Reporting Important Information to IRB (Reportable New Information)

HRP-224 REPORTABLE NEW INFORMATION FORM – INSTRUCTION GUIDE

The HRP-224 Reportable New Information Form replaces the Death on Protocol form, and the Adverse Event/Unanticipated Problems policy. In addition, there is a change in definition from “probably or possibly related to research procedures” to “at least probably related to research procedures”.

All information must be reported to the IRB within 5 business days of the date the PI became aware of the information.

This form is to be used to report any information listed on page 2 of the form.

Only information that falls under the categories on page 2 must be reported to the IRB.

If any changes to the protocol or consent are required based on the information being reported, HRP-213 Modification of Approved Human Research [DOC] must also be submitted.