In light of the recent Supreme Court of India judgment affirming the applicability of the Consumer Protection Act to medical services, this book offers a timely and comprehensive exploration of informed consent within the realities of modern medical practice in India. Strategically crafted to balance Indian specificity with global relevance, the book bridges the gap between the ethical ideal of informed consent, its legal interpretation, and its practical implementation in clinical settings. Drawing on extensive research, landmark legal cases, and firsthand clinical experience, it offers a clear, accessible guide to navigating this complex terrain. The chapters address universal principles and best practices that align with international standards of informed consent, medical ethics, and patient communication. While the primary context is within the Indian clinical landscape, the principles of informed consent remain universally applicable, with a few variations arising mainly from local regulatory frameworks and cultural contexts across jurisdictions. The book covers the principles of Informed Consent established through landmark cases worldwide, highlighting their proper role and implementation in both clinical practice and medical research. Tailored for medical practitioners, it covers critical topics such as risk disclosure, paediatric assent, therapeutic privilege, and documentation protocols. It also introduces practical tools, such as the Request for Treatment Model, to enhance doctor-patient communication and support informed decision-making. By addressing common ethical misconceptions and legal ambiguities, this book empowers clinicians, surgeons, educators, and medical students to deliver safer, more patient-centred care. Whether you're just beginning your postgraduate training or are well into your professional career, this book serves as a valuable and enduring resource.

Dr. Shalaka S. Agarkhedkar (MBBS, D.O., Ophthalmology, PGDCRCDM, PhD) is a Clinical Trials and Research Specialist and Consultant Ophthalmologist with over three decades of experience in medicine and research. She holds a pioneering PhD in Informed Consent in Clinical Practice and Research, combining qualitative and quantitative research, the first such study in India and globally. It offers key insights into ethical and legal consent issues. She has successfully conducted over 50 clinical trials across all phases, working with leading sponsors such as WHO, Sanofi, Novartis, Serum, BE, GSK, and Pfizer. In her role as a faculty member at Pune University and Bilcare Research Academy, for the course of Clinical Research and Clinical Data Management, she actively mentored researchers and postgraduate students. She subsequently assumed the role of Course Director for Clinical Research and Clinical Data Management (CRCDM) at Deccan Education Society Pune University, Pune. Her academic achievements are reflected in top-ranking performances in her Ophthalmology, postgraduate diploma in Clinical Research, and doctoral programs. She has published internationally in peer-reviewed journals and contributed to national scientific programs, including reviewing for the All-India Ophthalmic Conferences and serving as an invited member at WHO Geneva. 

Dr S. R. Agarkhedkar (MD) is a senior paediatrician, researcher, and educator with over four decades of experience in child health and vaccine trials. He has led more than 55 clinical trials and studies as Principal Investigator, including collaborations with the WHO that contributed to India’s polio-free status and COVID-19 vaccine trials. He serves as Chairperson of multiple Data Safety Monitoring Boards for various pharmaceutical companies. A former department head and professor in the Medical College, he has mentored hundreds of undergraduate and postgraduate students, nurturing their clinical knowledge, skills, and professional development, guiding them towards becoming accomplished paediatricians. He has authored over 175 publications, including international ones. His leadership spans clinical research, public health, and community outreach, making him a widely respected voice in paediatric care and ethical research.