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SUBMISSION OVERVIEW
 

Submission Process

Initial or post-approval research applications requiring IRB review are submitted through the Kuali Research (KR) electronic submission system. Click the first or second Kuali Icon to the right to access the system. If currently you are not a registerd user in KR, please consult the document Accessing Kuali Research on the Kuali QuickGuides webpage for registration instructions. This page, along with the Kuali Support Documents page, contains additional documents with instructions for navigating KR and submitting different types of applications.
 

Initial Submissions

Investigators may submit research studies for initial review by the IRB using one of several protocol configurations (types); these protocols are reviewed using one of three procedures.


Review Procedures

The procedure used for review is in part dependent on the nature of the study and the level of risk to the subject participating in that study. The risk level is compared to “minimal risk” as defined by federal regulations:

Minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests (45.CFR.46.102(j))(Common Rule).

The three review procedures are:

  • Administrative Review - This review is conducted by members of the IRB Office staff.
     
  • Expedited Review Procedure - This review is applicable to minimal risk studies and is conducted by the IRB Chair or an experienced IRB member designated by the Chair. This procedure is sometimes referred to as Designated Member Review.
     
  • Convened Meeting Review - This review is applicable to greater than minimal risk research and is conducted by the Board at a convened meeting. Research reviewed at a convened meeting sometimes is referred to as a Full Board protocol or application.


Protocol Types

The review procedures and their applicable protocol types for initial review by the IRB are tabulated below. More information about the specific protocol types is available by clicking on the link.
 

  REVIEW PROCEDURE PROTOCOL TYPE
     
  Administrative Review Not Human Subjects Research Determination
    Reliance Request
    Exempt Determination
     
  Expedited Review Expedited Research
    Emergency Use of a Test Article
     
  Convened Meeting Full Board Research
    Humanitarian Use Device


Post-Approval Submissions

Investigators are responsible for ongoing requirements in the conduct of approved research. These include obtaining prior approval from the IRB before implementing any modifications, reporting any new information that may impact on the conduct of an IRB-approved research study or the safety and welfare of the participants in that study, and complying with federal regulations that require an IRB to conduct Continuing Review of research at intervals appropriate to the degree of risk.

More information about these post-approval requirements are available by clicking on the links below: