August 2010

The JHM IRBs are authorized to review and approve applications to conduct human subjects research.  Actions taken to approve research are documented in written notifications to the Principal Investigator (PI).  The format for written notification to the PI was revised on March 1, 1999.  As of that date notices, not letters, were adopted as the notification format.  The notices do not contain a signature block or require the initials of the IRB Chair. DHHS regulations 45 CFR 46 and FDA regulations 21 CFR 56 state “An IRB shall notify investigators and the institution in writing of its decision to approve or disapprove the proposed research activity, or of modifications required to secure IRB approval of the research activity.”  The regulations do not state the notification must be in the form of a signed or initialed letter.  Please see FDA Information Sheets Frequently Asked Questions, IRB Procedures, question 29 “Does FDA expect the IRB chair to sign approval letters?” for additional clarification. Written notices from the JHM IRBs meet the regulatory requirements and signature of the IRB Chairs is not required at JHM.