The Right to Informed Consentin a Clinical Trial

A patient participating in a clinical trial has the right to know all the information regarding the trial, including its potential benefits and risks, so that he can make an informed decision

Clinical trials are scientific research experiments, conducted on human volunteers in order to find new ways to prevent, detect and cure diseases. Medical science has grown leaps and bounds on the back of such biomedical research. When done properly, such studies are very useful in improving our medical knowledge base.

However, not all clinical trials are conducted ethically. This is especially true in India, which is fast becoming an attractive destination for carrying out clinical trials, primarily because we have a huge and diverse pool of patients on whom these trials can be conducted fairly inexpensively. Many of the patients chosen are uneducated, who can easily be exploited by doctors, researchers and pharmaceutical companies, alike. Unethical researchers (who get paid huge sums for signing up as many participants as possible) may exaggerate the benefits of a treatment, offer financial sweeteners, or attempt to play down the risks of the trial.

In 1997, the oncology division of the Indian Council of Medical Research (ICMR) carried out an observational study on cervical cancer in Indian women. The study did not have any ethical clearance from the All India Institute of Medical Sciences (AIIMS) from where the subjects were drawn; nor did the researchers get informed consent from the subjects themselves. Under the ICMR study, 1100 uneducated urban women from Delhi with pre-cancerous lesions were studied between 1976 and 1988. The objective was to study the natural progression of cervical dysplasia to cervical cancer (the most prevalent cancer amongst Indian women) without any medical intervention. So despite the fact that a simple surgery would have removed the cervical lesions, before they could turn cancerous, the women were wantonly left untreated. The outcome was that 62 of these women needlessly developed cancer; and in nine the disease had already spread to other parts of their body.

In another equally scandalous incident, an Indian scientist attempted to inject the bovine HIV strain into a human subject. This research was also not approved by any ethical body. Likewise there have been reports of a pig’s heart transplant into humans; and controversial trials with mepacrine, an anti-malarial drug that is injected into a woman’s uterus for contraceptive purposes, although some doctors suspect it causes cancer. Although every hospital unit is supposed to have its own ethical committee, in our country most are defunct bodies. The National Human Rights Commission (NHRC) guidelines propose that a research group must provide human subjects with printed literature, explaining in simple, non-technical language, the purpose of the study; details of the procedure; the risks involved; the financial or other interests of the researcher; and a commitment to treat, completely and free-of-cost, any complication that may arise during the course of the trial.

The subject too has to certify in writing that she has understood the document and is volunteering to participate in the research, without the promise of any monetary inducement that is not permitted under the Indian law. There are a few other government bodies that monitor clinical trials such as the Drug Controller of India and the Clinical Trial Registry in India (CTRI). Nonetheless, the Supreme Court recently expressed reservations about the unethical way in which most clinical trials are being conducted in the country, and has directed the Ministry of Health to formulate proper guidelines on this, to protect patients’ interests. According to existing rules, an ethically sound clinical trial:

                Will aim for the enhancement of medical knowledge

                Will have strong scientific validity

                Will recruit participants fairly

                Will have a favourable risk-benefit ratio

                Will have people who independently review, approve, amend or terminate it

                Will obtain informed consent from its participants

                Will respect the participants privacy and will strive hard to protect their wellness and rights

Role of patient advocates in clinical trials

Patient-advocates can play an extremely important role in clinical trials. Among other things they are required to:

                Make sure whether the information about the trial is presented in a format which is easily understandable to the patient

                Assist the research team in developing relevant educational materials about the trial in lay-friendly terms that is simple and easy to understand

                Identify and address potential ethical issues in the trial

                Promote patient safety and confidentiality

                Assist the research team in obtaining valid informed consent from the patients, recruited in the trial

QUIZ TIME: Informed Consent Quality Assessment Questionnaire

Use this form to gauge patient’s understanding of their participation in clinical trials

                Do you feel that you have been informed how long your participation in this clinical trial will last?

                Do you think that all the treatments and procedures that the investigator proposed for you are the best for your disease?

                Do you understand what “randomisation” means?

                Do you know that no direct medical benefit will derive to you from your participation in this clinical trial?

                Are you sure that your participation in this trial will not involve any additional risk or discomforts?

                Do you know that because you are participating in a clinical trial, it is possible that the study sponsor, various government agencies, or others not directly involved in your health care could have access to your medical records?

                Do you know that the consent form you signed lists the names of the contact persons, who must answer any of your questions or concerns about the clinical trial?

                Do you know that the consent form you signed describes how you will be covered by insurance if you are injured or become ill as a result of participation in the clinical trial?

                Do you understand that if you do not want to participate in the clinical trial you are free to refuse to sign the consent form? This will not affect the quality of medical care you receive, so you do not need to be scared that your doctor will get angry or upset if you refuse to participate.

                Do you understand that you are not obliged to remain in the clinical trial if you decide to withdraw at any point of time?

                Explain in your words the purpose of the clinical trial to which you have consented to be a subject.

A patient-advocate who uses such questionnaires with patients who have been recruited to participate in a clinical trial will help to protect the patients; and will also ensure that the research team is never caught on the wrong side of the fence.

Right to Privacy and Confidentiality

Right to Privacy and Confidentiality

The 1997 medical ethics guidelines proposed by the National Human Rights Commission debar doctors from sharing a patient’s confidential information for any monetary inducement

The exchange of information between a doctor and patient is always confidential and personal. Confidentiality helps patients to be frank and honest with their physician, which in turn leads to better health outcomes. A good doctor will protect patient privacy, as it helps build trust and bonding between them. The issue of confidentiality needs to be addressed even more urgently with the introduction of electronic medical records, which can be shared easily with the click of a mouse. Although the electronic exchange of health information offers significant benefits, it increases the risk of inadvertently exposing private medical information.

The meaning of confidentiality

Because patients share so much sensitive, private and personal information with their doctor, the duty to maintain confidentiality has been enshrined in the Hippocratic Oath. The International Code of Medical Ethics states that “A physician shall preserve absolute confidentiality about all he knows about his patient, even after his patient has died.”

As per the Medical Council of India Code of Ethics Section Clause 7.14, “The registered medical practitioner shall not disclose the secrets of a patient that have been learnt in the exercise of his/her profession except –

i) In a court of law under orders of the Presiding Judge;

ii) In circumstances where there is a serious and identified risk to a specific person and/or community; and

iii) Notifiable diseases. It is his duty that he should inform public health authorities immediately about any communicable or notifiable disease. “

Of course, matters become more complex when there is a conflict between the right to privacy and the right to health of another individual.

Ideally, information about a patient’s records should not be released to anyone outside of the hospital without the patient’s authorization, unless it’s being shared with another healthcare facility to which the patient is being transferred, or if the release has been ordered by a court. If this is being done under a third-party payment contract for research work on aggregated statistics, information sharing is permissible, provided the patient’s identity is masked.

When software engineer, Abdul Mustafa (name changed) tested HIV-positive, he did not want his employers or his friends to know about it. Had the doctor still gone ahead and divulged this information, it would have amounted to a breach of trust and the confidentiality proviso. The Health Insurance Portability and Accountability Act of 1996 (HIPAA) in the USDA made several sweeping changes relating to privacy and confidentiality of medical records. It established privacy procedures, the need to inform patients about these procedures; the need to train employees to follow strict privacy guidelines, and the importance of designating an individual to oversee the healthcare organisation’s privacy initiatives. In India, where such laws don’t exist, it’s important that patients seek the help of patient-advocates in securing their right to privacy and confidentiality.

Shh….A Patient Has the Right to Confidentiality Patients need to be confident that the doctor will protect their confidentiality. Thus, if you don’t want your psychiatrist or your infertility consultant to call your secretary to leave a reminder about your next appointment, please make this request in writing.

ch� � t r �Z� ؿ� nguistic barriers.

Right to Simplified Information

Advocates can assist healthcare professions in providing culturally-competent care to patients

Imagine lying on a hospital bed - anxious, uncomfortable, waiting for test results and fearing the worst. Now imagine being probed in all the sore places by unconcerned doctors and nurses who wear deadpan expressions as they stop by to take your vital signs, do blood tests, and listen to your chest. Also imagine that the hospital that you have landed up in is in some remote corner of Africa, and you don’t have a clue what the medical staff is saying, and you cannot explain what you are feeling. This is often how poor, uneducated, illiterate patients feel when they find themselves in a large hospital in the city, where everything is unfamiliar and threatening.

The reasons for healthcare disparities

Some factors that contribute to health disparities are:

                Persistence of centuries-old racial stereotypes

                Time pressures caused by increasing case loads

                Lack of decision-making skills in the junior health care staff

                Absence of a patient-advocate in the picture

Real or perceived discrimination in hospitals can lead minorities and the poor to mistrust doctors and nurses. The onus is on the healthcare provider, who is the “more powerful actor in clinical encounters” to see to it that such disparities do not occur, and if he fails in this duty, it’s the patient-advocate’s responsibility to step in and correct matters.

In a recent survey, physicians reported that more than half of their patients do not follow medical treatment as a result of cultural or linguistic barriers. While the majority of doctors surveyed agree that language and culture are important in the delivery of care to patients, only half of the doctors reported having any form of “cultural competency training.” This lacuna is one which a caring patient advocate can fill competently, allowing him to act as a bridge between the doctor and the patient.

The need for cultural competence in patient-advocates

Cultural competence leads to cultural awareness, knowledge, understanding, sensitivity, interaction, and skill. It necessarily flows from good “communication.” Efficient health care delivery also depends upon health literacy, which varies between different cultural groups.

Although poor health literacy can be a particularly thorny problem in patients with low literacy skills, it can also affect patients who think of themselves as being literate. Even doctors sometimes find it hard to make sense of the convoluted language which health insurance companies and hospital administrators use in their forms. A patient advocate can help in decoding this medical jargon.

Lay theories of anatomy and physiology can also influence how people interpret and respond to their illness. In Indian villages, women often describe their menstrual blood as “bad” or “toxic”, and are forbidden from entering temples or even their kitchens, when they are menstruating. It is hardly surprising that they have a hard time describing their gynaecological problems to doctors. The presence of an advocate can help transcend such cultural and linguistic barriers.

The Right to Informed Consent in a Clinical Trial

A patient participating in a clinical trial has the right to know all the information regarding the trial, including its potential benefits and risks, so that he can make an informed decision

Clinical trials are scientific research experiments, conducted on human volunteers in order to find new ways to prevent, detect and cure diseases. Medical science has grown leaps and bounds on the back of such biomedical research. When done properly, such studies are very useful in improving our medical knowledge base.

However, not all clinical trials are conducted ethically. This is especially true in India, which is fast becoming an attractive destination for carrying out clinical trials, primarily because we have a huge and diverse pool of patients on whom these trials can be conducted fairly inexpensively. Many of the patients chosen are uneducated, who can easily be exploited by doctors, researchers and pharmaceutical companies, alike. Unethical researchers (who get paid huge sums for signing up as many participants as possible) may exaggerate the benefits of a treatment, offer financial sweeteners, or attempt to play down the risks of the trial.

In 1997, the oncology division of the Indian Council of Medical Research (ICMR) carried out an observational study on cervical cancer in Indian women. The study did not have any ethical clearance from the All India Institute of Medical Sciences (AIIMS) from where the subjects were drawn; nor did the researchers get informed consent from the subjects themselves. Under the ICMR study, 1100 uneducated urban women from Delhi with pre-cancerous lesions were studied between 1976 and 1988. The objective was to study the natural progression of cervical dysplasia to cervical cancer (the most prevalent cancer amongst Indian women) without any medical intervention. So despite the fact that a simple surgery would have removed the cervical lesions, before they could turn cancerous, the women were wantonly left untreated. The outcome was that 62 of these women needlessly developed cancer; and in nine the disease had already spread to other parts of their body.

In another equally scandalous incident, an Indian scientist attempted to inject the bovine HIV strain into a human subject. This research was also not approved by any ethical body. Likewise there have been reports of a pig’s heart transplant into humans; and controversial trials with mepacrine, an anti-malarial drug that is injected into a woman’s uterus for contraceptive purposes, although some doctors suspect it causes cancer. Although every hospital unit is supposed to have its own ethical committee, in our country most are defunct bodies. The National Human Rights Commission (NHRC) guidelines propose that a research group must provide human subjects with printed literature, explaining in simple, non-technical language, the purpose of the study; details of the procedure; the risks involved; the financial or other interests of the researcher; and a commitment to treat, completely and free-of-cost, any complication that may arise during the course of the trial.

The subject too has to certify in writing that she has understood the document and is volunteering to participate in the research, without the promise of any monetary inducement that is not permitted under the Indian law. There are a few other government bodies that monitor clinical trials such as the Drug Controller of India and the Clinical Trial Registry in India (CTRI). Nonetheless, the Supreme Court recently expressed reservations about the unethical way in which most clinical trials are being conducted in the country, and has directed the Ministry of Health to formulate proper guidelines on this, to protect patients’ interests. According to existing rules, an ethically sound clinical trial:

                Will aim for the enhancement of medical knowledge

                Will have strong scientific validity

                Will recruit participants fairly

                Will have a favourable risk-benefit ratio

                Will have people who independently review, approve, amend or terminate it

                Will obtain informed consent from its participants

                Will respect the participants privacy and will strive hard to protect their wellness and rights

Role of patient advocates in clinical trials

Patient-advocates can play an extremely important role in clinical trials. Among other things they are required to:

                Make sure whether the information about the trial is presented in a format which is easily understandable to the patient

                Assist the research team in developing relevant educational materials about the trial in lay-friendly terms that is simple and easy to understand

                Identify and address potential ethical issues in the trial

                Promote patient safety and confidentiality

                Assist the research team in obtaining valid informed consent from the patients, recruited in the trial

QUIZ TIME: Informed Consent Quality Assessment Questionnaire

Use this form to gauge patient’s understanding of their participation in clinical trials

                Do you feel that you have been informed how long your participation in this clinical trial will last?

                Do you think that all the treatments and procedures that the investigator proposed for you are the best for your disease?

                Do you understand what “randomisation” means?

                Do you know that no direct medical benefit will derive to you from your participation in this clinical trial?

                Are you sure that your participation in this trial will not involve any additional risk or discomforts?

                Do you know that because you are participating in a clinical trial, it is possible that the study sponsor, various government agencies, or others not directly involved in your health care could have access to your medical records?

                Do you know that the consent form you signed lists the names of the contact persons, who must answer any of your questions or concerns about the clinical trial?

                Do you know that the consent form you signed describes how you will be covered by insurance if you are injured or become ill as a result of participation in the clinical trial?

                Do you understand that if you do not want to participate in the clinical trial you are free to refuse to sign the consent form? This will not affect the quality of medical care you receive, so you do not need to be scared that your doctor will get angry or upset if you refuse to participate.

                Do you understand that you are not obliged to remain in the clinical trial if you decide to withdraw at any point of time?

                Explain in your words the purpose of the clinical trial to which you have consented to be a subject.

A patient-advocate who uses such questionnaires with patients who have been recruited to participate in a clinical trial will help to protect the patients; and will also ensure that the research team is never caught on the wrong side of the fence.

Right to Full Disclosure and Information

A patient has the right to know why a test is needed; what the expected results are; how much it costs; and how it can change her treatment options

Sample these reported cases reported in the media:

In October 1989, Zairunnisa Parekh got admitted for treatment of a tiny 1-cm stone in her kidney at Jaslok Hospital, Mumbai. She died 35 days later of peritonitis. Her husband Yusuf and son Mushtaq filed a case of negligence against the doctors, stating that the hospital denied them a copy of her medical records.

In another such case, Bhagwati Raheja died after a by-pass surgery at Mumbai’s Nanavati Hospital. The deceased’s husband maintained he was refused a copy of his wife’s medical records.

On 11 July 2001, Sandhya Karmakar, 36, mother of a ten-year-old boy, died at the SSKM hospital in Kolkata. She had been admitted for appendectomy on 26 June. The surgery went fine, but a surgical mop was ‘inadvertently’ left behind in her abdomen. Surgeon M L Shaha had to perform a second surgery to remedy the error on July 3. A leakage developed and to fix that, a third surgery had to be done on July 7. It was later discovered that the doctor who had performed the appendectomy had left the entire post-operative process, including suturing the wound, to his nursing staff.

In these, and several other such cases, patients or their families had to seek intervention from the Courts in order simply to access their medical records - documents that were legally their property. When complications occur, hospitals invariably deny wrong-doing and the onus shifts to the patient’s family to prove that what went wrong was a result of the doctor’s or the hospital’s negligence. Without concrete evidence in their possession, this can Patients and their families often complain that a particular doctor is keeping them in the dark about the diagnosis or prognosis of a disease. A busy doctor, walking away from anxious relatives with nothing more than a pat on the shoulder (and sometimes not even that), is unfortunately a very common sight in our hospitals. Patients commonly complain that a physician orders a battery of tests or procedures, without explaining why they are needed, how much would they cost; what results are expected; and how these would affect their line of treatment. When this basic information is not readily forthcoming, the outcome can be frustration that leads to growing discontent with the doctor and the hospital.

The reporting of several incidents of medical negligence and subsequent cover-up attempts by hospitals and doctors have resulted in patients being better informed about their legal rights. Patients are now demanding a more transparent and accountable doctor-patient relationship. According to a Supreme Court directive, patients and their relatives have the right to be informed and this consent is meant to educate the patient, not be almost impossible.

Patients and their families often complain that a particular doctor is keeping them in the dark about the diagnosis or prognosis of a disease. A busy doctor, walking away from anxious relatives with nothing more than a pat on the shoulder (and sometimes not even that), is unfortunately a very common sight in our hospitals. Patients commonly complain that a physician orders a battery of tests or procedures, without explaining why they are needed, how much would they cost; what results are expected; and how these would affect their line of treatment. When this basic information is not readily forthcoming, the outcome can be frustration that leads to growing discontent with the doctor and the hospital.

The reporting of several incidents of medical negligence and subsequent cover-up attempts by hospitals and doctors have resulted in patients being better informed about their legal rights. Patients are now demanding a more transparent and accountable doctor-patient relationship. According to a Supreme Court directive, patients and their relatives have the right to be informed and this consent is meant to educate the patient, not just protect the doctor and hospital. Merely asking the patient to sign a piece of paper thrust in front of him by a nurse on his way to the Operation Theater will not serve the purpose.

Patient-advocates can help doctors to build a rapport with the patient, so that there can be a full and frank discussion of the risks and uncertainties which are inherent in any medical treatment.

The Truth, the Whole Truth, and Nothing but Truth… Sometimes, withholding the harsh truth from the patient is not a result of medical paternalism, but arises out of the doctor’s sincere desire to protect the patient from emotional distress.. It’s not always easy for a doctor to know how much truth the patient can tolerate and this can create a dilemma for the doctor, as the following story, “The doctor’s word” by R K Narayan illustrates: Dr. Raman diagnoses his close friend to be critically ill. The doctor knows that the patient has a good chance of recovery if his condition does not deteriorate during the night. Now the ethical dilemma confronting Dr Raman is - should he tell the patient the truth about his dire prognosis, or should be wait until the next morning? The patient has already expressed his wish to write a will. The good doctor is in a fix. He resolves it by deciding to deceive the patient, and tells him that he can easily write the will the next morning, since there is no urgency. The patient is relieved, and survives What is the moral of the story? The doctor needs to use his judgment as to whether or not to disclose information that has the potential to harm the patient

Patients' Rights: The Right to be treated with Respect and Dignity

An advocate’s first priority is to alleviate the patient’s suffering andto help them cope with their illnesses

A patient advocate understands that his client is not a laboratory rat. A patient’s right to compassion and kindness from every hospital staff member is undisputed. Additionally, a patient also has the right to voice grievances and complaints and have those redressed promptly. If a patient for some reason can’t do this himself, he can always seek help from the advocate.

Healthcare professionals are intimately involved with every aspect of life, right from birth to death. It is the only profession, where no matter what is going on in their personal life, their first priority must be their patient - and as a patient advocate your task is to remind them that their patients come first. They are blessed to be granted such a huge privilege, which is why it is alarming to hear of horror stories about the utterly shabby way in which some doctors treat their patients. What gives them the right to undermine the dignity of a patient?

Insensitivity to another’s pain might explain why the rights of respectful treatment and autonomy are being undermined with impunity by today’s health practitioners. Constant exposure to pain and suffering sometimes de-humanizes doctors and nurses - especially when they are overworked, stressed and burnt out. Respect for the patient should be reflected in every staff member’s action, word and behavior. “Putting Patients First” cannot just be an empty platitude that hospitals print as a mission statement on their websites. The medical staff needs to be specially trained to act with empathy, so they are able to show compassion to patients at all times, even in the most provocative and stress-inducing situations.

Let me illustrate this with the case of an elderly man (78), who has a brain stroke and is left with his right side paralysed. He is admitted into a government hospital, where the staff is so overworked or time-strapped, they have little time to indulge a “senile, old man.” They don’t understand that the patient is scared to death about the long-term implications of his immobility, and why he demands so much attention from his attendants.

So once, when the patient has the urge to urinate in the middle of the night, he rings the bell for the ward boy, who assumes that the patient is indulging in one of his tantrums, and decides not to show up. After waiting for a few minutes, the patient gets impatient and tries to rise from the bed unaided. He loses his balance, falls off the bed and ends up fracturing his hip bone. Fractures are very common in patients of his age, but the untrained paramedic did not see this coming, eventually leading to an accident that could well have been avoided. Even worse, the fact that it was the ward boy’s tardiness that led to the fracture was hushed up, and the family members remained clueless as to why this complication had occurred. The moral of the story is that even when a patient is unreasonably demanding, the nursing staff has to be patient and understanding.

Modern medicine’s emphasis on the technological and pharmacological treatment of symptoms overlooks the fact that recovery from disease and trauma requires healing on all levels: emotional, social, and spiritual. The outcome of a clinical intervention also depends on the manner in which it is provided - and the doctor’s personality is often as important as his technical skill. For example, some patients may be more comfortable receiving individual counseling, while others (e.g. breast cancer survivors) may benefit more from group support, where they are able to share their experiences with each other. These are carefully considered decisions that only an empathetic doctor or advocate would be able to take on the patient’s behalf.

It is an advocate’s responsibility to ensure that the care that the patient receives meets with the accepted standards of medical ethics, and that the patient’s dignity is respected. If this is breached, it’s her responsibility to report the matter to the hospital authorities, and have it addressed to the patient’s complete satisfaction.

What Rights Do Patients Have ?

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What Rights Do Patients Have ?

Under the Indian healthcare system, a patient enjoys several rights. It’s the advocate’s responsibility to understand them all and tailor their services accordingly The Supreme Court of India set aside a writ filed by the Indian Medical Association (IMA) in 1995 and decreed that the medical profession is a “service” that should be covered under The Consumer Protection Act, 1986. This implied that patients are to be considered as consumers of healthcare services. A lot of water has flown down the Ganga since then. Although malpractice still happens, thanks to the fact that medical services are now covered under The Consumer Protection Act, 1986, there is evidence that patients’ rights are better protected these days. A landmark judgment In the famous V. Kishan Rao Vs. Nikhil Super Specialty Hospital and another, dated March 8, 2010, the Supreme Court did not even ask for a medical expert’s opinion, when it became clear that the patient suffering from intermittent fever and chills was wrongly treated for typhoid instead of malaria for four days, ultimately resulting in her death. The apex court upheld the decision of the District Forum in awarding compensation to the victim’s family, when investigation by another hospital to which the patient was shifted in a very critical condition on day 5 revealed that the doctor had overlooked the fact that the Widal Test for typhoid was negative, whereas the test for malaria parasite was positive in her case. This was sufficient evidence for the District Forum to conclude that it was a case of wrong diagnosis and treatment. Throughout this trial, the deceased’s husband (the petitioner) was guided by several patient-advocates, who didn’t necessarily have lawyer’s degrees. A huge leap for patients In November 2012, a renowned cancer surgeon was asked to deposit a fine of Rs 50,000 with the metropolitan magistrate’s court in a case of “medical negligence.” This case makes for interesting reading, because it highlights the fact that the lack of a good ‘bedside manner’ in the doctor was perceived as a personal snub by the patient’s husband, and this slight caused him to pursue the matter doggedly through the labyrinthine Indian judicial system for many years. Ironically, in this case, the deceased was not even officially registered as the surgeon’s patient. Yet her husband hauled the surgeon to court and has been ‘patiently’ fighting this battle for over two decades, simply because he is upset that the surgeon allegedly did not attend to his wife in the operation theatre (where he was present as a bystander) and did not bother to meet the family after the surgery. Throughout the course of his fight, the patient’s husband has steadfastly maintained: “Had the doctor apologized or even shown some remorse, I would have forgiven him.” Even though this may come across as an extreme example of a patient’s expectations from a doctor, the fact cannot be denied that a doctor’s job is ultra-sensitive and as health care providers, the buck stops with them. Further, as with the delivery of any service, doctors are accountable for deficient deliveries, especially since they are dealing with human life, where decisions once made are often irreversible. The demand for efficient and error-free service is therefore legally and morally justified in their case, especially as surgeons these days command a hefty premium for the services they render. The low level of health literacy in this country tilts the balance unfairly in favor of doctors, who are quite aware of their patient’s limited means and inadequate understanding of health issues. Even the well-educated and the well-heeled are vulnerable, and withholding crucial information is a common strategy that the medical fraternity deploys to prevent a patient from seeking a second or third opinion from another doctor. Often the patient and her family place blind faith in one doctor, only to have their hopes dashed. While busy doctors lament that they do not have enough time to look into individual complaints, patients are unhappy over how long they have to wait to see a doctor - and even when they do manage to get their chance, they are often very dissatisfied about the quality of the doctor’s communication, most of which goes over their head because it’s replete with medical jargon. The Consumer Protection Act 1986 has undoubtedly made it easier for aggrieved patients to seek redressal and sue for compensation but the process is time-consuming and given the huge backlog of cases in consumer courts, the litigation process is tedious, timeconsuming, costly and confusing for lay consumers. Lately, while courts have begun to award handsome damages to the victim, as in the much-cited 2009 case of a computer professional, Prashant S Dhananka who found himself paralysed waist-down after a surgeon ‘accidentally’ damaged his spinal cord during a surgery performed for removal of a chest tumor, and the apex court awarded him Rs 1 crore in damages - such cases are still few and far between. The onus of proving medical negligence largely rests with the patients’ family and that’s where patient advocacy becomes important for receiving safe health care. Medical negligence, defined In an oft-cited judgment in Bolam v. Friern Hospital Management Committee (1957) 2 All ER 118, Mc. Nair, L.J. observed: “I must explain what in law we mean by ‘negligence’. In cases that do not require any special skill, negligence in law means - some failure to do some act which a reasonable man in the  circumstances would do, or the doing of some act which a reasonable man in the circumstances would not do; and if that failure or the doing of that act results in injury, then there is a cause of action.” This in a nutshell is the parameter for defining deficient medical service. The apex court’s definition of patients’ rights According to the Consumer Guidance Society of India, a patient under the Consumer Protection Act, 1986 has the right to be told about his illness and to have his medical records explained. In addition: Patients should be explained what treatments and medicines are being prescribed to them. They should be made aware of the risks and side effects, if any. They have the right to ask questions and clarify their doubts about the treatment. Patients have the right to know a doctor’s qualifications. Patients have the right to be handled with consideration and due regard for their modesty when being physically examined by the doctor. Patients have the right to maintain confidentiality regarding their illness and can expect the same from the doctors. Patients have the right to a second opinion if they are doubtful about the medicines or treatment suggested.  Patients have the right to know what a suggested operation is for and the possible risks involved. If he is unconscious or unable to make the decision due to other reasons, informed consent needs to be taken from their nearest relatives. Patients have the right to get a copy of their medical records and case papers on request from the doctor/hospital.  If the patient needs to be transferred to another hospital, he has the right to know the reason for this; and also has the right to make their choice of which hospital to go to, in consultation with the doctor.  Patients have the right to get a detailed explanation of the bills they are asked to pay. Patient advocates can help patients secure the rights they are legally entitled to in India. The following chapters will explain these rights in greater detail, and how a patient-advocate can help uphold them. Remember Tenzin Gyatso’s wise words, “ It is not enough to be compassionate. You must act”. Please click here if you are unable to view the email