IBC Frequently Asked Questions

TABLE OF CONTENTS

ABOUT THE IBC

PROPOSALS & AMENDMENTS

FACILITY INSPECTIONS

TRAINING

CHEMICALS & OTHER HAZARDS


ABOUT THE IBC

What is an IBC?

The Institutional Biosafety Committee



What are the responsibilities of the IBC?

The Institutional Biosafety Committee is charged with reviewing and approving projects involving recombinant DNA and other potential biohazards.



What regulations/guidelines does the IBC follow?

The IBC is established to ensure compliance with all applicable state and federal laws including National Institutes of Health Guidelines for Research Involving Recombinant DNA Molecules.



Why is it necessary to have IBC approval?

To comply with Federal and State laws and the NIH Guidelines. For more information, see the NIH PowerPoint presentation, "Requirements for Institutional Biosafety Committees under the NIH Guidelines" offered on this page.



Who can I contact if I am not sure if I need IBC approval?

If you have any questions or need any further information, please contact Tom Schultz at 989-774-3279 or schul1te@cmich.edu or the Office of Research Compliance at ResearchConcern@cmich.edu.



Why do the regulations and policies keep changing?

CMU policies are derived from laws and regulations of the State and Federal government. As those laws change, so will the policies. Some policies and procedures may change in an effort to improve oversight.



PROPOSALS & AMENDMENTS

What must be reviewed by the IBC?

Research involving recombinant or synthetic nucleic acid molecules. The IBC at CMU is also charged with oversight of research involving: Select agents and toxins, Blood borne pathogens, Xenotransplantation involving human derived materials, human stem cell research, "Dual Use" research and Nanotechnology.



Where can I find the IBC registration form?

The IBC registration form and instructions on how to complete the form can be found here.



Who may serve as the principal investigator (PI) of an IBC protocol?

A faculty member or full time lab manager must be the principal investigator on an IBC registration.





For what kinds of projects do I need to have an approved IBC protocol?

The IBC at Central Michigan University reviews research projects involving recombinant DNA, as well as certain biohazards, toxins and infectious agents.



The project I have planned is not specifically covered by the NIH guidelines. Do I still need to have approval?

If you're not sure, it's best to ask. Your research may fall into one of the other categories that the IBC oversees.



What is the process for getting a protocol reviewed by the IBC?

Fill out the IBC registration form and supporting documentation, and then submit by e-mail to the addresses at the top of the form.



What is the time period for the review of a protocol or protocol amendment request?

Time to review varies depending on the content of the application and timing of submission, but most protocols can be reviewed and approved in 4-6 weeks (or less).



Is there anything I can do to speed up the review process for my protocol or amendment?

Fill out the registration form completely. Be sure to include the goals and a brief non-technical summary of the research, as well as how you will mitigate potential biosafety issues. Make sure any training or lab inspections required to obtain approval are in place. Respond promptly to any questions or requests for information from the IBC.



What other steps do I need to take to start a project in addition to submitting an IBC protocol?

Laboratory Risk Assessments and Biosafety inspection are required, as well as Biosafety training for laboratory personnel. Please contact Tom Schultz at 989-774-3279 or schul1te@cmich.edu or the Office of Research Compliance at ResearchConcern@cmich.edu.



What factors do IBC members consider when reviewing my research proposal?

  • That the proposed research conforms to NIH Guidelines, as well as other applicable laws or guidelines
  • That all regulatory authorizations have been obtained
  • That the risks associated with the project will be appropriately managed through: training, facility assessment, risk assessment and an appropriate occupational health program



Besides the registration form, should I submit anything else?

  • Documentation of training
  • Regulatory authorizations
  • IACUC safety form (if working with animals)
  • Safety protocols
  • SOPs for working with pathogens



Is it possible that the IBC will deny approval of my research proposal?

It is more likely that the IBC would respond with required changes or request additional information. In the rare instance where a protocol is not approved, it is because the committee cannot verify that the research will comply with NIH Guidelines or other applicable laws or regulations, or that the risks associated with the research cannot be appropriately addressed.



May I initiate my project before I receive IBC approval?

No.



I have received word that my proposal was approved. When can I start my project?

Work may begin once you have received written IBC approval, as well as any other institutional approvals required.



How long is an IBC registration valid?

Protocols are approved for the period of time requested by the PI, up to a maximum of 3 years.



Can my protocol or amendment be expedited?

There currently in not an expedited process for IBC protocol review.



Do I always need to submit an amendment for changes to my protocol?

Yes.

Any changes in a protocol including personnel changes should be reported to the IBC.



Does the approval of an amendment extend the original approval date?

No.

The original approval period will remain even after the approval of an amendment.



What happens if my current registration expires before its renewal is approved by the IBC?

All research must be suspended pending a decision of the renewal.



I've done this work quite often and have similar protocols with the IBC. Why is the committee so concerned about the details of my most recent application?

The IBC reviews each individual application on it's own merits. Changes in regulations or the composition of the IBC may also lead to different questions than have arisen in the past.



How do I add personnel to an approved protocol?

Submit an amended registration form to the IBC and make sure the personnel to be added have received all required training.



I closed my protocol before its 3-year expiration. Can I reactivate the protocol?

No.

If a project is closed, you must submit a new application for the project.



FACILITY INSPECTIONS


Why is my lab being inspected?

Lab inspections are part of the risk assessment that occurs to ensure compliance with NIH Guidelines.



Do I have to be present for inspections?

A laboratory representative can host inspections in the event a faculty member cannot be present.



What type of protocol records may be requested during the annual evaluation?

  • Door signage must be appropriate/available
  • Training documentation might be requested
  • Previous lab survey records
  • Other relevant laboratory safety records might be needed



What if I have a disagreement with the committee's findings?

You may state your reasons for disagreeing and ask that the committee reconsider, particularly if you believe additional information might clarify any issues. You may also ask the Vice President for Research to request that the committee reconsider your protocol.



TRAINING


What are the training requirements?

In person training is currently the only option, however online training through CITI may be available soon.



Is it a serious matter if personnel are performing studies with animals and they aren't listed on the protocol?

Yes.



CHEMICALS & OTHER HAZARDS


Where can I find information on Biosafety levels?

You may find more information here on Biosafety level criteria.



What does the IBC require from an investigator if a protocol contains chemical hazards?

That the CMU policies and procedures for working with chemicals are being followed. For more details, please go here.



What steps do I need to take to use hazardous materials?

See the Chemical Hygiene Plan, especially Appendices C, D, F, and G for more information.



How do I dispose of potentially biohazardous regulated medical waste (RMW)?

Information on RMW waste disposal can be found on the Biosafety Management: Waste Management website.



How do I dispose of hazardous chemical waste?

Information on chemical waste disposal can be found here.



Updated 5/17/2016

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