Institutional Biosafety Committee

  • The Institutional Biosafety Committee reviews protocols for research involving recombinant DNA, biohazardous materials, infectious agents and biologically derived toxins, including select agents.

    IBCThe National Institutes of Health and Biosafety in Microbiological and Biomedical Laboratories provide the bulk of regulations governing biohazardous materials, to which the IBC ensures protocols comply. Before any research with biohazardous materials is initiated at the University, investigators must apply and receive approval from the IBC.

    Please plan on at least a month between the time an application is submitted and the time a decision is rendered. Various factors can lead to decisions taking more than a month, so please consider this in your study planning. Forms to submit to the IBC are available on IRBNet.

  • Compliance Training

    Before any research with biohazardous materials and/or coming under the jurisdiction of the IBC can be initiated, all required training must be completed. Use the resources found in the Compliance Training section to determine what training is needed.

    Standard Operating Procedures

    Regulations

    Frequently Asked Questions

    When do I need to complete an application?
    Complete the necessary applications if your research involves:

    • Animals – IACUC
    • Biohazardous materials, etc. – IBC
    • Humans – IRB

    Does secondary analysis of existing data need IRB approval?
    Yes, research involving secondary analysis of existing data must have IRB review to ensure the original data was collected properly and ethically, and that objectives of secondary analysis keep with those for which consent was obtained.

    Can students be Principle Investigators?
    No, only faculty members and preceptors may be Principle Investigators. However, students may work on and submit materials with the Principal Investigator’s permission and guidance.

    How do I create an account?
    All applications must be created/submitted via IRBNet.org, an e-protocol system. Create an account by going to IRBNet and clicking the “New User Registration” link under the login fields in the upper right-hand corner of the page. When creating your account, make sure you select Kansas City University of Medicine and Biosciences as your organization. Once you have created your account, you will receive an activation email. Please click the link in the email to activate your account. If experience difficulty when activating your account, please contact IRBNet support at 877-261-6461.

    How do I submit an application?
    To submit your application, first sign the package electronically and then click on "Submit this Package" and select one or more boards for review.

    What additional materials do I need to submit?
    Elements of a Research Protocol
    IACUC Application Materials (PDF)
    IBC Application Materials (PDF)
    IRB Application Materials (PDF)

    Do I have to sign hard copies?
    Electronic signatures are accepted for all documents except for:

    • Student Data Use Form (IRB)
    • Lab Specific Training Form (IBC)

    What happens after I submit my application?
    A preliminary review begins upon receipt of your application, in which the compliance office confirms your application is complete. During this time, you will be asked to modify your application (see how to submit an amendment). Upon confirmation of a complete application, your review will begin.

    How long is the review?
    The length of time for review depends on several factors, the largest being when the applicable committee is scheduled to convene. The minimum about of time for review is typically one month for this reason.

    How do I know my application is approved?
    Once the committee has rendered a decision, you will receive an automatic e-mail notification. All notifications will be sent to your registered e-mail address. You will be notified via email when a decision is reached and a letter is uploaded to IRBNet org.

    How long does approval last?
    IRB and IBC approval cannot exceed one year. IACUC approval cannot exceed three years.

    How do I renew a study?
    To renew an application, click on the original project and click on create a new package.

    When should I renew a study?
    You have 30 days from your study’s expiration to submit a renewal application. After which, you must submit a new protocol.

    What happens if my study expires before I receive annual renewal approval?
    All research activity must cease immediately upon expiration of approval, unless abrupt ceasing would jeopardize human or animal welfare. Make all efforts to contact your Principle Investigator before continuing your study. To recommence research, you must receive an approval letter from the applicable committee.

    When should I submit an amendment?
    Submit an amendment whenever there is a change to the original application materials.

    How do I submit an amendment?
    If revisions are needed before your submission is reviewed, your coordinator may unlock the package for you to revise. Unlocked projects can easily be managed from the My Projects page. While the package is unlocked, you may add new documents or revise existing ones as needed.

    To revise or submit a previously submitted document for review, refer to the "Documents from Previous Packages" section at the bottom of the Designer page.

    How do I report an adverse or unanticipated event or suspected non-compliance?
    Within 48 hours, complete an adverse event form, found on IRBNet.org, and contact your Principal Investigator, if other than you, and the ORSP at 816-654-7605 or irb@kcumb.edu.

    Biological Safety, Occupational Health and Infectious Disease Committee

    Committee Chair/Animal Containment - Christopher Theisen, PhD
    Committee Vice Chair/Animal Containment - Abdulbaki Agbas, PhD
    Biological Safety Officer/Animal Containment/Lab Tech Staff - Paul Ramlow, MBS
    Unaffiliated Representative - Karen Kover, PhD
    Facilities - Anna Graether
    Basic Science Representative/Human Subjects - Steve Gustafson, DO
    Clinical Science Representative/Human Subjects - George Kolo, DO
    Library Representative - Jessica Berry
    Building & Grounds - Nina Tali
    Unaffiliated Representative - Matthew Conwell, CRNA
    Alternate Basic Science Rep. - Jill Schriewer
    Alternate Library Rep. - Open

    Ex-Officio

    Research Representative - Jeff Joyce, PhD
    Campus Operations - James Herrington
    Research Compliance - Teresa Williams, MS

    Administrative Support

    Administrative Support - Deb Mitchell

    IBC Committee 2015 Schedule

    IBC Committee meetings take place from 10-11 a.m. in DC 240, unless otherwise noted.

    Meeting Date     Full review protocols should be fully uploaded
    in IRBNet.org by the end of business on:

     
    Jan. 16, 2015
      Jan. 9, 2015 (SEP 250A)
    Jan. 30, 2015
      Jan. 23, 2015
    Feb. 20, 2015   Feb. 13, 2015
    March 20, 2015   March 13, 2015
    April 17, 2015   April 10, 2015
    May 15, 2015   May 5, 2015
    June 19, 2015   June 9, 2015


     If you have questions, please call the compliance office at 816-654-7605.