INFORMED CONSENT IN MEDICAL PRACTICE Principles and Conventions
INFORMED CONSENT IN MEDICAL PRACTICE Principles and ConventionsKalidas D Chavan MBBS MD (Forensic Medicine) Registrar Maharashtra University of Health Sciences Nashik, Maharashtra, India Rajendra S Bangal MBBS MD (FMT) DNB LLB PGDLPO Professor and Head Department of Forensic Medicine Smt Kashibai Navale Medical College Pune, Maharashtra, India Forewords Hon'ble Justice Sanjay V Gangapurwala Pravin H Shingare
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Informed Consent in Medical Practice: Principles and Conventions
First Edition: 2019
Our parents and families
Dr Kalidas D Chavan has rich experience and vast knowledge of medical jurisprudence. He is academician par excellence and the same would be vouched by various conferences and workshops, he has attended and chaired. He has various national and international publications to his credit on varied subjects in medical field.
In legal parlance consent means “consensus ad idem”, i.e. both parties agree upon same thing in the same sense. However in the medical parlance, the same is not sufficient. The doctor stands in a fiduciary capacity, the patient reposes utmost faith in the doctor. A consent implies conscious assent. For a patient to give a conscious assent, it is obligatory on the medical practitioner to inform the patient about the nature of treatment, the risk and the benefits of the proposed treatment, as well as alternative to it and all the attending circumstances that would affect the willingness of the patient or his relatives to give consent. So the concept of “informed consent” has evolved.
This book intensively deals from alpha to omega, the law regulating the consent, inter alia informed consent.
The book is thorough exposition of the concept, “informed consent”. It is peppered with healthy doses of judicial precedent and the provisions of other statutes governing the consent. The book would be of great benefit to all the medical practitioners. This compilation shall enrich the possession of the medical practitioners. The use of the book will not be limited to medical practitioner, but also layman and patients. The author has also provided the forms of “informed consent”. The same would be handy for the medical practitioners.
Hon'ble Justice Sanjay V Gangapurwala
Bombay High Court
Mumbai, Maharashtra, IndiaForeword
Informed Consent in Medical Practice: Principles and Conventions is an important and admirable book. It is thorough and extremely practical and is a manual of all that medical and law practitioners need to know about “Informed Consent in Medical Practice”. The book is like a ready reckoner and readers can find answers to many of their doubts relating to the concept and process of informed consent in a required yet readable format.
This book is truly an excellent compilation of extremely practical and relevant information by highly distinguished personalities deeply connected with legal aspects of the medical profession, Kalidas D Chavan and Rajendra S Bangal. They have done an excellent job in bringing out this book and it is a commendable effort. The book provides a comprehensive view of the issue of informed consent in medical practice and deals with it in a lucid and yet exhaustive manner. Clarity is the essence and the authors have condensed without sacrificing essential features of individual cases and principles discernible from landmark judgments. It is a much needed contribution in the medicolegal field and will indeed be useful to doctors, lawyers, social organizations, and medical students.
I hope this book encourages and enthuses the readers to initiate recording of informed consent seriously and methodically and remove from them the pervasive lethargy of neglecting it. I have no hesitation to say that this book would be very useful to all the stakeholders in the hospital setup. The work done by the authors deserves appreciation.
According to Salvador Dali, the most famous surrealist of 20th century, “Have no fear of perfection: you will never reach it”. Yet, truly, this book is a near complete guide on the very important but equally ignored topic of “informed consent”. Without any doubt, this book qualifies as a “must read and refer” desktop essentials.
Pravin H Shingare
Directorate of Medical Education and Research
Government of Maharashtra
Mumbai, Maharashtra, IndiaPreface
The doctor-patient relationship is a unique “working model” of trust and compassion. In the healthcare as a profession, the patient is in a role of a healthcare consumer and the doctor performs service provider's role. Patients increasingly seek more information in black and white from their doctors. The reasons could be many, but as a realistic fact, there may be no other means of obtaining that information, especially in the context of the set of symptoms and diagnosis specific to them. From the doctor's perspective, the diagnosis involves assessment of etiological factors and details of health and disease history and authenticated report documents of various investigative tests addressing various parameters of disease process, in the interest of patient care. The notion that doctors must keep themselves professionally secured with a rightful prophylactic documentation goes directly to the core of the concept of informed consent. This reflects a logical approach of doctors, which is other than the best interests of their patients at heart.
The issue of informed consent (IC) was discussed with an emphasis on current scenario of healthcare in India in the hearing of Samira Kohli versus Dr Prabha Manchanda case. We would like to recall the relevant portion from those comments here. While voicing his concern on the current situation of healthcare in India, Justice Raveendran RV of the Hon'ble Supreme Court, commented, “In India, majority of citizens requiring medical care and treatment fall below the poverty line. Most of them are illiterate or semiliterate. They cannot comprehend medical terms, concepts, and treatment procedures. They cannot understand the functions of various organs or the effect of removal of such organs. They do not have access to effective but costly diagnostic procedures”. “For them, any treatment with reference to rough and ready diagnosis based on their outward symptoms, and doctor's experience or intuition is acceptable and welcome, so long, as it is free or cheap; and whatever the doctor decides as being in their interest, is usually unquestioningly accepted. They are passive, ignorant, and uninvolved in treatment procedures. The poor and needy face a hostile medical environment—inadequacy in the number of hospitals and beds, nonavailability of adequate treatment facilities, utter lack of qualitative treatment, corruption, callousness, and apathy. Many poor patients with serious ailments (e.g., heart patients and cancer patients) have to wait for months for their turn even for diagnosis, and due to limited treatment facilities, many die even before their turn comes for treatment. What choice do these poor patients have? Any treatment of whatever degree is a boon or a favor for them. The stark reality is that for a vast majority in the country, the concepts of informed consent or any form of consent, and choice in treatment, have no meaning or relevance”.
“The position of doctors in government and charitable hospitals, who treat them, is also unenviable. They are overworked, understaffed, with little or no diagnostic or surgical facilities and limited choice of medicines and treatment procedures. They have to improvise with virtual nonexistent facilities and limited dubious medicines. They are required to be committed, service oriented, and noncommercial in outlook. What choice of treatment can these doctors give to the poor patients? What informed consent they can take from them?” “On the other hand, we have the doctors, hospitals, nursing homes, and clinics in the private commercial sector. There is a general perception among the middle class public that these private hospitals and doctors prescribe avoidable costly diagnostic procedures and medicines, and subject them to unwanted surgical procedures, for financial gain”.
In the light of this fact, there should not be any reason for having the argument on the necessity of “informed consent”. The issue of obtaining “informed consent” is not only an ethical issue, but also an important aspect of the law of our land. The question before various courts all over the world is only about the degree of “information” to be provided by the doctors to the patient.
Currently the two main approaches or tests available are the UK's Bolam's test or “Professional Standard Test” and the US's Canterbury theory or the “Reasonable Patient Standard” which cast the burden on doctors of disclosing “material risks” to the patients. Bolam is much milder test for the doctors to implement. Canterbury is a stricter test to follow.
Moreover, based on the concerned facts and variable circumstances of each case, the courts decide which type of test is to be applied (i.e. extent of disclosure by the doctor to the patient). The track record of majority Indian courts reveals that they expect the extent of disclosure from the doctors as per the Bolam's professional standard.
An intense focus on investigating patient safety, performance of the physician and the healthcare institution, and the quality measures in healthcare are the recent observations of Bal and Choma. This focus is unlikely to recede in the near future as medical care becomes more depersonalized and patients seek more information related to the odds of success and failure of surgical procedures and variables related to surgeon training, personal characteristics, motives, and outcomes. In the model of the patient as a healthcare consumer, patients will increasingly seek more information from their doctors, especially because there may be no other means of obtaining that information.
During practice of the medical profession, doctors come across varied situations pertaining not only to the medical investigations or treatment but also many medicolegal issues. These include situations of emergency patients, medicolegal cases, unidentified patients, prisoners, under trials, cases of sexual assault, injuries, intoxicated patients, etc. The law and convention in each case is different. This treatise has attempted to elaborate on all such possible situations.
As medical practitioners, practicing in India, we observed, experienced, and then realized that the authentic textbook specific to informed consent in medical practice which would present a systematic description and methodology in one place is a need of the medical practitioners in India. This textbook attempts to provide an overview of approaches to the concept of Informed Consent (IC) within the medical practice. It mentions basic principles and conventions which could be followed by the doctors practicing in various sectors like Corporate, Private, Government, Corporation, Rural, etc. We studied, explored various resources and put our best efforts to ensure that the contents are updated till the date of publication of this textbook. However, the facts and circumstances can be specific and varying from case to case, references and concepts of law and ethics leading to judgments can be ever evolving, readers are requested to communicate with the concerned legal authorities in the context of their own experience while handling their case. By chance, if it is observed that any concepts, references, etc. mentioned here are out of date. We shall update the same in the next edition.
Readers are requested to post their views, feedback, suggestions, comments, etc on email@example.com
Kalidas D Chavan
Rajendra S BangalAcknowledgments
Words are just not enough to share our feelings regarding all those who participated in this book in so many ways. We would like to acknowledge our many teachers we have had and continue to have and respectfully acknowledge the valuable contribution of editing and writing inputs by Dr Savita Rajurkar.
We thank Dr Ajay Patil, Professor and Head, Department of Forensic Medicine, Krishna Institute of Medical Sciences, Karad, Maharashtra, India, for his contribution to this textbook and expert advice. We convey our profound thanks to Dr Jitendra Ingole, Professor, Department of Medicine, SKN Medical College, Pune, and Dr Mandar Karmarkar, Professor, Department of Forensic Medicine, Bharati Vidyapeeth Medical College, Pune, for reviewing the contents of the book and giving their valuable suggestions. A special word of thanks is due towards Nishigandha Bangal for her assistance in legal search and proofreading.
Our special thanks to Dr Shailesh Vaidya, Professor, Obstetrics and Gynecology, Ambajogai, Maharashtra; Dr Sachin Mumbre, Dean, Medical Faculty, Maharashtra University of Health Sciences (MUHS), Nashik, Maharashtra; Dr Sandip Mane, Director, Origin Foundation, Mumbai, Maharashtra; and Kishore Sant, Advocate, High Court of Bombay Bench at Aurangabad, Maharashtra, for valuable contributions.
Our sincere thanks to Shri Jitendar P Vij (Group Chairman), Mr Ankit Vij (Managing Director), Mr MS Mani (Group President), Ms Chetna Malhotra Vohra (Associate Director—Content Strategy), Ms Pooja Bhandari (Production Head), Ms Nedup Denka Bhutia (Development Editor), and all the staff of M/s Jaypee Brothers Medical Publishers (P) Ltd, New Delhi, India, for completing the responsibility of publishing this book in a timely fashion.
We also thank our family members, our extended family of innumerable friends, associates, students and patients.