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  • Format: ePub

"Clinical Trials: Ethical Considerations and Regulations" is a comprehensive guide that delves into the ethical principles and regulatory frameworks essential for conducting ethical clinical research. This book covers a wide range of topics, including the historical perspective and importance of ethics in clinical research, the components and process of obtaining informed consent, the role and responsibilities of Institutional Review Boards (IRBs), and international ethical guidelines such as the Declaration of Helsinki and the Belmont Report. It also examines regulatory requirements from…mehr

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Produktbeschreibung
"Clinical Trials: Ethical Considerations and Regulations" is a comprehensive guide that delves into the ethical principles and regulatory frameworks essential for conducting ethical clinical research. This book covers a wide range of topics, including the historical perspective and importance of ethics in clinical research, the components and process of obtaining informed consent, the role and responsibilities of Institutional Review Boards (IRBs), and international ethical guidelines such as the Declaration of Helsinki and the Belmont Report. It also examines regulatory requirements from bodies like the FDA and EMA, participant protection and rights, ethical issues in study design, conflict of interest management, and the complexities of conducting multinational trials. Additionally, the book addresses emerging ethical challenges in genetic research, digital health, and AI, and provides real-world case studies and best practices. It concludes with future directions for enhancing ethical standards and ensuring rigorous ethical oversight in clinical trials.


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Autorenporträt
Dr. Nilesh Panchal is a distinguished Public Health Practitioner and Health Scientist with over two decades of experience, making significant contributions to the fields of infectious diseases, mental health, and public health education. Holding a DrPH in Public Health Practice, Dr. Panchal is a prolific author known for his ability to translate complex medical concepts into accessible and engaging content for a broad audience. His work, including the acclaimed series "Global Outbreaks: The Saga of Humanity's Health Battles," provides invaluable insights into the challenges posed by infectious diseases, making it an authoritative source for understanding humanity's ongoing battle against deadly pathogens. Dr. Panchal's dedication to educating the public extends to his "Mindfulness and Well-Being Series," where his compassionate and practical approach empowers readers to enhance their mental and emotional well-being.

In addition to his focus on infectious diseases and mental health, Dr. Panchal has made remarkable strides in lifestyle medicine, particularly in the prevention of diabetes. His book series "Healthy Living, Healthy Future: Diabetes Prevention Series" offers evidence-based strategies that empower individuals to make lasting lifestyle changes for a healthier, diabetes-free life. Dr. Panchal's commitment to public health is also reflected in his guide "Essential First Aid: Life-Saving Techniques for Everyone," where he provides clear, step-by-step instructions for managing emergencies. Through his extensive research, Dr. Panchal continues to be a respected voice in global health, contributing to medical journals, speaking at international conferences, and leading health innovation projects aimed at integrating AI into clinical practice. His body of work not only informs but also inspires, making a lasting impact on global health practices and public education.