This project explores the fundamental aspects of patient consent, rights, and responsibilities within the healthcare system. It aims to provide a comprehensive understanding of the legal, ethical, and practical dimensions that govern patient autonomy and the shared responsibility between healthcare providers and patients. Informed consent is a central theme of this study, as it empowers patients to make educated decisions about their medical treatments after being fully informed about the risks, benefits, and alternatives. The concept of consent goes beyond simply signing a document; it is a dynamic process that involves open communication and trust between patients and healthcare professionals.

In addition to consent, this project delves into patient rights, including the right to privacy, confidentiality, and access to information. These rights are crucial in protecting patient dignity and ensuring that care is delivered with respect and transparency. The discussion highlights the legal frameworks and ethical principles, such as autonomy and beneficence, that uphold these rights.

The responsibilities of patients are equally critical, as they play a vital role in achieving successful healthcare outcomes. Patients are expected to provide accurate medical histories, comply with treatment plans, and actively participate in their care. The project emphasizes that the healthcare relationship is a two-way street, where both parties must fulfill their obligations to ensure effective and ethical care.

By addressing both patient rights and responsibilities, this project seeks to foster a better understanding of the shared nature of healthcare, where mutual respect and collaboration are key. The study contributes to improving patient-provider relationships, enhancing the quality of care, and promoting a healthcare environment that respects patient autonomy while encouraging responsibility in personal health management.

Introduction:
Patient consent, rights, and responsibilities are fundamental to ethical healthcare delivery. Understanding these concepts ensures that patients are informed, empowered, and active participants in their care decisions. In an evolving healthcare environment, it is essential to explore how consent is obtained, the scope of patient rights, and the responsibilities patients have to safeguard their own well-being, thus fostering a balanced and collaborative doctor-patient relationship.

Objective of the Study:
The study aims to analyze the key elements of patient consent, the rights they hold within healthcare settings, and their responsibilities towards ensuring proper treatment and collaboration with healthcare providers. The objective is to deepen the understanding of these dynamics to improve patient experiences and outcomes.

Scope of the Study:
This study will examine legal, ethical, and procedural frameworks governing patient consent, rights, and responsibilities. It will assess policies in diverse healthcare systems, focusing on how they align with international medical standards, and explore the challenges faced in achieving patient-centered care, especially in complex or emergency medical situations.

Significance of the Study:
Understanding patient consent and rights ensures a transparent and ethical healthcare process, reducing legal disputes and enhancing patient trust. Additionally, recognizing patient responsibilities emphasizes the importance of shared accountability, which is critical for efficient healthcare delivery. This research contributes to the overall enhancement of medical ethics, patient satisfaction, and healthcare policies.

Research Question:

1. Whether current healthcare systems adequately balance patient consent, rights, and responsibilities to ensure ethical and effective medical treatment?

Hypothesis:
The hypothesis is that while patient consent and rights are well-established in healthcare systems, a lack of emphasis on patient responsibilities may hinder optimal medical care and outcomes.

Introduction
One of the most important challenges in the field of medical treatment nowadays is the aspect of permission. It is common knowledge that the patient must give informed permission before receiving treatment, and that he or she has the right to decline care even if it will save their lives. This undoubtedly sparks a lot of ethical discussion and lies at the core of current medical law. This fundamental value, which is founded on autonomy, is first expressed in the Nuremberg Code of 1947.

In response to the horrific medical and experimental practices carried out by the German Nazi authority soon following World War II, the Nuremberg Code was enacted. The code requires that human subjects give their voluntary, informed consent. Similar to this, the 1964 World Medical Association Declaration of Helsinki highlights the significance of gaining freely given informed permission for medical research by appropriately educating the subjects of the study's objectives, procedures, anticipated benefits, potential risks, and discomforts.[1]

Similar international conventions and declarations have affirmed the significance of getting patients' consent before conducting tests and administering treatments. The current study addresses the full range of consent-related concerns from the perspective of the current legal system in India.

When the top court in India recently ruled that it is not just the consent or informed consent (as it is known throughout the world), but it shall also be prior informed consent, generally speaking, barring some specific cases of emergency, the circle of legal development in the area (i.e., consent) appears to be almost complete. This creates a serious conundrum for a medical expert. Therefore, it is necessary to examine the topic of consent and medical treatment in order to comprehend the delicate and underpinning elements.

The Legal Basis Of Consent
Perhaps the only guiding factor guiding all facets of today's health care provisions is consent. Additionally, it stands for the moral and legal manifestation of the fundamental right to autonomy and self-determination. A medical professional will be held accountable both under tort and criminal law if they seek to treat someone without their legitimate consent. A party that has suffered a civil harm known as a tort may seek restitution from the wrongdoer. Payment of compensation (in civil cases) and incarceration would be the results (in criminal).

The patient may first file a tort claim against the doctor for trespassing on someone's privacy. Alternately, the medical expert can be held liable for carelessness. It is theoretically possible to be charged with assault or battery in some severe situations. The classic definition of battery is an act that directly creates physical contact with another person without that person's consent, whether unintentionally or purposefully.

There is no abuse if the other person has given their express or implied agreement to the contact. Unless there is blatant disregard for the patient's bodily autonomy, such as if the patient's organs are removed without his consent, it is uncommon for a doctor to be charged with a criminal offence.

In tort law, using force against any human body without a good reason is illegal, regardless of the amount of force used. Under tort law, a doctor will be found guilty of treating a patient without getting their proper consent. Treatment consent may be explicitly given or assumed. A clinical diagnosis may be performed with the patient's permission if he enters the consultation rooms of his own free will.

From a patient's general compliance with instructions given by a doctor during clinical diagnosis, consent may be inferred. This is a great illustration of implied permission in action. An intimate examination of the patient, such as a vaginal examination, may be required during the clinical evaluation.

The best way to get consent for such an examination is for the doctor to ask the patient verbally. Furthermore, it is best to acquire the patient's written agreement before doing any invasive examinations that require an incision or the collection of bodily fluid samples.

Medical professionals frequently request specific prescriptions when a written consent is required. It is interesting to notice that the legislation just requires consent, not written consent, and that it does not mandate this need. In actuality, the requirement for written consent is determined by the medical practice itself. A written consent might be beneficial in situations where the patient is put under anesthesia (local or general) or experiences significant discomfort while receiving treatment.

There is no requirement that a doctor always seeks written consent, and if he did not, he would be held accountable. However, in the event of litigation, the doctor would have an easier time showing consent if there was written consent. The Medical Council of India (MCI) has established recommendations that are published as regulations in which agreement is necessary to be obtained in writing before performing an operation in order to standardize the procedure. [2]The MCI guidelines are applicable to operations and do not cover other treatments. For other treatments, the following may be noted as general guidelines:

• For routine types of treatment, implied consent would suffice
• For detailed types of treatment; ideally express oral consent may be needed
• For complex type's of treatment, written express consent is required

Capacity And Information While Seeking Consent
There are two other things to keep in mind: first, a patient must be competent to consent in order to give consent, and second, the consent must be given voluntarily and with full knowledge of the consequences. The patient must possess the capacity to consider the risks and benefits of the proposed course of treatment in order to be competent to provide a legally binding consent.

The legislation assumes that attaining the age of maturity normally results in the development of such skill. A person who has reached the legal age of consent and is of sound mind may offer a doctor's treatment authorization in writing. People who have turned 18 are typically regarded as having reached maturity and are competent to give consent. The law thus presumes capacity, rationality, autonomy, and freedom if the person has attained the age of so called maturity.

on the other hand, it is vital to assess whether an adult presumption of ability is rebutted in a given situation when there is cause to suspect that a patient is unable to comprehend the nature of the treatment and its advantages or adverse effects before making a decision. obtaining consent from the patient's attendant is a option if the patient is unable to do so. In the UK, a number of ethical concerns have been raised in relation to the proxy permission on behalf of such people.

Few modifications are even recommended in the Law Commission Report on Mental Incapacity from 1995. No of the patient's age, the patient's guardian must give their approval if they are deemed incompetent owing to unsoundness of mind. In India, the court has not come across borderline cases of an adult refusing treatment leading to emergency and leaving the doctor in a dilemma, unlike in the west.[3]

The medical professional must seek proper consent by fully disclosing all pertinent information since the law assumes that he or she is in a dominant position toward the patient. Consent that doesn't include the relevant details is invalid. Unfortunately, the phrase informed consent is frequently used carelessly. The informed consent philosophy, which has its roots in America, refers to how much information a patient should get in order to prevent any potential negligence on their part.

When the patient claims that he was forced to sign on the dotted lines of such an format without providing the relevant information, a doctor or hospital administrator may infrequently be able to rely on the consent form he or she has received from the patient.

This practice is also a result of treating consent forms like ordinary contracts and getting rid of any sweeping or unreasonable clauses that would exclusively serve the interests of the doctor. It is actually rather necessary because the patient has to decide whether to accept the pro-forma in its entirety or not after the medical professional or hospital administration has produced it. Therefore, it is crucial that a doctor obtains the patient's necessary consent for the proposed treatment while providing him with all pertinent information about it in a language he can understand.

When a doctor is considering doing a significant operation on a patient, the doctor can decide whether the procedure should be carried out or not based on the patient's medical history, the doctor's medical training, and his or her objective viewpoint. In these situations, the doctor's obligation is to give the patient information that will allow them to make a balanced decision if they so desire, subject to the doctor's overriding obligation to consider the patient's best interests.[4]

Regardless of the approaches used, it is clear that a medical professional must disclose the required information before requesting consent from a patient. In order to explain the Indian stance, it might be said that the courts have given the necessity of informed consent a great deal of weight even if there isn't as much litigation here as there is in the West. In India, a doctor has a responsibility to give the patient all the information they need in a language they can understand.

There are no specific guidelines established by the courts regarding the amount of information. The professional regulatory body's consideration of the knowledge gap in this regard. Considering the knowledge gap in this regard, the professional regulatory body for medicine can play an important role in establishing standards.

Indian Law On Consent
The right to life and personal liberty are protected by Article 21 of the Indian Constitution, which also enshrines the concept of autonomy. The term personal liberty as used in Article 21 has the broadest scope and refers to a wide range of rights, including the right to live in dignity and all that entails as well as any act that interferes with a person's ability to utilize a limb or other faculty, either permanently or temporarily. Despite the fact that Indian courts have frequently referred to these ideas, the common law application of consent has not yet been fully evolved in India. The Indian Contract Act and the Indian Penal Code's guiding principles must, of course, be consulted in such circumstances.

A contract between persons with the legal capacity to enter into contracts and create contractual obligations exists between a medical professional and his or her patient. According to the Indian Majority Act, parties are generally considered competent if they have reached the age of 18, or are of sound mind, and are not ineligible under any applicable laws. Additionally, a clause in contract law states that any consent from a party (in this case, the patient) that was obtained through pressure, undue influence, error, misrepresentation, or fraud will invalidate the contract. The General Medical Council's recommendations, however, state that the consenting age in England is 16 years old. A young person can be treated like an adult and be assumed to be able to make decisions.

Depending on how well the child can comprehend the situation, a youngster under the age of 16 may be able to make a decision. A person with parental responsibility or the court may approve an investigation or treatment that is in the kid's best interests when the youngster is competent and refuses it. Its interesting to note that in Scotland, a competent child's refusal of a procedure cannot be approved by people with parental responsibility.

Naturally, the consent gained after receiving the pertinent information will have its own set of operating parameters to provide protection for the medical professional. Beyond these limits, the doctor would be treating the patient at his own risk because it is believed that there is no consent at all for such treatment. A doctor who continued treating a patient in order to safeguard the patient's own interests was held accountable since he was acting against the patient's will. Appendicitis was thought to be the patient's condition. After receiving the proper consent, she underwent surgery. But after the incision, it was discovered that her appendix was healthy and inflamed. The doctor removed the patient's gangrenous gall bladder to safeguard her interests.

Later, it was found that the patient's kidney was compromised. Due to his unauthorised operation, the doctor was held accountable. This case law also exemplifies the typical paternalism held by many in the medical community. It is a theory in which the doctor begins to act as the patient's parent and makes decisions on the patient's behalf. Unfortunately, this idea is not recognised by the law. The patient's right to autonomy is always given top priority by the law, provided that he has the essential capacity.

Perhaps it is understandable for a medical professional to think that the principle of autonomy should be surrendered for the benefit of the patient if they feel that a medical operation is reasonable and required for the patient's health. In this instance, the doctor would have been protected if he had stopped after learning that the patient's appendix was normal because he was acting with the patient's lawful consent and, more crucially, because a simple mistake in judgment is not criminally responsible.

He did not have her legitimate consent before removing her gall bladder, which was a severe instance of professional paternalism and flagrant disregard for the patient's autonomy. Hence, some commentators like Mill, et al. have advocated for minimal level of paternalism in the interest of the medical profession and the overall inability of humans in taking rational decisions, during the time of crises.[5]

There are no established rules or guidelines for proxy consent in India when the patient is unable to give approval for them. If such a circumstance exists, the doctor may continue the treatment with the patient's consent and that of any relative or even a companion. In one instance, the patient's wife gave clear instructions to hospital officials that she had no objections to her husband having bypass surgery, and her approval was judged adequate for the purposes of any formalities that the hospital was obligated to follow.[6]

Interestingly, the patient's connection with his wife was strained in another example. Sterilization surgery was performed on a patient. He testified that he is married and has two infant girls while providing his approval. In reality, the only reason he had the surgery was for the financial reward. After the procedure, his father argued that the patient was mentally disturbed and lacked the capacity to provide consent. The court ruled that a doctor is protected provided there are no circumstances that would lead him to suspect wrongdoing or have second thoughts regarding the patient's capacity. [7]

These two incidents demonstrate that a doctor who acts fairly and within the bounds of the law is always protected and is never obliged to serve as an investigative body. Recently, the Supreme Court made a crucial ruling in the case. Where a patient consults a surgeon and consent is obtained from the patient for a diagnostic procedure or surgery, such consent cannot be considered as authorization or permission to perform therapeutic surgery, either conservative or radical (except in a life-threatening emergent situation), the court ruled in that case.[8]

The court determined that although a diagnostic technique may have wide consent, it cannot be used for therapeutic surgery, setting a precedent in India. The court further stated that where the patient's consent is for a particular operative surgery, it cannot be treated as consent for an additional procedure involving the removal of an organ solely on the ground that it is beneficial to the patient or is likely to prevent some danger developing in the future, where there is no immediate danger to the patient's life or health. This idea restricts the function of a "paternal doctor" in the Indian context.

In one instance, a 44-year-old single woman was encouraged by her doctor to have a laparoscopy. She was asked to sign many consent papers, including one for admittance and another for operation. one of these consent forms specifically authorized the doctor to perform a diagnostic and operational laparoscopy, and it also said that a "laparotomy may be required. Proxy consent was obtained from the patient's attending mother for a hysterectomy when the patient was in the operating room (and unconscious). Her fallopian tubes, ovaries, and uterus were all removed. When a lawsuit was later filed, it was determined that the operation had been performed without genuine permission and that the doctors should have been held accountable.

This choice will have far-reaching effects and will advance the field of consent law. It is argued that previous informed permission is also required unless there is an immediate threat to the patient's life, in addition to the informed consent that is now required. Additionally, this ruling limit the breadth of proxy authorization from a parent or other caregiver.

Emergency Situation And Consent
It's interesting to note that if a medical emergency occurs, the full spectrum of consent rules in India become convoluted concepts. The Supreme Court declared that a doctor has an obligation to treat a patient in an emergency in a couple of the landmark rulings. According to the Supreme Court, Article 21 requires the State to protect every person's right to life, underscoring the fundamental responsibility of any welfare state.

Thus, protecting human life is of utmost importance. The state-run government hospitals have a duty to provide medical care in order to preserve human life. When a person in need of medical care is not given timely care by a government hospital, this has negative consequences results in the violation of his right to life guaranteed under Article 21.[9]

In a similar vein, the court further highlighted that every doctor, whether practicing in a government hospital or elsewhere, has a professional duty to extend his services with the necessary knowledge for preserving life. The paramount duty placed on medical professionals cannot be avoided or delayed by the use of any law or state action. A doctor has a complete, unwavering, and primary duty.

Laws of procedure, whether contained in statutes or not, that would prevent the fulfillment of this obligation cannot be upheld and must, as a result, be disregarded. [10]In one case, the top court established some crucial rules, including I the doctor treating the injured person shall provide all assistance that is within his power at the time, including referring him to the appropriate experts, (ii) the doctor treating the injured person shall be protected by law, as they are not breaking any procedural laws of the country (regarding jurisdictions, etc.), and (iii) all legal barriers (whether actual or perceived by the doctors) are deemed to be immaterial.

This is in line with the hypocritical oath that a doctor swears when they first enter the field. As a result, a doctor has a duty to attend to a patient in an emergency without delaying care. The need to treat emergency patients, particularly accident victims, are mandated by a number of statutes (such as medical institutions regulating acts in different states).

The original argument (and the Supreme Court's attempt) is quite logical because a doctor must always try to preserve lives in an emergency. This holds true whether or not the formalities, including consent, are followed. What should happen, hypothetically, if a patient in an emergency refuses to receive treatment? on that, Indian courts are not particularly clear. The decisions made above were made with the accident victims in mind who were denied medical care by the doctors, citing them as medico legal cases. Moreover, in the above instances, the patient would go himself, or be taken by someone (due to an unconscious state) to the doctor to seek medical treatment.

In Dr. T.T. Thomas vs. Elisa,[11] on March 11, 1974, the patient was admitted to the hospital. The patient was diagnosed with a perforated appendix and peritonitis upon admission, necessitating surgery. Unfortunately, no surgery was performed until after his passing on March 13, 1974. The doctor argued that, despite the proposal, no surgery could be performed because the patient had not given her consent. other actions were therefore attempted to improve the patient's health, which got worse by the next day.

Even if the patient was then willing to have the procedure, his health prevented it. on the other hand, the respondent's (i.e., the Plaintiff's) version was that the surgeon requested payment before conducting the procedure. Additionally, the doctor was attending to some chores in an outside private nursing home to conduct operations on the other patients and that the appellant doctor came back only after the death of the patient.

The physicians' rejection for consent and the plaintiff's (the deceased patient's wife) claim that the doctors sought a bribe, which caused the procedure to be postponed until it was fatal, were the two versions that were presented to the court. Finally, the court ruled in favour of the plaintiffs, holding that permission is not required in such an emergency scenario. The following remarks are noteworthy: "The consent component may be crucial frequently in cases of selective surgeries, which may not be urgently required to preserve the patient's life.

There are, however, some circumstances in which a surgeon may not be expected to claim, "I did not operate on him because, I did not acquire his consent." These situations frequently include emergency operations when a doctor cannot wait for the patient's assent or where the patient is not mentally fit to offer or withhold a conscious answer regarding consent. Even if he is well enough to respond voluntarily, the surgeon has a responsibility to warn him as soon as feasible about the hazards involved in forgoing a procedure.

The burden of proving that the failure to execute the surgery or administer the recommended course of treatment was due to the patient's unwillingness to give consent is on the surgeon or medical professional who makes the claim that the patient refused to give consent for the procedure. This is particularly true when the patient is not present to provide testimony. When a patient submits to a doctor, permission is assumed, and the patient who is arguing there was no consent must provide evidence of this.

As previously indicated, the court further declared that "we also hold that the failure to execute an emergency operation on the deceased on 11-3-1974 amounts to carelessness and the deceased's death was on account of that failure" before finding the doctor accountable. The debate over consent law has become more complicated as a result of this decision. Due to the fact that it was a High Court ruling, this case law cannot be highlighted further; yet, the point of view is worth noting. In light of all these developments, it is possible to draw the conclusion that there are still a lot of murky areas in India's consent law that may be cleared up with proactive action from the relevant professional regulatory body.

Informed Consent
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[12], highlighted with concern that a patient's informed permission was not obtained before they got a hair transplant, which caused problems and ultimately led to the patient's death.

The Court emphasized that while hair transplantation is an aesthetic procedure, it must be carried out with the patient's knowledge and agreement by board-certified dermatologists or experienced surgeons. Although this case only deals with a small portion of informed consent in the context of cosmetic surgery, the problems presented therein could have wider ramifications.

It has long been controversial to use informed consent for medical interventions. Although it is widely agreed that informed consent is necessary before beginning any medical treatment, it is unclear exactly what that means or how it should be given. Permission under medical ethics: The Indian Medical Council (Professional conduct, Etiquette and Ethics) Regulations, 2oo2 (Ethics Regulations), which set down the duty to seek patients' informed consent, govern the obligations of registered medical practitioners (RMP). For instance, the RMP must seek written agreement from the patient, their spouse, their parent, or their legal guardian before performing an operation (in the case of a minor).

Both the husband and wife must give their agreement for a procedure that could make them sterile. Furthermore, the female patient, her spouse, and the donor must all give their informed consent before any in vitro fertilization or artificial insemination procedures are carried out. After receiving adequate information regarding the procedure's aim, methods, dangers, inconveniences, disappointments, and potential risks and hazards, a patient is required to give written consent for such treatments.

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[13]. For instance, if the patient requests the telemedicine consultation, consent is presumed. The Telemedicine Guidelines include examples such as the phrase "Yes, I consent to avail consultation via telemedicine," or any such communication in simple words. Explicit consent would be required, though, if the RMP initiates the consultation, and it may be documented in any form, such as via email, text, or audio/video message.

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 [14]in a seminal judgment on the subject. Broadly these principles are as follows:

In order for a patient to make an informed decision about the recommended therapy, a doctor must provide sufficient information so that the patient is aware of all the relevant details, as listed below. What would make up this are the following:

The information provided to the patient should include:

1. the nature and procedure of the treatment;
2. its purpose and benefits;
3. its likely effects and complications;
4. any alternatives, if available;
5. an outline of the substantial risks; and
6. adverse consequences of refusing the treatment.

Such sufficient information should not cover improbable hazards, uncommon complications, or potential outcomes of a faulty surgery. Additionally, the patient's consent must be genuine and valid in order for the treatment (including surgery) to proceed. This requires that the patient have the capacity and competence to give consent, that the consent be given voluntarily, and that the consent be given after receiving sufficient information about the treatment procedure so that the patient is aware of what the consent is for.
 

Specific Regulations Governing Consent:

Certain regulations also contain specific provisions dealing with informed consent, which are as follows:

1. 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.^[15]
    
2. 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.^[16]
    
3. 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.^[17]

Additionally, the investigator is required to keep an audio-video recording of the informed consent process, including the method of informing the subject and his understanding of such permission, in the case of vulnerable individuals in clinical trials of "New Chemical Entity" or "New Molecular Entity." However, only an audio recording of the informed consent procedure needs to be kept in cases where anti-HIV and anti-leprosy medications are being tested in clinical trials.

As can be inferred from the foregoing, Indian law is quite solid when it comes to patient informed consent. Along with judicial rulings, general, overarching principles have been established in the Ethics Regulations. Additionally, there are certain rules for specific operations and activities, such carrying out clinical trials and medically ending pregnancies. However, problems with informed patient consent continue to arise, as seen in the Delhi High Court case. This is due to the fact that, despite the aforementioned rules, some details nevertheless go unresolved.

Conclusion
According to the Supreme Court of India, consent in the context of a doctor-patient relationship is defined as the patient's approval of a medical professional performing an act, such as a diagnostic, surgical, or therapeutic operation. In some cases, a patient's activity can be interpreted as consent.

The consent rules for medical treatment is outlined in this order. Written agreement confirms patient autonomy, which is the cornerstone of contemporary bioethics, in addition to serving as legal proof in court. In order to clarify the age at which a person's right to medical secrecy begins, it is necessary to revisit the anomalies and ambiguities surrounding the age of permission to participate in invasive therapeutic or investigative procedures and clinical trials. Protocols must also be developed to obtain consent from youngsters, mentally ill people, and illiterate people.

Bibliography:

• G. Sinha, 'Outsourcing Drug Work: Pharmaceuticals Ship R&D and Clinical Trials to India', Scientific American 291 (2004), pp. 24–25.
• Indian Council of Medical Research, Ethical Guidelines on Medical and Health Research on Human Participants, 2017.
• https://icmr.nic.in/guidelines/ICMR_Ethical_Guidelines_2017.pdf
• S. Balganesh, 'The Constitutionalization of Indian Private Law', Penn Law Faculty Scholarship Paper 1557 (2016).
• L. Shepherd and M.A. Hall, 'Patient-Centered Health Law and Ethics', Wake Forest Law Review 45 (2010), p. 1450; also citing J.H. Krause, 'Can Health Law Truly Become Patient-Centered?', Wake Forest Law Review 45 (2010), pp. 1490–1492.
• T.K. Koley, Medical Negligence and the Law in India: Duties, Responsibilities, Rights (Oxford: Oxford University Press, 2010).

End Notes:

1. 1964, Declaration of Helsinki.
2. Reg. 7.16, Medical Council of India (Professional Conduct, Etiquette and Ethics) Regulations. 2002.
3. Re C (Adult: Refusal of Treatment) [1944] 1 All ER 819, Re T (Adult: Refusal of Treatment), [1992] 4 All ER 649, F v West Berkshire Health Authority, [1989] 2 All ER 545, and Gillick v West Norfolk and Wisbech AHA, [1985] 3 All ER 402.
4. Sidaway v Board of Governors of the Bethlem Royal Hospital and the Maudsley Hospital and others (1985) 1 AC 871, HL.
5. Mill, J.S., 'On Liberty' Harmondsworth: Penguin; 1982. p. 68.
6. C A Muthu Krishnan v. M. Rajyalakshmi. AIR 1999 AP 311.
7. Chandra Shukla v. Union of India. AIR 1987 ACJ 628.
8. Samera Kohli v. Dr. Prabha Manchanda and Another. 2008;(1) SCALE 442.
9. Paschim Banga Khet Mazdoor Samity and ors v. State of West Bengal and Another, 1996. 4 SCC 37.
10. Pt. Parmanand Katara v. Union of India. AIR 1989 SC 2039.
11. TT Thomas (Dr.) v. Elisa. AIR 1987 Ker. 52.
12. Azhar Rasheed v. State of NCT of Delhi and ors, (W.P.(CRL) 115/2022).
13. Paragraph 3.4 of the Telemedicine Guidelines.
14. Samira Kohli vs. Dr. Prabha Manchanda & Anr., (2008) 2 SCC 1.
15. Sec. 5, Pre-conception and Pre-natal Diagnostic Techniques (Prohibition of Sex Selection) Act, 1994.
16. Sec.3 of the Medical Termination of Pregnancy Act, 1971.
17. Third Schedule of the New Drugs and Clinical Trials Rules, 2019.