Regulatory Affairs & IRB's
Workshop Summary
Presentation - Pennington
Presentation - Drew
Presentation - Higgins
NIH HIPAA
NIH HIPAA Web Site
DHHS Office of Civil Rights
HIPAA front page
FDA Form -1572
FDA Form -1572
Code of Federal Regulations Part 46 Protection of Human Subjects
Mfutso-Bengu JM, Taylor TE.
Ethical jurisdictions in biomedical research
.
Trends Parasitol
. 2002 May;18(5):231-4.
Web Resources
Entire OHRP Web Site
Federalwide Assurance (FWA) and Registration of IRBs
OHRP Education Materials
45 CFR Part 46
English version
Spanish version
(from Web site)
Russian version
(from Web site)
Decision Charts
IRB Guidebook
NIH Clinical Research Course
FDA Human Subject Protection Regulations
21 CFR part 50
21 CFR part 56
ICH - E-6 Good Clinical Practice Guidelines On FDA Web Site
English version
(from Web site)
Spanish version
(from Web site)
French version