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Enforceability of Informed Consent

Business Law – Term 1 EPGP 2013-14


Team Details
Aditya Ramakrishnan Chithra Kallil Hariharan S R Jaya Jha Poornima Sivakumar 1314004 1314015 1314021 1314023 1314037


(ii) the patient has the capacity and competence to give and (iii) the patient has the minimum of adequate level of information about the nature of the procedure to which he is consenting to”2. including the effect on the prognosis and the material risks associated with no treatment. 3 Id. Also included are 1 2 Samira Kohli versus Dr. the elements of consent are defined with reference to the patient and consent is considered to be valid and “real” when (i) the patient gives it voluntarily without any coercion. In the US. when a patient consults a doctor. This approach is called the Prudent Patient approach ““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. Implied consent: For example.Prabha Manchanda (MANU/SC/0430/2008 – Id. an explicit consent is to be sought from the patient On the nature of express consent of the patient. This approach is called the Prudent doctor approach 2. 2 . surgical or therapeutic procedure. Express consent: In cases where the consent is not implied. the expected outcome and the likelihood of success. the alternatives to the procedure and supporting information regarding those alternatives to the procedure and supporting information regarding those alternatives. the risks. and the effect of not treatment or procedure.1 There are two types of consent: 1.manupatra. ‘consent’ means the grant of permission by the patient for an act to be carried out by the Doctor. the emphasis is on the Doctor’s duty to disclose the necessary information to the patient to secure his consent3. there is an implied consent on the part of the patient to reveal personal information as well as to be diagnosed for the symptoms 2.Introduction In the context of a Doctor-Patient relationship. such as diagnostic. the United Kingdom and the United States have different approaches: 1. “In UK.

The autonomy of a patient is derived from his Right to Life and Personal Liberty which is enshrined in Article 21 of the Indian Constitution – “No person shall be deprived of his life or personal liberty except according to procedure established by law”5 2. is an offence by reason of any harm which it may cause. 4 5 Id.manupatra. Section 13 of Indian Contract Act.”7 Another important point to note is that the law only requires consent of the patient and does not demand a written consent. In an operation which may result in sterility the consent of both husband and wife is 8 Code of Ethics Regulations 1872. Manupatra. the law would prevail over guidelines set by MCI.”4 In the Indian context. or be intended by the doer to cause.Act not intended to cause death. there is no explicit law guiding Informed Consent in the medical field.aspx 3 .in 7 www. or the patient himself as the case may be.instructions concerning what should be done if the procedure turns out to be harmful or unsuccessful. Medical Council of India.”8 In case of arbitration over the specific point of whether oral consent is acceptable. and who has given a consent. However guidelines set by the Medical Council of India (MCI) dictate “Before performing an operation the physician should obtain in writing the consent from the husband or wife. done by consent in good faith for person's benefit Nothing which is not intended to cause death. The relationship between a doctor and a patient is deemed to be a contractual agreement and is hence governed by Contract Law. or be known by the doer to be likely to cause. 1872 defines “Consent”.co. page 151 6 Indian Contract Act. parent or guardian in the case of minor. Shorter Constitution of India by Durga Das Basu. Section 88 of Indian Penal Code: “Section 88 . www. to suffer that harm. to any person for whose benefit it is done in good faith. or to take the risk of that harm. “Two or more persons are said to consent when they agree upon the same thing in the same sense”6 3. The legal reference is only from the following sources: 1. whether express or implied. http://www.mciindia. Section

Therapeutic privilege: If the doctor deems that the information can harm the patient’s health – both physical and mental. the doctor shall provide the information to the close relatives of the patient. Is of sound mind and capable of making own decisions 3. Emergency: If the doctor determines that the course of treatment is needed immediately and any delay would be detrimental to the health of the patient. For example. he/she can choose not to disclose such 10 Informed consent: An ethical obligation or a legal compulsion? – K H Satyanarayana Rao (http://www. informed consent is deemed to be valid only if the patient9: 1.nih. Placebo: Revealing the information is contrary to the usage of a placebo to cure the patient 9 Consent and medical treatment: The legal paradigm in India.ncbi. the doctor shall treat the patient as needed to save his life 2.nlm. Informed consent is not required under the following cases10: 1. he/she can go ahead with the treatment without informed consent. Is not disqualified by any Law he/she is subject 4 .ncbi. http://www.nih. Is a major (18 years and above) 2. 3. However.The following diagram below shows the areas where Informed consent is applicable: Applicability of Informed Consent Medical Treatment Surgeries Clinical Trials In the Indian context. Indian Journal of Urology: IJU: Journal of the Urological Society of India. if an accident victim in emergency condition is brought to a hospital.nlm.

pdf 5 . it might lead to “Paralysis by Analysis” and will ultimately lead to potentially wrong decisions by the patient. The following are some of the challenges in enforcing ‘Informed Consent’ and their implications: 1. Negotiation opportunities for the patient: Typically the forms used for obtaining the informed consent from patients are prepared by hospital administration or drug companies – standard form contracts. Assumption that majors (adults) are mature enough to make decisions: To be able to make an informed The law presumes that this capacity is attained with maturity at the age of 18. The doctors need to observe special level of care towards their patients during the medical treatment.nih. The doctor/patient relationship is characterized by uberrima fide. Therefore it is imperative that the doctor provides all the necessary information to the patient before he/she can make an 11 Consent and medical treatment: The legal paradigm in India – Omprakash V Nandimath (http://www.12 4. In the case of clinical trials for instance. Information vs. Information Overload: The doctors face a major dilemma in the context of Informed consent – How much of information needs to be provided to the patient? If the patient is provided with too much of information. At the same time withholding information leads to other 12 Cultural Issues – Informed consent: http://www. There exists a school of thought that claims that a teenager who hardly has gained any worldly experience would be capable of making lifechanging decisions on her own. a person must be capable of understanding the pros and cons of a medical treatment being provided by the doctor. It would be better if the parents or guardians make such informed decisions on her behalf.nlm.ncbi. 2. “Doctor-is-God” Syndrome: The attitude of most Indian patients towards doctors is that of implicit and unquestioning trust. the patients are neither aware of the implications of the decision nor the fact that they have a right to refuse. In most an informed consent is a mere formality especially when patients from a low economic strata (assumed to be uneducated) are involved.Challenges in Enforceability of informed consent There are many problems faced by both doctors and patients in the context of informed consent. The patients have only 2 possible options: either accepting it as a whole or rejecting it.11 3.

Thiruvanathapuram. Moreover. stressing on the need for the ‘voluntariness’ of the individual. www. Gopalan & Others versus Government Regional Cancer Centre. which gives rise to serious concerns on the ethics of clinical trials in India14 6 . How do we enforce informed consent in this case? This is a Government run Cancer the trial was unapproved by the Drug Controller of India. Greediness of Government agencies in grabbing research grants: M. persuasion or manipulation. 25 people go to the Government Regional Cancer center. who was financing the M. the language in which the consent form is printed may not be the language the patient knows. the US. had released the grant even though they had not considered the trial ethical c. 14 15 http://icmr. There is no informed consent obtained and the patients are oblivious to the fact that they are being denied a well-established treatment b.15 a.13 5. Patients hailing from low income groups are vulnerable for exploitation by medical practitioners/healthcare institutions.manupatra.nic. Taking a step back. There is another issue with enforceability in this case: Section 36 of Human Rights Act states that “The Commission or the State Commission shall not inquire into any matter 13 Id. From the case it appears that the center carried out the trial for monetary reasons d.Gopalan & Others vs Government Regional Cancer Center. The act of consent should not be under the influence of any external constraint such as coercion. Manupatra MANU/KE/0473/2005. High Court of Kerala. Economic status of subjects undergoing clinical trials: The Indian Council for Medical Research (ICMR) stipulates standard guidelines for the informed consent. for treatment of oral cancer and are administered Nor-Dihydro-Guaiaretic Acid (NGDA) even though an established treatment for their condition exists. Thiruvananthapuram in the High Court of Kerala. John Hopkins University.informed decision as the negotiating opportunities for a patient are almost non-existent.

we still come back to the issue of enforceability of informed consent in the first place. The emphasis is on the Doctor to provide the adequate information including the nature. the Central Government hereby suspends the manufacture for 7 . alternatives. Sun Pharmaceuticals in Mumbai enrolls more than 400 women through 9 centers across India in benefits and risks of treatment and consequences of refusing the treatment. Prabha Manchanda18. MANU/HFAM/0125/2011. Drug companies involving in unethical trials: “Letrozole” belongs to the group of aromatase inhibitors. www. Delhi based NGO Social Jurist filed a complaint in Supreme Court. for the trial of this drug. Dr. How do we change the mindset? Conclusion The landmark judgment in the Samira Kohli vs.” Even though the Supreme Court suspended the manufacture and sale of Letrozole retrospectively.after the expiry of one year from the date on which the act constituting violation of human rights is alleged to have been committed. The format of the informed consent should be as simple as possible and must have translations to the local language (where applicable) 2. 1940 (23 of 1940). Drug companies exploit the very basic of human emotions and needs to engage in unethical trials. sale and distribution of the following drug with immediate effect 'Letrozole for induction of ovulation in anovulatory infertility. They are uninformed and no verbal or written consent is obtained from them.Prabha Manchanda (MANU/SC/0430/2008 – www. in exercise of the powers conferred by Section 26A of the Drugs and Cosmetic Act. This drug is approved globally ONLY for the treatment of breast cancer in post-menopausal women. Supreme Court ruling17: “Now therefore. The possible areas of improvement in the enforcement of Informed consent are: 1. the approach to cases dealing with Informed Consent is clearly the “Prudent” doctor approach. These women have been trying to conceive without success.manupatra. Improvement of communication skills of the doctors 16 17 Id. However the doctor need not disclose any remote and improbable risks that may arise during the treatment as these would confuse the patient unnecessarily in making a decision.”16 18 Samira Kohli versus Dr. The drug company wants to test the ability of the drug to induce ovulation.

or a pharmaceutical company. Due to the many problems being faced due to Informed consent. They also need to ensure subjects are fully aware of the treatment and that the agencies are obtaining informed consent 5.3. including the record keeping for Informed Consent 4. the Drugs and Cosmetics Rules. or a trial agency. the liability could be defined in terms of a ban on practice / manufacture / trials. 1945 has been amended to mandate an Ethics Committee for every drug trial. Be it a medical practitioner. Increase role of non-profit organizations and global bodies in facilitating recruitment of trial subjects and increasing transparency of the process. Increasing liability for whoever violates the informed consent regulations. 8 . One of the major responsibilities of this Ethics committee is to ensure that clinical trials adhere to standard protocols.