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Indian Journal of Medical Sciences
Medknow Publications on behalf of Indian Journal of Medical Sciences Trust
ISSN: 0019-5359 EISSN: 1998-3654
Vol. 59, Num. 2, 2005, pp. 74-78
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Indian Journal of Medical Sciences, Vol. 59, No. 2, February, 2005, pp. 74-78
Practitioners section
Validity of consent - A review of statutes
Bastia Binaya K., Kuruvilla Ajee, Saralaya K.M.
Department of Forensic Medicine and Toxicology, Kasturba Medical College, Mangalore, Karnataka
Correspondence Address:Department of Forensic Medicine and Toxicology,
Kasturba Medical College, Mangalore.
Karnatakadrbastia@indiatimes.com
Code Number: ms05013
Abstract
In recent years there have been a number of malpractice suits based on
lack of consent or inadequate consent from the patient for the procedure
used in treatment. This is a particularly dangerous suit for the doctor
since the burden of proof lies on the doctor. Furthermore since the suit
is based on intentional assault, some insurance policies do not cover the
doctor for his liability. The common meaning of consent is permission,
whereas the law perceives it as a contract i.e. an agreement enforceable
by law. So a doctor needs to understand the legal basis of consent rather
than the common meaning of it. The present article aims to discuss the
various legal aspects of consent as viewed in the Indian law.KEYWORDS: Consent, Medical practice, Legal validity
INTRODUCTION
The doctor-patient relationship is a special type of contract which starts when
a patient comes to a doctor seeking medical care, and when the doctor starts
treating the patient the contract comes into being. One of the essential features
of establishing a contract is consent, which means "an agreement, compliance or permission given voluntarily without any compulsion".[1] Although there is no legal definition of consent in Indian law, Sec. 13 of the Indian Contract Act states that "two or more persons are said to consent when they agree upon the same thing in the same sense". This has been reflected in Article 21 of the Indian Constitution, which declares, "No person shall be deprived of his life or personal liberty except according to the procedure established by law".
IMPLIED AND EXPRESSED CONSENT
Consent may be implied or expressed. When a patient comes to a doctor, an implied
consent is presumed. Here it is in a general sense, for taking history and for
general physical examination like inspection, palpation, percussion, auscultation
and taking pulse rate, BP etc. Even for routine gynecological examination by
a lady doctor, consent is presumed. If this is not so, consent cannot be presumed.
If there is no implied consent or when any material risk is involved, an expressed consent should be obtained. An expressed consent can be oral or written. An oral consent is legally valid and can be taken for some specific examinations like gynecological examinations, injecting medications, drawing blood for pathological examination etc.
It is always advisable to take written consent for examinations like rape cases, special diagnostic procedures and when the risk involved is much as in the case of major surgical procedures, anesthesia etc.
If, for whatever reason it is possible only to take oral consent, a doctor must ensure to enter it into the case record of the patient. This entry will serve as corroborative evidence to support the defense.
CONSTITUENTS OF A VALID CONSENT
According to Sec. 14 of the Indian Contract Act, consent is said to be free when
it is not caused by coercion (Sec.15), undue influence (Sec.16), fraud (Sec.17),
misrepresentation (Sec.18) and mistake (Sec.19). The consent must be to do a
lawful act and it must not disobey any provision of the law, e.g. consent for
euthanasia is null and void in India. The consent must not be against morality
or public policy, e.g. performing sterilization operation on a prostitute, with
consent.
Specificity
The consent must be person- and procedure-specific. The consent is an agreement between a doctor and a patient. The consent is not valid if the assistant does an operation when the patient has consented to be operated on by a particular doctor. Similarly, when the consent is for a particular procedure, the doctor cannot perform another without a fresh consent.
Full disclosure
For a consent to be legally valid the patient has to be informed properly about what the doctor is going to do to his body. There should not be suppression of any facts either by the doctor or by the patient. The essential components of informed consent are:
- All the relevant information of the disease and treatment needs to be told to the patient.
- All significant and material risks are to be disclosed to the patient.
- The patient should also be informed about other alternative treatments available.
- This must always be explained in simple language so that the patient can
understand and take the necessary decision.[2]
While recommending a particular line of treatment, the doctor must provide
the patient with all the information, which must be truthful, adequate and
should
be given at the right time, in appropriate style and preferably in the patient′s
own language. The doctor himself must give the information because this is
a contract between the doctor and the patient. The doctor must ensure that
the patient has comprehended it without any distortion. The patient may be
unable to understand the proposed line of treatment due to technical difficulties,
or language, nevertheless it is the duty of the doctor to make all reasonable
efforts to ensure comprehension.
The Therapeutic Privilege enables the doctor to withhold from the patient some information (the risks), if it can be shown that, disclosure would have posed a serious threat to the psychological health of the patient. This should be noted in the medical record. However, in certain critical situations, the choice of the patient should prevail over the good intentions of the doctor.
Age
Consent is a contract and to make a valid contract both the parties must have
attained majority. The Indian Majority Act, 1875 declares that every person
domiciled in India shall be deemed to have attained majority when he/she has
completed 18 years of age. According to Sec. 11 of the Indian Contract Act "Every person is competent to contract who is of the age of majority according to the law to which he is the subject, and who is of sound mind and is not disqualified from contracting by any law to which he is the subject".
Mental status
As per Sec. 12 of the Indian Contract Act "A person is said to be of sound mind for the purpose of making a contract, if at the time he makes it, he is capable of understanding it and of forming a rational judgment as to its effect upon his interest".
So a person in the lucid interval can make a valid contract. The fact that
the person is mentally ill, or has learning difficulties is not in itself sufficient
ground to determine that he is not competent. If he possesses sensory and mental
powers to process the information, data and to derive a conclusion he can give
a valid consent.
Medical emergencies
In case of medical emergencies, consent need not be obtained, the well-being of the patient has paramount importance. Hence the ethical rather than the legal consideration shall prevail.[3] SEC
92 IPC states that "Nothing is an offence by reason of any harm which it may cause to a person for whose benefit it is done in good faith even without the person′s consent if the circumstances are such that it is impossible for that person to give consent and has no guardian or other person in lawful charge of him to obtain consent in time for the things done for his benefit".
Law, therefore expressly declares that an act done in emergencies and done
in good faith for the benefit of the person will not be called in question
for want of consent.
Female patients
When a male doctor is to examine a female patient, even with a proper consent, the presence of a female attendant is mandatory, though this is not true regarding lady doctors. The presence of the husband of the female patient cannot be substituted for a female attendant. No one including the court can compel a woman to be physically examined without her consent.
Proxy consent
When a person in need of treatment is incapable of giving expressed consent (minors, insane, intoxicated), a substituted consent (proxy consent) should be obtained from the next kin. The generally accepted order for proxy consent is spouse, adult child, parent, sibling, and lawful guardian.
In case of minors the consent of one parent is sufficient vide 89 IPC. While treating the inmates of a hostel, the consent of the warden or the principal of the school should be taken (loco parentis).
As per the MTP Act of 1971, consent of the guardian is mandatory to terminate the pregnancy of a minor girl. But if the girl is not willing then the pregnancy should never be terminated. In case of a married woman pregnancy can never be terminated at the request of her husband. But, if the woman is consenting, consent of the husband is not mandatory.
For the purpose of the treatment of either husband or the wife, consent of the person to be treated should be taken. But in case of any treatment or operation, when the loss of potency or fertility is involved, it is always advisable to take the consent of both the spouses.
When an unknown person brings an accident victim in a serious condition to the hospital, he should not be asked to sign the consent form, but his identity must be noted in the medical record. In such circumstances, if possible, consent can be obtained from the relatives by telephone. If this is not possible then the doctor should go ahead with the operation for the best interest of the patient.
For the purpose of transplantation of human organs, consent of the donor is required. In case of cadaver transplantation, however, consent of the next kith and kin is required, even though directive is available mentioning the wishes of the deceased about his organs to be transplanted.
Who should take the consent
Unilaterally executed consents are void. Consent being an agreement between two or more persons, all concerned parties must execute the same. The doctor himself must take the consent because this is a contract between the doctor and the patient. Consent signed only by the patient and not by the doctor is null and void.
When should the consent be taken
Consent can be taken immediately before the specific procedure in emergency situations. But in case of elective procedures, it should preferably be taken at least a day or two before. On the day of the operation a patient may not be considered mentally sound to execute a contract when he is not likely to be in the right frame of mind.
Witnesses
Consents duly witnessed and signed by uninterested third parties are more dependable legally, as the parties concerned cannot subsequently deny execution. Nurses, assistants and medical students cannot always be considered as uninterested third parties.
The court may question their interest. The same also holds good regarding the
patient′s relatives.
CONCLUSION
A consent form is a legal document. It must contain the name and signature of
the patient, two witnesses, and the doctor along with his registration number.
There is no standard format for taking consent for all the situations. The formats
can be modified according to the need and preferably translated in the local
language so that the patient can understand the nature of the consent clearly.
This will also avoid complications in a suit filed by the patient in respect
to consent.
Statutes
- Indian Contract Act- 1872
- Constitution of India
- Indian Majority Act- 1875
- Indian Penal Code-1860
References
| 1. | Pillay VV. Medical Law and Ethics. In: Handbook of Forensic Medicine and Toxicology. 13th Ed. Hyderabad: Paras Publication; 2003. p. 24-5. Back to cited text no. 1 |
| 2. | Gupta RL. Consent to treatment. In: The Medicolegal Aspects of Surgery. 1st Ed. New Delhi: Jaypee Brothers; 1999. p. 16-30. Back to cited text no. 2 |
| 3. | Sec7.17.Indian Medical Council (Professional conduct, Ettiquette and Ethics) Regulation, 2002. Published in Part-III, Sec 4 of the Gazette of India, Dated 6th April 2002. Back to cited text no. 3 |
Copyright 2005 - Indian Journal of Medical Sciences
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