‘Life is short, art is long; opportunity is fleeting, experiment is dangerous; judgment is difficult. It is not enough for the physician to do what is necessary, the cooperation of the patient and the attendants must be secured, and circumstances must be favorable.’
Hippocrates (Greek physician and father of Western Medicine)
ABSTRACT
According to the standard conception of medical ethics, informed consent is fundamental to ethical practice. It is the mechanism by which patients authorize medical intervention or course of treatment. This also acts a constraint on medical practitioner's power and a curb to their paternalistic impulses. Since the origins of the consent doctrine, physicians have been perturbed by the difficulty of attaining meaningful consents—consents that truly fulfilled the high ideals of the doctrine. The blanket consent taken by most of the hospitals and nursing homes is legally invalid. The consent should be informed one. The basic essentials for valid consent are—voluntary decision, competent patient, sufficient disclosure of the relevant facts, understanding of those facts and then authorization (informed consent) or decline (informed refusal) of the proposed course of treatment are discussed. Exceptions to informed consent, economic or financial consent, rules of consent and consent related to various medicolegal cases have also been discussed.
INTRODUCTION
Medicine nowadays is practiced within an expanding and evolving system of legal rights and obligations, patient protections, health care financing regulation and standards of care. Thus, medical care can involve significant legal issues, including capacity of patients to make health care decisions, confidentiality of medical information and malpractice liability.
The element of consent is perhaps the only principle that runs through all aspects of health care provisions (Box 1.1). It also represents the legal and ethical expression of the basic right to have one's autonomy and self-determination (Article 21 of the Indian Constitution).1
In actual practice, this important principle is usually either ignored or only partially accepted, particularly in the Indian context since the scenario is somewhat different from the West with respect to the doctor-patient relationship.
Here, the doctor-patient relationship is governed more by trust wherein doctor is the authoritative figure. Obtaining informed consent is therefore considered to be an unnecessary ritual (Box 1.2).2 Moreover, it is taught in 2nd Professional MBBS curriculum as a small note during their study in forensic medicine. At that time, the students are not mature enough to understand the intricacies involved in the process of informed consent.
In India, informed consent was practically nonexistent till the Consumer Protection Act was made applicable to the medical profession. Now, both doctors and patients are becoming more aware about this concept, and patients are better informed of their rights.2,3
All over India, there are diversities in the way consent are taken and interpreted. The consent practiced in most hospitals in which patients being admitted are asked to sign a form stating that they are willing for any form of treatment, is a blanket consent of questionable legal validity. In some cases, patients are presented with complex information that they do not understand, and they duly sign or place their thumb prints on the dotted line.2,3 At present, legal cases concerning absence of consent are rare. Such cases will increase in the coming years as level of awareness and education of population increases.4
The present chapter examines the entire gamut of issues pertaining to consent from the point of view of the legal environment as it exists in India and worldwide as of today.
DEFINITION
Literally, consent [Etymology Latin: consentire, to feel with; to agree] means to give assent or permission or compliance.5,6 ‘Consent’ as defined under Section 13 of the Indian Contract Act, 1872—‘Two or more persons are said to consent when they agree upon the same thing in the same sense’.6
Furthermore, there is a stipulation in the contract law stating that consent of any party (in our case it is the patient) that is obtained by coercion, undue influence, mistake, misrepresentation or fraud, will render the agreement invalid.
The relationship between a medical professional and his patient is a contract by parties competent to contract giving rise to contractual obligations. Consent, 5in the context of medical profession, implies to voluntary permission or authorization by the patient to perform an act on his body, either for diagnosis or therapeutic procedure.7
HISTORY
The principle of patient's autonomy is a not a new concept. Documents pertaining to the Egyptian, Greek and Roman civilization show how the medical practitioner's intervention had, in some way, first to be approved by the patient. The procedures and the modes of information which Plato advocated were the principles of the present day informed consent and correlated the practice of information and consensus with the quality and social position of the patient.8
The first reported legal case in which surgeons were accused of disuniting a patient's healing fracture without the patient's consent occurred in England during the 18th century (Box 1.3).9 In another case, the court found that the operation to which the plaintiff did not consent constituted medical battery (Box 1.4). Justice Benjamin Cardozo wrote in the court's opinion:
‘Every human being of adult years and sound mind has a right to determine what shall be done with his own body; and a surgeon who performs an operation without his patient's consent commits an assault for which he is liable in damages.’4,7,9–11
TYPES OF CONSENT
- Implied consent: It is the granting of permission for health care without a formal agreement between the patient and the doctor. Usually, the demeanor of the patient implies consent. Consent may be inferred from the general submission by a patient to orders given by a doctor during clinical diagnosis.
Implied consent is restricted only to history taking, routine examination (inspection, palpation, percussion and auscultation) and prescribing treatment.
This does not extend to the performance of intimate examination (such as breast or vaginal examination) or diagnostic procedures.
For interventions considered routine and unlikely to cause harm, implied consent will suffice. For example, patients are presumed to indicate consent to receive certain routine interventions by holding out their arm (routine phlebotomy, placement of an intravenous line), or by opening their mouth for a dental examination. For more invasive or risky interventions, express informed consent is always required.1,6,7
- II. Expressed consent: This may be verbal (oral) or written and should be taken for all procedures beyond routine examination.
- Oral: Oral consents are easily administered, and can aid doctor-patient rapport because of the joint decision making shared by them. Oral consent should be taken in the presence of disinterested third party (for e.g., a near relative of the patient or female police constable) mainly in cases where intimate examination of female is required. Some medical practitioner may take this in presence of a nurse which may not be adequate. She is an employee of the examining physician and not actually an independent party. Tests necessitating removal of body fluids, gynecological examinations, such as, per vaginal examination or radiological examination can be done, after securing oral consent. If, for whatever reason, only oral consent is taken, it is recommended to make an entry in the patient's hospital record. If any action is brought on this count, this entry may afford corroborative evidence to support the defense taken by the medical practitioner concerned. Without such documentation, the burden will be on the doctor to demonstrate legally sufficient reasons for such absence.5,6,8
- Written: It is advisable to take written consent in the presence of disinterested third party (this third party is only to attest the signature of the patient). Expressed written consent should be obtained for the following:5,6
- Medicolegal examinations for injury, sexual assault, alcoholism, determining age, potency and virginity.
- All invasive and major diagnostic procedures like lumbar puncture, ventricular tap, invasive monitoring (for e.g., intracranial pressure), nerve or bone harvesting, putting any foreign body such as implants, coils and devices.
- Extraction of tooth or restorative procedures by a dentist.
- General or spinal anesthesia.
- Surgical operations.
It is to be noted that law demands mere consent and not written consent and does not prescribe such requirement on a mandatory basis. There is no mandate that a doctor should always obtain written consent and failure of which would hold him liable. However, as per the Indian Medical Council (Professional Conduct and Ethics) Regulations 2002, a written consent should be obtained before performing an operation.5 This would afford documentary evidence that the consent was actually obtained in case of litigation.1,6
DOCTRINE OF INFORMED CONSENT
The term ‘informed consent’ entered American jurisprudence in 1957 and was first used in medical malpractice case by Paul G. Gebhard.4 The doctrine of informed consent underlines the principle of providing sufficient information to a patient so as to enable him/her make an informed and knowledgeable decision about the course of examination, procedure or treatment. The doctor must ensure that the patient is explained the following as given in Box 1.5.2,4,6,7,10,13,14
Informed consent is considered as a process (mutual communication) rather than an event (document signing) (Fig. 1.1). The information provided to patients should be simple, easy to understand and list any possible major complications to enable the patient determine whether to undergo or decline a procedure.
The knowledge regarding the intervention should be imparted in an understandable language and format so that decision in the form of authorization by patient can be made.11 The law requires that health care practitioners take reasonable steps to communicate adequately with patients who do not speak English or who have other communication barriers. Patient should be given opportunity to ask questions and clarify all doubts. Video of the procedure, wherever possible and feasible, may be shown to make the patient aware of the details that were discussed earlier.
Impairments to reasoning and judgment which may make it impossible for someone to give informed consent include factors such as basic intellectual or emotional immaturity, high levels of stress such as PTSD, severe mental retardation, senility, severe mental illness, delirious intoxication, severe sleep deprivation, Alzheimer's disease, or being in a coma.15
REASONS FOR OBTAINING CONSENT
- To examine, treat or operate upon a patient without consent is considered battery/assault in law, even if it is beneficial and done in good faith. If a medical practitioner attempts to treat a person without valid consent, then he will be liable under both civil and criminal law. The definition of battery is an act that directly and either intentionally or negligently causes some physical contact with another person without that person's consent. If a person has consented to contact, then there is no battery. The consequences would be payment of compensation (in civil) and imprisonment (in criminal).
- If a doctor fails to give the required information to patient before taking consent to a particular procedure/treatment, he may be charged for negligence in case of any undesirable side-effects (Box 1.6). The practitioner can cite proof of consent as evidence of disclosure, thereby protecting him from an action based on failure to disclose material facts.
- Not taking consent is considered as deficiency in medical services under the Section 2(1) of the Consumer Protection Act.
Legally Valid Consent
The following three separate but correlated elements are the legal requisites to conform to the doctrine of informed consent:5,7,10,11,13,15,17
- Voluntariness—willingness of patient to undergo treatment.
- Capacity—degree of ability of the patient to understand the nature and consequences of treatment offered. The law presumes that such ability is generally acquired with the attainment of the age of maturity.
- Knowledge—appropriate and adequate amount of information about the nature and consequence of treatment has been disclosed to patient.
Invalid Consent
Consent is invalid if:6
- It is not an informed consent
- Given for committing a crime or an illegal act such as criminal abortion
- Obtained by misrepresentation or fraud
- Given by one who had no legal capacity to give it, for e.g., a minor or an insane person.
Exceptions to Informed Consent
Emergency cases: If a patient is unconscious or in a state of coma and there is an imminent danger to the life of the patient and there is no designated surrogate or the surrogate is unavailable, then the law presumes that consent for treatment has been deemed to be given (implied consent, Sec. 92 IPC). For implied consent to apply, the injured party must require emergency treatment to save life or limb and the treatment rendered must be so limited. Once the emergency treatment is no longer required, the doctrine of implied consent does not govern.1,5–7,18
Therapeutic privilege: In case of full disclosure (for e.g., presence of malignancy or unavoidable total results) in patients prone for anxiety or have detrimental effect on the health of the patient, the doctor should use therapeutic privilege in the interest of patient. However, he should disclose full information to the competent relative of the patient.6
Therapeutic waiver: A competent person who is aware of being entitled to informed consent may give up his right by waiving it.6
Placebo: The doctor may use placebos in certain self-limiting conditions or in patients with high psychological overlay or in those who insist for some particular medication (for e.g., addiction forming drugs). Informed consent may be withheld since there are high chances of benefit to the patient with negligible risk. Revealing the truth to the patient takes away the very purpose of administration of placebo.14
Prisoners: Prisoners and persons released on bail can be treated without their consent in the interest of the society. A registered medical practitioner can examine an accused by using reasonable force (force should be applied by police) if the examination is requested by the investigating police officer not below the rank of police subinspector (Sec. 53 CrPC). The obtaining of such evidence is not violative of Article 20(3) of Constitution, which grants protection against self-incrimination, it was held so by High Court of Bombay in Kathi Kalu case.4
INFORMED FINANCIAL/ECONOMIC CONSENT
Medical decisions are increasingly shared decisions. In current scenario, where the cost of treatment is exorbitant, the cost of surgical procedure, diagnostic test, biopsy, MRI or any other procedure are not discussed. This may be one of the issues for litigation. The patient may refuse to pay citing no information regarding the cost of the treatment being given during the process of consent. In this regard, the patient should be provided an opportunity for a ‘financial or economic informed consent’. Informed consent can only be given by a patient who has had the opportunity to consider a range of reasonable treatment options along with associated fee estimates.
A frank discussion about the treatment costs and charges, and the options available for payment, whether by the patient or insurance company, or shared, should be included in the consent process. Discussion of fees should typically include the cost of the procedure/therapy, any escalation in costs once treatment has started, types of reimbursement accepted (for e.g., cash, checks, credit card payments, direct payment from insurance companies).19 This information should preferably be provided in writing.
In instances wherein a doctor is unfamiliar with the cost of treatment or the patient's insurance plan, he/she should advise the patient to communicate with the billing section or insurer and discuss coverage and payment options.19 The patient should enquire whether he/she needs to pay an excess over and above the insurance cover.
RIGHT TO REFUSE
Although, medical practitioners are ethically bound to provide sufficient information and to encourage decisions judged to be in the patient's best interest, a competent patient still has a right to refuse treatment even if others, including the medical practitioner, believe that the refusal is neither in his/her best interest nor reasonable.
If a patient refuses the treatment/procedure after explanation, his/her understanding should be checked and concerns addressed. If the patient still refuses, the doctor should not proceed further. There should not be a forceful approach, as consent obtained under duress is invalid. The patient's signature should be taken along with witness and document each step of refusal process.4,12
There had been instances where the patient has alleged forgery or had claimed signing it under stress or pressure of doctors, without actually understanding the document. It is advisable to have consent from at least two persons—one from the patient and other from spouse, parents or close relatives.7
CONSENTING AGE
In India, the age of consent for medical or medicolegal examination is not legally laid down. There are unclear provisions made in Criminal Procedure Code (CrPC), Indian Penal Code (IPC Sec 87 to 90) and Indian Contract Act which refers to the validity of consent, which may occur from any act done in good faith and for individual benefit. These provisions are not specifically directed at medical examination or treatment. When combined, one can conclude that:1,4–6,13,20,21
- For a person under 12 years of age or of unsound mind, his/her guardian or person in whose lawful custody he/she is, can give consent.
- For any invasive and diagnostic procedures, general anesthesia and surgical operations, age of consent is 18 years and above.
For medicolegal examination, the consent should be signed by the person if he/she is above 12 years of age. Consent must be taken from the guardian/parent if the individual is under the age of 12 years (Department of Health Research guidelines for ‘Forensic medical care for Victims of Sexual Assault’ and Ministry of Health and Family Welfare ‘Guidelines on Sexual Assault Survivors’). However, the author is of the view that a person between 12 and 18 years of age may not be able to understand the intricacies associated with such an examination, and nature and consequences for which he/she is giving consent (invasive examination, appearing in the court, cross-examination, etc). Written consent can also be considered as a contract between the doctor and the patient which has got legal consequences. Hence, the age of consent for such examination should be 18 years.
It is emphasized that persons with mental illness and intellectual disabilities should also be informed of the examination procedure or treatment. Some specific steps may be required while taking consent from such persons. If necessary, they should be:
- Provided the necessary information in a simple language and in a form that makes it easy for them to understand the information.
- Given adequate time to arrive at a decision.
- Provided the assistance of a friend/colleague/caregiver in making the informed consent decision and in conveying their decision to medical personnel.
The decision of the person to either give or refuse consent with the above supports, to the medical examination, should be respected (MOHFW, Guidelines on Sexual Assault Survivors).
Global Scenario
In England, Wales and Northern Ireland, the General Medical Council guidelines state that the consenting age is 16 years old. In many respects, they are treated as adults and can give consent for their own surgical and medical treatment. The Department of Health recommends that it is nevertheless good practice to encourage children of this age to involve their families in decisions about their care, unless it would not be in their interests to do so. If a competent child requests that confidentiality be maintained, it is respected, unless the doctor considers that failing to disclose information would result in significant harm to the child. However, a child aged 16–18 years cannot refuse treatment, if it has been agreed by a person with parental responsibility or the court, and it is in their best interests. Therefore, they do not have the same status as adults. If the child is under the age of 16, he/she may have the capacity to decide, depending on his/her ability to understand what is involved.1,4,5,2213
Most states in the United States allow minors aged 13 through 18 to provide consent for some medical care, including contraception, sexually transmitted diseases, pregnancy, alcohol and drug abuse and psychiatric problems, varying by state.22 No state explicitly requires parental consent or notification for any of these services. In Alabama, for e.g., minors aged 14 years and older may consent to general medical care; in South Carolina, they may do so at 16 years. However, some states prohibit the use of state funds to provide contraceptive services to minors without parental consent. The one notable exception to the expansion of minors’ decision-making authority on health care matters is abortion. Only three states have laws that affirm a minor's ability to obtain an abortion on her own. In contrast, rest of the states requires the involvement of at least one parent in their daughter's abortion decision.
In Australia, according to the Minors (Property and Contracts) Act 1970, a child aged 14 years or over may consent to his/her medical or dental treatment. The Consent to Medical Treatment and Palliative Care Act, 1995 prescribes that an individual of 16 years of age or over can consent to medical and dental treatment ‘as validly and effectively as an adult’.22
HOW MUCH INFORMATION IS ADEQUATE?
The amount of information that a patient must be given in order to give informed consent is a debatable question. There are three concepts:
- Reasonable physician standard (prudent doctor test): It asserts that a physician has a duty to disclose information (including risks) that any reasonable physician would disclose under similar circumstances.10
- Subject specific standard: It asserts that the nature of disclosure shall depend upon physical (state of illness) and mental condition (psychological status) and cultural background of the patient.
In the United States, Australia and Canada, a more patient-centered approach is taken which provides the highest respect for the patient's right of self-determination about a particular therapy. Informed consent in these jurisdictions requires that significant risks be disclosed, as well as risks which would be of particular importance to that patient. This approach combines an objective (the reasonable patient) and subjective (this particular patient) approach.1,3,13,23
In the United Kingdom, Malaysia and Singapore, informed consent requires proof as to the standard of care to be expected as a recognized standard of acceptable professional practice, that is, what risks would a medical professional usually disclose in the circumstances.1,13
There are no clear parameters laid down by the courts about the Indian position regarding the quantum of information. Therefore, it is reasonable information which a doctor deems fit considering best practices. The standard to which physicians are held in negligence suits is that of a ‘reasonable physician’ dealing with a ‘reasonable patient.’ The nature and extent of information imparted to a patient is a question of professional judgment and is subject to proof by the testimony of expert witnesses.1,7,1214
Whatever might be the difference of approach, there is a need to provide adequate information so as to enable the patient make a balanced judgment as to whether he/she should submit himself/herself to a particular procedure or not. But, there is no need to explain the remote or theoretical risks which may frighten the patient resulting in refusal of treatment or opting for fanciful or unnecessary options or resulting in psychological stress of the patient.14
An important issue in informed consent cases deals with whether the complication or side effect suffered by the patient was actually discussed. Most often, a disagreement exists between the doctor, who claims that he/she did advise the patient of the risk, and the patient, who claims that the occurring risk was never mentioned. A significant study, assessing the degree to which patients actually recall the information imparted during the informed consent discussion, found that patients had primary recollection of only about 20% of the information provided. Significantly, the discussion least remembered by patients was the one regarding complications, where only 10% of the patients indicated that the possible complications associated with the operation had been discussed.24
GUIDELINES FOR CONSENT
- Consent should be free, voluntary, clear, intelligent, direct and personal, and only for legal acts. There should be no undue influence, fraud, compulsion, misrepresentation of facts, coercion or other consequences.
- During the consent process, the doctor should remain emotionally detached/impartial so as to allow the patient's decision/choice to be made voluntarily. The medical practitioner should politely refuse anyone, even another qualified doctor, from interfering in the consent process.
- Mental capacity, physical condition as well as age of the patient should be considered while delivering the information, or else the same information can be passed on to any other authorized person.
- Consent should be obtained in the presence of a witness and the same documented in writing to prevent any allegation that the consent was forged or obtained under pressure. Assisting nurse preferably should not be a witness.
- Written consent should refer to one specific procedure and not blanket permission on admission to hospital. In case alternative procedures have already been contemplated, it is advisable to clearly specify each of these procedures in the consent form. Specific consent for each and every type of anesthesia that is anticipated should be taken.
- The consent form should be filled by the concerned doctor, in one sitting, if possible without changing the pen, though counseling the patient may take more than one sitting. It should be prepared in duplicate and a copy handed 15over to the patient. In the consent form, the entries should be made at the appropriate spaces. Entries made at the wrong place may raise suspicion.
- If the patient withdraws consent during the procedure, it should be stopped and concerns addressed. If the patient does not consent again, the procedure should be discontinued.
- Unconscious/unknown patient when admitted in hospital, the medical superintendent/in-charge of hospital can give consent for treatment.
- Consent of one's spouse is not necessary for the treatment of other.
- Husband or wife has no right to refuse consent to any operation, which is required to safeguard the health of the partner.
- In prenatal diagnostic procedures, informed written consent of pregnant woman is obtained and a copy of the consent obtained above is given to the woman (as per PCPNDT Act, 1988).
- If found under the influence of alcohol, then consent of such person will not be valid, so it is always better to obtain consent from guardian/parents.
- In civil cases, examination should not be done without the consent of the person to be medically examined.
- Informed consent is necessary for photographing a patient for scientific/educational/research purpose. Although efforts should be made not to reveal the identity of the patient in publication, specific consent must be taken in case of the unlikely event where the identity is likely to be revealed.
- Informed consent is a must for participation in clinical trials and research projects.
- In case of consent for donation of organ after death, the will of the deceased is enough.
- Pathological autopsy should not be carried out, without the consent of next of kin of the deceased.
INFORMED CONSENT RELATED TO MEDICOLEGAL CASES
In medicolegal cases, following protocol is suggested:
- In case of conscious patient, he/she should be asked whether he/she wants any medicolegal report (MLR) or not.
- In case of unconscious/serious patients, accompanying relatives should be asked, whether they want any MLR or not.
- If there is consent for MLR, a call should be sent in writing/telephone to the concerned doctor on the duty roster.
- The concerned doctor should come immediately and do the medicolegal examination.
- The doctor should explain the object of examination to the patient—that the examination conducted will be medicolegal and would culminate in the preparation of a medicolegal injury report.
- All relevant investigations needed for the said purpose would be done (X-ray, CT, MRI, etc).
- The patient must have a clear understanding of the implications of the release of the medical records, laboratory investigations, photographs and related information. The normal expectation of confidentiality between doctor and patient does not exist, or is limited, and the report may be seen by others including the opposite party, lawyer, counsel, Judge, or others. Further, the patient needs to be explained that the doctor/hospital authorities would not be held liable for any claims of injury which may in any manner result from the release of such information.
In case, patient does not want any medicolegal action against the alleged perpetrator(s), the same should be documented in writing in the hospital register/file and signature should be taken from the concerned person(s).
At any given time, the patient may withdraw the consent already given or may even leave the hospital. The doctor has no right to force anything on the patient, even though its a medicolegal case. In all such situations, the doctor should carefully document all the findings in the case file, note the exact moment at which the consent was withdrawn and inform the nearest police station regarding the same, giving reasons for his actions. Hospital file should be stamped on the title page about the status of the case by the emergency medical officer. The following should be documented:
- Police informed
- Medicolegal examination done/refused/deferred.
CONSENT FORM
Consent forms should be clearly worded, comprehensive, and provide doctors with the necessary authority to carry forward the specified examination/procedure/treatment. The ideal consent form will therefore depend upon the individual case and circumstances (Box 1.8).2 Nonetheless certain essential ingredients of an ideal consent form shall provide all possible and likely happenings in most of the cases.
Who should obtain consent?
A house surgeon, interns or even a postgraduate (resident) are the ones who obtain the consent. Ideally, the attending doctor who will be actually examining/treating the patient should obtain the informed consent.7
Who should sign the consent form?
Consent has to be signed by the patient, unless minor, unconscious or insane wherein a legal guardian should sign. The form should also be signed by the doctor and an independent witness. Even in emergency, unless patient is unconscious, the consent offered by the parents of major is void and amount to negligence, if the procedure/treatment is not an emergency.7
When patients lose their ability to make treatment decisions (incompetent patient), some other reasonable person has to take decisions on behalf of the patient. Usually ‘next of kin’ (legal heir) would be the surrogate decision maker. In India, the typical hierarchy sequence is spouse, eldest child, next child, parent, sibling and lawful guradian.5,18
Is a signed consent form adequate defense?
A signed consent form of any nature neither guarantees a doctor protection against legal action nor ensures patient satisfaction. It merely demonstrates that some process to exchange information was followed.3
Just providing information is not sufficient—a patient needs to have an understanding of the information in order to make an informed decision. Validity depends on whether the patient understood what was on the consent form and had the opportunity to ask questions. If the patient didn't understand it, it is invalid.12
Despite the potential shortcomings, written consent forms may nevertheless serve as deterrents to negligence suits alleging failure to obtain informed consent because of the existence of written evidence to disprove this claim. In addition, patients are usually presumed to have read the consent forms they sign, thereby requiring the plaintiff to disprove this presumption.
At some places, the literate patient is asked to write down the salient features of consent in his/her own dialect and handwriting or video recording of the process is done. In this way, chances of subsequent denial of informed consent become negligible.
In spite of taking all necessary precautions, a doctor cannot sit contentedly with the belief that the signed ‘informed consent’ can certainly avoid legal liability. This is highlighted by one of the observation by the California Supreme Court ‘one cannot know with certainty whether a consent is valid until a lawsuit has been filed and resolved’.14
COMMON MEDICOLEGAL SITUATIONS
Abortion
Consent of the female is mandatory except when she is minor or mentally ill, where consent of guardian is obtained. Consent of husband is not necessary.
In some states of the United States, informed consent laws require that a woman seeking an elective abortion be given factual information by the doctor about her legal rights, alternatives to abortion (such as adoption), available public and private assistance and medical facts (some of which are disputed—fetal pain), before the abortion is performed (usually 24 hours in advance of the abortion).15
Contraception, Pregnancy and Delivery
Written informed consent needs to be taken after explaining reasons and possible consequences. For contraceptive sterilization, consent of both husband and wife should be obtained. It is on the safer side to take the consent of spouse, if the operation destroys or limits sexual functions.
Consent to obstetric procedure should be discussed during the antenatal period. If the medical practitioner finds that the wishes of the pregnant woman are unusual, these should be noted carefully in the antenatal record. It is necessary because the doctor who discussed the matter with the patient may not be on duty when she is admitted in labor.
Impotence and Sterility
In cases of impotence and sterility, the person is examined only when asked by court or by the police. Informed consent of the person should be taken.
In artificial insemination homologous (AIH), consent is needed from both husband and wife. In artificial insemination donor (AID), consent is needed from husband, wife, donor and donor's wife.6
Rape
In alleged rape cases, the written consent of the victim is mandatory and should be obtained in the presence of a witness.6 It must be ‘informed consent’, as she must be told that any evidence obtained may be used in court and she will then be exposed to publicity and cross-examination (Box 1.9).
The victim or guardian may refuse to give consent for any part of examination. In this case the doctor should explain the importance of examination and evidence collection; however the refusal should be respected. Such informed refusal for examination and evidence collection must be documented. In case there is informed refusal for police intimation, then that should be documented. At the time of intimation being sent to the police, a clear note stating ‘informed refusal for police intimation’ should be made (MOHFW, Guidelines on Sexual Assault Survivors).
Sec. 164A (7) CrPC explicitly states the court or the police have no power to compel the victim of sexual assault for medicolegal examination against her consent. It also recognizes her right to consent for partial examination—she may also decide on whether she wants to undergo a physical examination and/or genital examination and allow the collection of bodily evidence.21
Rape Accused
In case of accused, consent should be asked for. But if refused, he can be examined and necessary evidence, for e.g., blood and swabs can be collected with application of reasonable degree of force by the accompanying police personnel [Sec. 53 (1) CrPC].6
Sodomy
Written informed consent should be obtained in case of nonconsenting victim of sodomy. Consent in case of accused and consensual partner is guided by Sec. 53 (1) CrPC.
Drunkenness
Detained intoxicated person should not be examined and blood, urine or breath should not be collected without his written consent.6 If unconscious or incapable of giving consent, examination and treatment can be carried out, but the doctor should not disclose any information and wait for his consent till he regains consciousness. At places where Bombay Prohibition Act, 1949 (Mumbai/Gujarat) is in vogue, the person can be examined and samples can be taken even without consent as per the said act.
Examination of an accused (for e.g., a driver involved in road traffic accident) can be carried out at the request of the police even without his consent and by use of force, if necessary. Such examination may include taking of body fluids [Sec. 53 (1) CrPC].
CONCLUSION
The doctor-patient relationship is a fiduciary one. Respect for patients is a foundational principle for informed consent and renders it a deontological obligation. However, surrogate consents seem more problematic than might be expected. Doctors are willing to override patient wishes at the request of surrogates.
It is also important not to overemphasize the gap between the legal and ethical senses of informed consent. Both seek to establish and protect patients’ rights to 21be informed about the consequences of medical choices and to select the choice that is most consistent with their values and goals.
REFERENCES
- Nandimath OV. Consent and medical treatment: The legal paradigm in India. Indian J Urol 2009; 25: 343–47.
- Bansal YS, Singh D. Medicolegal aspects of informed consent. Ind J For Med Toxicol 2007; 1: 19-23. Available from: http://www.indmedica.com/journals.php?journalid=11…98.
- Bal A. Informed consent—legal and ethical aspects. A review of the case law. Ind J Med Ethics 1999; 7: 56–57. Available from: http://www.issuesinmedicalethics.org/072mi056.html.
- Murkey PN, Khandekar IL, Tirpude BH, Ninave SV. Consent—Medicolegal aspects. Medicolegal Update 2006; 6(4). Available from: http://www.indmedica.com/journals.php?journalid=9…86.
- Kohli A. Medical consent in India—Ethical and legal issues. Anil Aggrawal's Internet Journal of Forensic Medicine and Toxicology [Internet]. 2007; 8(2). Available from: http://www.anilaggrawal.com/ij/vol_008_no_002/papers/paper004.html.
- Biswas G. Medical jurisprudence and ethics. Review of forensic medicine and toxicology. 2nd edn, New Delhi: Jaypee brothers; 2012. p. 3–24.
- Singh D. Informed vs. valid consent: Legislation and responsibilities. Indian J Neurotrauma 2008; 5: 105–08.
- Mallardi V. The origin of informed consent. Acta Otorhinolaryngol Ital 2005; 25: 312–27.
- Brazell NE. The significance and application of informed consent. AORN Journal 1997 [Internet]. Available from: http://findarticles.com/p/articles/mi_m0FSL/is_n2_v65/ai_19163364/.
- Makdessian AS. Informed consent in facial plastic surgery. Arch Facial Plast Surg 2004; 6: 26–30.
- Joffe S, Truog RD. Consent to medical care: the importance of fiduciary context. In: Miller FG, Wertheimer A (eds). The ethics of consent-theory and practice. Oxford university press; New York: 2010. p. 347–74.
- Saunders N. It's a matter of consent. 2007. Synergy [Internet]. Available from: http://findarticles.com/p/articles/mi_hb5752/is_200707/ai_n32234936/.
- Sabatino C. Legal and ethical issues. Merck manual online medical dictionary. Available from: http://www.merckmanuals.com/home/sec01/ch009/ch009c.html.
- Rao KHS. Informed consent: An ethical obligation or legal compulsion? J Cutan Aesthet Surg 2008; 1: 33–35.
- Informed consent. Available from: http://www.en.wikipedia.org/wiki/Informed_consent.
- Lupton M. Informed consent: can a patient ever be fully informed? Curr Opin Obstet Gynecol 2005; 17: 601–04.
- Chaturvedi A. Consent—its medicolegal aspects. In: Singal RK (ed). Medicine Update. The Association of Physicians of India. 2007. p. 883–87. Available from: http://www.apiindia.org/medicine_update_2007/153.pdf
- Sundaram ALM. Medicolegal aspects of critical care medicine. Ind J Anaesth 2007; 51: 344. Available from: http://www.ijaweb.org/text.asp?2007/51/4/344/61163.
- Lundberg G. Why we need an economic informed consent? Available from: http://www.kevinmd.com/blog/2012/04/economic-informed-consent.html.
- Indian Contract Act 1872 (act number 9 of 1872).
- Sobti PC, Biswas G. Adolescent health care: Informed consent and confidentiality. In: Gupte S (ed). Recent advances in pediatrics. Jaypee brothers; New Delhi: 2005. p. 375–99.
- Hassan M. Informed consent and the law—an English legal perspective. Dig Dis 2008; 26: 23–7.
- Trosty RS. Key issues in the litigation of informed consent claims. American Physicians Assurance Corporation.
- Consent in radiology practice. Indian J Radiol Imaging 2009; 19: 21–22. Available from: http://www.ijri.org/text.asp?2009/19/1/21/45339.
- Harish D, Chavali KH. The medicolegal case— should we be afraid of it? Anil Aggrawal's Internet Journal of Forensic Medicine and Toxicology [Internet]. 2007; 8(1). Available from: http://www.anilaggrawal.com/ij/vol_008_no_001/others/pg/pg001.html.
- The Criminal Law (Amendment) Act, 2013. Available from: http://indiacode.nic.in/acts-in-pdf/132013.pdf.