Clinical trials – a guide for CAB members (page 9)

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  • An Ethics Committee must approve a clinical trial before it can be conducted. Ethics committees are made up of experts and members of the general public. None of the members of the Ethics Committee is a member of the research team of the study they are evaluating. Ethics committees are responsible to oversee clinical trials for a specific hospital or institution, or for a specific country.
  • The Ethics Committee will not allow a clinical trial to be conducted in their institution or their country if they feel the potential risk to study participants is greater than the potential benefit. Ethics committees are designed to protect participants at their hospital or in their country from research that is not scientific or has an unreasonable risk.
  • It is also the job of the Ethics Committee to ensure that the informed consent form explains the trial completely in language that is very clear. Every participant must understand this form before entering the study, and participants must indicate their understanding with a signature or other mark if they choose to join the study.
  • Ethics committees continue to monitor the progress of the clinical trial as it moves forward to watch for unexpected safety issues that may arise. They are responsible to specifically monitor the safety and progress of clinical trials at their hospital, institution, or in their country.
Published: August 31, 2008
Last edited: January 28, 2011