Human Research Protection Program
Initial Study Submission
All human research study applications (except reliance studies involving Wesley and Ascension Via Christi) are submitted and stored online in our electronic IRB system (eCompliance).
All KUSM-W IRB submissions will be reviewed by the KUMC (Kansas City) campus IRB that meets every second and fourth Tuesday of each month. There are no submission deadlines. Complete submissions will be placed on the agenda of the next available meeting.
Step 1: Review a complete list of documents to prepare matched with the correct screen in eCompliance/eIRB for each document you plan to upload for your study.
This list includes preparing and uploading the required Study Protocol. If you are seeking a protocol format, the KUMC Protocol Templates are ready for your use.
- Protocol Template with Instructions
- Secondary Analysis Research - Federally Funded
- Secondary Analysis Research - Flexible Review
Step 2: Choose a Review Type
Step 3: Complete the Corresponding Project Description or Request for Determinations of Other Projects
Each new proposal will be accompanied by an applicable Project Description. The Project Description provides the IRB with additional information, necessary for local review that is not captured in the electronic system.
- Full Committee Project Description (November 2018)
- Industry Trials Project Description documents:
- Investigator Initiated Trial Project Description documents:
- Flexible IRB Review Form 04/2019 (For minimal risk research that is NOT federally funded or supported)
- Expedited Project Description 01/2019 (For Federally Funded Research)
- Exempt Project Description 01/2019 (For Federally Funded Research)
- Requests to Use External IRBs are found on our Collaborations & IRB Reciprocity page.
- Requests for the following reviews/determinations can be submitted by downloading, completing, scanning and emailing the forms below to email@example.com:
Step 4: Request Scientific Merit and Department Reviews
Scientific Merit Review is required for all full committee and expedited studies; it is not required for exempt or retrospective studies. Department approval is required for all submissions.
- Scientific Review and Administrative Certification (combined form)
- Use this form when the department chair is providing both the scientific review and the administrative certification.
- Scientific Merit Form (for Reliance Studies)
- 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 exempt or retrospective studies.
- Administrative Certification for IRB Submission (for Exempt or Retrospective Studies)
- Use this form if the Department Chair/Director is approving the IRB submission on paper. The Chair/Director can provide electronic approval fo rthe submission by being designated an an Ancillary Reviewer. Please contact the IRB office with questions about ancillary reviews.
Step 5: Complete Supplemental Initial Submission Forms as Needed
- Community-Based Participatory Research Supplemental Form
- Lead Investigator Supplemental Form
- Radiation Safety Form RS06 (Required for all studies that involve any form of radiation or use of a radioisotope.)
Step 6: Log into https://ecompliance.ku.edu
Please refer to the following guides as needed:
- Creating and Submitting a New Study (Quick Start Guide)
- Creating and Submitting a New Study (Screen Shot Guide)
- Changing the Primary Contact (Screen Shot Guide)
- For New Studies: Coordination of PRMC and eIRB Submission (Quick Start Guide)
- For Department Chairs: Reviewing a Study for Administrative/Department Approval (Screen Shot Guide)
Step 7: Submit the Study or Notify the PI to submit
Don't forget this step! Your submission cannot be reviewed by the IRB until it has been submitted.
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)