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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.
IRB 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.
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.
The KCUMB Institutional Review Board may review protocols of external organizations, provided it has adequate expertise, subject to the following fee schedule:
The KCUMB Institutional Review Board reviews external studies in accordance with KCUMB’s policies, procedures, and standard operating procedures, unless negotiated otherwise.
When do I need to complete an application?Complete the necessary applications if your research involves:
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 ProtocolIACUC 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:
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 email@example.com.
IRB Committee meetings take place 11:30 a.m.-12:30 p.m. in DC 240. Meetings are typically scheduled the third Thursday of each month.
If you have questions, please call ORSP at 816-654-7605.
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