Regulations on the Use of Human Subjects in Research

• Belmont Report (1979)
http://www.hhs.gov/ohrp/humansubjects/guidance/belmont.htm

• Helsinki declaration (1964-2000)
http://www.wma.net/e/policy/b3.htm

• Nuremberg Code (1949)
http://ohsr.od.nih.gov/guidelines/nuremberg.html

• DHHS (2001): Protection of Human Subjects , Title 45 Part 46
http://www.access.gpo.gov/nara/cfr/waisidx_01/45cfr46_01.html

• FDA (2001): Institutional Review Boards , Title 21 Part 56
http://www.access.gpo.gov/nara/cfr/waisidx_01/21cfr56_01.html

• FDA (2001): Protection of Human Subjects , Title 21 Part 50
http://www.access.gpo.gov/nara/cfr/waisidx_01/21cfr50_01.html

• NIH (2000): Required education in the protection of human research participants. Notice OD-00-039, June 5, 2000
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html

• Protecting Human Research Subjects: Institutional Review Board Guidebook. US Government Printing Office, Washington, DC.
http://www.hhs.gov/ohrp/irb/irb_guidebook.htm


Offices and Programs

• OHRP
Office for Human Research Protections, Dept. of Health and Human Services
http://ohrp.osophs.dhhs.gov

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