IMPORTANCE OF CONSENT                                IN                            TREATMENT                                                      Adv.C.K.SIVADASAN                                                                                                   M.A.(PMIR), LL.B., PGDADR(NALSAR)., PGDT, DACT, DEM,C.Coun                                                                                                                                                                                                                                                          CONSULTANT                                                                                              (MEDICO-LEGAL & HOSPITAL ADMINISTRATION)                                                                             Email:cksdas@yahoo.co.in ----------------------------------------------------            IMPORTANCE OF CONSENT IN TREATMENT Is there any  legal validity for the removal of uterus and other reproductive organs (abdominal hysterectomy and bilateral salpingo-oopherectomy) of a patient by means of a surgical procedure, who consented for doing diagnostic surgical procedure (Eg:-“diagnostic and operative laparoscopy, Laparotomy may be needed”, etc.) to the doctor, while undergoing treatment for her menstrual problems? Is that patient eligible for compensation from that doctor for such medical negligence? What type of consent is ‘Legally Valid Consent’, which acquired by the doctor from the patient and/or from responsible guardian of that patient and what time is the appropriate time for acquiring such consent for providing treatment to that patient? Whether filling the blank spaces and signature in a pre-prepared consent form with general conditions in a manner applicable to treatment and entrusting the doctor without any specific direction is valid and sufficient for treatment? Even though the above subject has taken for analysis by different courts in various countries while dealing with Medical Negligence Cases and provided guidelines in this matter so as to give enlightenment to the professionals as well as to the general public, there occurs an apparent chaotic thinking about it. Verdicts of Rogers   vs. Whitaker(Australia); Schoendorff   vs. Society of New York Hospital(New York); Canterbury   vs. Spence(U.S); Reibl  vs. Hughes(U.S); Chester  vs. Afshar (UK); Chhatterton  vs. Gerson(UK); Murray vs. McMurchy (Canada); Nizam Institute of Medical Sciences  vs. Prasanth S. Dhanaka(Supreme Court of India); Samira Kohli  vs. Dr.Prabha Manchanda(Supreme Court of India); Dr.C.P.Sreekumar   vs. S.Ramanujam(Supreme Court of India); Dr.Ritu Rawat  vs. Tej Singh (Indraprastha Apollo Hospital case - Delhi High Court); Dr.Sathy M. Pillai   vs. S. Sharma (National Consumer Disputes Redressal Commission); Dr.B.N. Gurudev vs. Dr.N. Ramanna(National Consumer Disputes Redressal Commission), etc. are leading lights in this subject. Two cardinal principles of medical ethics are Patient Autonomy and Beneficence. We can see that in most of the cases there occurs no dispute on the knowledge and skill of the professional in the realm of his/her service and is proved fact regarding their intention to provide relief to the patient from the sufferings due to the disease but the contentious issue is always whether the provided treatment is acceptable to the patient or not. Such things are usually happens mainly because of the ignorance of the truth related with relevance and importance of the inviolable nature of the patient’s right in regard to his body and his right to decide whether he should undergo the particular treatment or surgery or not, probably during the treatment of diseases leading to harmful consequences to the patient. Another important fact is ‘valid consent’ provides exemption from punishment, as per the legal principles of Criminal Law and Law of Torts, based on the legal maxim “volenti non fit injuria”. Consent is defined in the Indian Contract Act as: “two or more persons are said to consent when they agree upon the same thing in the same sense” and Free Consent as: “Consent is said to be free when it is not caused by coercion, undue influence, fraud, misrepresentation or mistake”. So the consent given by the patient with the same knowledge on the subject after acquiring relevant information only shall be reckoned as valid consent as per jurisprudential principles. ‘Informed Consent’ is defined in Taber’s Cyclopedic Medical Dictionary as: “Consent that is given by a person after receipt of the following information - the nature and purpose of the proposed procedure or treatment; the expected outcome and the likelihood of success; the risks; the alternatives to the procedure and supporting information regarding those alternatives; and the effect of no treatment or procedure, including the effect on the prognosis and the material risks associated with no treatment. Also included are instructions concerning what should be done if the procedure turns out to be harmful or unsuccessful.” The Code of Medical Ethics laid down by the Medical Council of India (As per the Indian Medical Council Act, 1956) contains a chapter relating to disciplinary action which enumerates a list of responsibilities, violation of which will be professional misconduct. Clause 13 of the said chapter: “Before performing an operation the physician should obtain in writing the consent from the husband or wife, parent or guardian in the case of a minor, or the patient himself as the case may be. In an operation which may result in sterility the consent of both husband and wife is needed.” General Medical Council of U.K. issued guidelines to doctors in seeking consent of the patient for investigation and treatment: “Patients have a right to information about their condition and the treatment options available to them. The amount of information you give each patient will vary, according to factors such as the nature of the condition, the complexity of the treatment, the risks associated with the treatment or procedure, and the patient’s own wishes. For example, patients may need more information to make an informed decision about the procedure which carries a high risk of failure or adverse side effects; or about an investigation for a condition which, if present, could have serious implications for the patient’s employment, social or personal life. You should raise with patients the possibility of additional problems coming to light during a procedure when the patient is unconscious or otherwise unable to make a decision. You should seek consent to treat any problems which you think may arise and ascertain whether there are any procedures to which the patient would object, or prefer to give further thought before you proceed.” The English law on this aspect is summarized in ‘Principles of Medical Law’ (published by Oxford University Press – 2nd Edition, edited by Andrew Grubb): “Any intentional touching of a person is unlawful and amounts to the tort of battery unless it is justified by consent or other lawful authority. In medical law, this means that a doctor may only carry out a medical treatment or procedure which involves contact with a patient if there exists a valid consent by the patient (or another person authorized by law to consent on his behalf) or if the touching is permitted notwithstanding the absence of consent.” ‘Gynaecology’ (2nd Edition) edited by Robert W. Shah, describes ‘real consent’ with reference to Gynaecologists as: “An increasingly important risk area for all doctors is the question of consent. No-one may lay hands on another against their will without running the risk of criminal prosecution for assault and, if injury results, a civil action for damages for trespass or negligence. In the case of a doctor, consent to any physical interference will readily be implied; a woman must be assumed to consent to a normal physical examination if she consults a Gynaecologist, in the absence of clear evidence of her refusal or restriction of such examination. The problems arise when the Gynaecologist’s intervention results in unfortunate side effects or permanent interference with a function, whether or not any part of the body is removed. For example, if the Gynaecologist agrees with the patient to perform a hysterectomy and removes the ovaries without her specific consent, that will be a trespass and an act of negligence.” In reality professionals are persons with deep knowledge in their subject, on the other side, patients are persons without any knowledge upto certain extent on the same subject. Due to this imbalance, it become difficult for the patient to comprehend, terms as well as ideas used in the consent documents as intended by the doctors without simplifications and further elaborate clarifications. Eg:-‘Laparotomy’ is a surgical procedure to open up the abdomen to examine the abdominal organs and aid diagnosis. But Doctors use the same term in Consent Documents as surgical procedure to open up the abdomen necessary to treat medical conditions and removal of related organs. Laparotomy may be either a diagnostic or therapeutic. In the former, more often referred to as the exploratory laparotomy, an exercise is undertaken to identify the nature of the disease. In the latter, a therapeutic laparatomy is conducted after the cause has been identified. When a specific operation say hysterectomy or salpingo-oopherectomy is planned, laparotomy is merely the first step of the procedure, followed by the actual specific operation, namely hysterectomy or salpingo- oopherectomy. Depending upon the incision placement, laparotomy gives access to any abdominal organ or space and is the first step in any major diagnostic or therapeutic surgical procedure involving a) the lower port of the digestive tract, b) liver, pancreas and spine, c) bladder, d) female reproductive organs and e) retroperitonium. On the other hand, hysterectomy and salpingo-oopherectomy follow laparotomy and are not themselves referred to as laparotomy. Therefore, while considering plain meaning, when the consent form refers to “diagnostic and operative laparoscopy and laparotomy if needed”, it refers to a consent for a definite laparoscopy with a contingent laparotomy if needed. In general sense, it is not possible to reach a conclusion that it amount to consent for hysterectomy and salpingo-oopherectomy surgery removing the uterus and ovaries/fallopian tubes. Like that, in medical circles, it is well recognized that catch all clause giving the surgeon permission to do anything necessary does not give roving authority to remove whatever he fancies may be for the good of the patient. The usages like “the informed choice left to the operating surgeon depending on his/her discretion, after assessing the damage to the internal organs, but subject to his/her exercising care and caution” and “such medical treatment as is considered necessary for me for”, etc. are some examples on this. This type of shortfalls are very common in most of the consent documents acquired by the doctors from their patients and because of such incongruence the same consent documents become worthless and provide no protection to their acts, even if they provide service in good faith, due to the incapability to prove the same in judicial process. Based on the guidance of courts, many professionals are started to utilize legal knowledge for preparing Consent Documents, so as to make them legally valid documents by minimizing such mistakes and experiences shows that such practice yielded beneficial results to them. A duty to impart information regarding the proposed treatment is the right of every patient. The patient’s right of self-decision shapes the boundaries of the duty to reveal. That right can be effectively exercised only if the patient possesses enough information to enable an intelligent choice. The scope of the physician’s communications to the patient, then, must be measured by the patient’s need, and that need is the information material to the decision. Thus the test for determining whether a particular peril must be divulged is important materially to the patient’s decisions for that all risks potentially affecting the decision must be unmasked. A reasonable thinking in these subjects tells us it as a necessity as well as a matter of the physician’s duty. It is a duty to warn of the dangers lurking in the proposed treatment, and that is surely a facet of due care. Much more, the patient’s reliance upon the physician is a trust of the kind which traditionally has exacted obligations beyond those associated with arms length transactions. His dependence upon the physician for information affecting his well being, in the fiducial nature (the physician- patient) relationship and it is physician’s duty, to reveal to the patient that which in his best interests it is important that he should know and the choices with respect to proposed therapy and the dangers inherently and potentially involve before acquiring consent from him. There used to see some argument that organs removed were not ‘vital’ organs and having regard to the advanced age of the patient virtually ‘redundant’ as well as the treatment is determined by severity of the disease in some cases, but the correctness or appropriateness of the treatment procedure, does not make the treatment legal, in the absence of consent for the treatment. The guidelines summarized by the Honourable Supreme Court of India, in Samira Kohli  vs. Dr.Prabha Manchanda is very relevant in this context: (i) A doctor has to seek and secure the consent of the patient before commencing a ‘treatment’ (the term ‘treatment’ includes surgery also). The consent so obtained should be real and valid, which means that: the patient should have the capacity and competence to consent; his consent should be voluntary; and his consent should be on the basis of adequate information concerning the nature of the treatment procedure, so that he knows what is consenting to. (ii) The ‘adequate information’ to be furnished by the doctor (or a member of his team) who treats the patient, should enable the patient to make a balanced judgment as to whether he should submit himself to the particular treatment as to whether he should submit himself to the particular treatment or not. This means that the Doctor should disclose (a) nature and procedure of the treatment and its purpose, benefits and effect; (b) alternatives if any available; (c) an outline of the substantial risks; and (d) adverse consequences of refusing treatment. (iii) Consent given only for a diagnostic procedure, cannot be considered as consent for therapeutic treatment. Consent given for a specific treatment procedure will not be valid for conducting some other treatment procedure. The fact that the unauthorized additional surgery is beneficial to the patient, or that it would save considerable time and expense to the patient, or would relieve the patient from pain and suffering in future, are not grounds of defence in an action in tort for negligence or assault and battery. (iv) There can be a common consent for diagnostic and operative procedures where they are contemplated. There can also be a common consent for a particular surgical procedure and an additional or further procedure that may become necessary during the course of surgery. (v) The nature and extent of information to be furnished by the doctor to the patient to secure the consent need not be of the stringent and high degree. It will depend upon the physical and mental condition of the patient, the nature of treatment, and the risk and consequences attached to the treatment.