What is informed consent in clinical trials?
DarshanTalks Podcast
English - May 16, 2024 13:00 - 46 seconds - 590 KB - ★★★★★ - 1 ratingNews pharma medical devices fda laws regulations guidances clinical research advertising mergers acquisitions Homepage Download Apple Podcasts Google Podcasts Overcast Castro Pocket Casts RSS feed
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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.
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