Federal Human Research Oversight of Clinical Trials in the United States

• Autores: Deborah A. Zarin, Tony Tse, Jerry Menikoff
• Localización: JAMA: the journal of the American Medical Association, ISSN 0098-7484, Vol. 311, Nº. 9, 2014, págs. 960-961
• Idioma: inglés
• Enlaces
  • Texto Completo Ejemplar
• Resumen

  • The primary federal human subjects protections (HSP) policies in the United States, including requirements for institutional review board review and informed consent, are the US Food and Drug Administration (FDA) HSP regulations1 and the Common Rule.2 The first covers FDA-regulated clinical investigations of drugs, biologics, and devices, regardless of funding source, whereas the second applies to human studies funded or conducted by 17 federal entities, regardless of the type of intervention studied. These regulations are largely consistent but contain differences. Concerns have been raised about burdens and inefficiencies for studies covered by both regulations (overlap trials),3 and about some studies that are covered by neither (gap trials).4 To inform such discussions, we estimated the numbers of active US-based clinical trials subject to these regulations.