio

    Howard Rush
    Unit for Laboratory Animal Medicine
    Medical School

    John Schiefelbein
    Molecular, Cellular & Developmental Biology
    College of Literature, Science and the Arts

    Andrew W. Tai
    Internal Medicine - Gastroenterology
    Medical School

    Jason B. Weinberg
    Pediatric Infectious Diseases and Microbiology & Immunology
    Medical School

    Please call (734) 936-3934 with questions and comments
    or send an e-mail to:

    Jacqueline Hoats Shields (jhoats@umich.edu),
    Biosafety Compliance Program Manager
    UM Office of Research


    This page was last updated March 31, 2014.

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