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Initial Study Submission

All human research study applications are submitted and stored online in our electronic IRB system (eCompliance). The submission process has 8 basic steps.

Step 1: Confirm that your project needs IRB review and determine which application form to use.

Our Decision Tree guides you through a determination of whether IRB review is required and, if so, which type of application form most likely fits your project. A video tutorial with more information about the decision tree can be found here.

Alternatively, two references have details for application forms based on project type and whether or not federal regulations apply:

Step 2: Prepare your study protocol

If you already have a protocol from a sponsor or external collaborator, upload this document for IRB review. If you are seeking a format for a protocol written by a KUMC investigator, the KUMC Protocol Templates are ready for use:

For secondary research projects, these forms are considered a study's project description and protocol. 

  • Protocol and Application for Secondary Research  08/2019HERON Information:
  • The HERON data repository is a search tool hosted by KUMC Medical Informatics to allow researchers to explore clinical data and identify patients who meet inclusion or exclusion criteria. HERON can be used for feasibility counts prior to IRB or grant submission. In addition, researchers are able to request clinical data on eligible subjects for either a de-identified or identified dataset. If your study team plans to use HERON to retrieve identified patient data, a feasibility search should be conducted in HERON to determine the approximate number of patients for whom an IRB HIPAA waiver will be required. Please visit Medical Informatics HERON Introduction for more information on how to build a search in HERON. You may contact the Department of Medical Informatics at misupport@kumc.edu with any questions.

Step 3: Assemble other required documents.

Review the complete list of documents to prepare (07/2020) matched with the correct screen in eCompliance for each document you plan to upload for your study.

Step 4: Complete your Project Description or Request for Determinations of Other Project, as directed in Step 1.

Step 5: Request scientific merit, when required

Scientific Merit Form-  Use this form when scientific review is being provided by an individual or committee within the department. Note that a Scientific Review form is not required for flexible review, exempt, retrospective, reliance studies or industry-sponsored, multi-center pharmaceutical trials.

Step 6: Complete supplemental initial submission forms as needed

Step 7: Submit the study in https://ecompliance.ku.edu

The IRB requires a Principal Investigator to make the initial submission. Detailed instructions for how to prepare documents, access, navigate and submit within the eCompliance system are provided in the eCompliance Guidance document. Departmental training and eCompliance assistance can be arranged by contacting the IRB office.

A video tutorial on submitting a new study can be found here.

Step 8: Respond to provisos/modifications required for approval

Research Administration

University of Kansas
Medical Center

Research Administration
Mailstop 1039
3901 Rainbow Boulevard
Kansas City, KS 66160

OFFICE LOCATION:
Fairway North, 1000
4330 Shawnee Mission Pkwy
Fairway, KS 66205
Phone: 913-588-1261
Fax: 866-255-2129