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Office of Human Research Protection (OHRP)
OHRP supports, strengthens and provides leadership to the nation’s system for protecting volunteers in research that is conducted or supported by the U.S. Department of Health and Human Services (HHS). This Office provides clarification and guidance to research institutions, develops educational programs and materials, and promotes innovative approaches to enhancing human subject protections. This site also includes information on Institutional Review Boards (IRBs). Food and Drug Administration (FDA)
The FDA is the U.S. scientific, regulatory, and public health agency whose jurisdiction encompasses most food products (other than meat and poultry), human and animal drugs, therapeutic agents of biological origin, medical devices, radiation-emitting products Agency scientists evaluate applications for new human drugs and biologics, complex medical devices, food and color additives, infant formulas, and animal drugs. FDA Investigators and inspectors visit more than 16,000 facilities a year. HIPAA Privacy Rule: Information for Researchers
The Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule is the first comprehensive Federal protection for the privacy of personal health information. This website provides information on the Privacy Rule for the research community; research organizations and researchers may or may not be covered by HIPAA. The Pediatric Research Equity Act of 2003
The Pediatric Research Equity Act, P.L 108-155 was signed into law December 3, 2003.
The Best Pharmaceuticals for Children Act
The Best Pharmaceuticals for Children Act (BPCA), P.L. 107-109 BPCA was signed into law January 4, 2002. BPCA renews and amends Section 111 of the Food and Drug Modernization Act.
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