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Informed Consent: Legal Analysis of Consent Forms

The patient who is armed with information, who wants to ask questions, sometimes difficult and awkward questions, should be seen as an asset in the process of care and not an impediment to it.- Sir Liam Donaldson

The concept of medical practice was to develop patient-centric services but this was quickly eroded by the virtue of paternalism and culture of authoritarianism or superiority to get quick and desired results. This tended to exclude patients from information and discouraging them from asking questions. One might think a patient-client service model works on the premise of capitalistic market functions with the forces of demand and supply.

It is true patients' desire for high-quality personalized care will drive the system which demands that there is a need to give people greater personal choice. But one needs to also take into account that laissez-faire the system until one person decides to cut corners and boom it takes no time for a capitalistic market to turn into a monopolistic regime or worse shows signs of crony capitalism hence the need for suitable legal protection is born.

Informed Consent can be distinguished under the heads of:
  • Consent By Proxy: Informed permission is given by the parents or legal guardian as an authority.
  • Informed Assent: Child's agreement to medical procedures in circumstances where he or she is not legally authorized for giving consent competently.
  • Implied Consent: When the patients go to a physician for treatment with the behaviour and overact to seek treatment for. The 2 most prevalent types of consent which I will discuss in this research paper is
  • Expressed Consent: When a patient specifically grants the physician permission to undertake the diagnosis and treatment of a specific problem. It may be an oral or signature/written consent.
  • Valid informed consent: Consent with emphasis on the patient is aware and understands the reasonable and irrational elements of his/her decision.

Define: Informed Consent
It is noted that the foundation of the traditional theory of consent to treatment lies in the law of battery, and is found in decisions of US courts as early as 1905. Justice Cardozo while talking about the principle of consent in the 1914 New York case of Schoendorff v. New York Hospital mentions 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 operates without his patient's consent commits an assault..

The above definition clearly sets out that informed consent means permission granted in full knowledge of the possible consequences, typically that which is given by a patient to a doctor for treatment with knowledge of the possible risks and benefits and any act was done outside of what is consented will amount to battery or intrusion of one's autonomy except in emergencies.

Dissecting a Consent Form:
For research purpose, a consent form was taken (which was deemed appropriate as it contained almost all information disclosures which are generally used by practitioners) as a sample informed consent form.
  • Details about the form: Informed Consent Form - Authorization for medical treatment, administration of anaesthesia and performance of the surgical operation and/or diagnostic/therapeutic procedure.
  • Origination of the form: SURAKSHA EYE SURGERY CENTRE
  • Parties required: Doctor, patient, witness
Authorization: Consent to perform/treatment: I hereby authorize
Two things always must be taken into account: firstly, only a patient who is competent to consent can give legitimate consent, and secondly, that consent must also be informed consent (which makes a person eligible to sign consent forms). This means that the patient must be endowed with the ability to weigh the costs and benefits of the care offered to him to be competent to provide legal and meaningful consent. The law presumes that with the achievement of the age of maturity, such a skill is usually acquired.

But as I searched through various resources, newspaper articles and foreign cases I couldn't single out/fixate a definite number which can be called 'age of majority'. To support this ambiguity I noted observations under the Nuremberg Code (1947) where The voluntary consent of the human subject is absolutely essential. This means that the person involved should have the legal capacity to give consent... excerpts from the Declaration of Helsinki under Art 25 were also referred ..... Although it may be appropriate to consult family members or community leaders, no individual capable of giving informed consent may be enrolled in a research study unless he or she freely agrees…, Art 28 . For a potential research subject who is incapable of giving informed consent, the physician must seek informed consent from the legally authorised representative .

Here in India while referring to the publication of Rk Sharma; Consent: Legal aspects of patient care by Rk Sharma it clears out that fixed guidelines are outlining the exact age of consent for medical or surgical treatment. As, 'majority' is achieved at an age of 18 years and considered a legal age for giving a valid consent for treatment as per Indian Majority Act, Indian Contract Act, Medical Termination of Pregnancy (MTP) Act, 1971 where a girl below the age of 18 years cannot give valid consent for termination of pregnancy. Also, other provisions of the Indian Penal Code mentions that a child below 12 years (minor) cannot give consent, and parents/guardian can consent for their medical/surgical procedures. After going through the research paper on Informed Consent in Pediatric Practice by Jaya Shankar Kaushik, Manish Narang, and Nupur Agarwal we concluded that a person in the age of 12-18years can give informed assent for medical examination but not for medical surgery of any kind.

To support the above-stated conclusions reference is made to the judgement by the Apex court in Common Cause v. Union of India, (2018)
 170. In Airedale [Airedale N.H.S. Trust v. Bland, 1993 AC 789 : (1993) 2 WLR 316 : (1993) 1 All ER 821 (CA & HL)], Lord Goff has expressed that it is established that the principle of self-determination requires that respect must be given to the wishes of the patient so that if an adult patient of sound mind refuses, however unreasonably, to consent to treatment or care by which his/her life would or might be prolonged, the doctors responsible for his/her care must give effect to his/her wishes, even though they do not consider it to be in his/her best interests to do so and to this extent, the principle of sanctity of human life must yield to the principle of self-determination.
Also on Pg 182

 331. ..In August 2012, the Law Commission came out with a detailed 241st Report …. wherein it approved the concept of right to self-determination also. The Law Commission made some important observations in its Report such as:
5.2. ….competent patient has a right to refuse treatment including discontinuance of life-sustaining measures and the same is binding on the doctor, provided that the decision of the patient is an informed decision. … The definition of a competent patient has to be understood by the definition of incompetent patient. Incompetent patient means a patient who is a minor or a person of unsound mind or a patient who is unable to weigh, understand or retain the relevant information about his or her medical treatment or unable to make an informed decision because of impairment of or a disturbance in the functioning of the mind or brain or a person who is unable to communicate the informed decision regarding medical treatment through speech, sign or language or any other mode [vide Section 2(d) of the 2006 Bill].

Necessitate Surgical or Emergency Procedure:  Unforeseen Condition
The second point in the consent form is generally the main bone of contention. As a plethora of disputes arises from 'Necessity or Emergency' procedure. Examples of this can be seen in almost every national daily where a doctor might have gone overboard to surge charge the medical bill or the Medicare provider does not consider the surgery/treatment performed as 'necessity' and this leaves the patient in this limbo of turmoil and uncertainty. The former case where a doctor goes overboard stems from the idea of paternalism as discussed above. If we try to define emergencies as to when an informed consent be ignored we would end up in the realm of Exceptions to Informed Consents which contain:
  • Emergency under Sec 92 IPC
  • Therapeutic Privilege
  • Therapeutic waiver
  • Medico-Legal Post-mortems as dwelled under Sec 174 Crpc
  • Examination of an arrested accused defined under Sec 53(1) Crpc
  • Treatment of Patient Suffering from 'notifiable diseases' for greater community interest
  • Psychiatric Examination or Treatment by court order
  • Prisoners ( new entrants)

The legal genus of the Principle of Necessity vs Right to Self Determination (infra) can be traced under Art 21 of the Indian Constitution, Art 37 of Helsinki Declaration, Section 92 of IPC and in The Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulations, 2002.

One for reference can also look into 'The Law Commission of India report on Emergency Medical Care to Victims of Accidents and other Emergencies' and various judgement of court like in Paramanand Katara vs. Union of India: AIR 1989 SC 2039 and Dr T.T Thomas vs Elisa wherein court delivered the judgement in favour of the plaintiff stating that consent under such an emergent situation is not mandatory.

The court in Paschim Banga Khel Mazdoor Samiti vs. State of West Bengal: 1996(4) SCC 37 focused on accident victims and need for emergency treatment to them within the golden hour, although not directly linked to our research paper it still contains traces of the discretion which it must be exercised by the doctor while treating the patient.

Placing reference of the judgment by the Apex Court to support my arguments wherein the court clearly defines as to when can a doctor exercise discretion. In Nizam's Institute of Medical Sciences vs. Prasanth S. Dhananka, (2009):

43.... In Samira Kohli case [(2008) 2 SCC 1] which are relevant for our purpose and raised before the Bench was: (SCC p. 15, para 21):
21. The next question is whether in an action for negligence/battery for the performance of an unauthorised surgical procedure, the doctor can put forth as defence the consent given for a particular operative procedure, as consent for any additional or further operative procedures performed in the interests of the patient.

In Murray v. McMurchy [(1949) 2 DLR 442: (1949) 1 WWR 989] the Supreme Court of British Columbia, Canada, was considering a claim for battery by a patient who underwent a caesarean section. During the course of the caesarean section, the doctor found fibroid tumours in the patient's uterus. Being of the view that such tumours would be a danger in case of future pregnancy, he performed a sterilisation operation. The Court upheld the claim for damages for battery.

It held that sterilisation could not be justified under the principle of necessity, as there was no immediate threat or danger to the patient's health or life and it would not have been unreasonable to postpone the operation to secure the patient's consent. The fact that the doctor found it convenient to perform the sterilisation operation without consent as the patient was already under general anaesthesia, was held to be not a valid defence.

23. Howsoever practical or convenient the reasons may be, they are not relevant. What is relevant and of importance is the inviolable nature of the patient's right in regard to his body and his right to decide whether he should undergo the particular treatment or surgery or not. Therefore at the risk of repetition, we may add that unless the unauthorised additional or further procedure is necessary to save the life or preserve the health of the patient and it would be unreasonable (as contrasted from being merely inconvenient) to delay the further procedure until the patient regains consciousness and takes a decision, a doctor cannot perform such procedure without the consent of the patient.

Exchange of Information: Nature and Purpose of the treatment
As discussed in the introductory paragraphs of the research paper we have established that the doctor-patient relationship can be also be brought to the scales of a service and user agreement.

As informed consent can be only made where both the parties agree on the same thing and in the same sense i.e 'Consensus-ad-idem'. This is mentioned in the landmark judgment of Canterbury vs Spence When the doctor himself is considering the possibility of a major operation…. The duty of the doctor in these circumstances, subject to his overriding duty to have regard to the best interests of the patient, is to provide the patient with information which will enable the patient to make a balanced judgment if the patient chooses to make a balanced judgment.

It is important to provide knowledge in a graded manner and the patient's consent to continue with the specifics must be obtained. The consent process highlights the doctor's complicated function as an information communicator and as a counsellor which in turn makes the patient feel much more autonomous and in control of what treatment he is opting for. Through shared decision-making would inevitably place conditions on doctors in time and interaction words.

Publication by Charles C, Gafni A and Whelan T provides certain key characteristics of this shared decision-making as:
  1. the physician and patient should be involved as participants;
  2. they should share information;
  3. they must arrive at a consensus on the preferred treatment; and
  4. they should agree to implement the treatment
Traces of its legal genus can be found Under Art 26, Art 30 of Helsinki Declaration, Chapter 3 of the IMC Regulation of 2002. Referring to the Judgement by the Supreme Court in Nizam's Institute of Medical Sciences v. Prasanth S. Dhananka

43. ….. in Samira Kohli case [(2008) 2 SCC 1] which are relevant for our purpose and raised before the Bench was: (SCC p. 15, para 17):
...(iii) the patient has the minimum of an adequate level of information about the nature of the procedure to which he is consenting to. On the other hand, the concept of 'informed consent' developed by American courts, while retaining the basic requirements of consent, shifts the emphasis on the doctor's duty to disclose the necessary information to the patient to secure his consent. 'Informed consent' is defined in Taber's Cyclopedic Medical Dictionary thus:
'Consent that is given by a person after receipt of the following information: the nature and purpose of the proposed procedure or treatment; the expected outcome and the likelihood of success; the risks; the alternatives to the procedure and supporting information regarding those alternatives; and the effect of no treatment or procedure, including the effect on the prognosis and the material risks associated with no treatment. Also included are instructions concerning what should be done if the procedure turns out to be harmful or unsuccessful.' 

The promise of success: No guarantee and promises have been made
As an everyday consumer one would want the service or the product he receives to deliver the result which he/she/they desires/wants/needs as rightly said by Adam Smith. But since the work done by a doctor resonates alongside the altruistic duty towards society and is still a science that doesn't give an exact result in a ratio of 1+1= 2, no one can or should promise a specified desired result.

As seen in the consent form it drops hints of the doctrine of 'Volenti non-fit Injuria'. The doctor tries to absolve his liability in case a surgery goes wrong by raising this particular clause in the court if it comes to a legal battle. While some doctors being prudent try to disclose as much information and make no promises of a 100% success rate, there were/are some who try to solicit patients. The Supreme Court has tried to discourage this practice in the recent case of Vinod Jain v. Santokba Durlabhji Memorial Hospital

 10. This Court in another judgment in Jacob Mathew v. State of Punjab [Jacob Mathew v. the State of Punjab, (2005) 6 SCC 1: 2005 SCC (Cri) 1369] dealt with the law of negligence in respect of professionals professing some special skills. Thus, any individual approaching such a skilled person would have a reasonable expectation of a degree of care and caution, but there could be no assurance of the result.

A physician, thus, would not assure a full recovery in every case, and the only assurance given, by implication, is that he possesses the requisite skills in the branch of the profession, and while undertaking the performance of his task, he would exercise his skills with reasonable competence. …

Confidentiality: Doctor - Patient Privilege
Patients reveal their secret or important personal details to health care professionals such as physicians, surgeons, hospitals, etc. regularly. If the patient thinks that the information is not secure at some stage in the process or there is a chance that it will be leaked, so they will not share the information in the first place.

Therefore maintaining privacy and confidentiality should be at the top priorities of health care providers. In the consent form allowing observers or video recording of the procedure for medical advances, education, etc can be construed as a breach of this privacy to some while others might not take note of this exercise. In the form, a rider is mentioned wherein the identity of the patient should not be revealed by any text or picture accompanying the recording and only then the patient can be said to have consented to it.

The protection of the privacy of the patient is paramount as noted in an article on Informed Consent Document and Process in India: Ethical and Quality Issues by Madhuri Patel, Kannan Sridharan, and Jayesh Patel where they talk about how The sociocultural environment in India is one of the challenges. Many eligible patients refuse to take part in studies because they are suspicious of the AV recording. There are chances that the videos might be misused as the rule does not make clear who should have access to the AV recordings... Patients with HIV/AIDs and other sexually transmitted diseases feel especially insecure as they can be identified and tracked. which mandates that the privacy of the patient should be protected at all cost.

The Medical Council of India's Code of Ethics Regulations protects patient confidentiality as one shall not disclose the secrets of a patient that have been learned in the exercise of his/her profession except in a court of law under orders of the Presiding Judge; in circumstances where there is a serious and identified risk to a specific person and/or community; [or in case of] notifiable diseases. Recently (01/12/2020) Supreme Court while hearing a PIL filed to discourage the practice of putting up a poster outside COVID patients home observed that: Putting up posters or other signages outside homes of Covid-positive people may end up making the occupants being treated as untouchables.

The Supreme court has also observed the landmark case of 'X' v. Hospital 'Z', (1998) 8 SCC 296 on page 307:
27. Right of privacy may, apart from contract, also arise out of a particular specific relationship which may be commercial, matrimonial, or even political. As already discussed above, the doctor-patient relationship, though commercial, is, professionally, a matter of confidence and, therefore, doctors are morally and ethically bound to maintain confidentiality. In such a situation, public disclosure of even true private facts may amount to an invasion of the right of privacy which may sometimes lead to the clash of one person's right to be let alone with another person's right to be informed.

Though one has right to privacy it should have riders attached to it in case of public health emergencies (Eg: COVID) or one's right to be informed like in the above case where a doctor was not held to be liable for disclosure.

Understanding the form: Explained to me in my own vernacular
In a nation where 74% of the population is termed as literate but not on the fulcrum of a nationwide understood language. It is very difficult to ascertain whether the patient has understood the procedure in regards to the information shared with him in the form. Therefore it becomes an obligation on the part of the physician/ doctor to come through and establish 'consensus-ad-idem'.

In cases of translation into the local language, it is another task that carries with itself certain burdens and loopholes. Translation into local languages of consent forms alters their content and context. When the material is discussed or paraphrased during oral presentations to illiterate patients, the context and content are modified again. Which can be detrimental for the patient who has consented for something and not for something else.

As to what should be the ideal scenario for a consent form's language, I am referring to a publication done by Jaya Shankar Kaushik, Manish Narang, and Nupur Agarwal wherein they observe that:
A consent form in developed nations is expected to be readable by 8th-grade level, but there are no guidelines developed in India. It was observed that the consent form given to the parents often has plenty of tough medical terminology and often is not legible and scribbled in poor handwriting. The consent forms need to be comprehensible and written/typed legibly.

It would be advisable to use short sentences with simple vocabulary and use of non-medical terminology as far as possible. The consent forms written in the patient's language might improve comprehension and understanding. In cases where the same language is not possible, a good interpreter should be provided. The consent form should be signed by all parties concerned (parents/guardian/doctor/witness) to make it a valid document.

Again referring to an Empirical study done by Madhuri Patel and her peers concluded that Several methods and possible steps can be taken to improve informed consent process. Notably, our findings show that 320/382 (83.8%) of participants agree that The consent form should be simplified and include pictorial images for better patient understanding. 296/382 (77.5%) selected:
Studies have also shown that simplification and repetition of consent information and multimedia presentations have improved subjects' understanding. In addition, oral consent combined with written consent, rather than written consent only, has been shown to lead to greater understanding.

Hence it is always advisable to write the consent form in the patient's vernacular language alongside having a person attest the form as a witness to make sure that free and informed consent was exercised by the patient while signing the consent form.

Conclusion
Originally this research paper was to be equipped with empirical data alongside doctrinal research but due to unforeseeable circumstances, I had to restrain my focus solely on the legal principles attached to Informed Consent.

Patients' participation in decision-making has moved beyond the principle of informed consent to the principles of patient autonomy, where the patient is in control and has the locus standi to challenge the physician's authority. The concept of informed has been advocated as a mechanism to lower the informational and power asymmetries that exists within the doctor-patient relationships which shifts it away from the idea of paternalism and authority. I with the help of this research have seen the plethora of articles, journals, international conventions and judgments where the court has balanced the scales of how much can the doctor's incision be allowed on patients body that doesn't attract sec 351 of IPC.

But still, there is a long way to go on the fronts of who is a competent patient, as the legal concept of emancipation which is prevalent in the USA has not developed in Indian legal system. Or how the idea of patient's privacy which is about to change as we see the introduction of the DISHA 2018 and the Personal Data Protection Bill.

Primary Sources
  • The Medical Termination Of Pregnancy Act, 1971
  • Indian Penal Code 1860
  • Indian Contract Act of 1872
  • Indian Majority Act of 1875
  • Helsinki Declaration
  • IMC Regulation 2002
  • Canterbury v Spence. 1972. 464 F 2d 772.
Cases
  • Pratt v. Davis, 118 Ill. App. 161 (1905). aff'd. 224 Ill 300, 79 N.E. 562 (1906)
  • Common Cause v. Union of India, (2018)
  • Nizam's Institute of Medical Sciences v. Prasanth S. Dhananka, (2009) 6 SCC 1 : (2009) 2 SCC (Civ) 688 on page 22
  • Vinod Jain v. Santokba Durlabhji Memorial Hospital
  • Paramanand Katara vs. Union of India: AIR 1989 SC 2039
  • Dr. T.T Thomas vs Elisa
  • Paschim Banga Khel Mazdoor Samiti vs. State of West Bengal: 1996(4) SCC 37
  • Nizam's Institute of Medical Sciences v. Prasanth S. Dhananka, (2009)
 
Secondary Sources
Articles
  • Derrick, D., Consent—A Commonly Understood Concept?, accessed 9 Dec. 2014, http://www.aims.org.uk/Journal/Vol24No3/editorial.htm.
  • Sharma RK. Consent. In: Sharma RK, editor. Legal aspects of patient care. New Delhi: Modernpublishers; 2000: 3-6
  • Charles C, Gafni A, Whelan T. Shared decision-making in the medical encounter: What does it mean? (or it takes at least two to tango). Soc Sci Med 1997;44:681–92. v
  • (2016) Project MUSE - Asian Bioethics Review-Volume 8, Issue 1, March 2016. In: Jhu.edu. https://muse.jhu.edu/issue/33353. Accessed 1 Dec 2020
  • Woodsong C, Karim QA. A model designed to enhance informed consent: Experiences from the HIV prevention trials network. Am J Public Health 2005; 95: 412-419
  • Kalantri SP. Informed consent in public hospitals. Ind J Med Ethics 2000; 8: 21-27. Accessed from: http://www.issuesinmedicalethics.org/084 di116.html. Accessed on 5 March 2010.
  • Pape T. Legal and ethical considerations of informed consent. AORN J 1997; 65: 1122-1127
  • Bastia BK. Consent to treatment: practice vis-à-vis principle. Indian J Med Ethics 2008; 5. Accessed from: http://www.issuesinmedicalethics.org/163ar 113.html. Accessed on 31 January 2010
  • Taylor HA. Barriers to informed consent. Semin Oncol Nurs 1999; 15: 89-95
  • Jeste, D.V., Enhancing the Informed Consent Process: A Conceptual Overview, Behav Sci Law 24 (2006): 553–68
  • Ijaweb.org. (2010). Indian Journal of Anaesthesia (IJA): Table of Contents. [online] Available at: https://www.ijaweb.org/article.asp?issn=0019-5049;year=2015;volume=59;issue=11;spage=695;epage=700;aulast=Kumar#ref34 [Accessed 3 Dec. 2020].
  • IERB or IEC guidelines for the proposals made in the case of Israel and Hay 2006, Kim in 2012
  • Bastia BK. Consent to treatment: Practice vis-à-vis principle. Indian J Med Ethics 2008;5:113

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