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Interim IRB Application Process

The IRB is in the process of transitioning to a new online IRB Application system. To submit an IRB Application between 6/21-7/25 (the IRB will not be accepting applications between 7/26-8/14):

  • Complete an IRB Application, and Information Sheets or Consent Forms as applicable
  • Submit these completed forms as separate Word Documents to the IRB Director via email
  • The IRB will respond with information regarding review timelines

Pathways for IRB Review

The IRB reviews studies through several pathways:

  • Exempt Research is minimal risk research which fits into one of the Exempt Categories outlined in 45 CFR 46.101. A researcher may not determine that a study is Exempt. Exempt Determinations are made by the IRB and appointed reviewers. Researchers are encouraged to consult with the IRB prior to submitting in IRBNet to ensure the correct application has been used. Download the Exempt Application.
  • Expedited Research is minimal risk research which fits into one of the Expedited Categories outlined in 45 CFR 46.110. Download the Expedited Application.
  • Research reviewed by Full Board Review is greater than minimal risk, or contains elements that preclude Expedited Review. Download the Full IRB Application.

Additional Forms

  • A Modification Form should be used to make any changes to an approved study. Changes to an approved study may not be implemented until approved by the IRB unless required to alleviate an immediate harm to a participant. Download the Modification/Amendment Application.
  • A Continuing Review Form should be submitted prior to the Expiration Date of your study, if you plan to continue conducting research. A Continuing Review is required at least once a year for all studies reviewed by Full Board or Expedited process. Download the Continuing Review Form.
  • A Study Closure Form must be submitted when all study procedures and analyses have been completed. Download the Study Closure Form.

Consent Forms and Materials

To select the correct Information Sheet or Consent Form, please see the Guidance for Selecting Lindenwood Consent Templates for assistance.

 

Lindenwood University
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St. Charles, MO 63301