What is the best standard for the standard of care in clinical research?
During the past decennium, one of the main issues discussed in research ethics has been focused on the care that should be provided to the control group in a clinical trial. This discussion is also called the standard of care debate. Current international research ethics guidelines contain a wide variety of standards for the standard of care--including the provision of the highest attainable, the best available, the best current, a proven, and an established effective treatment. In this article, we systematically review the currently used standards and argue that none of the current standards is adequate to serve as a universal standard for the standard of care. Alex London has made a substantial proposal for a universal standard, but universally adopting his standard is problematic. In this article, we propose a revised version of London's standard.
van der Graaf
Rieke
R
Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht, The Netherlands. r.vandergraaf@umcutrecht.nl
van Delden
Johannes J M
JJ
D019380:Anti-HIV Agents / Q000008:administration & dosage; D035061:Control Groups; D019049:Developed Countries; D003906:Developing Countries; D004334:Drug Administration Schedule; D032984:Ethics, Research; D017408:Guidelines as Topic / Q000592:standards; D015658:HIV Infections / Q000517:prevention & control / Q000635:transmission; D006801:Humans; D018445:Infectious Disease Transmission, Vertical / Q000517:prevention & control; D038622:Internationality; D011787:Quality of Health Care; D016032:Randomized Controlled Trials as Topic / Q000941:ethics* / Q000592:standards*; D012107:Research Design; D015215:Zidovudine / Q000008:administration & dosage
D019380:Anti-HIV Agents; D015215:Zidovudine