UAB Institutional Review Board

• UAB Integrated Research Administration Portal (IRAP)

• UAB Institutional Review Board (IRB)

U.S. Food and Drug Administration

• U.S. Food and Drug Administration (FDA)

• FDA Final Rule on IND Safety Reporting Requirements for Human Drug and Biological Products and Safety Reporting Requirements for Bioavailability and Bioequivalence Studies in Humans (September 2010)

• FDA Human Subject Protection/Bioresearch Monitoring Initiative Update (September 2010)

• FDA Guidance on Investigator Responsibilities (October 2009)

• FDA Federal Regulations

Office for Human Research Protections

• Department of Health and Human Services

• DHHS Code of Federal Regulations

• Office for Human Research Protections (OHRP)

• Office for Human Research Protections (OHRP) – Guidance Topics by Subject

• OHRP Guidance on Withdrawal of Subjects from Research: Data Retention and Other Related Issues

Other

• Federal Certificate of Confidentiality

• National Institutes of Health (NIH)

• NIH Human Embryonic Stem Cell Registry

• Office of Research Integrity

Regulatory and Clinical Research Organizations

• Public Responsibility in Medicine and Research (PRIM&R)

• Regulatory Affairs Professionals Society (RAPS)

• Association of Clinical Research Professionals (ACRP)

• The Institutional Review Board – Discussion and News Forum

• Society of Clinical Research Associates (SoCRA)

Tips on Informed Consent

• OHRP Informed Consent Form Checklist

• OHRP Human Subject Regulations Decision Charts

• NIH IRB Review Standards