A major and important aspect of medical practice which has been a cause of action in several litigations is that a doctor has administered treatment or performed a procedure or investigation without consent or consent taken was invalid. This aspect of medical practice, which is considered routine by doctors, has been subject matter of judicial scrutiny in quite of a few medical malpractice cases as it involves the individual right of a patient on one hand and the duty of a doctor to take due care of his patient. Hence it is of paramount importance that correct and proper consent should be obtained by a doctor before proceeding to perform any Investigation or procedure.

Under Section 13 of the Indian Contract Act, 1872, “Consent” is defined and states that two or more persons are said to consent when they agree to the same thing in the same sense. The above language, on the face of it is more judicial or expository than a legislative kind. A doctors relation with a patient is contractual. One of the essential features for creation of a valid contract is consent i.e. an agreement to do the same thing in the same sense. Therefore, if one party to the contract is misled or has entered into it in a different sense to that in which it ought to have been understood then it would not be construed as a valid contract.

In order to enter into a valid contract the person should be competent to do so. Section 11 of the Contract Act stipulates that every person who is of age of majority and is of sound mind and is not disqualified to contracting by any law to which he is subject is competent to contract.

The Indian Majority Act, 1875 declares that every person domiciled in India shall be deemed to have attained majority when he has completed 18 years of age. Thus a person who is 18 years of age and above, who is mentally sound and conscious is competent to contract. In the case of a minor the parents of the minor, being the natural guardian or a guardian appointed by a Court shall be the person competent to contract for and on behalf of the minor.

Under Criminal Law the Indian Penal Code, 1860 in Chapter IV has set out general exceptions to an offence. Section 89 stipulates that an act done in good faith for benefit of a person under 12 years of age or of un-sound mind by consent either express or implied by the guardian or other person having lawful charge is not an offence by reason of any harm. The aforesaid exception is not available if there is an intention to cause death or grievous hurt. Section 90 of the said Code further stipulates that a consent given under fear of injury or mis-conception of fact would not be a valid consent under the Code.

The fact that a patient comes to a doctor for treatment of an ailment implies that he is agreeable to medical examination in the general sense. This is implied consent and would encompass physical examination (not intimate examination), palpation, percussion, auscultation and routine sonography. IMPLIED CONSENT (TACIT CONSENT) is the most common variety and is generally accepted in the practice of a family physician or consultant who generally prescribes medicines after nothing the history of the patient and physical examination.

For other major diagnostic/therapeutic procedure such as lumbar puncture, radiology endoscopy, laser treatment, dye- induced tests, CLW suturing, FNAC, I/D of abscess, CT Scan, MRI, etc. EXPRESS WRITTEN CONSENT should be obtained. It is advisable that Written Consent should be obtained in presence of a dis-interested 3rd party. Consent should be taken in the patients own language and it is vital that if the patient is incapable of giving Consent, then Consent of guardian or person in lawful charge of him should be taken. Many a times in gynecological cases it is observed that a gynecologist takes the consent of the husband and proceeds to perform procedure on the wife. In the event of marital disharmony the doctor is put to tremendous harassment, as variety of charges including charge of being an accessory to killing the baby, pre-leveled against the Doctor. It is, therefore, advisable to ensure that Written Consent of the patient is taken.

INFORMED CONSENT is a part of the physicians duty to disclosure, however, this duty has an exception. In the event, the physician is of a considered opinion that, the patient is in a highly disturbed condition or so anxious that the information given would not be processed rationally or that it would only cause significant psychological harm then the doctor may choose not to inform the patient about the treatment or procedure. The other exception is where the patient prefers not to be informed. These exceptions are known as “Therapeutic Privilege”.

A word of caution would be in order and a physician seeking to exercise Therapeutic Privilege would be well advised to discuss the matter with the family physician of the patient. It is well known that revelation of the risk may frighten off the patient from beneficial treatment but at the same time the patient has a valuable right of benefit of reasonable information. In such an event a fine balance ought to be struck and law always values the judgment and opinion of the treating physician and would examine it on the anvil of the condition and circumstances of the patient at the time when the treatment was being administered or procedure/investigation performed.

The three vital components of Informed Consent are, (i) the capacity of the patient to contract, (ii) complete information in comprehensive terms and (iii) voluntary acceptance of the patient to undergo treatment or procedure as prescribed. Informed Consent is always advisable where surgery is major, planned and performed on a non-emergency basis. In case Informed Consent is obtained then in case of a medical mishap the doctor has a better defence and Courts generally have taken a view that where the patient underwent the surgery with full knowledge of attendant risk the doctor cannot be held liable. A recent study of reported cases under the Consumer Protection Act, 1986 filed against doctors it is noticed that in 16 cases one of the allegation, amongst others, was of lack of consent or invalid consent. In four of the aforesaid cases there was no dispute that consent was not taken and that the doctor had administered treatment or performed procedure without consent and was found liable for damages. In three cases though consent was obtained the same was held to be invalid on the basis of evidence adduced before the Commission. However, in 9 cases where consent was taken the same was held to be valid and the complaint was dismissed and in one of the cases cost was awarded in favour of the doctor as the procedures have been performed after obtaining Informed Consent. It is, therefore, very important to ensure that the patient, in a complicated case and where surgery is planned, has thoroughly understood the procedure which a doctor intends to perform upon him.

In case of Medical Emergency consent need not be obtained, the well being in the patient is paramount and hence medical rather than legal consideration shall prevail. In fact Section 92 of the Indian Penal Code, 1860 specifically declares that nothing is an offence by reason of any harm which it may cause to a person for whose benefit the act is done in good faith even without that person’s consent if the circumstances are such that it is impossible for that person to signify consent or if that person is incapable of giving consent and has no guardian or other person in lawful charge of him from whom it is possible to obtain Consent in time for the thing to be done for his benefit. Law, therefore, expressly declares that an act done in an emergency will not be called in question for want of consent. In other words emergency ratifies an act done for the benefit of a person even in absence of a consent.

Besides Medical Emergencies the other situations where consent need not be obtained are when

• A person is suffering from not if able diseases
• Immigrants
• New admissions to prisons
• Examination under Court Order – especially to ascertain mental condition of the person ordered to be examined.
• Request by a police officer under Cr.P.C. Section 53(1)
• Members of Armed Forces.
• Persons handling food or dairy products

In case of failure to obtain proper consent a doctor would be open to charge of battery. Besides being liable for civil action for damages for performing a procedure or investigation without consent of the individual concerned.

A leading case where for want of proper consent the Court held that the action of the doctor amounted to battery andawarded damages in favour of the patient and against the doctor was Bailey vs. Belinfante which is summarised below:

A patient was referred by his dentist to an oral surgeon. While waiting in the waiting room, and before even seeing the surgeon, he was given a surgical consent form to sign which gave the surgeon authority to do whatever procedure he thought best. When he saw the surgeon it was agreed that 11 teeth would be pulled. He went to the hospital, signed another general consent, and while he was under general anaesthesia, the surgeon pulled 27 teeth. The court upheld his action for battery as to the 16 teeth for which no consent had been obtained.

Where there is no emergency condition, before the surgeon proceeds to extend surgery he should attempt to get the consent of someone in the patient’s family. If this is not possible, he should probably decide not to extend the scope of the surgery unduly. An extension of a minor operation into a major one is usually considered assault and battery in the absence of an emergency. However, want of consent would not imped a doctor from extending the operation if the said extension was demanded in exercise of sound professional judgment and was required to remedy any abnormal or diseased condition of the patient. In the case of Kennedy vs. Parrott, the Court upheld a surgery which was extended beyond the consent taken and observed as under:

During an appendectomy the surgeon discovered that his patient had several large ovarian cysts, which he punctured. The patient sued him for assault and batter but did not allege negligence. The Court dismissed the action and stated that it was “unreasonable to hold a physician to the exact operation that the preliminary examination indicates is necessary. A complete diagnosis may not be possible until the incision is made. The surgeon may extend the operation to remedy any abnormal or diseased condition in the area of the original incision whenever he, in the exercise of sound professional judgment, determines that correct surgical procedure demands it.

For a proper and valid consent a doctor would be well advised to ensure that :-

1. The consent must be a free consent. That is, it must not be obtained under coercion, undue influence, misrepresentation, fraud or mistake.
2. The consent must be executed by parties having capacity to enter into contracts. That is they must not be minors, they must not be of unsound mind, unconscious or intoxicated.
3. In case of minor or person otherwise incpacitated consent of guardian or person in lawful charge of the patient can give consent.
4. The consent must be to do a lawful act and it must not defeat any provisions of law. For example: a free consent to terminate a 22 weeks pregnancy is void ab-initio.
5. The consent must not be against `Morality’ or `Public Policy’. For example : Husband consenting to inseminate donor semen in his wife who believes the semen to be her husband’s.
6. Unilaterally executed consents are void. Consents being an agreement between two or more persons, all concerned parties must execute the same. Consent signed only by patients and not by the doctor or his representatives is void ab-initio.
7. Consents duly witnessed are more dependable legally, as the parties concerned can not subsequently deny execution.

A Model of Express Consent and Informed Consent is given herein below and surgeons/physicians may utilise it with necessary adaptation to their speciality. ———————————————————-

INFORMED CONSENT

1) I——————– aged — yrs. Wife/Son/Daughter of ————- residing at ———- state that I am admitting/submitting myself to the above Nursing Home/Hospital/Clinic, for all necessary treatment, under the care and supervision of Dr.——- , voluntarily without any coercion, misrepresentation, mistake, fraud or undue influence.

2) I hereby consent and agree to the administration of all necessary drugs, medications, intravenous fluids, blood, blood products, etc. and also to subject myself to all necessary investigations and references as my attending Doctors may deem necessary.

3) I am not allergic to any drug/I am allergic to —– drugs.

4) I hereby consent and agree to the administration of General/Regional/Local Anaesthesia and or Sedation by Dr.—— for the performance of Surgical/Dental Operations, Delivery, Diagnostic or Therapeutic procedures, Investigations, etc., and also to be supplemented with any other mode of anaesthesia if necessary. I say that I have been explained the risks of consuming solids/liquids including water eight hours prior to the induction of anaesthesia.

5) I hereby also consent and agree to the performance of —— upon myself by Dr.—— I also further consent to such further or alternative operative measures as may be deemed necessary, to be performed upon myself, during or subsequent to the course of the above operation and also to the administration of anaesthesia for its purpose. I say that I have also obtained the consent of my spouse/relatives for the said operations, procedures and treatment.

6) I say that I have no objection to the reuse of single use disposable items provided the same is properly sterilized.

7) I say that I have objection to the reuse of single use disposable items.

8) I further say that I have been explained and I have fully understood, the nature and the procedures involved in my treatment, the administration of anaesthesia, the surgical/dental operations, diagnostic/therapeutic procedures, delivery, administration of drugs, pathological, radiological, & sonographical investigations, etc. together with the expected benefits, the associated risks, untoward, unfavorable effects, effects of non treatment and all possible consequences of the same.

9) I further say that I have had an opportunity, to ask all questions regarding my illness/treatment and the same have been satisfactorily answered by the attending Doctors. Other alternative methods of treatment have also been discussed. No warranty or guarantee has been give to me with respect to the results of the treatment by my attending Doctors, the Hospital/Nursing Home/Clinic or its Staff.

10) I say that I have together with my Family Doctor checked the facilities available at this Hospital/Nursing Home and found the same satisfactory.

11) I also hereby consent to and permit my attending Doctor to use assistants such as the Hospital/Nursing Home/Clinic Residents, Other Doctors, Nurses, Staff, etc. as he deems necessary.

12) I further consent and agree to the disposal by the Hospital Authority of any tissues or parts that may be removed in the course of my treatment at this Hospital/Nursing Home/Clinic.

13) I further consent and agree to the disposal by the Hospital Authority of any tissues or parts that may be removed in the course of my treatment at this Hospital/Nursing Home/Clinic.

14) I further consent and agree to the publication of my treatment for medical, scientific or educational purposes provided the pictures or the descriptive texts accompanying them do not reveal my identity.

15) I further consent and agree to being transferred to any other Hospital/Nursing Home/Clinic, as considered fit by my Doctor, during any time of the treatment, if my Doctors feel that it is beneficial for my recovery.

16) I further say that I have informed the Doctor of all my previous illnesses, allergies, drug reactions, surgical procedures and all other facts relevant to my treatment. I shall not hold the Hospital or the Doctor responsible for the consequences, which may arise for the non-disclosure of the same.

17) I hereby release the Hospital/Nursing Home, its personals, attending Doctors, Anesthetists, Pathologists, Radiologists and all other person participating in my care from any liability whatsoever for any untoward of unfavorable consequences or results that may arise out of, or in the course of my treatment (including surgery and anaestheisa) at this Hospital/Nursing Home/Clinic.

18) I have seen the schedule of all charges and the same are acceptable to me and I undertake not to leave the Nursing Home/Hospital/Clinic until full and final settlement of all dues has been made by me.

19) I also undertake to pay the clinic/Hospital/Nursing Home bills immediately/within twenty four hours of its presentation and I am agreeable to pay interest for delayed payment at the rate determined by the Hospital/Nursing Home/Clinic from time to time.

20) I have fully understood the rules & regulations of the Nursing Home/Hospital/Clinic and I agree to abide by the same.

21) The above has been explained to me and I have fully understood the same and I am signing this consent cum undertaking by my own free will and in a fully alert state of mind.

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SIGNATURE ———————————————————————

MODEL FORM OF EXPRESS CONSENT

I——————– son of———- aged—- resident of ——– being under the treatment of —— (state here name of doctor/hospital/nursing home) do hereby give consent to the performance of medical/surgical/anesthesia/diagnostic procedure of———- (mention nature of procedure/treatment to be performed, etc.) upon myself/upon—— aged —- who is related to me as —– (mentioned here relationship, e.g., son, daughter, father, mother, wife, etc.)

I declare that I am more than 18 years of age.

I have been informed that there are inherent risks involved in the treatment/procedure. I have signed this consent voluntarily out of my free will without any pressure and in my full senses.

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SIGNATURE