How is informed consent for a clinical trial different than consent for a standard medical procedure?
The primary difference is that a patient giving informed consent for a clinical trial is agreeing to receive treatments that may not yet have been proven to be effective or may have greater risk than standard treatments. Q: What is an Institutional Review Board, and what is its role in the informed consent process? A: The Institutional Review Board (IRB) is a group of individuals who review proposed research protocols (blueprints of a trial, outlining the purpose and detailed plan) and consent forms before patient enrollment begins. Its primary responsibility is to promote the safety and well-being of research participants. The IRB ensures that the potential risks to patients are clearly described in the clinical trial process and consent form and are justified by the patient’s condition and the potential benefits to the patient. IRB members typically include doctors, scientists, clergy, lawyers, ethicists, and community members who have no direct involvement in the research study unde
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