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            Forms      Tutorial     Submission Guidelines     Research Manual (Manual Updated 08/09!!)

Reference Material:

This section of our website provides you with regulatory links regarding how you conduct your research.

Federal Regulations

• Federal Policy for the Protection of Human Subjects (OHRP, DHHS 45 CFR 46)
• FDA Regulations on Protection of Human Subjects

Federal Guidance

• OHRP Guidebook
• FDA Investigational Device Exemptions (IDE) Manual
• FDA IRB Guidance
• FDA Frequently Asked Questions on Drug Development and New Drug Applications
• FDA Guidance on IND Exemptions for Studies of Approved Drugs for Treatment of Cancer

Ethics Documents

• Belmont Report
• Declaration of Helsinki
• Nuremberg Code

Glossaries

• Acronyms A listing of all acronyms listed in the UVM "Protectioin of Human Subjects in Research" tutorial
• OHRP
• UC Davis printed with permission from Stanford University (Lay Terminology - esp. for Consent Forms)
• HIPAA Glossary - from Partners Healthcare

External Links :

• U.S. Office for Human Research Protections (OHRP) is one of the federal oversight agencies for IRBs. (http://www.hhs.gov/ohrp/)
• U.S. Food and Drug Administration (FDA) is one of the federal oversight agencies for IRBs. (http://www.fda.gov)
• Public Responsibility in Medicine and Research (PRIM&R) is a national organization for advancement of strong research programs and for the consistent application of ethical precepts in both medicine and research. (http://www.primr.org)
• Applied Research Ethics National Association (ARENA) is a national service organization for professionals involved in bioethics, research and IRBs. (http://http://www.primr.org/membership/overview.html )
• National Institutes of Health (NIH) mission is to improve overall human health through biomedical and behavioral research. (http://www.nih.gov)

 

Last modified November 09 2009 01:51 PM