UAB Institutional
Review Board
For Human Use
Prepared by
The Office of the IRB
February 2008
Updated
November 11, 2008
UAB Institutional
Review Board
For Human Use
Prepared by
The Office of the IRB
February 2008
Updated
November 11, 2008
What Is The Application
Process?
Certification
and Record-Keeping
Classifying, Correcting,
and Reporting Non-compliance
Definitions
Related to Non-compliance
Ionizing Electromagnetic
Radiation
Exemption from the NIH Guidelines
Institutional Biosafety
Committee Approval
Gene Therapy Project
Review Panel
Members of the UAB Gene Therapy Project Panel
Initial Review of Gene Therapy Protocols
Continuing Review
of Gene Therapy Protocols
Vaccine Trials Project
Review Panel
Members of the UAB Vaccine Trials Project Review Panel
The Comprehensive Cancer
Center Clinical Trials Review Committee
(CTRC)
The Pittman General
Clinical Research Center (GCRC)
Jefferson County
Department of Health (JCDH)
Release of Pathologic
Materials
Research Involving
Participants with Contagious Infections
Policies Concerning
Drugs for Research Use
The Children's Hospital
of Alabama and Use of Drugs for Research
UAB, University of
Alabama Hospital, and Use of Drugs for Research
Participants and
Resources from Other Institutions
University of Alabama
Hospital (UAHosp)
Callahan Eye Foundation
Hospital (CEFH)
The Children’s Hospital
of Alabama (TCHA)
Birmingham Veterans
Affairs Medical Center (BVAMC)
Health Information Management Research Guidelines
Before Applying for IRB Review
Scientific, Scholarly
Integrity
Devices, Inventions and
Patent Policy
Pregnant Women,
Fetuses, Neonates/Nonviable Neonates
Approval of Informed Consent Documents
No Modifications Without Prior IRB Approval
Notify OIRB of all Reportable Problems
Provide
OIRB with Copies of All Monitoring
Reports
Fines and Fees for Regulatory Documents
Requirement to Obtain
Signature
Requirement to Use Understandable Language
Requirements for Cooperative Group Studies
Elements and
Disclosures of the Informed Consent
Process