Informed Consent in Medical Practice: Principles and Conventions Kalidas D Chavan, Rajendra S Bangal
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Concepts and Principles of Informed ConsentCHAPTER 1

 
INTRODUCTION
Medical jurisprudence incorporates the knowledge of law in the practice of medicine. Practice of medicine deals with conception, birth, health, life, diseases and death of a person, and hence it is required to be guided by ethics and safeguarded with control by applicable laws. While dealing with patients, the four basic ethical principles namely; respect for persons (autonomy), beneficence, nonmaleficence, and justice have been enunciated for protecting the dignity, rights, safety, and well-being of patients. Autonomy of a patient is protected by informed consent by allowing the patient to freely decide whether to undergo the treatment or not. The process involves three components: providing relevant information to patients, ensuring the information is comprehended by them, and assuring voluntariness in deciding. Informed consent should explain medical terminology in simple terms and be in a language that the patient understands.
Clinicians are expected to be aware of and comply with the concepts, specific requirements, and standards of Informed Consent during their practice. The best way to prevent allegations and litigations is to keep oneself updated with legal and ethical concepts applicable to practice of medicine and to follow those.
 
EVOLUTION OF CONSENT IN MEDICAL PRACTICE
The practice of obtaining patient's consent before medical treatment existed since early 20th century. It took five more decades for the consent to mature into informed consent. In those times, the doctors were supposed to inform the risks, benefits, and alternatives to patients before commencing the treatment. However, this information was limited only to the extent to which another doctor, in similar situation, would have provided. This was in tune with the concept known as the Professional Standard test, which was being practiced in UK.
During the same period, the US judiciary conceptualized the Material Risk Test (Reasonable Prudent Patient Test) by way of Mr. Canterbury's case. 2This concept originates from ethical and legal right of the patient to decide the fate of one's own body. Justice Cordazo, in Canterbury versus Spence (1972 [464] Federal Reporter 2d. 772, the United States Courts of appeals, District of Columbia Circuit) clarified that, “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”.
The English Court also accepted this principle. They have summarized the law as follows: “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.”
With increasing awareness among consumers of medical services, the scope of disclosure while obtaining an “informed” consent needs to be reviewed. With rising awareness among patients about their rights and doctor's duties, in addition to disclosure of the risks, benefits, and alternatives, in future it might be required to disclose the qualifications, training and experience of the physician, his performance, research conflicts, his medical illnesses and disability, infrastructure and logistics available at the hospital, availability of trained and experienced nursing and support staff, the quality of instruments and equipment, availability of blood bank, intensive care unit (ICU), critical care unit (CCU), ambulances services, superspecialty services in the hospital itself, etc.
 
The Indian Scenario
With dramatic advances in fields of medical sciences and information technology, patients can now easily access the relevant and updated medical information. Also, the increasing treatment costs and few instances of professional malpractice and/or negligence by doctors have strengthened the medical consumer movement.
In India, till recently, a patient primarily used to place his trust in his selection of the doctor and leave all other decisions to him. In traditional doctor–patient relationship, the patient did not wish to make therapeutic decisions for his/her illness. However, the law looks upon the relationship differently.
Legally, the doctor and the patient are not on the same level playing fields. The doctor is at an advantage because of his/her special knowledge that creates the advantage. Hence, the concept of informed consent demands that the doctor should provide his patient the necessary knowledge that will make him or her equal partners in discussing the health case. Thus, informed consent is meant to give a legal status to the doctor–patient relationship, i.e. to transform it from “status” to “contract”. A large portion of cases today is 3litigated on the theory that the doctor has negligently failed to inform the patient about the proposed treatment, its risks and alternatives.
India being a large country and with different streams (allopathy, Ayurveda, homeopathy, Unani) of medicines, and variety of healthcare establishments (clinics, polyclinics, daycare centers, private hospitals, corporate hospitals, sub-centers, primary health centers, cottage hospitals, sub-district hospitals, district hospitals, medical college hospitals, etc.), it is important to disclose to the patient the scope and standard of medical services that can be rendered (and more specifically, which cannot be rendered, in view of limited resources, unavailability of ambulance/blood bank/ICU, etc. facilities, power cuts, unqualified and untrained staff, etc.) by a particular doctor at a particular center at that material time in addition to all other components of informed consent described in details in subsequent paragraphs.
Indian Penal Code (IPC) provides protection to those who obtain prior consent, vide its Section 88, which states, Nothing, which is not intended to cause death, is an offence by reason of any harm which it may cause, or be intended by the doer to cause, or be known by the doer to be likely to cause, to any person for whose benefit it is done in good faith, and who has given a consent, whether express or implied to suffer that harm, or to take the risk of that harm”. In case, a due informed written consent of a patient is not obtained, the doctor cannot claim protection under this section of IPC.
As regards the matters related to allegations of medical negligence, though Indian courts broadly follow the professional standard test, however, in some cases, the Apex court has indicated if the need arises it might adopt the stricter Material Risk Test.
 
CONSENT
 
Definition
Consent means agreement or permission. It is the informed exercise of a choice that entails an opportunity to evaluate knowledgeably the options available and the risks involved.
Section 13 of the Indian Contract Act, 1972, defines “Consent” as, “Two or more persons are said to consent when they agree upon the same thing in the same sense”. To be valid, the consent should be a “Free Consent”, i.e. it should not be caused by coercion or undue influence or fraud, or misrepresentation or mistake (Section 14 of Indian Contract Act).
 
TYPES OF CONSENT
 
Implied Consent
  • It means an assumed permission that a person would provide to carry out a course of action if asked. This assumption is based on the demeanor 4of the patient and the circumstances. Thus, it is a consent which is not expressly provided by a person, but rather indirectly assumed to be granted by a person's actions or inactions and the facts and circumstances of a particular situation. Implied consent can be of use only for purpose of inspection, palpation, percussion, and auscultation. Examination of private parts should not be carried out unless an expressed and written consent is obtained. “Private parts” as defined by European countries generally include all natural orifices of the body, genitals, and breasts in females. UK excludes the oral cavity from the list of intimate parts (as for the requirement of DNA sampling).
  • A patient voluntarily coming to a doctor's clinic implies his/her willingness for general examination by the doctor such as inspection, palpation, percussion, and auscultation. Also, an implied consent for particular examination should be considered to be limited to that purpose only and not be automatically construed to be further implied for any other procedure subsequent to such examination, even though related to it. In Nizam's Institute of Medical Sciences versus Prasanth Dhanaka, the patient had alleged that consent that had been taken was only for the purpose of an excision biopsy which was an exploratory procedure, but the doctor had carried out a complete excision removing the tumor mass. The NCDRC (National Consumer Disputes Redressal Commission) rejected the patient's plea that the consent for the excision of the tumor had not been taken, holding that prior consent for excision biopsy implied consent for excision to tumor. However, the Supreme Court clarified that in this case any implied consent for the excision of the tumor cannot be inferred.
  • Consent can be implied in some circumstances from the action or demeanor of the patient. For example, when a patient rolls up his sleeve to have his blood pressure recorded or when a patient approaches a dentist and occupies the dental chair, it implies that he has consented for his dental examination, diagnosis, and consultation. Except in situations where an implied consent is clear and obvious, an expressed written consent should always be obtained.
  • In view of the greater significance attached to the area of “consent” in various legal proceedings coupled with varying perceptions and interpretations of the concept of “consent” by various courts, it is advisable that this implied consent, should only be practiced when that person is incapable of understanding the information provided to him/her and of giving his/her consent (e.g. unconscious or incompetent patients, where Next of Kin is not available).
  • Patient's mere presence in clinic/hospital does not represent implied consent to all or any medical intervention and does not give the doctor an unfettered right to do whatever she/he believes to be in the best interest 5of the patient. The wishes and values of patients and physicians may not be similar. It is the principle of respect for person that obligates the doctor to do his best to involve the patient in the healthcare decisions affecting his life and body, whereas it is the principle of beneficence that require the doctors to act on behalf of the patient to save their lives and health.
  • In cases of implied consent, there is neither proof of actual willingness nor sufficient manifestation of consent by the patient. Also, there are chances of misunderstanding between doctor and patient on what was actually implied by the patient's actions (or silence). While proceeding with implied consent, the doctors must have reason to believe that the patient or another on his behalf would not decline treatment if he had an opportunity to consent.
 
Expressed Consent
Here the patient expresses his approval to undergo a treatment/procedure/surgery, either orally or in writing, in response to a suggestion made by the doctor.
  • For procedures like internal examination including rectal or vaginal examination, withdrawal of blood, etc. doctors should obtain an expressed consent, either oral or written. Before any complicated diagnostic or therapeutic procedures like surgeries, pleural/peritoneal tap, lumbar puncture, tracheostomy, CT/MRI with/without contrast, anesthesia, etc. an express written consent should be obtained, because risks are involved in these procedures.
  • Oral or written expressed consent has same evidentiary value; however, written consent is easy to prove at a later date. It is advisable that even when the consent is orally expressed by the patient, while writing the clinical notes, the fact of such oral consent should be documented. This comes handy whenever it is required to prove such an oral consent. All written consents (and also entry about oral consent) should always be dated with time. In case consent is not documented, the contention that it was in fact obtained, is required to be inferred from the available documented evidence.
  • An express consent in UK is known as “real consent”, whereas in America, it is the “informed consent” and both differ significantly in their nature of disclosure to the patient. In UK, it is a standard practice to disclose to a patient that which a reasonable medical practitioner would disclose, whereas in America, the courts stress on disclosure of the “material” information to the patient before obtaining his consent (the reasonable patient standard). UK standard has an advantage that it is practical and knowable for a physician to determine what the reasonable practices of their medical community are. However, American reasonable patient standard requires the doctor 6to determine what a reasonable or average patient would want to know before making an informed decision. In any case the rule of thumb for risk management in clinical practice is that, the more information one provides to his patients, the lesser the risk of litigations.
 
Free Consent
Consent is said to be free when it is not caused by (Indian Contract Act, 1872):
  1. Coercion: Committing, or threatening to commit, any act forbidden by the Indian Penal Code, with the intention of causing any person to enter into an agreement (It is immaterial whether the Indian Penal Code is or is not in force in the place where the coercion is employed).
  2. Undue influence: A person is deemed to be in a position to dominate the will of another:
    1. Where he holds a real or apparent authority over the other, or where he stands in a fiduciary relation to the other; or
    2. Where he makes a contract with a person whose mental capacity is temporarily or permanently affected by reason of age, illness, or mental or bodily distress (The burden of proving that such contract was not induced by undue influence shall lie upon the person in a position to dominate the will of the other). For example, a patient, is induced, by his doctor, to agree to pay him an unreasonable sum for his professional services, the doctor employs undue influence.
  3. Fraud: “Fraud” means and includes any of the following acts committed by a party to a contract, or with his connivance, or by his agent, with intent to deceive another party thereto or his agent, or to induce him to enter into the contract:
    1. The suggestion, as a fact, of that which is not true, by one who does not believe it to be true;
    2. The active concealment of a fact by one having knowledge or belief of the fact;
    3. A promise made without any intention of performing it;
    4. Any other act fitted to deceive;
    5. Any such act or omission as the law specially declares to be fraudulent.
      (Mere silence as to facts likely to affect the willingness of a person to enter into a contract is not fraud, unless the circumstances of the case are such that, regard being had to them, it is the duty of the person keeping silence to speak, or unless his silence is, in itself, equivalent to speech).
  4. Misrepresentation: It means and includes:
    1. The positive assertion, in a manner not warranted by the information of the person making it, of that which is not true, though he believes it to be true;7
    2. Any breach of duty which, without an intent to deceive, gains an advantage to the person committing it, or any one claiming under him; by misleading another to his prejudice, or to the prejudice of any one claiming under him;
    3. Causing, however innocently, a party to an agreement, to make a mistake as to the substance of the thing which is the subject of the agreement.
  5. Mistake: Where both the parties to an agreement are under a mistake as to a matter of fact essential to the agreement, the agreement is void.
    Consent is said to be so caused when it would not have been given but for the existence of such coercion, undue influence, fraud, misrepresentation or mistake.
 
Proxy Consent (Surrogate/Substituted Consent)
It is a consent given by an adult Next of Kin for a patient who is not capable or not competent to make healthcare decisions for himself/herself. For example, a legal guardian giving consent for a minor or a Next of Kin giving consent for an unconscious patient or a warden of a hostel for an unconscious hostel inmate, etc.
  • At the time of admitting any patient, the hospitals should have a practice of recording the name/s of “Next of Kin” of the patient. Though generally all close family members are involved in discussions and decisions, ideally proxy consent of such named Next of Kin should be obtained for such incapacitated/incapable patient. The following hierarchy of family relations should be followed for determining the “Next of Kin” or the official spokesperson:
    1. Legal guardian with healthcare decision-making authority
    2. Individual given durable power of attorney for healthcare decisions
    3. Spouse
    4. Adult children of patient (all in agreement)
    5. Parents of patient
    6. Adult siblings of patient (all in agreement) [As per the Indian Majority Act, 1875, every other person domiciled in India shall be deemed to have attained his majority when he shall have completed his age of eighteen years and not before].
  • Parents have the authority to take healthcare decisions on behalf of their minor children, till the time such decisions are in good faith and are not detrimental to the well-being of the children.
  • Situations might arise if the parents deny permission for treatment of their children when such treatment has the potential to prevent substantial harm or suffering of the child. In such situations, a doctor may be required to approach the court to proceed with treatment 8against the wishes of the parents. However, it is advisable that even in such situations, the doctors should respect family's beliefs and should be willing to discuss reasonable alternatives with the family. In any case, a perfect documentation of all clinical findings, events, discussions, and counseling sessions must be maintained with date and time. Such cases must be decided, first, on the doctor's assessment of the importance of the matter and, secondly, on the chance of mishap; any decision to override parental opposition must be justified on the legal basis of necessity. The more assured alternative would be to institute care proceedings, in the course of which to pursue a court order.
  • When a 30-year-old woman, third time pregnant, was brought to a hospital with ruptured membranes and in spontaneous labor, had refused to consent for lower segment cesarean section (LSCS) on religious ground; the court exercising its inherent jurisdiction, authorized the surgeon and the staff of the hospital to carry out an emergency LSCS contrary to patient's belief. [Re, S (adult: refusal of medical treatment) (1992) 9BMLR 69: (1992)4 ALL ER 671]. A 15-year-old boy suffering from leukemia required blood as a lifesaving measure. As Jehovah's Witness, the parents of the boy refused consent to blood transfusion. The court under Wardship Jurisdiction granted leave to hospital authorities to carry out the treatment.
  • A representative draft of documentation regarding assignment of Next of Kin by a patient may be as follows:
    Assignment of Next of Kin (NOK)
    1. I assign Mr./Ms/Mrs. _______________________________________ relation________________________ as my Next of Kin (NOK) for my current hospitalization in XYZ Hospital.
    2. He/She (NOK as declared by me) will be responsible for taking clinical decisions in consultation with the doctors, about my treatment if I am not in conscious/oriented state to do so.
    3. My NOK does understand the responsibility of abiding by XYZ Hospital rules, regulations, and instructions. My NOK promises to abide by the rules, regulations of, and instructions by XYZ Hospital.
    4. I and/or my Next of Kin (NOK), will be responsible for paying Deposits/Hospital Bills in timely manner (As per Hospital policy).
    5. I and/or my Next of Kin (NOK) will be responsible for such deducted amount or non-payable amount by Insurance Company/Third Party Administrator/Any other agency who is supposed to pay XYZ Hospital on my behalf.
    Date and Time
    Patient's Name and Signature
    9I, ______________________________ (Name of Next of Kin) have understood the above responsibilities assigned to me by ______________________ (Name of the patient) and I voluntarily and freely promise to fulfill those.
    Date and Time
    NOK's Name and Signature
 
Blanket Consent
  • It is a general, vague and all inclusive consent, permitting doctors, hospital, nurses to treat the patient by any sort of diagnostic or treatment modality, at any time in future, including surgeries and under whatever anesthesia as decided by the doctors, without specifically mentioning any names (neither of the doctor nor of the procedure), risks, alternatives, etc. obtained before/during hospitalization. Such consents are not legally valid as they do not serve any purpose for which consent is meant for. However, many hospitals in India, out of ignorance, continue the practice of obtaining such blanket consent, which gives them a false sense of security, that consent has been obtained.
  • In Indian scenario, customarily, when the patient is admitted in hospital for surgery, written consent is generally not obtained for minor pre-operative procedures like giving enema or shaving of the site of operation. Also, some administrative aspects of the hospitalization are verbally informed to the patient, without any documentation. It is advisable that instead of obtaining blanket consent from the patient, a format of “general consent cum undertaking form” should be developed which should include all such general tasks, procedures, information, etc. for which a written informed consent/undertaking is generally not obtained. This will serve a better purpose.
  • A representative form of such “consent cum undertaking” format may be as follows:
    1. I, the undersigned, am getting admitted at this hospital for necessary treatment voluntarily and hereby provide my general consent for my treatment by the staff of this hospital. I have read and understood the following information and the same also has been conveyed to me in my own language and I have cleared all my doubts.
    2. I am aware of the rules and regulations of this hospital and undertake to comply with the same. I am aware of the facilities, infrastructure, and expertise available in this hospital and also those which are not available here.
    3. I have been told that doctors do not guarantee cure. They only provide treatment and do investigations to the best of their skills, acumen, and knowledge.10
    4. I understand that situation may arise where even after days of admission; the diagnosis may not be reached by my treating consultants. In cases of emergency, I hereby authorize my primary treating doctor/s to call upon other specialist for a second opinion.
    5. I undertake not to smoke, consume alcohol or any other drugs of addiction or habituation during my hospital stay.
    6. I do not have any objection for my treating doctor to discuss my case with my primary referral doctor or a family physician or other consultants involved in my medical care.
    7. I hereby authorize my treating doctor/s to investigate me to the best of their skill and knowledge and which is in my best interest.
    8. I have been explained about the hospital charges including the policy of advance payment and will abide by the same.
    9. I understand that a situation may arise where I may need a blood transfusion; I hereby authorize my treating doctors to arrange necessary blood from voluntary donors for transfusion.
    10. I have checked the spelling of my name, age, and address at the time of admission. I understand that it will not be possible to change these parameters at the time of discharge or after the discharge, at hospital level.
    11. Many of the consumables may not be covered by the Mediclaim policy/Public sector undertaking/Government units. For these, I may be billed separately and may have to pay cash. It is my duty, at the time of admission, to clarify with the IPD counter as to which are the items that are not reimbursable.
    12. I understand that the hospital policy does not allow children to visit the hospital as relations. I understand that there are strict visiting hours which my relations shall have to abide.
    13. I understand that the hospital charges may be different for different categories of patients. The charges, for surgery, anesthesia, doctors’ fee, etc. may vary as per the applicable bed category.
    14. I understand that it is my duty to disclose if I am aware of my HIV, hepatitis B and C positive status. I understand that it is my duty to disclose if I am aware of my suffering from tuberculosis/or any other form of TB.
    15. I understand that there are always chances of acquiring new infection in the hospital premises by me or my relations/friends visiting me. Getting hospital acquired infection/s in spite of precautions may not mean medical negligence on the part of the treating doctors.
    16. For certain facilities not available in the hospital, hospital may direct/refer me to outside centers.
    17. I have been explained and have understood the above instructions fully. By signing below, I affirm that I have read all the clauses above/have been explained to me, etc.11
  • Hospitals may suitably design a general consent form cum undertaking as per the specialty of their practice and requirement of their healthcare establishment and the area in which they practice.
  • However, this general consent cum undertaking form cannot be a substitute for carrying out all and any form of treatment/investigation/procedure. For these, a patient-specific and procedure-specific duly informed written consent should be obtained.
 
Informed Consent
  • As discussed hereinabove, implied consent cannot extend to procedures beyond inspection, palpation, percussion, and auscultation. However, this implied consent does not, however, necessarily include consent to a risk and it is this distinction that underlies the concept of “informed consent”.
  • It is clear that the patient, in consenting to operation, does not consent to a negligent performance on the part of the surgeon. The critical issue is that of consent to the risks that are inherent to the proposed procedure. Should such a risk materialize, the patient who was unaware of the possibility can rightly say: “but for the fact that I did not know of the risk, I would not have had the operation. The risk has materialized and I am suffering a disability due to an operation which I would not have undergone had I known of the risk. Thus, my disability is caused by your failure to inform me the risk”. The surgeon who fails to inform about risk is, therefore, liable to an action in negligence. In Taber's Cyclopedic Medical Dictionary, informed consent is defined as, “a consent that is given by a person after receiving 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”.
  • Thus, informed consent is a process by which the doctor provides all necessary and relevant healthcare-related information to the patient so as to involve the patient in her medical management by allowing her to choose what she considers best for her, based on the information provided by the doctor.
  • Justice Cordazo's judgment in Canterbury case (discussed in foregoing paragraphs and also in Chapter 4) highlighted the duty of doctors in obtaining informed consent in following words: “It is well-established 12that the physician must seek and secure his patient's consent before commencing an operation or other course of treatment. It is also clear that the consent, to be efficacious, must be free from imposition upon the patient. It is the settled rule that therapy not authorized by the patient may amount to a tort—a common law battery—by the physician. And it is evident that it is normally impossible to obtain consent worthy of the name unless the physician first elucidates the options and the perils for the patient's edification. Thus, the physician has long borne a duty, on pain of liability for unauthorized treatment, to make adequate disclosure to the patient”.
  • The process of obtaining informed consent should comprise of open discussion between the doctor and the patient, where doctor should provide all relevant information about the disease and treatment and also that which is specifically asked for by the patient. This informed consent should be voluntary without any coercion, influence or force that will affect the patient's autonomy in any way. There are chances that the autonomy may be compromised in patients who are either institutionalized or imprisoned and who may not be aware of their right to obtain information from doctors or right to refuse treatment.
  • In general, patient must be given relevant and required information to enable him or her to make a free and voluntary decision about clinical intervention after fully understanding the risks involved. What constitutes sufficient information is, however, still in the dispute. Briefly, there are two ways of measuring the requirement. There are two tests to determine if the doctor has complied with his duty to disclosure:
    1. The Professional Standard Test (Bolam's test): That the doctor must make such a disclosure of the proposed treatment, and the risks inherent in it, and the alternatives there to, “as would be made by a reasonable practitioner similarly situated” (responsible body of medical men skilled in that particular art) [Bolam versus Friern Hospital Management Committee, decided by Queens Bench Division on 16 February 1957, on the issue pertaining to Medical Negligence]. Alternatively, if a doctor is acting in accordance with such a practice, he is not negligent, just because there is another school of thought that is taking a contrary view. Indian courts have broadly accepted the Bolam test as the general rule. However, while discussing the Samira Kohli case, Hon'ble Supreme Court of India has warned that, “We have however, consciously preferred the ‘real consent’ concept evolved in Bolam and Sidaway in preference to the ‘reasonably prudent patient test’ in Canterbury, having regard to the ground realities in medical and healthcare in India. But if medical practitioners and private hospitals become more and more commercialized, and if there is a 13corresponding increase in the awareness of patient's rights among the public, inevitably, a day may come when we may have to move towards Canterbury”.
    2. The Material Risk Test (Reasonable Prudent Patient Test of Canterbury): That the doctor must disclose to the patient “all the information that would be material to the patient in making a decision on proposed therapy”; that disclosure should include the diagnosis and prognosis and warning as to any material risks inherent in or collateral to the therapy, and the alternatives thereto, so as to enable the patient to make an informed and intelligent decision regarding his treatment. (Thus, the approaches toward informed consent are different in UK compared to US. In US, disclosure of all material risks is required, whereas in UK the approach is less demanding and requires that obviously necessary risks are disclosed).
  • The material risk test is more difficult to follow in its true spirit. It requires that the scope of physicians’ communication with patients be measured by patients’ needs of information “material” to the decision. The “Material Risk” is defined in Canterbury versus Spence as “the risk is thus material when a reasonable person, in what the physician knows or should know to be the patient's position, would be likely to attach significance to the risk or cluster of risks in deciding whether or not to forgo the proposed therapy”.
  • While discussing the Sidaway case, Lord Bridge, though adopted the Bolam test, however clarified that when the patient specifically enquires about the risks involved in the proposed treatment, the doctor is duty bound to answer truthfully and to the satisfaction of the patient. He further distinguished the risk of damage as “remote risk” (referred to as risk at 1 or 2%) which need not be disclosed and “substantial risk” (referred to as 10% risk), which may have to be disclosed.
  • Thus, in order to comply with the “material risk test”, the information required to be conveyed to the patient includes the diagnosis, the proposed treatment, inherent and potential risks involved in the proposed treatment, its incidence, the available alternatives to the treatment and the likely consequences if the patient refuses consent to treatment. Chances of death, even if very small, permanent disability and any such serious disablement or hazard which has the potential to outweigh the benefit of the therapy shall be discussed with the patient.
  • It is this principle of the law that is significant in the context of the disclosure of information to a patient to enable him to make a decision. The view of Lord Bridge that it would be impractical to expect the doctor to explain absolutely everything to the patient, has in fact been flipped on its head, and the prevailing sentiment now seems to be that it would 14be unreasonable for the patient to explain the entire circumstances of his life, medical, social, economic and otherwise, that would be necessary to make a truly informed decision and that therefore, it is the patient who is in a far better position to make the best decision based on the information available.
  • The “material risk test” has a disadvantage that, to comply with its requirement, printed consent forms are developed by doctors and hospitals. Doctors view these consent forms as an alternative to talk to patients, counseling and informing them. Patients also tend to undermine the significance of these forms and consider these as nothing but paperwork. Thus, a well drafted and signed consent form is considered to imply that everything that is mentioned in the consent form is understood by the patients, but in Indian Scenario, many times it is a myth. Doctors and hospitals obtain signatures of patients on such forms merely as a security for themselves rather than for the very purpose and spirit of “material risk test”. This results in situations where even a signed informed consent form cannot establish valid consent because of evidence that the patient signed standard hospital consent 10–15 minutes before being wheeled into the labor room or operation theater and that the patient was functionally illiterate. Thus, the rule indicating that signed informed consent form constitutes a presumption of informed consent creates more of an illusion of security. In order to avoid this, it is suggested that the physician should document the consent discussion/counseling/questions asked by patients and replies provided by doctor, etc. in notes separate from the consent form.
  • Legal view of the duty to disclose, and the rather serious consequences imposed upon a doctor for a perceived failure to disclose, may lead to argument that patients, being medically illiterate, are not able to understand what is informed to them and are generally not in a good psychological position to remember what they are told nor to make really sound judgments. It appears from the literature and the experiments reported there in that patients fail to recall the entire information that was disclosed to them by the doctor before obtaining informed consent and most alarmingly, often they seem to block out the information pertaining to the issue which is prone for litigation, especially the one regarding warnings about risk, residual defects/disability, possible therapeutic failure, need for extension of surgery, etc. In case any of these problems occur (which was informed to the patient but got blocked by the patient) the patient will allege about its non-disclosure by the doctor. It does no good to fuss and fume that the patient is lying, because empirical studies indicate that, in fact, the patient is probably not lying, just blocking.15
  • In general, the extent of necessary disclosure will be regarded as being proportional to the understanding of the patient, the questions he or she asks, the extent of the risk, the availability of alternatives, any element of experimentation, and the effect on the patient of imparting the knowledge; but, at the end of the day, the question of whether any failure to disclose was negligent will be determined by current medical opinion. The position is probably best summarized in the words of Lord Templeman: “the duty of a doctor is to provide the patient with information that will enable the patient to make a balanced judgment if the patient chooses to make a balanced judgment”.
  • Montgomery versus Lanarkshire Health Board case decided by the UK Supreme Court on 11 March 2015 closed the gap between regulatory guidance and case law by shifting the focus of consent toward the specific needs of the patient. The Montgomery case emphasized that the doctors must ensure that all material risks and alternatives to treatment are conveyed to the patient. It was clarified by the judges in Montgomery case that Bolam principle still applies in all other aspects of clinical practice apart from consent. Thus, the court decided to move away from the traditional model of consent and toward a patient-centered approach. This will require a change in attitude of doctor community while obtaining informed consent, as they are no longer the only stakeholders to determine what risks are material to their patients. In this case the court held that, “in any event, once the argument departs from purely medical considerations and involves value judgments of this sort, it becomes clear, that the Bolam test, of conduct supported by a responsible body of medical opinion, becomes quite inappropriate.”
  • Effects of Montgomery judgment:
    1. The traditional standards for informed consent and disclosure were redefined by the Montgomery decision. Bolam's test previously applied to determine what should be disclosed to the patient, used to ask whether a doctor's conduct would be supported by a responsible body of clinicians. However, the Montgomery case firmly rejected the application of Bolam to consent and established a duty of care to warn of material risks. The Montgomery ruling defined the test of materiality as whether “a reasonable person in the patient's position would be likely to attach significance to the risk, or the doctor is or should reasonably be aware that the particular patient would be likely to attach significance to it”.
    2. In Montgomery case, the judges decided between patient autonomy versus medical paternalism. In practice, the doctors have to balance between these two principles. However, as today's patients expect 16more information from doctors about the disease, treatment, risks, alternatives, etc. this judgment has given the patients appropriate recognition as decision makers.
 
OBJECT OF CONSENT
Any intentional nonconsensual touching which is harmful or offensive to a person's reasonable sense of dignity is actionable. If a person chooses to waive this protection and consent to the intentional invasion of this interest, then action for battery will not be maintainable. In this regard, no special exceptions are made for medical care, other than in emergency situations. The general rules governing actions for battery are applicable to the doctor–patient relationship. Thus, a medical intervention in which a doctor touches the body of a patient, without consent, would constitute a battery. Patients have the decisive role in the medical decision-making process. Their right of self-determination is recognized and protected by the law.
Thus, any unauthorized and unjustified touching, including contact for medical interventions, is considered battery under civil law. So, the primary object of consent, from doctor's point of view, is to give a legal status to the interference with human body done by a doctor during course of medical treatment and surgical procedures, so that such interference is not considered as assault or battery. However, more importantly, from patient's point of view, the object of consent is to respect the rights of the patient to determine what should be done with his/her body.
 
NECESSITY OF CONSENT
  • The law creates the duty of disclosure on the doctor because of the right of self-determination and because the law looks upon the doctor–patient relationship as a “fiduciary relationship,” which requires a person, in whom another has placed a special trust, to act in good faith, and to deal with that person to the person's benefit.
  • By signing consent form the patient indicates that he has understood the procedure or operation the doctor is going to conduct on him. He has also understood the various complications that can occur and by signing; he is giving you permission to carry out the procedure or operation.
  • Moreover, a legally valid consent protects and defends the doctors from allegations of assault and battery as well as from the allegations of professional misconduct. If a doctor does not inform the patient of the risks, complications, alternatives, consequences of a medical procedure then any “consent” given to it will be considered as in form only and will be ineffective in substance.
  • Consent proves “good faith” under section 88 of IPC.17
  • A thorough informed consent is necessary as it helps the physician avoid the unilateral burden of paternalism. It is necessary for compliance with the doctor's legal obligation, ethical duties, and clinical responsibilities.
  • In medicolegal cases, the process of consent serves to protect the human rights of the victims who do not wish to undergo medical examination.
 
LAWS RELATED TO CONSENT
  • Section 87 IPC: Act not intended and not known to be likely to cause death or grievous hurt, done by consent—“Nothing which is not intended to cause death, or grievous hurt, and which is not known by the doer to be likely to cause death or grievous hurt, is an offence:
    • By reason of any harm which it may cause, or be intended by the doer to cause, to any person, above eighteen years of age, who has given consent, whether express or implied, to suffer that harm; or
    • By reason of any harm which it may be known by the doer to be likely to cause to any such person who has consented to take the risk of that harm.” Illustrations: A doctor informs the patient of the risk of harm during surgery. The patient agrees to undergo the operation and provides his informed consent to the doctor. The doctor performs the surgery skillfully to avoid any harm to the patient. However, in spite of taking all reasonable care and caution, the patient suffers harm. Doctor has committed no offence.
  • Section 88 IPC: Act not intended to cause death, done by consent in good faith for person's benefit—“Nothing, which is not intended to cause death, is an offence by reason of any harm which it may cause, or be intended by the doer to cause, or be known by the doer to be likely to cause, to any person for whose benefit it is done in good faith, and who has given a consent, whether express or implied to suffer that harm, or to take the risk of that harm.” Illustrations: A, a surgeon, knowing that a particular operation is likely to cause the death of Z, who suffers under the painful complaint, but not intending to cause Z's death, and intending, in good faith, Z's benefit, performs that operation on Z, with Z's consent. A has committed no offence.
  • Section 89 IPC: Act done in good faith for benefit of child or insane person, by or by consent of guardian—“Nothing which is done in good faith for the benefit of a person under twelve years of age, or of unsound mind, by or by consent, either express or implied, of the guardian or other person having lawful charge of that person, is an offence by reason of any harm which it may cause, or be intended by the doer to cause or be known by the doer to be likely to cause to that person: Provided:
    1. 18That this exception shall not extend to the intentional causing of death, or to the attempting to cause death;
    2. That this exception shall not extend to the doing of anything which the person doing it knows to be likely to cause death, for any purpose other than the preventing of death or grievous hurt, or the curing of any grievous disease or infirmity;
    3. That this exception shall not extend to the voluntary causing of grievous hurt, or to the attempting to cause grievous hurt, unless it be for the purpose of preventing death or grievous hurt, or the curing of any grievous disease or infirmity;
    4. That this exception shall not extend to the abetment of any offence, to the committing of which offence it would not extend.
      Illustrations: A, in good faith, for his child's benefit without his child's consent, has his child cut for the stone by a surgeon knowing it to be likely that the operation will cause the child's death, but not intending to cause the child's death. A is within the exception, in as much as his object was the cure of the child.
  • Section 90 IPC: A consent is not such a consent as it intended by any section of this code:
    1. If the consent is given by a person under fear of injury, or under a misconception of fact, and if the person doing the act knows, or has reason to believe, that the consent was given in consequence of such fear or misconception; or
    2. If the consent is given by a person who, from unsoundness of mind, or intoxication, is unable to understand the nature and consequence of that to which he gives his consent; or
    3. Unless the contrary appears from the context, if the consent is given by a person who is under twelve years of age.
  • Section 92 IPC: Act done in good faith for benefit of a person without consent: 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 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 with benefit: Provided:
    1. That this exception shall not extend to the intentional causing of death, or the attempting to cause death;
    2. That this exception shall not extend to the doing of anything which the person doing it knows to be likely to cause death, for any purpose other than the preventing of death or grievous hurt, or the curing of any grievous disease or infirmity;19
    3. That this exception shall not extend to the voluntary causing of hurt, or to the attempting to cause hurt, for any purpose other than the preventing of death or hurt;
    4. That this exception shall not extend to the abetment of any offence, to the committing of which offence it would not extend.
      Illustrations:
      1. Z sustains a vehicular accident and becomes unconscious. A, a surgeon, after examining Z, is of the opinion that Z requires “burr-hole” surgery. A, not intending Z's death, but in good faith, for Z's benefit, performs the burr hole before Z recovers his power of judging for himself. A has committed no offence.
      2. A is a surgeon. A child who has fell from height is brought to A's hospital. A, after examining the child is of the opinion that the injuries are likely to prove fatal unless an operation be immediately performed. There is no time to apply to the child's parents/guardian. A performs the operation, intending, in good faith, the child's benefit. A has committed no offence.
  • Section 93 IPC: No communication made in good faith is an offence by reason of any harm to the person to whom it is made, if it is made for the benefit of that person. Illustration: A, a surgeon, in good faith, communicates to a patient his opinion that he cannot live. The patient dies in consequence of the shock. A has committed no offence, though he knew it to be likely that the communication might cause the patient's death.
  • The Medical Council of India lays down a code of ethics regulations (2002). Chapter No. 7 of the said code, mentions acts of commission or omission on the part of a physician which shall constitute professional misconduct rendering him/her liable for disciplinary action. Clause 7.16 of the said chapter places the following responsibility on a doctor: “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”.
 
VALIDITY OF CONSENT
In India, the overall awareness amongst doctors about the concept of informed consent and of requirement of obtaining an informed consent is poor. Even when consent is obtained, most of the times, it proves to be invalid on following accounts:
  1. Oral consent is taken, which cannot be proved
  2. It is a blanket consent20
  3. The act consented to is unlawful, e.g. criminal abortion
  4. Patient's signature is obtained on a consent form written in language that the patient does not understand
  5. Signature of the patient is obtained on the consent form when the patient is being wheeled into the operation theater or labor room
  6. When the patient signed the consent, she/he was under influence of sedatives, premedications or other drugs affecting the consciousness/orientation/intelligence/reasoning/alertness of the patient
  7. Patient's signature is obtained when the patient's ability to make decisions about surgery/anesthesia is in question, e.g. when she/he is under stress, in labor, with organic brain disease, etc.
  8. It is not an informed consent
  9. It is obtained by misrepresentation or fraud
  10. Patient is minor or with known mental illness or one who does not have legal capacity to give the consent
  11. Patient is immature to understand the information conveyed to him/her, etc.
    Valid consent to medical procedures intended for the benefit of the patient absolves the doctor from blame. The important word here is “valid” and it is now well established that, to be valid, consent must be in the nature of what is popularly known as “informed consent”.
    Thus, to be legally valid, the consent should comply with the following requirements:
    1. The patient should be an adult, conscious, oriented and without any mental illness or organic brain disease. In case of minor/mentally ill/unconscious patient, consent should be obtained from the legal guardian or Next of Kin. Thus, the patient should have the capacity and competence to consent.
    2. Consent should be voluntary.
    3. Consent should be free and real.
    4. Consent should be in a language understood by the patient. Ideally the consent forms should be in the vernacular of the patient.
    5. Consent should be documented. Even when it is implied or oral expressed consent, the doctor should document the fact and circumstances of the consent in his clinical notes.
    6. The consent should be patient-specific and procedure-specific.
    7. Consent should contain all the components of consent, i.e. it should be on the basis of adequate information concerning the nature of treatment procedure, so that the patient knows what he is consenting to.
    8. Doctors should seek and secure the consent of the patient before commencing a treatment/procedure/surgery.
    9. Consent should be based only on correct information.21
    10. It should be signed by the patient, a witness, and the doctor. All signatures should be named. If witness is related to the patient, then his/her relation should be stated. If the witness is unrelated and independent, then a detailed postal address of such witness along with contact details should be mentioned.
    11. Signatures of all signatories (Patient, witness, and doctor) should be at the same time and not at different times. All signatories should mention the time of their respective signatures. Doctors should affix their official seal.
    12. The witness and the doctor should be present when the patient is signing the consent form. A witness can attest patient's signature only if she/he is present while the patient is signing.
    13. It should be dated and should bear the time.
    14. It should not be obtained by means of fraud, mistake or misrepresentation.
    15. Each and every applicable column/blank spaces should be completely filled. No applicable space should be left blank.
 
DURATION OF CONSENT
There is no time limit to the validity of a patient's consent. Only if significant period has elapsed since time of initial informed consent and in this intervening period between the consent discussion and the procedure, circumstances have changed in a way that has significantly and materially altered the patient's condition, the consent will become invalid. Also, in case any material risks or any other aspect of the treatment or new information has become available, for example, about the risks of treatment or about other treatment options, then also, the initial consent will become invalid. So, even when a prior consent is obtained, before beginning treatment, the doctor should ensure that the patient still wants to go ahead; and doctor must respond to any new or repeated concerns or questions they raise.
 
LANGUAGES OF CONSENT
  1. Because the very purpose of consent is to first provide information to the patient and then obtain his voluntary consent, the consent must be in a language which the patient understands. The hospital should translate the consent forms in the local language.
  2. In case a patient is unable to understand the language of the doctor, services of a translator should be used. Once the translator explains the contents of the consent form to the patient, the patient should mention in his handwriting that the contents of consent form were explained to him in his own language and that he understood them, followed by signature of the patient. The translator should also sign as a witness.22
  3. In case of an illiterate patient (who is able to speak and understands the language of communication, but cannot read and write it or is visually impaired), the contents of consent form should be explained to him in his language in presence of a witness. The witness should be present throughout the process of explanation of the consent form to such patient. After the process, the witness should document that the contents of consent form were explained by the doctor to the patient in patient's language to the satisfaction of the patient and that he witnessed the entire process.
  4. The language used in the consent form should be understandable by an ordinary lay person. It does little good to have a consent form that describes a potential procedure in terms cognizable in a medical treatise, because when it is presented to lay jury they will be readily convinced that they would not have understood the consent form either.
  5. Doctors must ensure the suitability of the information for the individual patient. He should take into account any issues that may impair effective communication, such as patients’ vision and hearing, language ability, and literacy levels.
 
TIME OF RECORDING OF INFORMED CONSENT
  • The consent form should be obtained at a time when the patient is best able to understand what he or she is signing. Consent forms that are executed after a patient has been premedicated for anesthesia, for instance, would hardly create much of a defense in a claim of lack of informed consent. Thus, the practice of obtaining signature on dotted lines in a preprinted consent form while the patient is being wheeled into the labor room or operation theater should be strictly avoided.
  • Sufficient time should be provided to the patient to imbibe the provided information, to discuss it with family members, family doctor, and their known consultants, to ask questions and get satisfactory replies from the doctor who has explained the consent to the patient. Ideally, whenever a procedure is to be carried out, all the above information should be provided at least 24 hours before. If the procedure is to be carried out on “daycare basis” or “OPD basis”, the information should be provided during the previous OPD visit and not during the same visit, when the procedure is to be carried out. The OPD paper should mention the details of information provided to the patient with date and time. A copy of OPD papers should be preserved by the doctor/hospital. Also any special instruction provided to the patient, e.g. starting/stopping of any medicine before coming to hospital, maintaining “Nil by Mouth” for minimum 6 hours, etc. should be documented in the OPD paper. The documents 23on the day of procedure should first mention whether the instructions provided to the patient are followed by him or not.
  • It is important for the doctors to understand that the patient is entitled to the time necessary to arrive at a reasonable determination as to therapy and alternatives and that the time taken for complete disclosure to the patient will not only serve well for the purpose of informed consent, but will also reinforce the entire doctor–patient relationship and may avoid litigation altogether. Patients rarely sue a doctor with whom they have good rapport.
  • If there has been a significant time gap between signing a consent and actual procedure, the relevant section on the form should be signed by the doctor to confirm consent.
 
PLACE OF OBTAINING INFORMED CONSENT
  • Situations where a patient is required to make the decisions about treatment choices in poor psychological settings should be avoided. Patient in preoperative wards or lying on stretcher or in dental chair or in labor room are not psychologically soothing areas for an average patient to make treatment choices. Conversations relative to important choices should be made before patients land in such areas, as the courts may well feel that decision made in such atmosphere was made hurriedly and without proper opportunity for reflection.
  • Consent should be obtained even for minor procedures like local anesthesia, abscess drainage, suturing of a laceration, etc. Patients should be informed of common risks even if they are not serious, and very serious risks, such as death, even if they are not common. Doctors should ask the patient if they require any specific information or are there any special informational needs, which is not obvious to doctors.
 
EXPRESSION OF CONSENT
  • In his advisory role, the doctor should engage in dialogue with the patient and ensure that the patient understands the nature and gravity of his illness, the proposed treatment and its benefits, risks involved, and alternatives available so that he can make an informed decision. Such advice by the doctor will be effective only if the information provided is comprehensible. Thus, a doctor should not bombard patients with technical information with medical jargon which he cannot reasonably be expected to understand.
  • While explaining the incidence of risk to patients, if doctors merely recite the statistical figures, it may not be understood by the patients. So, the 24risks should be explained in such a way so that the information will be related to the risks which have some meaning for the patient. Thus, while explaining 1 in 50,000 risk of death during general anesthesia in healthy patients, it can be compared to the number of deaths in vehicular accidents (about twice that), so that the provided information will be relevant to the patients.
  • Some corporate hospitals have started with a practice to show a patient a video tape concerning a prospective procedure and the risks attendant or to have the patient review a written literature of the proposed therapy and the risks attendant and to sign that they have either viewed the video tape or read the literature. This obviously is an effective tool in defense, of medical negligence claims based upon lack of informed consent (provided that the video clip or written statement is properly complete) because it obviously gets around the question of the patients failing memory and assertions that written notations in the doctors records are self-serving and not indicative of actual communication. However, these methods obviously have a chilling effect on the doctor–patient relationship if not handled diplomatically, and they are subject to the criticism that they are not tailored to each individual patient. If they are used, the physician should still take the time to discuss the situation with the patient in order to tailor any further explanation to the particular patient; notes of that subsequent conversation should be carefully made. When you support your discussion with patients by written material, pictures, diagrams or video clips, please ensure that the contents are accurate and up to date.
  • Never tell a patient that you are going to perform a routine procedure, as none is routine. Also do not ever mention that the treatment or procedure is simple. Similarly, never tell the patient that no complications will occur because complications may occur.
  • Unless doctors provide relevant and sufficient information about the disease and planned treatment, the patients cannot be expected to ask relevant questions. Hence, doctors should not just tell the patients to ask if they have any doubts and then expect to obtain informed consent by just answering the question asked by the patients.
  • Follow the rule “the greater the risk and the lesser the chances of therapeutic benefit, the more you should explain to the patient to obtain his consent”.
  • The wider the choice or greater the risks involved in one or other course of treatment, the greater must be the communication. Merely asking the patient if they want to know anything else will not suffice. Because patients cannot be expected to ask if they do not know about risks involved and treatment options.25
  • When sharing information with patients, a doctor should not make assumptions about the nature of information that the patient might require or consider significant, the level of his understanding or knowledge about proposed therapy and also about the option which a patient might choose. The choices made by the patient might be different from doctor's choice of therapy, if the doctor was the one having the treatment.
 
RESPONSIBILITY FOR DISCLOSURE OF INFORMATION
  • Good doctor–patient relationships are by far the best defense to any claim of medical negligence. The doctor must himself make the disclosure of the proposed therapy and the risks and the alternatives and not delegate this to any other persons, another practitioner. The duty is upon the attending doctor, delegation of the duty may become important in litigation, as it may very well be interpreted by the courts as an indication of lack of interest and care.
  • A patient's consent to undergo a procedure by one physician does not ordinarily constitute consent to performance by a substitute physician.
  • It is observed that many consultants cite a common reason of lack of time to discuss with the patients/relatives. However, this is not a valid reason for avoiding consent discussions and courts do not accept it. According to the judges in the Montgomery case, “even those doctors who have less skill or inclination for communication, or are more hurried, are obliged to pause and engage in the discussion which the law requires”.
 
RECORDING OF AN INFORMED CONSENT
  • While recording an informed consent, patient's autonomy should be maintained and patients should be treated as individuals. Patient's lack of capacity to understand the information provided and make a decision should not be assumed just because of their state of illness or disability, age, appearance and apparent inability to communicate, level of literacy, behavior, their beliefs, or the fact that patients choose an option with which doctor disagrees.
  • It may also be advisable to have someone else to be present with the patient when discussing proposed therapy because the patient is often not in the best psychological position to remember or to evaluate what is being disclosed. Of course, one runs the risk of having both of these parties assert that the doctor did not make a proper disclosure. Experiments conducted by some physicians indicate that spouses do not have an appreciable higher recall than the patient, but it creates an atmosphere of openness that may appeal to the courts.26
  • Every informed consent obtained by the doctor should be “patient-specific” and “procedure-specific”. Even when printed informed consent forms are used by most hospitals, they should be made “patient-specific” and “procedure-specific” by intelligently filling in the blank spaces meant for name and qualifications of doctors, details of the proposed procedure, inherent and material risk factors, frequent and grave complications, signatures of patient, witness and the doctor, date and time.
  • Obtaining consent is a continuous process. Therefore, it is better to inform the patient in at least two sitting and the same can be noted in the consent form. This procedure will only strengthen the case of the medical professional before the appropriate forum as consent was obtained first and the second time the patient again reconfirmed what he agreed to earlier. For admitted patients, continuity of consent process should be maintained at each stage of clinical management. It must be understood by the patient that they are free to withhold or withdraw the consent even during treatment if the patient is conscious.
  • Doctors are advised to act as if they or their family members are on the receiving end of the treatment and factual and impartial advice should be provided, in good faith, about which treatment will, in your medical opinion, be the most appropriate for the patient. Doctors should avoid influencing the options and choices of the patient with their own views and preferences. Once the doctor provides options to the patient, the patients do ask doctors their opinion. However, in such situations, doctors should provide their honest view, taking care that it does not have a pressurizing effect on the patient to choose an option which would not have been their choice.
  • Doctors should maintain a contemporaneous documentation of decision-making records containing main points of the consent discussion and patient's decision in addition to completing the consent form. This should be done even if the patient decides not to undergo a procedure or not to have any treatment. Any discussion regarding consent with patient's relatives, Next of Kin should also be documented. All oral instructions given to the patient and also contents of written information provided should also be documented. Copies should be included in the patient's notes.
  • After informing all relevant details about the treatment options and risks to the patient, if the patient provides a partial consent by imposing certain limits on the proposed standard treatment protocol, then the doctor should clearly document all such patient-imposed restrictions and the effects of such limits in the clinical management of the patient and the final outcome. All the discussion with the patient about the effects of such limits should also be documented. In case the doctor believes that treating the patient with such restrictions might lead to suboptimal clinical results 27or increase the chances of complications then he may refer the patient to another doctor.
  • Before the Montgomery case, surgeon would provide the relevant information to the patient and explain him the procedure and obtain his informed consent. However, post-Montgomery, the doctors have to set out all available treatment options before the patient and allow the patient to decide. Because of this development, the doctors are required to inspect the values and wishes of the patient about the treatment. The doctors are also required to obtain enough understanding about the risks and benefits that are material to the patient.
 
REFERRALS BETWEEN SPECIALTIES
There is a particular risk with patients being transferred between specialties. Patients can come to harm when there is lack of clarity about which doctor is responsible for the management of the patient. When a surgeon refers a patient for another procedure (e.g. interventional radiological procedure), it is the referring doctor who should formally hold the first part of the consent discussion and document it, as they understand the risks and benefits of the proposed options and any alternatives (including doing nothing) and can discuss these with the patient. The final confirmation of informed consent remains the responsibility of the doctor who will carry out the procedure.
 
SIGNING THE CONSENT FORMS
  • A duly signed consent form is an evidence to confirm the fact of discussion related to treatment options between a doctor and his patient, it follows that the same doctor who personally so discussed with the patient should complete the consent form and sign it.
  • The consent form should always be signed by the patient himself/herself, if they are adults and capable of signing. In India, doctors commonly obtain signatures of relatives, even when the adult patient is capable of providing his/her consent, but it should be avoided. Once such patient provides his informed consent, other relatives can sign as witness, if they have witnessed the patient sign.
  • The patient, the doctor, and the witness, all should sign the consent form contemporaneously.
 
WITNESSING THE PROCESS OF INFORMED CONSENT
  1. Legal provisions:
    1. Section 13 of the Indian Contract Act, defines Consent as: Two or more persons are said to consent when they agree upon the same 28thing in the same sense. Consent in the context of medical profession implies permission by the patient to perform an act on his body either for diagnosis or therapeutic procedure.
    2. The Supreme Court of India in Samira Kohli versus Prabha Manchanda Dr & ANR 1 (2008) CPJ 56 (SC) has elaborated various aspects of obtaining consent. Also, guidelines to obtain valid informed consent were also laid down. As such it is an attempt to streamline consent process in India; however there is no reference to the requirement of witness while recording of consent of a patient for treatment.
    3. Section 10 of the Indian Contract Act provides that if the presence of witness is required by any law, such requirement must be observed. A witness is a person who observes the process of signing of a document and then himself signs it as a witness. By this the witness attests that the document was signed in his presence.
    4. Indian legal system is heavily influenced by the UK legal system. Moreover, currently, great emphasis is given to the practice of evidence-based medicine. In view of these it is advisable to implement a suitable system as regards the necessity of a “witness” in the consent forms.
    5. Though the role of a witness in informed consent process is limited, it is important as witnessing of consent protects the patients. Thus, it should be ensured that by witnessing consent, any conflict of interest or privacy violation of the patient is protected.
    6. Witness’ role in consent: When a witness signs the consent form, he attests to have actually observed the parties to the consent signing the consent form. The witness's signature does not imply that he witnessed the practitioner fully informed the patient of the risks and benefits of the procedure or that the patient understood it. The basic purpose of a witness is to authenticate that the parties to the consent signed the consent form. It follows that the witness may be called to testify to that fact.
    7. Witness can be:
      1. A signature witness: A signature witness only witnesses the act of signing the consent form by the doctor and the patient freely. Such a witness does not verify the identity of the participants. A signature witness also does not witness whether the participant was competent or whether understood the consent discussion. It also does not witness that sufficient information was provided.
      2. Witness to the consent process: In some situations, it may be required that the witness needs to assume broader responsibilities in the informed consent process. This will depend on the situation/types of patient/treatment planned, etc. It is required when:29
        1. When the consent giver cannot read (either the patient or the patient's legally authorized representative speaks and understands the language of communication, but cannot read and write it or is visually impaired). In such cases the witness must be present throughout the consent process and witness the information being shared by the doctor with the patient. After the consenting parties sign the consent form in presence of the witness, such witness should sign and date the consent form. Thereby such a witness attests the fact that all written information was correctly explained by the doctor and apparently understood by the patient and that the informed consent was freely provided by the patient.
        2. When the patient has impaired capacity to consent. The impairment or disability or injury may be temporary or episodic. In such situations, consent should be obtained at a time when such impairment does not interfere with their capacity to consent. In such cases the witness must be someone who has the capacity to understand the proposed treatment, its merits and associated risks.
    8. Criteria of a witness:
      1. Legally, a witness may be a relative, friend or a stranger but must have completed at least eighteen years of age and must be competent and capable. A member of the hospital staff can also be a witness, but it is not advisable as it might create conflict of interest and his credibility may be called in question. Moreover, if a member of the treatment team serves as witness, it may be alleged that the patient was pressurized to sign the consent form.
      2. Generally, any adult may sign as a witness on the consent form. Hospitals have printed consent forms with blank spaces to fill in the various components of the consent. It is possible that the courts interpret the contents of these forms in patient's favor (i.e. that the consent is invalid or was not really obtained, etc.). For this reason, preferably, any non-interested employee of the hospital or a family member, friend, or escort of the patient should be preferred. Such a person (a witness) should witness the entire process of the consent process and then only she/he should put his/her sign on the consent form as a “witness”.
      3. In situations where the risks and complications in the treatment are more severe and hazardous, it should be ensured that patient's signature or that of Next of Kin should always be witnessed by someone other than hospital staff.30
      1. Thus, it is advisable for the hospitals to have a predefined written policy regarding the witness criteria. It should have parameters as to who may serve as an Impartial Witness. Once so defined, the hospitals should identify and educate the hospital staff about their role and duties while witnessing consent, if they are required to do so. This will help reduce the incidences of selecting unqualified, inexperienced, untrained, and inappropriate witnesses from amongst the hospital staff hurriedly, to act as impartial witnesses, especially where the situation demands presence of a witness who has the capacity to understand the proposed treatment, its merits and associated risks, e.g. in case of when the patient has impaired capacity to consent.
  2. Even though there is no existing law in India, applicable to medical profession, which mandates witnessing the signatures of doctor and patient on the consent form or the entire consent process to be witnessed by an impartial witness, still, because the western world has already adopted the concept of a “witness” on consent form, hospitals may also commence/continue the said concept.
  3. In order to effectively implement the same, hospitals may incorporate the following criteria in the protocol for a “witness”:
    1. Consents for all routine investigations/procedures and surgeries should be witnessed by a “signature witness”.
    2. Patient, doctor, and witness, should all sign the consent form simultaneously and not at different times. The contemporaneous signature of a witness serves two purposes. First, it impresses upon the patient the importance of the document the patient is signing. Second, it documents a part of the informed consent process, namely the patient's agreement to undergo the procedure.
    3. The roles and responsibilities of a signature witness should be mentioned in the protocol for a “witness”.
    4. As the role of the “signature witness” is only to witness that the participants to the consent were seen by the witness to freely sign the consent form, this need not be an impartial witness.
    5. In those cases in which the patient/relatives are illiterate (cannot read and write the language of the consent form or are blind), or the patient has impaired capacity to consent (and consent is being obtained at a time when their condition does not interfere with their capacity to consent) the person witnessing should witness the entire process of obtaining consent.
    6. In the situation as mentioned in above clause, the role of a witness is to understand the merits, risks, and procedures of the proposed treatment and explain it to the patient/legal representatives, if they do not comprehend or have any doubts etc.; so, such a witness has to be 31someone who has this clinical knowledge. So, such a witness has to be necessarily either a doctor colleague or a trained nurse.
    7. Such hospital staff should be identified and trained to be witnesses, and the record of their training should be maintained. So that the clinicians need not search for a witness randomly when the consent is required to be obtained.
    8. If a nurse is witnessing consent, she/he should be careful, though, not to offer advice about the risk/benefit calculations; such calculations and advice should be left to the doctors.
    9. In very rare situation and when it is reasonably apprehended by the doctors/nurses that the patient/relatives are potential trouble makers, the signature of an independent and impartial person should be taken as a witness.
  4. Such a protocol may be included in the hospital policy. All the nursing, paramedic and medical staff be sensitized toward this issue of “being a witness”, roles and responsibilities of a witness.
 
SCOPE OF CONSENT
This is an important aspect of consent which is not seriously considered by most of the surgeons. Even if a proper informed consent is obtained, but if the scope of the consent is not sufficiently broad, the doctors may not be able to defend themselves.
  • The failure to fully and adequately advise the risks of a surgery to which the patient has consented is generally categorized as negligence. But performing a surgery that the patient has not consented to, or which is substantially different than what was consented to, is battery, an intentional tort. Intentional torts are, by their nature, uninsurable, so professional indemnity insurance will typically not cover the exposure created. Moreover, the exclusion clauses in most of the indemnity insurance policies state that battery will destroy the indemnity for the offending physician.
  • In case of Dr Karl Pizzalotto versus Ms Wilson, decided by Supreme Court of Louisiana on 2nd September 1983, the doctor has obtained a general consent for “laparotomy, lysis of adhesions, fulguration of endometrioma”. The doctor never discussed with his patient the possible removal of her reproductive organs, nor was it included in the consent form. However, during surgery, hysterectomy and bilateral salpingo-oophorectomy was performed. It was held that, “Regardless of the reasonableness of the surgery or its eventual necessity, a physician may not act beyond his patient's authorization, except when a situation seriously threatens the health or life of the patient.”
  • Thus, scope of surgery should be intelligently decided by the surgeon at the time of obtaining informed consent. The surgeon, with his subject 32knowledge and experience, should reasonably anticipate/suspect any requirement for extension of surgery. He should take special precautions to investigate the patient preoperatively in view of this anticipation. He should consciously think about most probable differential diagnoses. If there is any such possibility, then include it in the scope of consent. For example, possibility of extensive endometriosis during diagnostic laparotomy or consent for excision of tumor during excision biopsy.
  • Allegations about “lack of consent” before various courts, commissions or enquiry committees are always discussed and decided on facts and circumstances of each case and the orders/judgments in any individual case cannot be generalized. Hence, it is advisable to operate within the scope of consent.
  • Surgeons should not delegate the task of deciding the scope of informed consent and obtaining the consent to subordinates. Moreover, the entire process of consent should be completed before posting the patient for surgery. Before commencing the surgery, surgeons should verify the compliance as regards the informed consent and ensure that the scope of consent is sufficiently broad.
  • Consent given only to diagnose/confirm or rule out an ailment/pathology cannot be considered as consent for surgery/therapy/treatment.
  • Consent given for certain specific treatment procedure will not be valid for conducting some other treatment procedure or the same treatment by other route (e.g. vaginal hysterectomy attempted when consent was for abdominal hysterectomy as in Smt Saroj Chandhoke versus Sir Ganga Ram Hospital decided by National Consumer Disputes Redressal Commission, New Delhi). Even if an additional surgery or extension of the planned surgery (to which the patient has consented) is advantageous to the patient or it would benefit the patient by saving his time and money or by relieving his pain and suffering, cannot be valid defenses for a doctor in cases of allegations of medical negligence or assault or battery, if the said additional surgery or extended surgery is unauthorized and not consented to by the patient.
  • However, an exception to the above rule is in cases of emergencies where, to save the life or limb of the patient, urgent medical intervention is required and the patient is not capable of giving a valid consent, e.g. by reason of being unconscious. In such situations, it will be unreasonable (as contrasted from being merely inconvenient) to prolong the treatment till the patient regains consciousness and becomes capable of giving consent.
  • If a diagnostic and therapeutic procedure is already planned, a common consent for both can be obtained. Similarly, if the surgeon, after thoroughly investigating the patient, anticipates that an extension of the surgical procedure or an additional procedure might be required, then a 33common consent for the primary surgery and such extension/additional surgery can be obtained.
  • Consent for surgery cannot imply consent for anesthesia for that surgery. Because the nature, procedure, and risks of anesthesia are totally different from those of surgical procedure, the consent for anesthesia must be separate. A surgeon cannot be expected to provide complete information about the details of anesthesia to the patient. It must be obtained by the anesthesiologist and should be sufficiently “informed” consent.
  • The scope of decisions must be always clearly explained to patients. This will apply particularly if a treatment is required to be provided in stages or different doctors will be providing specific parts of the treatment procedure like anesthesia, surgery, and physiotherapy. Also, it is advisable to define the scope of consent when the diagnosis is uncertain or when the further treatment options depend on the progress once the initial treatment has started and if at that time the patient may not be capable of providing his consent.
  • In such cases, the patient should be fully informed about the circumstances which will decide whether and when it will be required to make changes in the investigation and/or treatment plan. Doctors should ensure and document whether the patient agrees fully or partly to the proposed plan. If the patient consents only to part of the proposed plan, then the doctor should inform the resultant various possibilities and alternatives and also the process that will be required to be followed in involving the patient in decision-making at a later stage.
  • Except in emergency, doctors must not exceed the scope of the consent given by a patient.
 
COMPONENTS OF CONSENT
The information provided by the doctor to a patient before initiating the treatment should be adequate enough for the patient to make a balanced judgment and an informed choice to decide whether or not to submit himself to the proposed treatment. Thus, the doctor should personally inform (wherever possible):
  • Name, nature, and purpose of the proposed investigative/treatment procedure, its risks and benefits, the available alternatives to the proposed procedure (if two kinds of treatment procedures are available from two schools of thought for the same disease).
  • The differential/final diagnosis and prognosis. Uncertainty, if any, about diagnosis and/or prognosis and also the possibility of requirement of additional diagnostic procedures.
  • The basis for choosing the proposed treatment for the patient, its advantages over the other, chances of success over the other method, 34the lesser risk of this method over the other, the advantage when cost is considered, the quick convalescence in the proposed treatment, etc.
  • The risks involved and their types with examples, especially those which are frequent (though not grave) and those that are grave (though not frequent). It is difficult to quote the assessment of materiality of risk in “percentages”. This is because, besides its magnitude, the significance of a particular risk also depends on multiple factors including its nature, its possible effect upon the patient's life, significance of the benefits of treatment to the patient, available alternatives and their risks and benefits vis-á-vis the proposed procedure. However, the percentage of risk in general population (not specific to that patient) as documented in standard treatises of medicine should be disclosed to the patient.
  • Alternatives to the proposed procedure, if any available and comparative benefits; even if the treating doctor or his hospital cannot offer such alternative treatments.
  • An outline of the substantial risks, benefits and uncertainties related to each alternative.
  • Adverse consequences and material risks of refusing treatment including effect on prognosis should also be informed.
  • Finally, information about the steps to be taken in case the proposed procedure turns out to be unsuccessful or harmful, should be provided.
All the above information should be provided in good faith and for the benefit of the patient, and with an aim to enable the patient to make an informed choice. The information so provided to the patient should be factual and it should not be influencing the patient to make such a choice which he does not wish to make even though the said choice has been proposed by a multidisciplinary team.
In addition, it is advisable to provide the following information to the patient:
  • Approximate cost of the proposed treatment. Inform an approximate cost of the proposed treatment/procedure and approximate cost of any additional procedure/surgery that may be required. For example, if the patient develops internal bleeding following a major abdominal surgery, e.g. partial gastrectomy with gastrojejunostomy, this may require another operation (to open the abdomen to identify the bleeding source and take steps to arrest bleeding). This will involve additional cost to the patient and the patient should be told about this. A 10% increase is generally allowed in the estimate.
  • Explain the relative chances of success or failure of the procedure so that the patient has an option to accept or refuse the treatment.
  • The disclosure of risk should be detailed and elaborate when the proposed treatment or procedure is new, or is capable of affecting the sexual 35functions/fertility or has mainly cosmetic effect or is ultra-hazardous or is still experimental in nature.
  • If a surgeon has any intention to perform procedures incidental to the planned procedure such as appendicectomy during a hysterectomy, it should be disclosed.
  • The expected length of stay.
  • Hospital resources.
  • Name, qualifications, and professional standing of the doctor performing the procedure and whether medical students doing their postgraduation will be involved.
  • That the patient has a right to refuse to participate in teaching or research. Patients have a right to refuse students to treat him.
  • Patients have a choice to seek further opinion from another doctor and/or, if indicated, to be reviewed by a doctor.
 
REVISITING INFORMED CONSENT
  • Doctors’ experience: Though some case law suggests that doctors’ experience may not be always disclosed, however the authors recommend that the qualifications, experience, and the professional standing of doctors should always be disclosed. The patients should never be kept in dark about any lack of experience, training or qualification of the doctor. In cases of litigations, it might be construed as breach of informed consent.
  • Doctors’ health status: While deciding the issue as to whether the doctor's health status should be disclosed to the patients while obtaining informed consent, the courts have examined the issue whether and how doctor's health affects his ability to treat the patient. Surgeons suffering from diseases that have a direct impact on the healthcare delivery, e.g. Raynaud's syndrome or HIV positive status should disclose these facts to their patients while obtaining informed consent. Whereas, conditions like epilepsy or HIV positive status in a nonoperating doctor may not be disclosed, provided the doctor genuinely believes that existence of such a disease will not harm the patients.
  • Details of assisting/attending doctors: It is recommended that details of all surgeons and anesthesiologists who are participating in the surgical procedure should be informed to the patient. The information should include the roles to be played by each one of them in the procedure. In a teaching hospital, if resident doctors who are in training stage are going to assist/observe during surgery, under supervision of senior suitably qualified and experienced staff, this information can be provided while obtaining generic consent form.
  • Doctors’ disciplinary history: It is possible that the treating doctors might have been implicated under charges of professional misconduct or 36professional negligence or a Criminal act. It is recommended that the doctors should disclose such history to the patient if it directly relates to doctors’ professional competence and patient's safety.
  • Approval status of medical device: In India, Central Drugs Standard Control Organization (CDSCO) is the Central Drug Authority for discharging functions assigned to the Central Government under the Drugs and Cosmetics Act. It has the regulatory control over the import of drugs, approval of new drugs, and clinical trials. As per section 3(b) of the Drugs and Cosmetic Act 1940, the definition of “drug” includes “all such devices intended for internal or external use”. If the status of a medical device is approved by CDSCO, it need not be disclosed to the patient. However, it the device is not approved by CDSCO, this fact must be informed to the patient before obtaining his informed consent.
  • Research and financial interests: If this information is related to treatment that the doctor has planned to provide to the patient, then it should be disclosed to the patient. A prudent doctor should honestly disclose such relationship before obtaining informed consent.
 
PERMISSIBLE EXCLUSIONS FROM INFORMED CONSENT
  • Any remote or theoretical risks need not be explained to the patient. It might have a frightening effect on the patient which might result in refusal of a much required procedure.
  • Similarly, any remote or theoretical risks of refusal to consent to treatment need not be explained.
  • Doctors should achieve a balance between providing the relevant and necessary information and avoiding disclosure of such information which will deter the patient from consenting to a necessary treatment or lure him to undergo an unnecessary treatment.
 
AUTHORITY TO CONSENT
  • In India, frequently, consent is obtained from patient's relatives (and not from the patient), even when the patient is an adult and capable and competent to give valid consent. This is mostly out of ignorance than anything else.
  • Similarly, many doctors disclose and discuss the results of investigations, need for surgery, procedure of surgery, etc. with the relatives and not with the patient and that too without consent of the patient.
  • Whenever the patient is capable to give consent, his consent must be obtained. The consent must necessarily be signed by the patient himself or herself. No one else has the right to give consent on patient's behalf 37in a matter pertaining to patient's body. It is the patient who must sign to give permission to perform a surgery or procedure on his/her body. Once such patient's consent is obtained, there is no need for anyone else's consent. Also, the information about the results of investigations, details about procedures and surgeries, plan of care, etc. should only be discussed with the patient. Only, if he consents, it may be discussed with others. Although, in Indian setup, it is sound practice to counsel and consult the family members, however, it should be done with the knowledge and consent of the patient.
  • In case of females too, doctors tend to insist on consent of her husband or parents, even if the patient is an adult and competent to give consent. Legally consent of the female is sufficient for sterilization operation and medical termination of pregnancy.
  • It is only when the patient is a minor or of unsound mind or unconscious or otherwise incapable of providing consent, that the consent of Next of Kin should be obtained.
  • As per Section 88 IPC, read with Section 90 IPC, consent can be provided for physical/clinical examination, diagnosis and treatment by a conscious, mentally sound person who has completed twelve years of age. Also, as per Section 87 IPC, those above 18 years of age can provide consent for major surgical operations. Even when this is so (i.e. even when the patients are above the consenting age), occasionally, it is not clear whether the patients are competent to make their own decisions due to the unusual amount of stress associated with the illness leading to fear, anxiety/depression. The mere fact that the patient is under stress due to illness, alone will not prevent him from participating in the informed consent process, however doctors should ensure the patient is capable of understanding the information provided and make an informed choice for himself. In order to assess the decision-making capacity, the doctors should understand the patient's situation, the associated risks with the available options, and inform the decision based on that understanding. In case of doubt, a psychiatric consultation may be sought.
  • If the patient is in critical condition and if the doctor is of the opinion that delaying treatment will worsen the situation leading to loss of life or limb, then in good faith and for the benefit of the patient, the doctor can proceed with the treatment/surgery even without anyone's consent (In such situations, the doctor should document the critical condition of the patient and his vital parameters in his clinical notes).
  • In cases of children, any one of the parents can provide consent on their behalf. However, if any one of the parents objects to the permission given by other parent for any procedure to be carried out on their child (e.g. in 38cases of nontherapeutic circumcision or major experimental treatment) the doctor should not proceed, but for a court order.
  • Similarly, a doctor should not rely on parent's consent if there are sufficient reasons to believe that the parents are not acting in good faith for the best interest of the child and for the benefit of the child. Such situations might be encountered, e.g. where the parents approach the doctor for psychiatric treatment of the child whereas the child alleges abuse by the parents.
  • Parents can give consent for the treatment of their children, if the parents themselves are capable of giving consent.
  • As per Section 3(4)(a) of the Medical Termination of Pregnancy Act, 1971, in India, no pregnancy of a woman, who has not attained the age of eighteen years, or, who, having attained the age of eighteen years, is a lunatic, shall be terminated except with the consent in writing of her guardian. Section 3(4)(b) states, save as otherwise provided in 3(4)(a), no pregnancy shall be terminated except with the consent of the pregnant woman.
  • In case of operations for sterilization, it is not necessary to have consent of both the spouses for operation on any of them, but, for practical reasons of harmony in the family it is advisable to do so.
  • The authority to obtain consent should vest in the treating doctor and it should not be delegated. The major element of the process of informed consent is discussion with the patient, providing all relevant and required information to him, answering all his doubts, use of printed material, audiovisual aids to ensure that the patient understands what is being told to him. It is not merely a mechanical act of obtaining signature on a form. Thus, the informed consent discussion cannot be delegated to the staff. Staff can assist in the process by providing educational materials such as pamphlets, brochures, videos, and online materials about the procedure generally (materials provided should be documented). But a physician must conduct the discussion with the patient about the anticipation of risks and benefits, available alternatives for the procedure for that specific patient. Inappropriate assurances (or even guarantees) made by staff members may subject the doctor and facility to additional liability based on the inappropriate information given.
 
CAPACITY TO CONSENT
  • Capacity to consent should be differentiated from competency. Whether the patient is competent or incompetent to consent is for the courts to decide. Doctors should decide patient's capacity to consent, which is the ability to receive, understand, and process the information provided by the doctor and communicate a meaningful response. A patient is said to be capable if she/he is an adult, is able to understand the nature 39of proposed treatment, risks involved, its benefits, pros and cons of available alternatives, effects of nontreatment, is able to communicate his healthcare decision and is not otherwise judged incompetent or prohibited from exercising decision-making capacity, by any court of law.
  • In medical practice, consent given by a capable patient for treatment is valid only for that particular treatment (treatment-specific) and at that particular time (time-specific). Hence, the best person to ascertain capability of the patient to provide consent is the treating doctor, who is providing information to the patient and obtaining his consent at that material time, and not any other consultant.
  • Fluctuating decision-making capacity: This situation is occasionally encountered in hospitals, where a patient's decision-making capacity varies from day-to-day as the patient moves in and out of a coherent state. It may be due to the effect of their medications or due to the underlying disease process. In these situations, doctors should try to provide the relevant information to the patient in his lucid state, even suitably modifying the dose of medications, if necessary, in order to include the patient in the decision-making process. The vital parameters of the patient and the state of his mental functions, consciousness, orientation, alertness, etc. should be documented, with date and time, just before obtaining the consent. The consent should also bear the date and time. Doctors should be vigilant about the possibility of patient's capacity to consent being affected in this manner and must ensure that the patient gets required time and to maximize their ability to make informed decisions for themselves.
  • As per Royal College of Surgeons of England, the following two questions should be asked in order to determine patient's decision-making capacity:
    1. Whether there is an impairment in the mind or brain of the patient or is there any disturbance in the functioning of mind or brain, either temporary or permanent?
    2. If yes, then whether due to such impairment, the patient is unable to receive, understand, retain, analyze the information provided by the doctor, at that material time, and to communicate his informed decision?
  • Decision-making capacity is task-specific. Thus, lack of capacity to make a decision at one time does not mean that the patient will also be incapable for same or similar decisions at all times, and, it also does not mean that the patient is incapable of making some other decisions at that material time. Hence, in cases of temporary impairments, the process of informed consent should be deferred till the patient regains his capacity to consent.
  • In case of any doubt regarding the capacity of a patient to consent, advise should be sought from your colleagues, patient's relatives, co-workers, 40etc. who may be aware of the patient's usual or current ability to make decisions. If required, assistance of psychiatrist, wherever indicated, may be sought or in more complicated issues (regarding capacity of a patient to consent), the matter may be referred to courts.
 
PROOF OF CONSENT AND THE BURDEN OF PROOF
  • This issue typically arises in cases of “implied consents” and “oral expressed consents”, which doctors generally do not record. A completely filled and duly signed written expressed consent form is generally accepted by the courts as proof of the consent (to the extent of the contents of such a form), unless the patient has evidence to the contrary.
  • If the doctor pleads availability of patient's consent by way of implied or orally expressed consent, the burden of proving will lie on the doctor so pleading. If the doctor produces a written expressed consent form duly completed and signed by all the parties, and if the patient pleads denial of consent, the burden of such denial will lie on the patient. This may happen if the patient alleges that his signatures on the consent form are forged or that the doctor has obtained his signature on blank form at the time of admission to the hospital and then later on written the matter to his benefit in the blank space above his signature or that his signature was obtained when he was being wheeled into the operation theater or when she was already in labor, etc. and as such she/he was under duress.
  • The burden of proof that consent was sought by the doctor and was refused by the patient is upon the doctor who advanced such a plea that the patient did not give consent for the course of treatment advised by him. In such cases, one has to prove that the nonperformance of surgery or the nonadministration of the treatment was on account of the refusal of the patient to give consent thereto.
  • Judges applying “reasonable patient standard” to decide a case, will determine whether the patient was informed of all that a reasonable patient would expect to be told, and in a way a reasonable patient could understand to assess the relative risks and benefits of undergoing the procedure. Before such courts, the physician must prove that he explained the procedure to the patient using nontechnical terms the patient can understand. So, here, having a family member or friend of the patient witness the consent can help to support the comprehensibility of the information given in the consent process. Inquiry should be made of the family member or friend to ensure all of their questions have been answered as well as those of the patient. However, some judges may apply “Reasonable physician” standard, to determine this issue. Such courts 41will look at whether the physician gave all information a “reasonable physician” would have provided. In these states, it might be preferable to have a witness who is familiar with the process and who might note if all the parts of the procedure were covered in the informed consent discussion.
  • Applying the standard of materiality, where the procedure is more important to patient's health, the claim that the procedure would have been refused, would be less credible. Conversely, the credibility of the patient's claim that he would have refused the procedure had the risks been fully explained to him, would be more, if the procedure was less important to his health.
  • When a therapeutic privilege is used (i.e. if the doctor withholds some information of risk from the anxious patient in order to obtain his consent) and the patient suffers some injury as a result of the undisclosed risk, the doctor should be prepared to shoulder the burden of convincing the court that the circumstances (of withholding the information) were as exceptional as he claimed. On the other hand, in such situations, the patient will be duty bound to show the damage caused to him was as a result of inadequate disclosure by the doctor.
 
EXCEPTIONS TO THE RULE OF CONSENT
  1. Medical emergencies: In all medical emergencies, when the patient's life or limb is in danger and emergency care is required to save it, the doctor need not wait for anyone's consent, but shall immediately start providing the required medical care. Situations where failure to treat a condition which has a potential to cause serious and irreversible damage to patient, are emergency conditions. This practice is justified as per the principle of necessity and of Loco Parentis, i.e. in the place of a parent. Once the patient is stabilized and out of danger, consent for further treatment, continuation of treatment can be obtained from the patient or his Next of Kin (Such a patient, who was provided emergency treatment, without his prior consent, is liable to pay the medical bills).
    • When a doctor operates on a patient in emergency situations, he should maintain detailed records of the patient's condition, especially reflecting the emergency. Moreover, it is advisable to seek consultation from a colleague who should record his opinion about necessity for emergency surgery in the medical records. All entries in the medical records should bear date and time. Treatment in emergency should be continued till the patient is stabilized. If the patient, when he was competent, has previously expressed his choice that he would refuse the emergency treatment, and when the doctor is aware of such 42choice of the patient, then patient's prior expressed decision cannot be overridden.
    • Treatment of those adult patients who are unconscious or who are incapable of understanding or for other reasons cannot give consent is described as nonvoluntary treatment. In such cases, the consent of a relative—which is commonly sought, has no legal force but would be valuable support for the doctor who treats by way of the doctrine of necessity. However, if in such a case the relatives approach the courts with allegations against the doctor of treatment without consent, the court can make a declaration that treatment will not be unlawful; and that doctors should depend upon their right, or even duty, to treat incompetent patient according to their best interests.
    • In dire circumstances, such as a road traffic accident, it is reasonable for a doctor to give treatment that he knows to be inadequate—for example, in the absence of sterile gauze, it would be quite proper to use unsterile material to stop lethal bleeding. Such treatment must be confined to the actual emergency; which cannot be postponed till admission to a hospital.
  2. Patient's waiver: Patients have a right to refuse consent and choose to defer from the opinion of the doctor. Doctors should document patient's capacity to refuse information and consent, but the request must originate from the patient and not the physician. If the request “to not to disclose information” (for the purpose of improving the likelihood that the anxious patient will cooperate with a particular therapy) arises from anyone other than the patient, then it will amount to “using” the patient to meet the ends of another individual, rather than to further his own goals, which will amount to an obvious act of unethical practice. In case the patient is anxious, the doctor may inform him that he has the right to refuse to have an in-depth discussion about the treatment procedure, if it might unduly stress him. It is possible that the patient is unreasonably fearing about the risks involved in treatment and so complete disclosure of the risks involved, is at times reassuring to the patient and decreases the anxiety about the planned procedure.
    Even when any relative or friend or any other Next of Kin requests a doctor to withhold any information related to treatment and its risks that is essential for the patient to make an informed decision, such request should not be entertained. However, if the doctor believes that disclosure of such information to the patient would cause serious harm to the patient, the doctor may opt to withhold it. In this context “serious harm” means more than that the patient might become upset or decide to refuse treatment.43
    If you withhold information from the patient you must record your reason for doing so in the patient's medical records, and you must be prepared to explain and justify your decision. You should regularly review your decision, and consider whether you could give information to the patient later, without causing them serious harm.
  3. Therapeutic privilege: It is an exemption from informed consent guidelines and is a frank exercise of paternalism.
    • If risks involved in the treatment are disclosed to the patient, it is always a compromise between providing reasonable information to the patient and the danger of frightening off the patient from beneficial treatment.
    • Doctor has a moral duty to inform the risks involved in treatment to the patient. Patient has a right to know it under principle of autonomy. However, at the same time, the doctor also has a duty to minimize patient's sufferings as per principle of beneficence. Sometimes, doctor is caught between this moral dilemma, whether to disclose or not. In such dilemma, the doctors may feel obliged to invoke the doctrine of “therapeutic privilege”, which is withholding by the doctor certain information from the patient about the risks involved in treatment, in the belief that disclosure of such information will prove harmful to the patient.
    • In such situations, the doctors should discuss and inform such risks with Next of Kin and obtain his consent.
    • However, such “withholding of information from the patient” does not apply if the doctor is concerned that providing all information to the patient would make the patient less likely to accept treatment.
    • Exceptionally a doctor may come across a situation where he is required to conceal some information from the patient as revealing it might pose such serious and immediate psychological harm so as to be medically contraindicated (therapeutic privilege), e.g. suicidal behavior. However, merely because the disclosure of risks to the patient will lead to refusal of consent for a medical procedure (which, according to the doctor is beneficial to the patient) cannot be an indication for using therapeutic privilege.
    • In Canterbury, the court recognized that patients occasionally are so adversely affected either physically or emotionally by the prospect of risks that the patient is subject to psychological damage or to physiologic damage, increasing the risk of the treatment itself. However, the court pointed out that the therapeutic privilege “must be carefully circumscribed, however, for otherwise it might devour the disclosure rule itself”.44
    • The issue of whether the therapeutic privilege was properly invoked; will always be a question to be decided by the courts even if all of the expert testimony is to the effect that the privilege was properly invoked in that patient. This would seem to allow medically laypersons to make judgments in hindsight of complex and difficult professional issues.
    • As discussed in Montgomery versus Lanarkshire Health Board, therapeutic exception should not be abused. The general principle is that the decision regarding whether or not to undergo a proposed course of treatment rests with the patient and therapeutic privilege is a limited exception to this rule.
    • Exception to therapeutic privilege: In Mr X versus Hospital Z [1998 (6) SC 39], the Hon'ble Supreme Court has held that whenever there is a potential danger of transmitting HIV infection to the would-be spouse, it is the duty of the doctor to inform the would-be spouse of the imminent and potential danger. It shall not come under therapeutic privilege.
    • However, the current American Medical Association (AMA) Code of Medical Ethics rejects the therapeutic privilege. It states: “Except in emergency situations in which a patient is incapable of making an informed decision, withholding information without the patient's knowledge or consent is ethically unacceptable.” According to AMA, it is essential for the doctor and his patients to have an open and truthful communication to build trust in the relationship and also for respect for autonomy. If a doctor withholds relevant information from the patient, believing that such disclosure will harm the patients’ health, it will lead to conflict between the physician's duty to promote patient welfare and to respect patient autonomy.
    • The Supreme Court of UK has clarified that therapeutic exception should be used only rarely. According to the Royal College of Surgeons, the possibility of therapeutic privilege presents significant legal challenges for doctors, including litigations. Hence, the doctors should ensure that whenever they use therapeutic privilege, they should always document the reasons for it.
    • Conflict between legal constraints and ethical practice gives rise to clinical dilemma regarding use of therapeutic privilege.
    • Whether it is for doing good or bad, information is a powerful tool. No doubt, patient's welfare and autonomy are important issues, however, more justification than these is required for disempowering the patient by deliberately not disclosing to him the relevant information about his treatment and risks.
  4. In medicolegal cases: Section 53(1) CrPC: Examination of accused by medical practitioner at the request of police officer—when a person 45is arrested on a charge of committing an offence of such a nature and alleged to have been committed under such circumstances that there are reasonable grounds for believing that an examination of his person will afford evidence as to the commission of an offence, it shall be lawful for a registered medical practitioner, acting at the request of a police officer not below the rank of sub-inspector, and for any person acting in good faith in his aid and under his direction, to make such an examination of the person arrested as is reasonably necessary in order to ascertain the facts which may afford such evidence, and to use such force as is reasonable for that purpose.
  5. Section 53-A CrPC: Examination of person accused of rape by medical practitioner—(1) When a person is arrested on a charge of committing an offence of rape or an attempt to commit rape and there are reasonable grounds for believing that an examination of his person will afford evidence as to the commission of such offence, it shall be lawful for a registered medical practitioner employed in a hospital run by the Government or by a local authority and in the absence of such a practitioner within the radius of 16 km from the place where the offence has been committed, by any other registered medical practitioner, acting at the request of a police officer not below the rank of a sub-inspector, and for any person acting in good faith in his aid and under his direction, to make such an examination of the arrested person and to use such force as is reasonably necessary for that purpose. (2) The registered medical practitioner conducting such examination shall, without delay, examine such person and prepare a report of his examination giving the following particulars, namely—(i) the name and address of the accused and of the person by whom he was brought, (ii) the age of the accused, (iii) marks of injury, if any, on the person of the accused, (iv) the description of material taken from the person of the accused for DNA profiling, and (v) other material particulars in reasonable detail. (3) The report shall state precisely the reasons for each conclusion arrived at. (4) The exact time of commencement and completion of the examination shall also be noted in the report. (5) The registered medical practitioner shall, without delay, forward the report to the investigating officer, who shall forward it to the Magistrate referred to in section 173 as part of the documents referred to in clause (a) of sub-section (5) of that section.
 
REFUSAL TO CONSENT (DISSENT)
  • When, every human being of adult years and sound mind has a right to determine what shall be done with his own body, it also implies that 46he has a right to refuse any advised treatment or choose an alternative modality of treatment.
  • A competent patient may decline any and all treatment, even those treatments that may be lifesaving. Mentally ill patients are also generally considered competent to refuse treatment. So, doctors should always refer a mentally ill patient who is refusing an apparently beneficial treatment, to a psychiatrist for evaluation. However, just because a patient does not consent to a treatment does not in itself mean the patient is not capable to consent. Thus, whenever a patient refuses his consent to an apparently beneficial procedure, the doctors should understand patients’ beliefs and introspect about decisions of the patient as well as their own decisions.
  • Doctors may come across certain situations where patients are required to be compelled to receive treatment. For example, if a person with mental illness is considered dangerous to the society. Such persons are required to be hospitalized against their will. There may be instances where competent persons with contagious diseases refuse treatment. Public health authorities are required to isolate such people, if they are harmful to the society at large.
  • Ability of a patient to consent or to refuse a medical procedure depends on his capacity to consent. To determine this capacity where a patient refuses his consent to a medical procedure recommended by his doctor, a psychiatrist may be required to assess the quality of patient's decision-making process.
  • The legal equivalent of capacity is competency. Its evaluation requires judicial determination and it must be evaluated in the context of a specific task and different tasks require different abilities, information, and thresholds of understanding. Under the law, though all adults are presumed to be competent, to evaluate their capacity, the question, “Capacity for what?” should be answered. Then, the doctors, in order to determine the elements of capacity assessment can use this information.
  • However, such a refusal has to be an “Informed Refusal”. Informed refusal should always be documented. It should never be “verbal” or “implied”. Such patient should be explained the advantages of undergoing the proposed therapy and the disadvantages/risks of rejecting the treatment. The reasons for his refusal should be understood and he should be effectively counseled.
  • All communication, discussions, explanations, and counseling should be documented. Signature of the patient should be obtained along with the signatures of the witnesses. The doctor should sign it. The form must bear the date and time.
  • In case the patient refuses to sign the dissent (refusal to consent) form then this fact should be clearly mentioned at the bottom of this “informed refusal” and once again the witnesses and the doctor should sign it.47
  • In case of minors who refuse treatment, the parents have the right to decide on behalf of such minors. Such right persists until the minor is aged 18. If a doctor (who feels that treatment is essential) proceeds to treat such a minor patient, a charge of “assault” will not lie on him. However, the fact that the minor had refused would be a very important factor influencing the doctor's decision.
 
MEDICATIONS AND EFFECT ON CONSENT PROCESS
Prior to surgery, certain medications are required to be administered to the patient, which include sedative and/or pain relievers. This is also the time when patient's consent for surgery is to be obtained. So, in order to obtain patient's consent in clear state of mind, uninfluenced by the effects of medication, some doctors withhold the medications till the consent is obtained. But, due to this, the patients may feel compelled to consent, in order to obtain the dose of medication for pain relief. In fact, relief from pain may actually enhance patient's ability to make decision. So, doctors should never withhold pain medications of a patient under the pretext of obtaining informed consent. As regards the administration of sedatives and other medications affecting the alertness, it is advisable to obtain the consent well in advance so that it does not coincide with the time of administration of medicines. It is a sound practice to mention the date and time of administration of all medicines as well as to mention date and time over all consent forms, so that one can defend any allegation that the patient was under the influence of medication and hence did not understand the information provided to him/her before obtaining signature on consent form.
One of the issues related to patients who are already in the operation theater or mothers who are in labor is that their capacity to understand the contents of consent form and to remember whether they have provided the consent is adversely affected because of the stress of the situation. In order to avoid such situations, it is advisable that an intelligent and informed consent with a reasonably broad scope should be obtained well in advance before they are shifted to OT/Labor room. For patients who are admitted in emergency requiring urgent surgeries or mothers brought to hospital in labor, the principle of emergency care will apply, wherein the necessity of consent gets relaxed.
 
INFLUENCING THE INFORMED CONSENT
Patients can be influenced in following ways:
  1. Coercion: It involves application of threat to the patient. It is always unethical.
  2. Manipulation: It involves incomplete or false presentation of information, such a lying, concealing or omitting relevant information, or deliberately 48deceiving. Manipulation makes the consent invalid, as it is against the concept of “free consent”.
  3. Persuasion: It involves the presentation of a scientific, logical, and rational explanation for a choice of treatment, amongst all available options. It is permissible and even desirable during the consent process, at least in Indian scenario. Patients do recognize that doctors are experts in their field. They even seek advice about their treatment and expect doctors to recommend.
 
WITHHOLDING OF INFORMED CONSENT
The burden of decision as to whether to commence the test is properly placed on the patient, but, once initiated, the analysis of risks inherent in proceedings, as opposed to terminating the test, becomes a matter of medical judgment. The doctor is not duty-bound to stop the medical test for withholding of consent by the patient before completion of the test [Ciarlariello et al. versus Schacter et al. (1991) 76 DLR (4th) 449]. However, it should be remembered that the patient has a right to withdraw from the treatment at any stage. The doctors should, in good faith and for patient's benefit, decide about the pros and cons of such withholding or withdrawal and act accordingly. The reasons for their action should be documented with date and time.
 
EFFECTS OF NONCONSENT
Often, allegations of medical negligence are accompanied by that of lack of informed consent. In cases of allegation of “lack of informed consent”, the contention that the doctor acted in good faith, is not a defense, except in cases of emergency treatments. The elements of the claim of “nonconsent” are:
  1. The treatment options, planned treatment, risks and benefits involved in various treatment modalities were not explained by the doctor;
  2. Had the doctor provided complete information, the patient would have denied the treatment/procedure; and
  3. The treatment, even when it was properly administered, has significantly contributed to the harm caused to the patient.
    To establish, what the patient should have been told, expert medical evidence will be required. However, there are no precedent judgments highlighting the necessity of expert evidence to know what the patient would have decided if he would have been fully informed.
    Cause of action in allegation of medical negligence is totally different from that in allegation of lack of informed consent. In case of medical negligence, the patient's allegation is regarding the medical care, caution, competence and prudence of the doctor, whereas in case of allegation of lack of informed consent, the implication is self-determination and autonomy. Success in 49proving lack of consent will enhance a favorable verdict for the patient. When the “medical negligence” case is weak, it is a convenient fallback position for the patient.
 
DEFENSES IN A CLAIM OF LACK OF INFORMATION
  1. In an “Emergency Case”:
    1. The law has always recognized that no consent is necessary to treat a patient in an emergency. But the doctors should understand that the law requires the emergency to be of such a gravity and urgency that it is impractical to obtain the patient's consent. Thus, it is not just the discovery of an unusual or unexpected condition that gives the right to handle that situation without consent. If the situation is not of such gravity and urgency as to cause immediate danger to the patient's life or limb, the consent must be obtained. And more importantly, such “gravity” and “urgency” should be reflected in the medical records.
    2. Some writers maintain that, in an emergency, consent should be obtained, if possible, from a relative. It is difficult to see how this provides any safety to the doctor other than having the person confirm that there is indeed an emergency, because it is the patient's right to informed consent from which the duty springs for the doctor to disclose. If the patient is not in a condition to give the consent because of an emergency, the doctor who is in-charge of the case certainly should be in as good a position as any relative to determine what should be done at that point from the standpoint of legal theory. From a practical standpoint, conferring with those who are available to join in the decision is advisable.
  2. When the risk is one that is not known at the time treatment is rendered, unless the ignorance of the doctor is itself negligence.
    1. A physician cannot disclose a risk of treatment if he is unaware of it.
    2. This casts a duty on the doctors to have sufficient knowledge of a suitably qualified, trained, and experienced doctor practicing under similar circumstances. If a physician should have known of a risk that should have been disclosed to the patient he may be liable for negligent nondisclosure. Duty of disclosure can arise, however, only if the physician knew or should have known the risk to be disclosed.
  3. A physician is not under a duty to disclose risks of which a patient is already aware or risks that a physician may reasonably judge that the normal patient would be aware of.
    1. There is no obligation to communicate risks of which persons of average sophistication are aware of hazards the patient has already discovered.50
    2. This defense, of course, would create a court question as to whether the patient new, or, by reason of reasonable sophistication should have known of the risk, except in the most blatant of cases.
  4. That the risk was too minimal or too remote to be disclosed.
    1. This defense requires a balancing of the severity of the complication with its likely occurrence. So that a very small chance of serious injury may well be considered significant and material and require disclosure, whereas more common but least serious complication might not require disclosure.
    2. Again, it should be remembered that, there are no magic formulas to determine whether a particular risk is of such category as to require disclosure.
  5. That the failure to inform was not the proximate cause of the injury alleged. This defense breaks down into two possible areas:
    1. That a patient would have accepted the treatment even if the patient had been fully informed (Most courts that have dealt with this question have ruled that the issue is not whether the particular patient would have accepted the proper treatment had he been fully informed, but whether a “reasonable” patient would have accepted the treatment). Thus, the courts have tried to make the test more objective. The courts may accept the subjective statement of the patient as to whether she would or would not have accepted the treatment, but this is looked upon with certain skepticism, because, “the answer which the patient supplies hardly represents more than a guess, perhaps tinged by the circumstances that the un-communicated hazard has in fact materialized”. Although the material risk theory would seem to do away with the necessity of testimony by experts; the patient's burden of proving that risks and alternatives did exist and that the disability about which the complaint is, is a result of the undisclosed risk, can be handled only by an expert witness.
    2. The injury suffered by the patient was a result of the disease condition for which he sought care rather than from the treatment.
  6. That the injury complained of did not result from the failure to disclose the risk.
    1. In Canterbury, a strong defense was made through the expert testimony of several outstanding neurosurgeons that Mr Canterbury's partial paralysis resulted from the diseased condition for which Dr Spence operated on him rather than from the operation itself.
    2. Quite often in medical malpractice cases the unhappy result can be attributed to the diseased condition rather than to the alleged failure to properly treat.
  7. Therapeutic privilege.51
    1. Some courts recognize that physicians have, in limited circumstances, therapeutic privilege to withhold communication of risks to a patient when full disclosure of the risks of treatment might prove harmful to the patient, physically or psychologically.
    2. Although, therapeutic privilege is universally recognized as a potential defense, it is difficult to state what precisely must be established in order to establish the defense, and how one would go about establishing those facts—that is, through lay or professional witnesses or a combination thereof.
    3. If one is convinced that a patient should not be informed of risks because of therapeutic reasons, it would be well to have a second opinion; and clear, good notes should be made so that the assertion of therapeutic privilege does not seem to be hind sight.
    4. However, the current American Medical Association (AMA) Code of Medical Ethics rejects the therapeutic privilege. It states: “Except in emergency situations in which a patient is incapable of making an informed decision, withholding information without the patient's knowledge or consent is ethically unacceptable”.
  8. That the patient was, in fact, properly advised of all of the risks that a reasonable practitioner would invoke; or that he was advised of all material risks and alternatives.
    1. In order to establish the various risks, whether the risks were material, available alternatives, etc. good expert testimony is necessary.
    2. It is also useful to have a complete written consent form that establishes what risks of the treatment were disclosed, the reasons why the treatment was advised, and the possible alternatives to the treatment, and that the patient was given an opportunity to enquire. The doctor should also keep explicit records with regard to conversations with the patient relative to consent.
  9. Proper record keeping:
    1. The patient is at liberty to refuse full disclosure or any disclosure. However, if an untoward result occurs, the patient may convince himself that he really did want to hear all of the risks and alternatives.
    2. Therefore, only with accurate records, and, in all probability, only with a written statement to the effect that the patient did not wish a full and reasonable disclosure of the risks signed by the patient and witnessed will the assertion of that defense can be done.
 
ROLE OF PROFESSIONAL ASSOCIATIONS
In India, all the specialties in medical subjects have their independent associations at state and national level. Till date, very few associations have attempted to frame guidelines for the members of their association as 52regards the issue of “informed consent”. The concept of “Informed Consent” is very broad and ever expanding. Whatever court judgments are available are given by the respective courts based on the facts and circumstances of each case. The court judgments will continue to be so based and hence vary. Whatever limited perspective the doctors have, about informed consent; has originated from such sporadic court judgments. It is the need of the hour that the professional associations at national level of each specialty should frame detail guidelines for the members of their association. These guidelines should be framed considering the court precedents across the world. While framing such guidelines the perspective of such professional organizations/associations should not be limited to the familiar and traditional elements of disclosure as they relate to the risk, benefits, and alternatives of a medical procedure, but should encompass futuristic parameters [Clin Orthop Relat Res. 2012;470:1346-56] and doctor-specific issues like doctors’ health, any disability, qualifications, training, experience, disciplinary history, financial interests, and statistics related to medical outcomes. Such comprehensive guidelines can be the basis for the courts to decide the cases before them.
Once such guidelines are developed by professional associations, all its members should be sensitized and educated about its legal significance, so that they are effectively implemented. Such published guidelines by professional associations will benefit the doctors whenever the question of “contents and extent of disclosure” by a doctor arises in a court of law. Thus, professional associations should be proactive in framing position statements having potential of guiding doctors and the courts in determining how much information to disclose during informed consent. In absence of such efforts on the part of medical associations, sporadic judicial opinions will continue to shape the doctrine of informed consent.
 
ROLE OF HOSPITALS
Informed consent is a contract between the doctor and patient. However, it is the hospital's duty to define and implement a policy for “informed consent” to be followed by all the doctors appointed by it. The hospital has to ensure that all doctors working in it are aware of existence of such a policy. That the doctors were made aware of such a policy, at the time of joining the hospital and periodically thereafter should be evident from the documentation of training/awareness sessions conducted for the doctors on the issue of informed consent. It is the hospitals’ duty to conduct regular audits of clinical records generated by its doctors and nurses. Such regular and continuous audits should focus on whether informed consents are being obtained, if the patients are in fact “well informed”, whether the information provided is documented, whether the treating doctor himself/herself is involved in the “information” and “consent” 53process or not, whether consent is obtained from the patient or the Next of Kin only, whether the criteria for “Next of Kin” is properly followed, whether the consent is obtained sufficiently before the procedure, whether the scope of consent is sufficiently broad, whether any investigations/procedures are performed out of the scope of consent, etc. Such audits should be conducted department wise and may also be doctor-specific (if any individual consultant is a repeated defaulter). The results of such audits should be discussed with the concerned department/doctor. The results should be quantifiable and measures should be taken to achieve a declining graph of noncompliance. The hospital shall have a policy to reprimand the defaulters and also a mechanism to initiate disciplinary actions. The implementation of the policy of a hospital should be evident from the documentation at various stages of its implementation.
 
WAYS TO IMPROVE INFORMED CONSENT PROCESS
  1. Maintain good rapport with the patients: Good rapport with the patients is better than actual contents of any particular discussion, as it reduces the risk of litigations.
  2. Inform and discuss all the available treatment options. This should be done irrespective of the insurance coverage of the patient or the expertise of the doctor or facilities available at his center.
  3. Inform all risks that are more frequent and more serious.
  4. Be prudent in prescribing and administering medications to the patients.
  5. Before advising any nonroutine pathology or radiology investigations discuss the advantages, disadvantages, and limitations of such tests and document the discussion.
  6. Prudently record and maintain all the medical records, including copies of OPD papers, investigations reports, referral letters, and refusals/denials of the patients.
  7. Do not guarantee any results. Discuss risks and benefits of all procedures. Discuss and document available alternative procedures and your reasons for not recommending them.
  8. Document everything: There is no option for documentation. It may be the only proof that a discussion took place.