April 21, 2014

Reminders from the IRB

1. Do not initiate a new human study or changes to existing protocols and consent without receiving documentation of IRB approval.  Submissions are not fully approved until you receive an official signed (and usually dated) document from the IRB office. This includes, but is not limited to, Initial Approval Notices, Extension Requested Approval Notices, and all Change Request forms.  Any data obtained out of sequence of IRB approval puts the investigator at risk of not being able to use the data since the IRB is not able to approve something retrospectively.

2. Be sure to download the latest versions of the applicant checklist, IRB applications, templates, and change request forms from the IRB Toolkit for Investigators.  Rather than saving these items on your hard-drive, we suggest you book-mark this link. IRB forms for investigators are frequently revised, either to clarify in response to investigators’ inquiries or to incorporate changes in regulatory and institutional policies.  Using outdated IRB forms can result in delays in the approval process.