Committees on Human Research
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
Glossaries
- Acronyms A listing of all acronyms listed in the UVM "Protection 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 August 08 2012 04:25 PM
