Institutional Review Board

  • The Institutional Review Board (IRB) is a committee that reviews protocols involving research with human beings. The IRB is essential for ensuring that humans participating in research as subjects are protected from physical, emotional and mental harm to the extent they agreed when entering a study.  

    IRBIRB review is conducted by performing a risk-benefit analysis and applying HHS regulations at 45 CFR 46, which implement the National Research Act of 1974.

    Please plan on at least a month between the time an application is submitted and the time an application is considered for review.

    Various factors pertaining to a study can lead to decisions taking more than a month, so please consider this in your study planning. Forms to submit to the IRB are available on IRBNet.

  • Compliance Training

    Before any research can be initiated, all required training must be completed. See research policies or contact the Division of Research for training requirements pertaining to your study.Use the resources found in the Compliance Training section to determine what training is needed.

    Standard Operating Procedures

     Regulations


    The KCUMB Institutional Review Board may review protocols of external organizations, provided it has adequate expertise, subject to the following fee schedule:

    Initial Review $1,500.00

    • Protocol (with all amendments and subject hand-outs included in initial packet)
    • Investigator Drug Brochure or Equivalent
    • Consent Forms: Up to three; after three, $50 per consent form
    • Recruitment Materials

    Continuing Review

    • Annual Review $400
    • Final Report at Closeout $100
    • Revised IDB $100
    • Protocol Deviations No Charge
    • Protocol Violations No Charge

    Modifications (Eligible for Expedited Review)

    • Recruitment Materials $200 per review
    • Consent Form $200 per sponsor request
    • Protocol Amendment $200 per amendment
    • Subject-provided Materials $200 per item

    Modifications Requiring Full Board $200 Per Review

    • Any modification that does not meet expedited review (i.e. does not change risk/benefit ratio)

    The KCUMB Institutional Review Board reviews external studies in accordance with KCUMB’s policies, procedures, and standard operating procedures, unless negotiated otherwise.

    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.

    IRB Committee 2014-2015 Schedule

    IRB Committee meetings take place from noon - 1 p.m. in DC 240. Meetings are typically scheduled the third Thursday of each month.

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

     
    July 17, 2014   July 10, 2014
    Aug. 21, 2014   Aug. 14, 2014
    Sept. 18, 2014   Sept. 11, 2014
    Oct. 16, 2014   Oct. 9, 2014
    Nov. 20, 2014   Nov. 13, 014
    Dec. 18, 2014   Dec. 11, 2014
    Jan. 15, 2015   Jan. 8, 2015
    Feb. 19, 2015   Feb. 12, 2015
    Mar. 19, 2015   Mar. 12, 2015
    Apr. 16, 2015   Apr. 9, 2015
    May 21, 2015   May 14, 2015
    June 18, 2015   June 11, 2015


     If you have questions, please call ORSP at 816-654-7605.