Institutional Review Board

HIPAA Update
HIPAA Authorization templates and waivers have moved to the Research HIPAA page
Contact Information
IRB Administration Office
[University Hospitals]
Lakeside 1400
11100 Euclid Avenue
Cleveland, OH 44106
MS: LKS 7061
(216) 844-1529
FAX: 216-844-1547
Forms & Templates
Checklists         (required as the first page of all submissions to the IRB)
New Protocol (N) :: Feb 2008
New Protocol Chart Review or Disc Tissue (N-C or /DT) :: May 2007
Continuing Review (CR) :: May 2007

Continuing Review Chart Review or Disc Tissue (CR-C or DT) :: August 2005
Exemption Determination Form :: May 2007 
Emergency Use of Drug or Device (EMRG) :: May 2007
Protocol Addendum (A) :: August 2005
Information to File with Protocol (F) :: August 2005
Report Unanticipated Problem or Protocol Deviation (UD) :: July 2007
Report External Adverse Events (EAE) :: July-2007
Report Internal Adverse Events (IAE) :: July-2007
Closure of an IRB Approved Protocol (C): May 2007 (Note: replaces Protocol Termination (T) )

Forms     (completed to provide additional information as part of a submission to the IRB)
Request for Expedited Review of New Protocol :: October 2002
Additional Required Information for a Study that Includes Prisoners :: Augsut 2004
External AE Summary Log :: July 2005
Internal AE Summary Log :: July 2005
Request for Exemption :: May 2007
Activity Determination Form (DET)

Templates for Consent Documents     (contain required and suggested language to use in developing consent forms)
Assent Language :: March 2008
Consent Language for International Studies :: April 2007
Consent Language :: October 2007
Consent Language and Tutorial :: October 2007
Reminder Lists     (lists to help users determine if IRB submissions are complete)
New Protocol :: August 2005
Continuing Review :: August 2005
Addendum :: August 2005
Chart Review/Discarded Tissue Reminders
 

Adverse Event Reporting Forms and Information
Adverse Event Reporting Flowchart :: July 2007
Adverse Event Reporting Policy Summary  :: July 2007
External Adverse Event Summary Log :: June 2005
Internal Adverse Event Summary Log :: July 2005