Table of Contents


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Regulatory Affairs & IRB's

Acrobat File Workshop Summary
PowerPoint File Presentation - Pennington
PowerPoint File Presentation - Drew
PowerPoint File Presentation - Higgins
Acrobat File NIH HIPAA
Web Site NIH HIPAA Web Site
Acrobat File DHHS Office of Civil Rights
Web Site HIPAA front page
MS Word File FDA Form -1572
Acrobat File FDA Form -1572
Acrobat File Code of Federal Regulations Part 46 Protection of Human Subjects
Web Site Mfutso-Bengu JM, Taylor TE. Ethical jurisdictions in biomedical research. Trends Parasitol . 2002 May;18(5):231-4.

Web Resources

Web Site Entire OHRP Web Site
Web Site Federalwide Assurance (FWA) and Registration of IRBs
Web Site OHRP Education Materials
45 CFR Part 46
Web Site English version
Acrobat File Spanish version (from Web site)
Acrobat File Russian version (from Web site)
Web Site Decision Charts
Web Site IRB Guidebook
Web Site NIH Clinical Research Course
FDA Human Subject Protection Regulations
Web Site 21 CFR part 50
Web Site 21 CFR part 56
ICH - E-6 Good Clinical Practice Guidelines On FDA Web Site
Acrobat File English version (from Web site)
Acrobat File Spanish version (from Web site)
Web Site French version