Initial Study Submission

All human research study applications are submitted and stored online in the myIRB system. 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:

• IRB application type for projects under federal regulation
• IRB application type for projects when federal regulations do not 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 KU Medical Center investigator, the KU Medical Center Protocol Template may be used:

• Protocol Template with Instructions (12/2024)

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

• Protocol and Application for Secondary Research (08/2019)
• HERON Information:The HERON data repository is a search tool hosted by KU Medical Center 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 myIRB 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.

• Full Committee Projects - Two documents are required:
  
  1. Principal Investigator Supplement (07/2021)
  2. Project Description (IIT or industry)
     
     1. Full Committee Project Description - Industry Trials (01/2024) OR
     2. Full Committee Project Description - Investigator-Initiated Trials (01/2024)

• Flexible IRB Review Form (01/2024)
• Expedited Project Description (01/2024)
• Exempt Project Description (01/2024)
• Requests to Use External IRBs are found our IRB Reliance Resources page
• Projects that do not involve human subjects research per the Decision Tree:
  
  • Determination of Not Human Subjects Research (12/2015)
  • Quality Improvement Determination (03/2021)

  Step 5: Request scientific merit when required.

  Scientific Merit Form (01/2024)- 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.

  • IRB checklist (01/2024) -Required for all Full Committee submission.
  • Protocol Review and Monitoring Committee (PRMC)- For cancer or cancer-related protocols.
  • Application for Use of Radiation in Research Involving Human Subjects (05/2024)- Required for all studies that involve any form of radiation or use of a radioisotope.
  • Data Use Agreement or Business Use Agreement Templates, contact hipaa@kumc.edu or Chris Griffith, Privacy Manager.
  • Genome Wide Association Study - Forms
  • Lead IRB Supplement Form (01/2024)- Required when the KU Medical Center IRB will be the Reviewing IRB for a multi-center study.

  Step 7: Submit the study in myIRB

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

  Step 8: Respond to provisos/modifications required for approval

  • Answering Provisos (Quick Start Guide)
  • Supplement for Answering Provisos (optional form for guidance in submitting provisos)