Forms

Initial Submission Forms

• Application for Full Committee Review of Human Subject Research
• Application for Expedited Review of Human Subject Research
• Application for Exempt Review of Human Subject Research
• Application for Review of Retrospective Human Subject Research
• Request for QI/QA Determination
• Request for Determination of Not Human Subjects Research

Here is the Departmental Scientific Review Checklist, if needed.

SUBMISSION INSTRUCTIONS (what is paper, what is electronic):  Click here

Amendments/Changes to Previously Approved Studies

• Request for Amendment Form
  (used primarily for protocol, consent form and funding revisions)
• Request to Add or Revise Recruitment/Retention Materials
• Request to Update or Add and Investigator's Drug or Device Brochure
• Changes to External Study Personnel or Off-Site Changes
• Request for Changes to KUMC/KULC Study Personnel

Continuing Review and Closing Studies

• Continuing Review Form 
  (This form is used for required recertification — annual or six-month — of non-exempt research)
• Closure Request
  (This form is used when a research study is completed or no longer pursued at KUMC)

Problem Reports / Reportable New Information

In anticipation of a new electronic reporting system, the KUMC IRB is revising its method for reporting problems that occur during research.  Beginning May 1, 2013, please use the form entitled "Reportable New Information."   Instructions and the form are posted below.

The Reportable New Information (RNI) form should be used if there is any increase in risk to subjects, any harm that occurs, problems, complaints, non-compliance, breach of confidentiality or any other event that indicates subjects may be at greater risk of harm than previously recognized.  The RNI form will also be used to submit all reports of sponsor monitoring visits or other study audits. 

Reports should be submitted within 5 working days of the investigator's knowledge of the problem.  Urgent information, or report of a study-related death, must be reported in 24 hours.  Please feel free to contact the HSC Office at (913) 588-1240 with any questions about these new reporting guidelines. 

Reportable New Information: Instructions

Reportable New Information: Form

Supplemental Initial Submission Forms

• Application Addendum for Cancer and Cancer-Related Studies
• Instructions
• Nursing Impact Form
• Supplemental Application for Research Involving Pregnant Women, Fetuses or Neonates
• Research Request for Human Specimens (This form is used to request materials from the Biospecimen Repository Core Facility)
• Radiation Safety Form RS06 (required for all studies that involve any form of radiation or use of a radioisotope)