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Legal Minute: What is informed consent in clinical trials?
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Informed consent is a crucial aspect of clinical trials, ensuring that prospective subjects understand the benefits, risks, and potential harms of participating in a study. This process involves full disclosure of information, allowing subjects to ask questions and address
concerns with a knowledgeable medical professional. For minors, parental involvement is required, and subjects have the right to withdraw consent at any time. It's not merely a form but an ongoing process that starts before the research begins and continues until the study concludes or the subject withdraws.
Need assistance with your clinical trial compliance program? Email us at darshan@kulkarnilawfirm.com
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