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Federal Requirements

Department of Health and Human Services (DHHS)

• 45 CFR 46 PHS Protection of Human Subjects
• HIPAA Privacy Rule and Research
• HIPAA Privacy Information

Office of Human Research Protection (OHRP)

• Informing Those Tested About HIV Serostatus OPRR Reports June 10, 1988
• Informed Consent Requirements in Emergency Research
  • OPRR Reports May 15, 1991
  • OPRR Reports Oct. 31, 1996
  • 21CFR 50.24 FDA
• Fetal Tissue Research Transplantation -OHRP Guidance, February 7, 2003
• Inclusion of Women and Minorities as Subjects in Clinical Research - NIH October 9, 2001
• Inclusion of Children in research - OPRR Reports July 1, 1998
• Research Involving Prisoners - OHRP Guidance, May 23, 2003

Food and Drug Administration (FDA)

• 21 CFR 50 FDA Protection of Human Subjects
• 21 CFR 56 FDA Institutional Review Boards
• Clinical Trials and Human Subject Protection
• Information for Clinical Investigators - (CDER) Drug Applications