Here is the Departmental Scientific Review Checklist, if needed.
SUBMISSION INSTRUCTIONS (what is paper, what is electronic): Click here
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.