Medical Council of India – 2012
Ethical guidelines for Medical education and Medical practice
The prime object of the medical profession is to render service to humanity with full respect for the dignity of profession and man. The honoured ideals of the medical profession imply that the responsibilities of the physician extend not only to individuals but also to society.
The medical profession has long subscribed to a body of ethical statements developed primarily for the benefit of the patient. As a member of this profession, a physician must recognize responsibility to patients first and foremost, as well as to society, to other health professionals, and to self.
Physicians should merit the confidence of patients entrusted to their care, rendering to each a full measure of service and devotion.
Physicians should try continuously to improve medical knowledge and skills and should make available to their patients and colleagues the benefits of their professional attainments.
The physician should practice methods of healing founded on scientific basis and should not associate professionally with anyone who violates this principle.
Reward or financial gain is a subordinate consideration. Who- so-ever chooses this profession, assumes the obligation to conduct himself in accordance with its ideals.
Scope of this Code
The Code of Medical Ethics describes what is expected of all doctors registered
to practise medicine in India. It sets out the principles that characterise good
medical practice and makes explicit the standards of ethical and professional conduct expected of doctors by their professional peers and the community.
The code is addressed to all registered medical practitioners and is also intended to let the community know what they can expect from doctors. The application of the code will vary according to individual circumstances, but the principles should not be compromised. This code does not set new standards. It brings together, standards that have long been at the core of medical practice.
This code is not a substitute for the provisions of legislation and case law. If there is any conflict between this code and the law, the law takes precedence. The following section provides interpretation and guidance on how the Code shall be applied to various areas of professional activity. Obviously it is impossible to be exhaustive, but doctors shall conscientiously study the guidelines, endeavour to follow them and extend their application to areas that may not be addressed specifically.
Breaches of these guidelines could lead to doctors being asked to defend their actions and ultimately to face disciplinary proceedings for professional misconduct.
Ethical Principles in Practice
I. A physician shall be dedicated to providing competent medical care, with compassion and respect for human dignity and rights.
II. A physician shall uphold the standards of professionalism, be honest in all professional interactions, and strive to report physicians deficient in character or competence, or engaging in fraud or deception, to appropriate entities.
III. A physician shall respect the law and also recognize a responsibility to seek changes in those requirements which are contrary to the best interests of the patient.
IV. A physician shall respect the rights of patients, colleagues, and other health professionals, and shall safeguard patient confidences and privacy within the constraints of the law.
V. A physician shall continue to study, apply, and advance scientific knowledge, maintain a commitment to medical education, make relevant information available to patients, colleagues, and the public, obtain consultation, and use the talents of other health professionals when indicated.
VI. A physician shall, in the provision of appropriate patient care, except in emergencies, be free to choose whom to serve, with whom to associate, and the environment in which to provide medical care.
VII. A physician shall recognize a responsibility to participate in activities contributing to the improvement of the community and the betterment of public health.
VIII. A physician shall, while caring for a patient, regard responsibility to the patient as paramount.
IX. A physician shall support access to medical care for all people.
Physician Patient Relationship:
A physician shall uphold the dignity and honour of his profession. He should be an upright man, instructed in the art of healings. He shall keep himself pure in character and be diligent in caring for the sick; he should be modest, sober, patient, prompt in discharging his duty without anxiety; conducting himself with propriety in his profession and in all the actions of his life.
A good doctor–patient partnership requires high standards of professional conduct. This involves:
o Being courteous, respectful, compassionate and honest.
o Treating each patient as an individual.
o Protecting patients’ privacy and right to confidentiality, unless release of information is required by law or by public-interest considerations.
o Encouraging and supporting patients and, when relevant, their career or family, in caring for themselves and managing their health.
o Encouraging and supporting patients to be well informed about their health and to use this information wisely when they are making decisions.
o Recognising that there is a power imbalance in the doctor–patient relationship, and not exploiting patients physically, emotionally, sexually or financially.
Obligations to the Sick
Though a physician is not bound to treat each and every person asking his services, he should not only be ever ready to respond to the calls of the sick and the injured, but should be mindful of the high character of his mission and the responsibility he discharges in the course of his professional duties. In his treatment, he should never forget that the health and the lives of those entrusted to his care depend on his skill and attention. A physician should endeavour to add to the comfort of the sick by making his visits at the hour indicated to the patients.
A physician advising a patient to seek service of another physician is acceptable, however, in case of emergency a physician must treat the patient. No physician shall arbitrarily refuse treatment to a patient. However for good reason, when a patient is suffering from an ailment which is not within the range of experience of the treating physician, the physician may refuse treatment and refer the patient to another physician.
Medical practitioner having any incapacity detrimental to the patient or which can affect his performance vis-à-vis the patient is not permitted to practice his profession.
Patience and delicacy should characterize the physician. Confidences concerning individual or domestic life entrusted by patients to a physician and defects in the disposition or character of patients observed during medical attendance should never be revealed unless their revelation is required by the laws of the State. Sometimes, however, a physician must determine whether his duty to society requires him to employ knowledge, obtained through confidence as a physician, to protect a healthy person against a communicable disease to which he is about to be exposed. In such instance, the physician should act as he would wish another to act toward one of his own family in like circumstances.
The physician should neither exaggerate nor minimize the gravity of a patient’s condition. He should ensure himself that the patient, his relatives or his responsible friends have such knowledge of the patient’s condition as will serve the best interests of the patient and the family.
A physician is free to choose whom he will serve. He should, however, respond to any request for his assistance in an emergency. Once having undertaken a case, the physician should not neglect the patient, nor should he withdraw from the case without giving adequate notice to the patient and his family. Provisionally or fully registered medical practitioner shall not willfully commit an act of negligence that may deprive his patient or patients from necessary medical care.
When a physician who has been engaged to attend an obstetric case is absent and another is sent for and delivery accomplished, the acting physician is entitled to his professional fees, but should secure the patient’s consent to resign on the arrival of the physician engaged.
However in case of serious illness and in doubtful or difficult conditions, the physician should request consultation, but under any circumstances such consultation should be justifiable and in the interest of the patient only and not for any other consideration. No decision should restrain the attending physician from making such subsequent variations in the treatment if any unexpected change occurs, but at the next consultation, reasons for the variations should be discussed/ explained. The same privilege, with its obligations, belongs to the consultant when sent for in an emergency during the absence of attending physician. The attending physician may prescribe medicine at any time for the patient, whereas the consultant may prescribe only in case of emergency or as an expert when called for.
When a patient is referred to a specialist by the attending physician, a case summary of the patient should be given to the specialist, who should communicate his opinion in writing to the attending physician.
A physician shall clearly display his fees and other charges on the board of his chamber and/or the hospitals he is visiting. Prescription should also make clear if the Physician himself dispensed any medicine.
A physician shall write his name and designation in full along with registration particulars in his prescription letter head.
An important part of the doctor–patient relationship is effective communication. This involves:
Listening to patients, asking for and respecting their views about their health, and responding to their concerns and preferences.
Encouraging patients to tell you about their condition and how they are currently managing it, including any alternative or complementary therapies they are using.
Informing patients of the nature of, and need for, all aspects of their clinical management, including examination and investigations, and giving them adequate opportunity to question or refuse intervention and treatment.
Discussing with patients their condition and the available management options, including their potential benefit and harm.
Endeavouring to confirm that your patient understands what you have said.
Ensuring that patients are informed of the material risks associated with any part of the proposed management plan.
Responding to patients’ questions and keeping them informed about their clinical progress.
Making sure, wherever practical, that arrangements are made to meet patients’ specific language, cultural and communication needs, and being aware of how these needs affect understanding.
Physician – Physician relationship
A physician should consider it as a pleasure and privilege to render gratuitous service to all physicians and their immediate family dependants.
Conduct in consultation : In consultations, no insincerity, rivalry or envy should be indulged in. All due respect should be observed towards the physician in-charge of the case and no statement or remark be made, which would impair the confidence reposed in him. For this purpose no discussion should be carried on in the presence of the patient or his representatives.
Consultant not to take charge of the case: When a physician has been called for consultation, the Consultant should normally not take charge of the case, especially on the solicitation of the patient or friends. The Consultant shall not criticize the referring physician. He / she shall discuss the diagnosis treatment plan with the referring physician.
Appointment of Substitute: Whenever a physician requests another physician to attend his patients during his temporary absence from his practice, professional courtesy requires the acceptance of such appointment only when he has the capacity to discharge the additional responsibility along with his / her other duties. The physician acting under such an appointment should give the utmost consideration to the interests and reputation of the absent physician and all such patients should be restored to the care of the latter upon his/her return.
Visiting another Physician’s Case: When it becomes the duty of a physician occupying an official position to see and report upon an illness or injury, he should communicate to the physician in attendance so as to give him an option of being present. The medical officer / physician occupying an official position should avoid remarks upon the diagnosis or the treatment that has been adopted.
Relationship with public and other health care professions
Physicians as Citizens: Physicians, as good citizens, possessed of special training should disseminate advice on public health issues. They should play their part in enforcing the laws of the community and in sustaining the institutions that advance the interests of humanity. They should particularly co-operate with the authorities in the administration of sanitary/public health laws and regulations.
Public and Community Health: Physicians, especially those engaged in public health work, should enlighten the public concerning quarantine regulations and measures for the prevention of epidemic and communicable diseases. At all times the physician should notify the constituted public health authorities of every case of communicable disease under his care, in accordance with the laws, rules and regulations of the health authorities. When an epidemic occurs a physician should not abandon his duty for fear of contracting the disease himself.
Pharmacists / Nurses: Physicians should recognize and promote the practice of different paramedical services such as, pharmacy and nursing as professions and should seek their cooperation wherever required.
Relationship with (Pharmaceutical) Industry Consultancy, Sponsoring conferences, Academics, funding thro’ NGOs /Foundations, Professional fees, Gifts, Cuts, Publication rights, IPR etc
Code of conduct for doctors and professional association of doctors in their relationship with pharmaceutical and allied health sector industry.
There has been growing concern about certain gifts from industry to physicians. Some gifts that reflect customary practices of industry may not be consistent with the Principles of Medical Ethics. To avoid the acceptance of inappropriate gifts, physicians should observe the following guidelines.
In dealing with Pharmaceutical and allied health sector industry, a medical practitioner shall follow and adhere to the stipulations given below:-
a) Gifts: A medical practitioner shall not receive any gift from any pharmaceutical or allied health care industry and their sales people or representatives.
b) Travel facilities: A medical practitioner shall not accept any travel facility inside the country or outside, including rail, air, ship, cruise tickets, paid vacations etc. from any pharmaceutical or allied healthcare industry or their representatives for self and family members for vacation or for attending conferences, seminars, workshops, CME programme etc as a delegate.
c) Hospitality: A medical practitioner shall not accept individually any hospitality like hotel accommodation for self and family members under any pretext.
d) Cash or monetary grants: A medical practitioner shall not receive any cash or monetary grants from any pharmaceutical and allied healthcare industry for individual purpose in individual capacity under any pretext.
e)Funding for medical research, study etc. can only be received through approved institutions by modalities laid down by law / rules / guidelines adopted by such approved institutions, in a transparent manner. It shall always be fully disclosed.
f) Scholarship or other special funds to permit medical students, residents, and fellows to attend carefully selected educational conferences may be permissible as long as the selection of students, residents, or fellows who will receive the funds is made by the academic or training institution. Carefully selected educational conferences are generally defined as the major educational, scientific or policy-making meetings of national, regional, or specialty medical associations.
A medical practitioner may carry out, participate in, work in research projects funded by pharmaceutical and allied healthcare industries. A medical practitioner is obliged to know that the fulfillment of the following items (i) to (vii) will be an imperative for undertaking any research assignment / project funded by industry – for being proper and ethical. Thus, in accepting such a position a medical practitioner shall:-
(i) Ensure that the particular research proposal(s) has the due permission from the competent concerned authorities.
(ii) Ensure that such a research project(s) has the clearance of national/ state / institutional ethics committees / bodies.
(iii) Ensure that it fulfils all the legal requirements prescribed for medical research.
(iv) Ensure that the source and amount of funding is publicly disclosed at the beginning itself.
(v) Ensure that proper care and facilities are provided to human volunteers, if they are necessary for the research project(s).
(vi) Ensure that undue animal experimentations are not done and when these are necessary they are done in a scientific and a humane way as per the relevant Act and Rules.
(vii) Ensure that while accepting such an assignment a medical practitioner shall have the freedom to publish the results of the research in the greater interest of the society by inserting such a clause in the MoU or any other document / agreement for any such assignment.
g) Maintaining Professional Autonomy: In dealing with pharmaceutical and allied healthcare industry a medical practitioner shall always ensure that there shall never be any compromise either with his / her own professional autonomy and / or with the autonomy and freedom of the medical institution.
h) Affiliation: A medical practitioner may work for pharmaceutical and allied healthcare industries in advisory capacities, as consultants, as researchers, as treating doctors or in any other professional capacity. In doing so, a medical practitioner shall always:
(i) Ensure that his professional integrity and freedom are maintained.
(ii) Ensure that patients interest are not compromised in any way.
(iii) Ensure that such affiliations are within the law.
(iv) Ensure that such affiliations / employments are fully transparent and disclosed.
i) Endorsement: A medical practitioner shall not endorse any drug or product of the industry publically. Any study conducted on the efficacy or otherwise of such products shall be presented to and / or through appropriate scientific bodies or published in appropriate scientific journals in a proper way”.
j)No gifts should be accepted if there are strings attached. For example, physicians should not accept gifts if they are given in relation to the physician’s prescribing practices. In addition, when companies underwrite medical conferences or lectures other than their own, responsibility for and control over the selection of content, faculty, educational methods, and materials should belong to the organizers of the conferences or lectures.
Relationship with media and issues in communication, advertisements
Physicians are ethically and legally required to protect the personal privacy and other legal rights of patients. When information concerning a specific patient is requested by the media, the physician must obtain the consent of the patient or an authorized representative before releasing such information. The physician may release only the authorized information or that which is public knowledge. The patient-physician relationship and its confidential nature must be maintained.
Doctors are responsible for their public statements and for ensuring that
journalists do not breach these standards in reporting about them. Doctors
must ensure that press and media reports based on interviews with them
are primarily for public education.
In addition, images used to illustrate medical procedures or treatments or
their outcomes can legitimately be used in educational talks organised by
professional bodies or healthcare institutions, or in professional journals.
However such images must be used much more judiciously in the public
media, where they could be deemed to be laudatory of the doctor named.
Hence any images used in the general media must not be related to
identifiable doctors or their patients either directly or by inference.
Where a doctor writes articles or columns or participates in broadcasts which
offer advice in response to public queries on particular subjects, the
guidelines on good clinical care and the establishment of a proper doctor patient relationship apply.
Healthcare organisations and individual practitioners nowadays use websites
to provide information to doctors and the public. These websites may be
about the organisation or doctor, or about a medical topic. The world-wideweb
is a very powerful tool for communication as it has great reach and
there are many features, such as design and interactivity that could make
the information content more attractive and alluring. However the standards
of information as spelt out above also apply to websites
and a doctor who appears in a website has the responsibility to ensure that
information about him and his practice contained in the website and any
hyperlinks from the website conform to these standards. In addition,
individual doctors’ or healthcare institutions’ websites must not be sponsored by any pharmaceutical and other such commercial companies.
Soliciting of patients directly or indirectly, by a physician, by a group of physicians or by institutions or organisations is unethical. A physician shall not make use of him / her (or his / her name) as subject of any form or manner of advertising or publicity through any mode either alone or in conjunction with others which is of such a character as to invite attention to him or to his professional position, skill, qualification, achievements, attainments, specialities, appointments, associations, affiliations or honours and/or of such character as would ordinarily result in his self aggrandizement.
A physician shall not give to any person, whether for compensation or otherwise, any approval, recommendation, endorsement, certificate, report or statement with respect of any drug, medicine, nostrum remedy, surgical, or therapeutic article, apparatus or appliance or any commercial product or article with respect of any property, quality or use thereof or any test, demonstration or trial thereof, for use in connection with his name, signature, or photograph in any form or manner of advertising through any mode nor shall he boast of cases, operations, cures or remedies or permit the publication of report thereof through any mode. A medical practitioner is however permitted to make a formal announcement in press regarding the following:
1. On starting practice.
2. On change of type of practice.
3. On changing address.
4. On temporary absence from duty.
5. On resumption of another practice.
6. On succeeding to another practice.
7. Public declaration of charges.
Printing of self photograph, or any such material of publicity in the letter head or on sign board of the consulting room or any such clinical establishment shall be regarded as acts of self advertisement and unethical conduct on the part of the physician. However, printing of sketches, diagrams, picture of human system shall not be treated as unethical.
(1)Privacy and Confidentiality
• The basis of the relationship between a doctor and his patient is that of absolute confidence and mutual respect .Patients have a right to expect that doctors and their staff will hold information about them in confidence, unless release of information is required by law or public interest considerations.
• The patient expects his doctor not only to exercise professional skills, but also to observe secrecy with respect to the information he acquires as a result of his examination and treatment of the patient
Good medical practice involves:
• Treating information about patients as confidential.
• Appropriately sharing information about patients for their health care, consistent with privacy law and professional guidelines about confidentiality.
• Being aware that there are complex issues related to genetic
information and seeking appropriate advice about disclosure of
Modern medical practice usually involves teams of doctors, other healthcare workers, and sometimes people from outside the healthcare profession. To provide patients with the best possible care, it is often essential to convey relevant information to members of the team. If a patient does not wish the doctor to share particular information with the
other members of the team, the doctor must respect those wishes. All
medical members of a team have a duty to make sure that other team
members understand and observe confidentiality.
Good communication between the doctor and patient is essential for consent. Patients should be given adequate information in a way they can understand to enable them to make decisions about their medical care. It is a general rule that doctors should examine and treat patients only with their consent. No consent is valid if obtained under the following conditions :
(i) when there is coercion or threat or force
(ii) when the party giving consent is not aware of the full implications of
When the patient is incompetent and therefore cannot give a valid consent, then consent should be obtained from the next-of-kin who is the legally acceptable representative (LAR).
In a grave situation where consent cannot be obtained at all, it is difficult to lay down any general principle. The matter is within the discretion of the individual doctor who should never hesitate to exercise his discretion having regard to his duty as the protector of the life and health of his patient. Under such circumstances, consultation with a colleague is advisable.
Informed consent is a person’s voluntary decision about medical care that is made with knowledge and understanding of the benefits and risks
involved. Providing information to patients in a way that they can understand before asking for their consent.
Obtaining informed consent or other valid authority before the physician
undertakes any examination,investigation or provide treatment
(except in an emergency), or before involving patients in teaching or
Ensuring that patients are informed about fees and charges
When referring a patient for investigation or treatment, advising the
patient that there may be additional costs, which patients may wish
to clarify before proceeding.
(3)Reporting clinical test results
To alleviate patients’ anxieties, physicians should report clinical test results to patients within a reasonable time frame. Anticipated delays should be explained to patients at the time of testing. Physicians should provide test results in language understandable to the patient and in the manner deemed most appropriate by the physician. Any information gathered from test results that would be necessary for patients to make intelligent medical decisions and give informed consent on future medical treatments must be disclosed to them. Physicians should take all appropriate precautions to ensure the confidentiality of test results.
A doctor may only prescribe medicines that are legally available in India
and must comply with all the statutory requirements governing their use.
A doctor shall prescribe, dispense or supply medicines only on clear medical grounds and in reasonable quantities as appropriate to the patient’s needs.This includes prescription by a doctor for his own use.
Every physician should, as far as possible, prescribe drugs with generic names and he / she shall ensure that there is a rational prescription and use of drugs.
Patients shall be appropriately informed about the purpose of the prescribed medicines, contraindications and possible side effects.
A doctor shall prescribe medicines only following an adequate personal
consultation and relevant investigations.
A decision to prescribe solely based on information provided by telephone or any electronic means is allowable for continuing care, or for exceptional situations where a patient’s best interests are being served by doing so.
(4)Informing patient’s death
Disclosing the death of a patient to the patient’s family is a duty which goes to the very heart of the patient-physician relationship and should not be readily delegated to others by the attending physician. The emotional needs of the family and the integrity of the physician-patient relationship must at all times be given foremost consideration.
(5)Reporting ADRs and AEs(Pharmacovigilance)
A physician who suspects the occurrence of an adverse reaction to a drug or medical device has an obligation to communicate that information to the broader medical community, (eg, through submitting a report or letter to a medical journal or informing the manufacturer of the suspect drug or device or to the Drug Control Authority ). Spontaneous reports of adverse events are irreplaceable as a source of valuable information about drugs and medical devices, particularly their rare or delayed effects, as well as their safety in vulnerable patient populations. Although premarketing and mandated postmarketing studies provide basic safeguards for the public health, they suffer from inherent deficiencies that limit their ability to detect rare or unexpected consequences of drug or medical device use. Physicians who prescribe and monitor the use of drugs and medical devices constitute the group best able to observe and communicate information about resulting adverse events.
Serious adverse events, such as those resulting in death, hospitalization, or medical or surgical intervention, are the most important to report and are the only adverse events for which the Pharmacovigilance programme desires a report. Certainty, or even reasonable likelihood, of a causal relationship between the drug or medical device and the serious adverse event will rarely exist. Suspicion of such a relationship is sufficient to give rise to an obligation to participate in the reporting system.
When adverse events occur, the physician has a responsibility to be open and honest in his/her communication with the patient, to review what has occurred and to report appropriately. When something goes wrong, good medical practice involves:
Recognising what has happened.
Acting immediately to rectify the problem, if possible, including seeking any necessary help and advice.
Explaining to the patient as promptly and fully as possible what has happened and the anticipated short-term and long-term consequences.
Acknowledging any patient distress and providing appropriate support.
Complying with any relevant policies, procedures and reporting requirements.
Reviewing adverse events and implementing changes to reduce the risk of
Reporting adverse events to the relevant authority, as necessary
Ensuring patients have access to information about the processes for making a complaint .
(6)Conflicts of interest
Patients rely on the independence and trustworthiness of doctors for any advice or treatment offered. A conflict of interest in medical practice arises when a doctor, entrusted with acting in the interests of a patient, also has financial, professional or personal interests, or relationships with third parties, which may affect their care of the patient. Multiple interests are common. They require identification, careful consideration, appropriate disclosure and accountability. When these interests compromise, or might reasonably be perceived by an independent observer to compromise, the doctor’s primary duty to the patient, doctors must recognise and resolve this conflict in the best interests of the patient. Good medical practice involves:
1. Recognising potential conflicts of interest that may arise in relation to
initiating or continuing a professional relationship with a patient.
2 .Acting in your patients’ best interests when making referrals and when
providing or arranging treatment or care.
3 .Informing patients when you have an interest that could affect, or could be perceived to affect, patient care.
4 .Recognising that pharmaceutical and other medical marketing influences doctors, and being aware of ways in which your practice may be being influenced.
5. Recognising potential conflicts of interest in relation to medical devices and appropriately managing any conflict that arises in your practice.
6. Not asking for or accepting any inducement, gift or hospitality of more than trivial value, from companies that sell or market drugs or appliances that may affect, or be seen to affect, the way you prescribe for, treat or refer patients.
7 .Not asking for or accepting fees for meeting sales representatives.
8 .Not offering inducements to colleagues, or entering into arrangements that could be perceived to provide inducements.
9. Not allowing any financial or commercial interest in a hospital, other health care organisation, or company providing health care services or products to adversely affect the way in which you treat patients. When you or your immediate family have such an interest and that interest could be perceived to influence the care you provide, you must inform your patient.
(7)Traditional and complementary medicines/New therapies/ Health claims
Throughout the world today people are looking to traditional methodologies and leading-edge alternative techniques because they offer alternatives to toxic, expensive drugs with their dangerous side effects, un-manageable and unreasonable costs and other invasive technologies of modern medicine. This search for alternatives is protected by the fundamental right of individuals to communicate and learn, to heal and be healed.
Many patients resort to traditional and other alternative medicines for a wide variety of conditions. It is also known that there are many patients who take both conventional or modern and traditional medicine at the same time. The doctor is responsible for the management of his patient including knowing about the safety and efficacy of the modalities of treatment or medication that he prescribes.
A modern medicine doctor should not practice or prescribe any form of traditional therapy unless he has undertaken recognized training and be sanctioned by appropriate registration with the concerned regulatory body .
Good medical records are an indication of good practice. The doctor is encouraged to record all relevant details of his management of a patient. Accurate, legible, comprehensive and contemporaneous notes are advised.
Doctors have obligations relating to the storage, access and use of health information available in the patients’ records.
The patient is entitled to a written report of the care that has been given to him. If any request is made for medical records either by the patients / authorised attendant or legal authorities involved, the same may be duly acknowledged and documents shall be issued within the period of 72 hours.
The withholding of information of the care given to the patient is unethical.
Every physician shall maintain the medical records pertaining to his / her indoor patients for a period of 3 years from the date of commencement of the treatment in a standard proforma laid down by the Medical Council of India.
A Registered medical practitioner shall maintain a Register of Medical Certificates giving full details of certificates issued. When issuing a medical certificate he / she shall always enter the identification marks of the patient and keep a copy of the certificate. He / She shall not omit to record the signature and/or thumb mark, address and at least one identification mark of the patient on the medical certificates or report.
Where medical information is sought, the doctor should make it a rule to refuse to give any information in the absence of the written consent of the patient or the competent relative.
Efforts shall be made to computerize medical records for quick retrieval.
(9)Paediatric patients/ Other Vulnerable groups
Caring for children and young people brings additional responsibilities for doctors. Good medical practice involves:
1 Placing the interests and wellbeing of the child or young person first.
2 Ensuring young people’s capacity for decision making and consent.
3 Ensuring that, when communicating with a child or young person,
• You treat them with respect and listen to their views
• encourage questions and answer their questions to the best of your ability
• provide information in a way that they can understand
• recognise the role of parents and when appropriate, encourage the young person to involve their parents in decisions about their care.
4 Being alert to children and young people who may be at risk, and notifying appropriate authorities, as required by law.
Patients who may have additional needs
Some vulnerable patients with impaired decision-making capacity have
additional needs. Good medical practice in managing the care of these patients involves:
1 Paying particular attention to communication.
2 Being aware that increased advocacy may be necessary to ensure just access to health care.
3 Recognising that there may be a range of people involved in their care, such as carers, family members or a guardian, and involving them when
4 Being aware that these patients may be at greater risk.
(10)Storage of clinical samples, Biobanks
Biobanks consist of systematically gathered biological samples and are valuable for both research and medical treatments. When tissues samples are linked to good clinical data, they become indispensable to medical science. At the same time a number of ethical issues are raised regarding the use of these samples. Hence while collecting biological samples for routine or special investigations during treatment or clinical trials, the physician and the health care team have a duty to inform the person concerned about the use, storage, future reuse etc and obtain appropriate written informed consent as prescribed in the ICMR guidelines.
(11)Disposal of waste/ protection of environment
Health care practitioners should protect the environment and the public by ensuring that healthcare waste is disposed off legally and in an environmentally friendly manner. Health care practitioners should recognise that they have a responsibility to ensure that in the conduct of their affairs they do not in any way contribute to environmental degradation. Should be well aware of the provisions under Bio-Medical Waste (Management and Handling) Rules, 1998.
(12)Publication practices :
Most good journals these days require clearance of the paper being submitted, by an Institute Review Board (IRB/Ethics Committee). Authorship is a very important issue on Case studies, stored data, retrospective studies, pooled data from multiple sources, collaborative studies and those involving other conflicts of interest. It is therefore important to adhere to ethical practices and guidelines.
The various intellectual works produced by the physicians include the case reports, papers, project reports ,images and other products in the paper or electronic media which are either published or prepared for other uses. Authorship of all these works involves giving credit as well assigning responsibilities. All the authors become jointly responsible for the contents, including the errors and the omissions. It may be pointed out that unnecessary inclusion of a name as a co-author does not really add to one’s achievements or merits. On the other hand, it may sometimes become a liability.
The three following fundamental principles should be met while considering authorship:
1. Substantial, intellectual contribution to the work. (Any other substantial contribution should be acknowledged).
2. Participation in the writing, reviewing the drafts and approval of the final version.
3. Precise contribution made to the work should be definable and justifiable.
What is intellectual contribution?
1. Conceptualization: Identifying the issues and hypothesis.
2. Performance of experiments and data collection.
3. Conducting analysis and interpreting data.
4. Reviewing the literature, assessing the accuracy and relevance of data and writing a significant part of the paper.
5. Involvement in data collection, verification, supervision and guidance, analysis and writing throughout the study or at least for most of the study period.
The following participations/contributions do not necessarily constitute a right to authorship, unless there is specific agreement to the contrary:
1. Work done by an employee in course of his/her employment for a specific purpose.
2. Laboratory data: Routine diagnostic or treatment, investigations in a laboratory for patients, unless: i, the tests are carried out for purpose of the study; ii, a significant laboratory data is being analysed and reported; iii, the laboratory data constitutes or forms the subject of the study; iv, Multiple laboratory data from a single laboratory are taken and highlighted; v, Even single data highlighted in case report.
3. Clinical data: Routine registration of a patient/s in an OPD/Clinic/Ward does not constitute the right to authorship, unless: i, the work is based on one or more of these patients or from the material from these patients including the stored samples, ii, or a study is being done with reference to a clinical issue. (eg. on clinical patterns, therapy, prognosis and natural history).
4. Mere provision of funds, facilities or administrative supports.
5. Sole participation in data collection.
6. Being Head of Department, does not quality to be author. Scientific contribution is required for authorship.
7. Authorship distribution should not be a charity, it should be earned.
8. Preservation of raw data is the responsibility of the primary author in the department.
Ethical issues in special situations:
1.Beginning of life or issues in Abortion
It would not be an offence to carry out an abortion or termination of pregnancy if the Procedure is undertaken as specified in the Medical Termination of Pregnancy Act,1971.and the practitioner is of the opinion, formed in good faith, that the continuance of the pregnancy would involve risk to the life of the pregnant woman, or injury to the mental or physical health of the pregnant woman, greater than if the pregnancy were terminated.
A doctor procuring a miscarriage may lawfully do so only if he acts in good
faith, and exercises sound clinical judgement in accordance with the
principles imposed by the law.
On no account sex determination test shall be undertaken with the intent to terminate the life of a female foetus developing in her mother’s womb, unless there are other absolute indications for termination of pregnancy as specified in the Medical Termination of Pregnancy Act, 1971. Any act of termination of pregnancy of normal female foetus amounting to female foeticide shall be regarded as professional misconduct on the part of the physician leading to penal erasure besides rendering him liable to criminal proceedings as per the provisions of this Act.
2.End of life issues – terminally ill patients,
withdrawing/withholding treatment, euthanasia etc
Where death is deemed to be imminent and where curative or life-prolonging treatment appears to be futile, it should be ensured that death occurs with dignity and comfort. Such futile therapy could be withheld, withdrawn or one may allow irreversible pathology to continue without active resuscitation.
One should always take into consideration any advance directives and the wishes of the family in this regard. In any circumstance, if therapy is considered to be life saving, it should never be withheld.
Practicing euthanasia shall constitute unethical and illegal conduct. However on specific occasion, the question of withdrawing supporting devices to sustain cardio-pulmonary function even after brain death, shall be decided only by a team of doctors and not merely by the treating physician alone. A team of doctors shall declare withdrawal of support system. Such team shall consist of the doctor in charge of the patient, Chief Medical Officer / Medical Officer in charge of the hospital and a doctor nominated by the in-charge of the hospital from the hospital staff or in accordance with the provisions of the Transplantation of Human Organ Act, 1994.
3.Assisted Reproductive technologies
No act of invitro fertilization or artificial insemination shall be undertaken without the informed consent of the female patient and her spouse as well as the donor. Such consent shall be obtained in writing only after the patient is provided, at her own level of comprehension, with sufficient information about the purpose, methods, risks, inconveniences, disappointments of the procedure and possible risks and hazards.
4.Organ and Tissue transplantation
Ethical issues have been associated with organ transplantation from the beginning and will continue to be a major consideration in this field. Doctors practicing in this field must be aware of all the issues and ensure that they do not transgress any ethical principles or provisions of the Human Organ Transplantation Act,1994.
If you are caring for a donor, you must provide to the donor, and/or their relatives where appropriate, a full disclosure of the intent of transplant organs, the purpose of the procedure and, in the case of a living donor, the risks of the procedure. In facilitating the potential donor to make a free and informed decision on organ donation, the institution should provide him/her with adequate information on all aspects of donor surgery including short and long term risks.
Potential donors should have access to other members of team such as nurses and social workers to whom they may find easier to relate. Finally, the potential donor should be assured that at any time he changes his mind on donating an organ, his wishes would be respected. Persons who are mentally incompetent to decide should not be allowed to donate.
In cadaver organ transplantation, definition of death is crucial as organs are best removed when the heart is still beating but the patient is already brain dead. It is important that pronouncement of brain death is done using rigid criteria and persons performing tests to determine brain death are independent of the transplant team as well as the team looking after the recipient.
5.Genetic testing and genetic counselling
Three primary areas of prenatal genetic testing are :
(1) screening or evaluating prospective parents for genetic disease before conception to predict the likelihood of conceiving an affected child;
(2) analysis of a pre-embryo at the preimplantation stage of artificial reproductive techniques; and
(3) in utero testing after conception, such as ultrasonography, amniocentesis, fetoscopy, and chorionic villus sampling, to determine the condition of the fetus.
Physicians engaged in genetic counseling are ethically obligated to provide prospective parents with the basis for an informed decision for childbearing. Counseling should include reasons for and against testing as well as discussion of inappropriate uses of genetic testing. Prenatal genetic testing is most appropriate for women or couples whose medical histories or family backgrounds indicate an elevated risk of fetal genetic disorders. Women or couples without an elevated risk of genetic disease may legitimately request prenatal diagnosis, provided they understand and accept the risks involved. When counseling prospective parents, physicians should avoid the imposition of their personal moral values and the substitution of their own moral judgment for that of the prospective parents.
The physician should be aware that where a genetic defect is found in the fetus, prospective parents may request or refuse an abortion. Physicians who consider the legal and ethical requirements applicable to genetic counseling to be in conflict with their moral values and conscience may choose to limit their services to preconception diagnosis and advice or not provide any genetic services. However, the physician who is so disposed is nevertheless obligated to alert prospective parents when a potential genetic problem does exist, so that the patient may decide whether to seek further genetic counseling from another qualified specialist.
Genetic selection refers to the abortion or discard of a fetus or pre-embryo with a genetic abnormality. In general, it is ethically permissible for physicians to participate in genetic selection only to prevent, cure, or treat genetic disease. However, selection to identify the sex of the child is not permissible under the law.
7. Public Health
Doctors have a responsibility to promote the health of the community through disease prevention and control, education and screening. Good medical practice involves:
Understanding the principles of public health, including health education, health promotion, disease prevention and control and screening.
Participating in efforts to promote the health of the community and being aware of the obligations in disease prevention, screening and reporting notifiable diseases.
A doctor shall be prepared to treat patients on an emergency or humanitarian basis unless circumstances prevent him from doing so.
Treating patients in emergencies requires doctors to consider a range of issues, in addition to the patient’s best care. Good medical practice involves offering assistance in an emergency that takes account of your own safety, your skills, the availability of other options and the impact on any other patients under your care and continuing to provide that assistance until your services are no longer required.
9.Medical and Health Research
Research involving humans, their tissue samples or their health information, is vital in improving the quality of health care and reducing uncertainty for patients now and in the future, and in improving the health of the population as a whole.
Research involving animals is governed by legislation and guidelines issued by the CPCSEA under the Ministry of Environment and Forests.
In any research on human beings, each potential subject must be adequately informed of the aims, methods, anticipated benefits and potential hazards of the study and the discomfort it may entail. He or she should be informed that he or she is at liberty to abstain from participation in the study and that he or she is free to withdraw from the study at any time. The practitioner should then obtain the subject’s informed consent in writing after ensuring that any dependent relationship between doctors and their patients is taken into account in the recruitment of patients as research participants. It is also to be ensured that a patient’s decision not to participate does not compromise the doctor–patient relationship or their care.
A doctor who participates in clinical research must put the care and safety
of patients first. If a doctor wishes to enter a patient into a clinical trial, he
must ensure that the trial is approved by a duly constituted ethics committee which conforms to the Ethical guidelines for biomedical research on human participants issued by the Indian Council of Medical Research in 1980 and subsequent amendments in 2000 and 2006 and Good Clinical Practice Guidelines issued by the CDSCO in 2002. In addition, written informed consent must be obtained from the patient or the legally acceptable representative(LAR) as the case may be.
It is not acceptable to experiment or authorise experiments or research
which are not part of a formal clinical trial and which are not primarily part
of treatment or in the best interest of the patient, or which could cause
undue suffering or threat to the life of a patient.
Clinical drug trials or other research involving patients or volunteers as per the guidelines of ICMR can be undertaken, provided ethical considerations are borne in mind. Violation of existing ICMR guidelines in this regard shall constitute misconduct. Consent taken from the patient for trial of drug or therapy which is not as per the guidelines shall also be construed as misconduct.
The current state of emergency medicine and research has resulted in the application of standard treatments that often have not been scientifically evaluated for safety and effectiveness and may render unsatisfactory outcomes. Given the insufficiency of standard treatment alternatives, it is appropriate, in certain situations and with special safeguards, to provide experimental treatments without obtaining the informed consent of the subject. However, in order to protect the rights and welfare of the subjects, several conditions must be met:
This type of research is limited to emergency, life-threatening situations, and may involve only experimental treatments that are ready for trials involving human subjects.
The subject must lack the capacity to give informed consent for participation in the research.
The window of opportunity for intervention must be so narrow as to make obtaining surrogate consent unfeasible.
Obtaining prospective informed consent for the protocol must not be feasible (ie, the life threatening emergency situation could not have been anticipated).
The experimental treatment must have a realistic probability of benefit equal to or greater than standard care.
The risks associated with the research should be reasonable in light of the critical nature of the conditions and the risks associated with standard treatment.
Where informed consent is waived, subjects or their representatives must be informed as soon as possible about inclusion in the study and asked to consent to further participation. Subjects, or their representatives, may choose to discontinue participation at any time after being fully informed about the possible consequences. Additionally, if the patient dies while participating in the research protocol, the patient’s family or representative must be informed that the patient was involved in an experimental protocol.
In situations where a doctor is undertaking an innovative or unusual treatment on his or her own initiative, he or she should consult suitably qualified colleagues before discussing it with, or offering it to, patients. They should carefully consider whether such treatments should be subject to formal research protocols.
It is the duty of doctors to ensure that the first communication of research results should be through recognised scientific channels, including journals and meetings of professional bodies, to ensure appropriate peer review. Participants in the research should also be informed of the results as soon as is practicable after completion.
Financial and administrative issues
Doctors must be honest and transparent in financial arrangements with patients. Good medical practice involves:
1. Not exploiting patients’ vulnerability or lack of medical knowledge when providing or recommending treatment or services.
2 .Not encouraging patients to give, lend or bequeath money or gifts that will benefit you directly or indirectly.
3 .Avoiding financial involvement, such as loans and investment schemes,
4 .Not pressuring patients or their families to make donations to other people or organisations.
5 .Being transparent in financial and commercial matters relating to your
work, including in your dealings with employers, insurers and other
organisations or individuals.
declaring any relevant and material financial or commercial interest that you or your family might have in any aspect of the patient’s care
declaring to your patients your professional and financial interest in any product you might endorse or sell from your practice, and not making an unjustifiable profit from the sale or endorsement.
Professional competence, CMEs etc
The doctor is expected to be up to date with the most appropriate methods
of medical management, procedures and operative techniques. Doctors
therefore have a responsibility to keep themselves updated through continuing medical education throughout their careers, by participating in continuing medical education (CME) programmes to serve patients to the best of their abilities and live up to professional standards of excellence.
Fulfillment of mandatory CME requirements does not necessarily fulfill the physician’s ethical obligation to maintain his or her medical expertise.
The physician choosing among CME activities should assess their educational value and select only those activities which are of high quality and appropriate for the physician’s educational needs.
Physicians should claim credit commensurate with only the actual time spent attending a CME activity or in studying a CME enduring material.
Physicians serving as presenters, moderators, or other faculty at a CME conference should ensure that research findings and therapeutic recommendations are based on scientifically accurate, up-to-date information and are presented in a balanced, objective manner.
When invited to present at non-CME activities that are primarily promotional, faculty should avoid participation unless the activity is clearly identified as promotional in its program announcements and other advertising. All conflicts of interest or biases, such as a financial connection to a particular commercial firm or product, should be disclosed by faculty members to the activity’s sponsor and to the audience. Physicians involved in the sponsorship of CME activities should ensure that the program is balanced, with faculty members presenting a broad range of scientifically supportable viewpoints related to the topic at hand.
A Physician should participate in professional meetings as part of Continuing Medical Education programmes, for at least 30 hours every five years, organized by reputed professional academic bodies or any other authorized organisations. The compliance of this requirement shall be informed regularly to Medical Council of India or the State Medical Councils as the case may be.
The physician, engaged in the practice of medicine shall give priority to the interests of patients. The personal financial interests of a physician should not conflict with the medical interests of patients. A physician should announce his fees before rendering service and not after the operation or treatment is under way. Remuneration received for such services should be in the form and amount specifically announced to the patient at the time the service is rendered. It is unethical to enter into a contract of “no cure no payment”. Physician rendering service on behalf of the state shall refrain from anticipating or accepting any consideration.
The physician shall observe the laws of the country in regulating the practice of medicine and shall also not assist others to evade such laws.
He should be cooperative in observance and enforcement of all relevant laws and regulations in the interest of public health.
A physician should observe the provisions of the State Acts like Drugs and Cosmetics Act, 1940; Pharmacy Act, 1948; Narcotic Drugs and Psychotropic substances Act, 1985; Medical Termination of Pregnancy Act, 1971; Transplantation of Human Organ Act, 1994; Mental Health Act, 1987; Environmental Protection Act, 1986; Pre–natal Sex Determination Test Act, 1994; Drugs and Magic Remedies (Objectionable Advertisement) Act, 1954; Persons with Disabilities (Equal Opportunities and Full Participation) Act, 1995 and Bio-Medical Waste (Management and Handling) Rules, 1998 and such other Acts, Rules, Regulations made by the Central/State Governments or local Administrative Bodies or any other relevant Act relating to the protection and promotion of public health.
PUNISHMENT AND DISCIPLINARY ACTION
The Ethical Code and Guidelines provide a guide as to what types of
conduct could amount to professional misconduct. Adherence to the Code
and Guidelines will not only protect the public but also practitioners from
allegations being made against them.
Circumstances may and do arise from time to time in relation to which there may occur questions of professional misconduct. Every care should be taken that the code is not violated in letter or spirit. In such instances as in all others, the Medical Council of India and/or State Medical Councils have to consider and decide upon the facts brought before the Medical Council of India and/or State Medical Councils.
It is made clear that any complaint with regard to professional misconduct can be brought before the appropriate Medical Council for Disciplinary action. Upon receipt of any complaint of professional misconduct, the appropriate Medical Council would hold an enquiry and give opportunity to the registered medical practitioner to be heard in person or by pleader. If the medical practitioner is found to be guilty of committing professional misconduct, the appropriate Medical Council may award such punishment as deemed necessary or may direct the removal altogether or for a specified period, from the register of the name of the delinquent registered practitioner. Deletion from the Register shall be widely publicized in local press as well as in the publications of different Medical Associations/ Societies/Bodies.
In case the punishment of removal from the register is for a limited period, the appropriate Council may also direct that the name so removed shall be restored in the register after the expiry of the period for which the name was ordered to be removed.
Decision on complaint against delinquent physician shall be taken within a time limit of 6 months.
During the pendency of the complaint the appropriate Council may restrain the physician from performing the procedure or practice which is under scrutiny.
Professional incompetence shall be judged by peer group as per guidelines prescribed by Medical Council of India.