How ethical is your clinical trial?

Int J Clin Pract. 2010 Aug;64(9):1179-82. doi: 10.1111/j.1742-1241.2010.02421.x. Epub 2010 Jun 16.

Abstract

Is Institutional Review Board (IRB) approval and a rigorous informed consent process enough? It is our view that this is no longer the case. Conventional research ethics emphasise the importance of weighing the risks and benefits for prospective participants as one of the key determinants of deeming a clinical trial ethical. We support the notion that ethical obligations of research should include considerations not only at the individual level, but also at the community level (1,2).

Publication types

  • Research Support, N.I.H., Extramural

MeSH terms

  • Clinical Trials as Topic / ethics*
  • Ethics, Research
  • Informed Consent / ethics