Informed consent is the bedrock of ethical medical practice. It is when a medical practitioner explains a medical treatment, irrespective of whether it is simple, sophisticated, fundamental, or specific, to a patient, before the patient agrees to it. It is crucial from a liability perspective as well. The Delhi High Court, in a recent order[1], noted with concern the absence of informed consent taken from a patient who underwent a hair transplant, which resulted in complications, leading to death of the said patient. The Court pointed out that hair transplantation, being an aesthetic surgery, needs to be performed by qualified dermatologists or trained surgeons with informed consent of the patient. While this matter relates to the limited aspect of informed consent in a cosmetic surgery setting, the issues raised in the case may have broader implications.
Informed consent for medical procedures has, for long, been a particularly ambiguous area of law. Even though there exists a consensus that informed consent is required before proceeding with any medical treatment, the contours of the same, including the mode of such consent is not clear.
Part 1 of our 2 blogs series (Consent in Healthcare: Outline, Gaps and Conundrum) provides a brief regulatory background related to informed consent in India, judicial pronouncements on the matter, and specific ways of obtaining consent, as laid down under such regulations. In the next part of our blog, we will discuss the impact of such regulations and judgments in practical terms, especially with respect to telemedicine and digital health, and situations where the patient is not in a position to give consent.
Consent under Medical Ethics:
The Indian Medical Council (Professional conduct, Etiquette and Ethics) Regulations, 2002 (Ethics Regulations), govern the duties and responsibilities of registered medical practitioners (RMP) and lay down the requirement to obtain informed consent from patients. For instance, before performing an operation, the RMP is required to obtain, in writing, consent from the patient, or their husband/ wife, or the parent/ guardian (in the case of a minor). In an operation which may result in sterility, consent of both husband and wife is needed. Further, no act of invitro fertilization or artificial insemination can be undertaken without the informed consent of the female patient, her spouse as well as the donor. A patient is required to provide consent for such procedures in writing, after he/ she is provided with sufficient information about the purpose, methods, risks, inconveniences, disappointments and possible risks and hazards, associated with the procedure.
The Telemedicine Practice Guidelines, 2020 (Telemedicine Guidelines), which also form part of the Ethics Regulations, have a dedicated and detailed section for patient consent. It lays down that patient consent is necessary for any telemedicine consultation, and that such consent can be implied or explicit, depending on situation[2]. For instance, the consent is implied if the patient initiates the telemedicine consultation. However, explicit consent would be required if the RMP initiates the consultation, and the same may be recorded in any form, for instance via an email, text or audio/ video message (examples included in the Telemedicine Guidelines include the phrase “Yes, I consent to avail consultation via telemedicine” or any such communication in simple words).
Judicial Precedent:
The most extensive guidance on informed consent can be found in judicial precedents on the matter. Jurisprudence pertaining to medical negligence and the nature of consent required from patients, before carrying out any medical procedure, has been laid down by the Indian Supreme Court[3] in a seminal judgment on the subject. Broadly these principles are as follows:
- A doctor must give a patient adequate information for him/her to understand the various aspects of the proposed treatment, as given below, so that he/she can take a call on the treatment. This would consist of the following:
i. the nature and procedure of the treatment;
ii. its purpose and benefits;
iii. its likely effects and complications;
iv. any alternatives, if available;
v. an outline of the substantial risks; and
vi. adverse consequences of refusing the treatment.
Such ‘adequate information’ need not include remote or theoretical risks, rare complications, and possible results of a hypothetical negligent surgery.
- Further, the consent obtained by the doctor from the patient before commencing a treatment (including surgery) should be real and valid, which means that: (a) the patient should have the capacity and competence to consent; (b) consent should be voluntary; and (c) consent should be on the basis of adequate information, concerning the nature of the treatment procedure, so that he/ she knows what the consent is for.
Specific Regulations governing consent:
Certain regulations also contain specific provisions dealing with informed consent, which are as follows:
(i) Pre-natal diagnostic procedures cannot be carried out unless all known side and after effects of such procedures have been explained to the pregnant woman, written consent to undergo such procedures in the language she understands has been obtained in the prescribed form, and a copy of the written consent so obtained has been provided to the pregnant woman[4];
(ii) No pregnancy of a minor woman, or a woman who, having attained the age of 18 (eighteen) years, is a mentally ill person, can be terminated, without the written consent of her guardian. Further, no pregnancy can be terminated without the consent of the pregnant woman[5];
(iii) In all clinical trials, a freely given, informed, written consent is required to be obtained from each study subject. The subject’s written consent is required to be obtained, using an ‘Informed Consent Form’ and if the subject is not able to give informed consent, the same may be obtained from a legally acceptable representative[6].
Further, an audio-video recording of the informed consent process, in case of vulnerable subjects in clinical trials of ‘New Chemical Entity’ or ‘New Molecular Entity’, including procedure of providing information to the subject and his understanding regarding such consent, is also required be maintained by the investigator. However, in case of clinical trial of anti-HIV and anti-leprosy drugs, only audio recording of the informed consent process is required to be maintained.
Conclusion:
As may be gleaned from the above, Indian jurisprudence on the subject of patients’ informed consent is quite robust. There are general, overarching principles that have been laid down in the Ethics Regulations as well as judicial pronouncements. Additionally, there are specific guidelines for certain procedures and activities, such as for medical termination of pregnancy and conducting clinical trials. However, as witnessed in the Delhi High Court case, issues related to informed patient consent still keep cropping up. This is because, notwithstanding the above guidelines, certain minutiae continue to remain unanswered.
In the next part of our blog series, we will discuss, in detail, the practical implications and issues faced by healthcare providers while providing medical treatment. Clarity on such aspects is especially necessary, considering the growth in telemedicine and digital health platforms, where traditional modes of obtaining consent may not be feasible.
For further information, please contact:
Biplab Lenin, Cyril Amarchand Mangaldas
biplab.lenin@cyrilshroff.com
[1]Azhar Rasheed v State of NCT of Delhi and Ors, (W.P.(CRL) 115/2022),
[2] Paragraph 3.4 of the Telemedicine Guidelines
[3] Samira Kohli vs. Dr. Prabha Manchanda & Anr., (2008) 2 SCC 1.
[4] Section 5 of the Pre-conception and Pre-natal Diagnostic Techniques (Prohibition of Sex Selection) Act, 1994.
[5] Section 3 of the Medical Termination of Pregnancy Act, 1971.
[6] Third Schedule of the New Drugs and Clinical Trials Rules, 2019.
