Guest guest Posted August 2, 2010 Report Share Posted August 2, 2010 The IC process begins when a potential participant is first approached to participate in a clinical trial. IC must be obtained from the participant or if appropriate, the participant's legally-authorized representative (LAR) under circumstances that minimize the possibility of coercion or undue influence. It should be an unhurried, private atmosphere where the participant has time to review the document. Participants should be allowed-and encouraged-to ask questions about the study. They should be able to take the document home with them if time permits. The participant should be approached in a respectful manner and the person obtaining consent should introduce him/herself by name and role, stating the purpose of their communication. As already indicated, the timing of this process is very important. Please note: IC is a process – not a piece of paper. It must be obtained in a manner that allows participants to voluntarily agree or decline to participate. The IC process is based on complete disclosure of the facts. During this process, the study coordinator or principal investigator should endeavor to establish a rapport and trusting relationship with the potential participant. The coordinator or investigator should thoroughly review each section of the IC with the study participant. Dr. Smita Quote Link to comment Share on other sites More sharing options...
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