Federal Regulations
 
Title 45 Code of Federal Regulations Part 46 (45 CFR 46) Protection of Human Subjects (Revised December 13, 2001)
http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm 
 
Title 21 Food and Drugs (Regulations applied by the Food and Drug Administration    relevant to human subjects research.)         

Part 11 Electronic Records
http://www.access.gpo.gov/nara/cfr/waisidx_01/21cfr11_01.html

Part 50 Protection of Human Subjects
http://www.access.gpo.gov/nara/cfr/waisidx_01/21cfr50_01.html

Part 56 Institutional Review Boards
http://www.access.gpo.gov/nara/cfr/waisidx_01/21cfr56_01.html

Part 312 Investigational New Drug Application
http://www.access.gpo.gov/nara/cfr/waisidx_01/21cfr312_01.html

Form 1571 (Investigational New Drug Application) and Form 1572 (Statement of Investigator)

Application for FDA Approval to Market a New Drug, Biologic or an Antibiotic Drug for Human Use (21 CFR Part 314)

Part 600 Biologic Products
http://www.access.gpo.gov/nara/cfr/waisidx_01/21cfr600_01.html

Application Process for FDA Approval of a Biologic License (21 CFR Part 601.2)

Part 812 Investigational Devices
http://www.access.gpo.gov/nara/cfr/waisidx_01/21cfr812_01.html

Other FDA Forms (Center for Drug Evaluation and Research)
 

Back to IRB Home