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Medical Ethics :-

 

Appendix I 


MEDICAL COUNCIL OF INDIA


CODE OF MEDICAL ETHICS


DECLARATION

At the time of registration, each applicant shall be given a copy of the following declaration by the Registrar concerned, and shall read and agree to abide by the same :-

I solemnly pledge myself to consecrate my life to the service of humanity.
Even under threat, I will not use my medical knowledge contrary, to the laws of humanity.
I will maintain the utmost respect for human life from the time of conception.
I will not permit consideration of religion, nationality, race, party politics or social standing to intervene between my duty and my patient.
I will practise my profession with conscience and dignity.
The health of my patient will be my first consideration.
I will respect the secrets which are confided in me.
I will give to my teachers the respect and gratitude which is their due.
I will maintain, by all means in my power, the honour and noble traditions of medical profession.
My colleagues will be my brothers.
I make these promises solemnly, freely and upon my honour.


CODE


GENERAL PRINCIPLES


Character of the Physician

The prime object of the medical profession is to render service to humanity; reward of financial gain is a subordinate consideration. Whosoever chooses this profession, assumes the obligation to conduct himself in accord with its ideals. A physician should be an upright man, instructed in the “art of healings.” He must keep himself pure in character and be diligent in caring for the sick. He should be modest, sober, patient, prompt to do his whole duty without anxiety; pious without going so far as superstition, conducting himself with propriety in his profession and in all the actions of his life.


The Physician’s Responsibility

The principle objective of the medical profession is to render service to humanity with full respect for the dignity of man. 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 skill and should make available to their patients and colleagues the benefits of their professional attainments. The physician should practise methods of healing founded on scientific basis and should not associate professionally with anyone who violates this principle. The honoured ideals of the medical profession imply that the responsibilities of the physician extend not only to individuals but also to society.


Advertising

Solicitation of patients, directly or indirectly , by a physician, by groups of physicians or by institutions or organisations is unethical. A physician shall not make use of or aid or permit others to make use of him (or his name) as subject of any form or manner of advertising or publicity though lay channels, either alone or in conjunction with others which will shall be 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 aggrandisement, nor shall he give to any person whosoever, 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 though lay channels, nor shall he boast of cases, operations, cures or remedies or permit the publication of report thereof through lay channels. A medical practitioner is permitted a formal announcement in press regarding the following :-

On starting practice.
On change of type of practice.
On changing address.
On temporary absence from duty.
On resumption of practice.
On succeeding to another practice.
Payment of Professional Services
The ethical physician, engaged in the practice of medicine, limits the sources of his income received from professional activities to services rendered to the patient. Remunerations 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.”


Patent and Copyrights

A physician may patent surgical instruments, appliances and medicines or copyright publications, methods and procedures. The use of such patents or copy-right or the receipt of remuneration from them which retards or inhibits research or restrict the benefits derivable therefrom are unethical.


Running an open shop (Dispensing of drugs and appliances by physicians)

A physician should not run an open shop for sale of medicine, for dispensing prescriptions prescribed by doctors other than himself or for sale of medical or surgical appliances. It is not unethical for a physician to prescribe or supply drugs, remedies or appliances so long as there is no exploitation of the patient.


Rebates and Commission

A physician shall not give, solicit, or receive nor shall he offer to give, solicit or receive, any gift, gratuity, commission or bonus in consideration of or in return for the referring, recommending or procuring of any patient for medical , surgical or other treatment. A physician shall not directly or by any subterfuge participate in or be a party to the act of division, transference, assignment, subordination, rebating, splitting or refunding of any fee for medical, surgical or other treatment. The provisions of this para shall apply with equal force to the referring, recommending or procuring by a physician or any person, specimen or material for diagnostic, or other study or work. Nothing in this section, however, shall prohibit payment of salaries by a qualified physician to other duly qualified persons, rendering medical care under his supervision.


Secret Remedies

The prescriptions or dispensing by, a physician of secret medicine or other secret remedial agents of which he does not know the composition, or the manufacture, or promotion of their use is unethical.


Evasion of legal restrictions

The physician will observe the laws of the country in regulating the practice of medicine and will not assist others to evade such laws. He should be co-operative in observance and enforcement of sanitary laws and regulations in the interest of public health. A physician should observe the provisions of the State Acts like Drugs Act, Pharmacy Act, Poisonous and Dangerous Drugs Act and such other Acts, Rules, Regulations made by the Central Government / State Governments or local Administrative Bodies for protection and promotion of public health.


DUTIES OF PHYSICIANS TO THEIR PATIENTS


Obligations to the sick

Though a physician is not bound to treat each and every one asking his services except in emergencies for the sake of humanity and the noble traditions of the profession, he should not only be everready 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 incurs in the discharge of his professional duties. In his ministrations, 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 endeavor to add to the comfort of the sick by making his visits at the hour indicated to the patients.


Patience, delicacy and secrecy

Patience and delicacy should characterize the physicians. 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 confidences to him 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 desire another to act towards one of his own family in like circumstances.


Prognosis

The physician should neither exaggerate nor minimize the gravity of a patient’s condition. He should assure 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.


The patient must not be neglected

A physician is free to choose whom he will serve. He should, however, respond to any request for his assistance in an emergency or whenever temperate public opinion expects the service. Once having undertaken a case, the physician should not neglect the patient, nor should he withdraw from the case without giving notice to the patient, his relatives or his responsible friends sufficiently long in advance of his withdraw to allow them to secure another medical attendant. No provisionally or fully registered medical practitioner shall willfully commit an act of negligence that may deprive his patient or patients from necessary medical care.


DUTIES OF THE PHYSICIAN TO THE PROFESSOIN AT LARGE

Upholding the honour of the profession

A physician is expected to uphold the dignity and honour of his profession.


Membership in medical society

For the advancement of his profession, a physician should affiliate with medical societies and contribute his time, energy and means so that these societies may represent the ideals of the profession.


Safeguarding the profession

Every physician should aid in safeguarding the profession against admission to it of those who are deficient in moral character or education. Physician should not employ, in connection with his professional practice, any attendant, who is neither registered nor enlisted under the Medical Act in force, and should not permit such persons to attend, treat or perform operations upon patients in respect of matters regarding professional discretion or skill, as it is dangerous to public health.


Exposure of Unethical Conduct

A physician should expose, without fear or favour, incompetent or corrupt, dishonest or unethical conduct on the part of members of the profession. Questions of such conduct should be considered, first before proper medical tribunals in executive sessions or by special or duly appointed committees on ethical relations, provided such a course is possible, and provided, also that the law is not hampered thereby. If doubt should arise as to the legality of the physician’s conduct, the situation under investigation may be placed before officers of the law, and the physician investigators may take the necessary steps to enlist the interest of the proper authority.


PROFESSIONAL SERVICES OF PHYSICIAN TO EACH OTHER

Dependence of physicians on each other
There is no rule that a physician should not charge another physician for his services but a physician should cheerfully and without recompense give his professional service to a physician or his dependents, if they are in his vicinity.


Compensation for expenses

A physician should consider it as a pleasure and privilege to render gratuitous service to all physicians and their immediate family dependents. When a physician is called from a distance to attend or advise another physician or his dependent, reimbursement should however be made for travelling and other incidental expenses.


DUTIES OF PHYSICIAN IN CONSULTATION


Consultation should be encouraged

In case of serious illness, especially in doubtful or difficult conditions, the physician should request consultations.


Consultation for Patient’s Benefits

In every consultation, the benefit to the patient is of first importance. All physicians interested in the case should be candid with the patient, a member of his family or responsible friend.


Punctuality in consultation

Utmost punctuality should be observed by a physician in meeting for consultation.


Conduct in consultation

In consultation, no insincerity, rivalry or envy should be indulged in. All due respect should be observed towards the physician incharge of the case, and no statement, or remarks 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.


Statement to patient after consultation

(a) All statements of the case to the patient or his representatives should take place in the presence of all the physicians consulting, except as otherwise agreed ; the announcement of the opinion to the patient or his relations or friends shall rest with the medical attendant.
(b) Differences of opinion should not be divulged unnecessarily, but when there is an irreconcilable difference of opinion, the circumstances should be frankly and impartially explained to the patient or his friends. It would be open to them to seek further advice should they so desire.


Treatment after consultation

No decision should restrain the attending physician from making such subsequent variations in the treatment as any unexpected change may require, but at the next consultation, reasons for the variations should be stated. 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 at any time for the patient the consultant only in case of emergency.


Consultant not to take charge of the case

When a physician has been called as a consultant none but the rarest and the most exceptional circumstances would justify that consultant taking charge of the case. He should not do so merely on the solicitation of the patient or friends.


Patients referred to specialists

When a patient is referred to a specialist by the attending physician, a statement of the case should be given to the specialist, who should communicate his opinion in writing in a closed cover direct to the attending physician.


DUTIES OF PHYSICIAN IN CASES OF INTEREFERENCE


Appointment of a substitute

Whenever a physician requests another physician to attend his patient during his temporary absence from his practice, professional courtesy requires the acceptance of such appointment, is consistent with his other duties. The physician acting under such an appointment should give the utmost consideration to the interests and reputation of the absent physician. All such patients should be restored to the care of the latter upon his return.


Visiting another physician’s case

A physician called to visit a patient, who has recently been under the care of another physician in the same illness, should not take charge of, nor prescribe for such patient except in a case of emergency when he should communicate to the former explaining the circumstances under which the patient was seen and treatment given, or when the physician has relinquished his case, or when the patient has notified such physician to discontinue his services. 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 should avoid remarks upon the diagnosis or the treatment that has been adopted.


Engagement for an Obstetric case

If a physician agrees to attend a woman during her confinement, he must do so. Inability to do so on an excuse of any other engagement is not tenable, except when he is already engaged on a similar or other serious case. When a physician who has been engaged to attend an obstetric case is absent and another is sent for the 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.


DUTIES OF PHYSICIAN TO THE PUBLIC


Physicians as Citizens

Physicians, as good citizens, possessed of special training, should advise concerning the health of the community where in they dwell. They should bear their part in enforcing the laws of the community and in sustaining the institutions that advance the interests of humanity. They should cooperate especially with the proper authorities in the administration of sanitary laws and regulations.


Public 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 law, rules and regulations of the health authorities. When an epidemic prevails, a physician must continue his labours without regard to the risk to his own health.


Pharmacists

Physicians should recognise and promote the practice of pharmacy as a profession and should recognise the cooperation of the pharmacist in education of the public concerning the practice of ethical and scientific medicine.


DISCIPLINARY ACTION

The Medical Council of India desires to bring to the notice of the registered medical practitioners the following statement upon offences and forms of professional misconduct which may be brought before the appropriate Medical Council for disciplinary action in view of the authority conferred upon the Medical Council of India and / or State Medical Councils, as provided under Indian Medical Council Act 1956, or State Medical Council Acts, as may be subsequently amended.
The appropriate Medical Council may award such punishment, as deemed necessary. It may direct the removal altogether (professional death sentence) or for a specified period (penal erasure), from the Register the name of any registered practitioner, who has been convicted of any such offence as implies in the opinion of the Medical Council of India and / or State Medical Councils, a defect of character, or who , after an enquiry, at which opportunity has been given to such registered practitioner to be heard in person or by pleader, has been held by the appropriate Medical Council to have been guilty of serious professional misconduct. The appropriate Medical Council may also direct that any name so removed shall be restored.
It must be clearly understood that the instances of offences of professional misconduct which are given do not constitute and are not intended to constitute, a complete list of the infamous acts, which may be punished by erasure from the Register, and that by issuing this notice the Medical Council of India and / or State Medical Councils are in no way precluded from considering and dealing with any form of professional misconduct on the part of a registered practitioner. Circumstances may and do arise from time to time in relation to which there may occur questions of professional misconduct which do not come within any of these categories. 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 Indian and / or State Medical Councils have to consider and decide upon the facts brought before the Medical Council of India and / or State Medical Council.
Note : A medical practitioner is entitled to appeal to the Central Health Ministry against the decision of the Medical Councils.


LIST

Adultery or improper Conduct or Association with a patient : Any medical practitioner who abuses his professional position by committing adultery or improper conduct with a patient or by maintaining an improper association with a patient, is liable for disciplinary action, as provided under the Indian Medical Council Act,1956 and / or State Medical Council Acts, as may be subsequently amended.
Conviction by Court of Law for offences involving moral turpitude.
Professional Certificates, Reports and Other Documents : Registered practitioners are in certain cases bound by law to give, or may from time to time be called upon or requested to give certificates, notifications, reports and other documents, of kindred character, signed by them in their professional capacity for subsequent use in the courts of justice or for administrative purpose etc.

(I) Such documents include , among other certificates, notifications, reports :-

Under the Acts relating to birth, death or disposal of the dead.
Under the Acts relating to Mental Health and Mental Deficiency and the rules made thereunder.
Under the Vaccination Acts and the Regulations made thereunder.
Under the Factories Acts and the Regulations made thereunder.
Under the Education Act.
Under the Public Health Acts and the orders made thereunder.
Under the Workmen’s Compensation Act
Under the Acts and orders relating to the notification of infections diseases.
Under the Employees State Insurance Act.
In connection with sick benefit insurance and friendly societies.
Under the Merchant Shipping Act.
For procuring the issuing of passports.
For excusing attendance in courts of justice, in public services, in public offices or in ordinary employments.
In connection with rural and Military Matters.
In connection with matters under the control of Ministry of the pensions.

(ii) Any registered practitioner, who shall be shown to have signed or given under his name and authority and such certificate, notification, report or document of a kindred character, which is untrue, misleading or improper, whether
relating to the several matters above specified or otherwise, is liable to have his name erased from the Register.

(iii) A registered medical practitioner shall maintain a Register of medical certificates, giving full details of the certificates issued. When issuing a medical certificate, always enter the identification marks of the patient and keep a copy of the certificate. Do not omit to note down the signature or thumb mark, address and identification marks of the patient on the medical certificates or reports.
Contravening the provisions of the Drugs Act and Regulations made thereunder.
Selling Schedule Position to the public under cover of his own qualification, except to his patients.
Performing or enabling an unqualified person : to perform an abortion or any illegal operation, for which there is no medical, surgical or psychological indication.
A physician should not issue certificates of efficiency in modern medicine to unqualified or non medical persons.
(Note : The foregoing does not apply so as to restrict the proper training and instruction of bonafide students, legitimate employees of doctors, midwives, dispensers, surgical attendants, or skilled mechanical and technical assistants under the personal supervision of physicians. )
A physician should not contribute to the lay-press articles and give interviews regarding disease and treatments, which may have the effect of advertising himself or soliciting practice ; but it is open to him to write to the lay press under his own name on matter of public health hygienic living or to deliver public lectures, give talks on the radio broadcast for the same purpose and send announcement of the same to the lay press.
An institution run by a physician for a particular purpose such as a maternity home, a sanatorium, a house for the crippled or the blind etc. may be advertised in the lay press, but such advertisement should not contain anything more than the name of the institution, type of patients admitted, facilities offered and the residential fees. Name of either the superintendent or the doctors attending should not appear in the advertisement.
It is improper for a physician to use an unusually large signboard and write on it anything other than his name, qualifications obtained from a University or a statutory body, titles and name of his speciality. The same should be the contents of his prescription papers. It is improper to affix a board on a chemist’s shop or in place where he does not reside or work.
Do not disclose the secrets of a patient that have been learnt in the exercise of your profession. Those may be disclosed only in court of Law under orders of the presiding Judge.
Refusal to give Professional Service on Religious Grounds : Refusing on religious grounds alone, to give assistance in or conduct cases of sterility, birth control, craniotomies on living children, and therapeutic abortions, when there is medical indication; unless the medical practitioner feels himself/herself incompetent to do so.
Before performing an operation, obtain in writing the consent from the husband or wife, parent or guarding in the case of a minor, or the patient himself, as the case may be. In an operation which may result in sterility, the consent of both husband and wife is needed.
Do not publish photographs or case reports of your patients in any medical or other journal in a manner, by which their identity could be made out, without their permission. Should the identity be not disclosed, his consent is not needed.
If you are running a nursing home and if you employ assistants to help you, the ultimate responsibility rests on you.
No physician must exhibit publicly the scale of fees. But there is no objection to the same being put in the physician’s consulting or waiting rooms. It is not unethical for physician to announce in press, lay or professional, his commencement of practice, interruption or resumption of it after a long interval, or a change of his address, but such announcements containing his address and telephone number shall not appear more than twice.
No physician shall use touts or agents for procuring patients.
Note : This is also known as canvassing.
Do not claim to be a specialist unless you have put in a good few years of study and experience or have a special qualification in that branch. Once you say you are one, do not undertake work outside your speciality even for your friends.


Appendix II


HIPPOCRATIC OATH

I swear by Apollo the Physician, by Aesculapius, Hygiea and Panacea, and I take to witness all the gods, all the goddesses, to keep according to my ability and my judgment the following Oath :
“To consider dear to me as my parents him who taught me this art;to live in common with him and if necessary to share my goods with him ; to look upon his children as my own brothers, to teach them this art if they so desire without fee or written promise; to impart to my sons and the sons of the master who taught me and the disciples who have enrolled themselves and have agreed to the rules of the profession, but to these alone, the precepts and the instruction. I will prescribe regimen for the good of my patients according to my ability and my judgment and never do harm to anyone. To please no one will I prescribe a deadly drug, nor give advice which may cause his death.Nor I will give a woman a pessary to procure abortion. But I will preserve the purity of my life and my art. I will not cut for stone, even for patients in whom the disease is manifest ; I will leave this operation to be performed by practitioners (specialists in this art). In every house where I come I will enter only for the good of my patients, keeping myself far from all intentional ill-doing and all seduction, and especially from the pleasures of love with women or with men, be they free or slaves. All that may come to my knowledge in the exercise of my profession or outside of my profession or in daily commerce with men, which ought not to be spread abroad, I will keep secret and will never reveal. If I keep this oath faithfully, may I enjoy my life and practise my art, respected by all men and in all times ; but if I swerve from it or violate it, may the reverse be my lot”


Appendix III 


DECLARATION OF GENEVA

(As amended at Sydney, 1968)

At the time of being admitted as a member of the medical profession :

I will solemnly pledge myself to consecrate my life to the service of humanity;
I will give to my teachers the respect and gratitude which is their due ;
I will practise my profession with conscience and dignity ;
The health of my patient will be my first consideration ;
I will respect the secret which are confided in me, even after the patient has died ;
I will maintain by all the means in my power the honour and the noble traditions of the medical profession ;
My colleagues will be my brothers ;
I will not permit considerations of religion, nationality, race, party politics or social standing to intervene between my duty and my patient ;
I will maintain the utmost respect for human life from the time of conception, even under threat. I will not use my medical knowledge contrary to the laws of humanity.
I make these promises solemnly, freely and upon my honour.
[index]


APPENDIX IV 


DECLARATION OF HELSINKI

(Revised 1975)

Recommendations guiding medical doctors in biomedical research involving human subjects


INTRODUCTION

It is the mission of the medical doctor to safeguard the health of the people. His or her knowledge and conscience are dedicated to the fulfillment of this mission.
The Declaration of Geneva of the World Medical Association binds the doctor with the words : ‘The health of my patient will be my first consideration ,’ and the International Code of Medical Ethics declares that, ‘ Any act or advice which could weaken physical or mental resistance of a human being may be used only in his interest. ‘
The purpose of biomedical research involving human subjects must be to improve diagnostic, therapeutic and prophylactic procedure and the understanding of the aetiology and pathogenesis of disease.
In current medical practice most diagnostic, therapeutic or prophylactic procedures involve hazards. This applies a fortiori to biomedical research.
Medical progress is based on research which ultimately must rest in part on examination involving human subjects. In the field of biomedical research a fundamental distinction must be recognised between medical research in which the aim is essentially diagnostic or therapeutic for a patient, and medical research the essential object of which is purely scientific and without direct diagnostic or therapeutic value to the person subjected to the research.
Special caution must be exercised in the conduct of research which may affect the environment, and the welfare of animals used for research must be respected.
Because it is essential that the results of laboratory experiments be applied to human beings to further scientific knowledge and to help suffering humanity, the World Medical Association has prepared the following recommendations as a guide to every doctor in biomedical research involving human subjects. They should be kept under review in the future. It must be stressed that the standards as drafted are only a guide to physicians all over the world. Doctors are not relieved from criminal, civil and ethical responsibilities under the laws of their own countries.


I. Basic Principles

Biomedical research involving human subjects must conform to generally accepted scientific principles and should be based on adequately accepted scientific principles and should be based on adequately performed laboratory and animal experimentation and on a thorough knowledge of the scientific tradition.
The design and performance of each experimental procedure involving human subjects should be clearly formulated in an experimental protocol which should be transmitted to a specially appointed independent committee for consideration, comment and guidance.
Biomedical research involving human subjects should be conducted only by scientifically qualified persons and under the supervision of a clinically competent medical person. The responsibility for the human subject must always rest with a medically qualified person and never rest on the subject of the research, even though the subject has given his or her consent.
Biomedical research involving human subjects cannot legitimately be carried out unless the importance of the objective is in proportion to the inherent risk to the subject.
Every biomedical research project involving human subjects should be preceded by careful assessment of predictable risks in comparison with foreseeable benefits to the subject or to others.Concern for the interests of the subject must always prevail over the interest of science and society.
The right of the research subject to safeguard his or her integrity must always be respected. Every precaution should be taken to respect the privacy of the subject and to minimize the impact of the study on the subject’s physical and mental integrity and on the personality of the subject.
Doctors should abstain from engaging in research projects involving human subjects unless they are satisfied that the hazards involved are believed to be predictable. Doctors should cease any investigation if the hazards are found to outweigh the potential benefits.
In publication of the results of his or her research, the doctor is obliged to preserve the accuracy of the results. Reports of experimentation not in accordance with the principles laid down in this Declaration should not be accepted for publication.
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 his or her consent to participation at any time. The doctor should then obtain the subject’s freely given informed consent, preferably in writing.
When obtaining informed consent for the research project the doctor should be particularly cautious if the subject is in a dependent relationship to him or her or may consent under duress. In that case the informed consent should be obtained by a doctor who is not engaged in the investigation and who is completely independent of this official relationship.
In case of legal incompetence, informed consent should be obtained from the legal guardian in accordance with national legislation. Where physical or mental incapacity makes it impossible to obtain informed consent, or when the subject is a minor,permission from the responsible relative replaces that of the subject in accordance with national legislation.
The research protocol should always contain a statement of the ethical considerations involved and should indicate that the principles enunciated in the present Declaration are complied with.
II. Medical Research Combined with Professional Care (Clinical Research)

In the treatment of the sick person, the doctor must be free to use a new diagnostic and therapeutic measure, if in his or her judgment it offers hope of saving life, re-establishing health or alleviating suffering.
The potential benefits, hazards and discomfort of a new method should be weighed against the advantages of the best current diagnostic and therapeutic methods.
In any medical study, every patient – including those of a control group, if any – should be assured of the best proven diagnostic and therapeutic method.
The refusal of the patient to participate in a study must never interfere with the doctor-patient relationship.
If the doctor considers it essential not to obtain informed consent,the specific reasons for this proposal should be stated in the experimental protocol for transmission to the independent committee.
The doctor can combine medical research with professional care,the objective being the acquisition of new medical knowledge, only to the extent that medical research is justified by its potential diagnostic of therapeutic value for the patient.
III – Non-therapeutic Biomedical Research involving Human Subjects (Non-Clinical Biomedical Research)

In the purely scientific application of medical research carried out on a human being, it is the duty of the doctor to remain the protector of the life and health of that person on whom biomedical research is being carried out.
The subjects should be volunteers -either healthy persons or patients for whom the experimental design is not related to the patient’s illness.
The investigator or the investigating team should discontinue the research if in his / her or their judgment it may, if continued, be harmful to the individual.
In research on man, the interest of science and society should never take precedence over considerations related to the wellbeing of the subject.
[index]


Appendix V 


INTERNATIONAL CODE OF MEDICAL ETHICS


Duties of Doctors in General

A DOCTOR MUST always maintain the highest standards of professional conduct.
A DOCTOR MUST practise his profession uninfluenced bymotives of profit.

THE FOLLOWING PRACTICES are deemed unethical :

Any self advertisement except such as is expressly authorised by the national code of medical ethics.
Collaboration in any form of medical service in which the does not have professional independence.
Receiving any money in connection with services rendered to a patient other than a proper professional care, even with the knowledge of the patient.
ANY ACT OR ADVICE which could weaken physical or mental resistance of a human being may be used only in his interest.
A DOCTOR IS ADVISED to use great caution in divulging discoveries or new techniques of treatment.
A DOCTOR SHOULD certify or testify only to that which he has personally verified.
Duties of Doctors to the Sick.

A DOCTOR MUST always bear in mind the obligation of preserving human life.
A DOCTOR OWES to his patient complete loyalty and all the resources of his science. Whenever an examination or treatment is beyond his capacity he should summon another doctor who has the necessary ability.
A DOCTOR SHALL preserve absolute secrecy on all he knows about his patients because of the confidence entrusted in him.
A DOCTOR MUST give emergency care as a humanitarian duty unless he is assured that others are willing and able to give such care.
Duties of Doctors to Each Other.
A DOCTOR OUGHT to behave to his colleagues as he would have them behaved to him.
A DOCTOR MUST NOT entice patients from his colleagues.
A DOCTOR MUST OBSERVE the principles of ‘The Declaration of Geneva’ approved by the World Medical Association.


Appendix VI 


GUIDELINES FOR STERILIZATION

(Issued by the Government of India )

Sterilization services are provided free of charge in Government Institutions. Guidelines have been issued from time to time by the Government covering various aspects of sterilization. These are :

The age of the husband should not ordinarily be less than 25 years nor should it be over 50 years.
The age of the wife should not be less than 20 years or more than 45 years.
The motivated couple must have 2 living children at the time of operation.
If the couple has 3 or more living children, the lower limit of age of husband or wife may be relaxed at the discretion of the operating surgeon.
It is sufficient if the acceptor declares having obtained the consent of his / her spouse to undergo sterilization operation without outside pressure, inducement or coercion, and that he /she knows that for all practical purposes, the operation is irreversible and also that the spouse has not been sterilized earlier.

   

 

-:Medical Ethics :-

 

Appendix I 

MEDICAL COUNCIL OF INDIACODE OF MEDICAL ETHICSDECLARATIONAt the time of registration, each applicant shall be given a copy of the following declaration by the Registrar concerned, and shall read and agree to abide by the same :-I solemnly pledge myself to consecrate my life to the service of humanity.Even under threat, I will not use my medical knowledge contrary, to the laws of humanity.I will maintain the utmost respect for human life from the time of conception.I will not permit consideration of religion, nationality, race, party politics or social standing to intervene between my duty and my patient.I will practise my profession with conscience and dignity.The health of my patient will be my first consideration.I will respect the secrets which are confided in me.I will give to my teachers the respect and gratitude which is their due.I will maintain, by all means in my power, the honour and noble traditions of medical profession.My colleagues will be my brothers.I make these promises solemnly, freely and upon my honour.CODEGENERAL PRINCIPLESCharacter of the PhysicianThe prime object of the medical profession is to render service to humanity; reward of financial gain is a subordinate consideration. Whosoever chooses this profession, assumes the obligation to conduct himself in accord with its ideals. A physician should be an upright man, instructed in the “art of healings.” He must keep himself pure in character and be diligent in caring for the sick. He should be modest, sober, patient, prompt to do his whole duty without anxiety; pious without going so far as superstition, conducting himself with propriety in his profession and in all the actions of his life.The Physician’s ResponsibilityThe principle objective of the medical profession is to render service to humanity with full respect for the dignity of man. 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 skill and should make available to their patients and colleagues the benefits of their professional attainments. The physician should practise methods of healing founded on scientific basis and should not associate professionally with anyone who violates this principle. The honoured ideals of the medical profession imply that the responsibilities of the physician extend not only to individuals but also to society.AdvertisingSolicitation of patients, directly or indirectly , by a physician, by groups of physicians or by institutions or organisations is unethical. A physician shall not make use of or aid or permit others to make use of him (or his name) as subject of any form or manner of advertising or publicity though lay channels, either alone or in conjunction with others which will shall be 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 aggrandisement, nor shall he give to any person whosoever, 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 though lay channels, nor shall he boast of cases, operations, cures or remedies or permit the publication of report thereof through lay channels. A medical practitioner is permitted a formal announcement in press regarding the following :-On starting practice.On change of type of practice.On changing address.On temporary absence from duty.On resumption of practice.On succeeding to another practice.Payment of Professional ServicesThe ethical physician, engaged in the practice of medicine, limits the sources of his income received from professional activities to services rendered to the patient. Remunerations 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.”Patent and CopyrightsA physician may patent surgical instruments, appliances and medicines or copyright publications, methods and procedures. The use of such patents or copy-right or the receipt of remuneration from them which retards or inhibits research or restrict the benefits derivable therefrom are unethical.Running an open shop (Dispensing of drugs and appliances by physicians)A physician should not run an open shop for sale of medicine, for dispensing prescriptions prescribed by doctors other than himself or for sale of medical or surgical appliances. It is not unethical for a physician to prescribe or supply drugs, remedies or appliances so long as there is no exploitation of the patient.Rebates and CommissionA physician shall not give, solicit, or receive nor shall he offer to give, solicit or receive, any gift, gratuity, commission or bonus in consideration of or in return for the referring, recommending or procuring of any patient for medical , surgical or other treatment. A physician shall not directly or by any subterfuge participate in or be a party to the act of division, transference, assignment, subordination, rebating, splitting or refunding of any fee for medical, surgical or other treatment. The provisions of this para shall apply with equal force to the referring, recommending or procuring by a physician or any person, specimen or material for diagnostic, or other study or work. Nothing in this section, however, shall prohibit payment of salaries by a qualified physician to other duly qualified persons, rendering medical care under his supervision.Secret RemediesThe prescriptions or dispensing by, a physician of secret medicine or other secret remedial agents of which he does not know the composition, or the manufacture, or promotion of their use is unethical.Evasion of legal restrictionsThe physician will observe the laws of the country in regulating the practice of medicine and will not assist others to evade such laws. He should be co-operative in observance and enforcement of sanitary laws and regulations in the interest of public health. A physician should observe the provisions of the State Acts like Drugs Act, Pharmacy Act, Poisonous and Dangerous Drugs Act and such other Acts, Rules, Regulations made by the Central Government / State Governments or local Administrative Bodies for protection and promotion of public health.DUTIES OF PHYSICIANS TO THEIR PATIENTSObligations to the sickThough a physician is not bound to treat each and every one asking his services except in emergencies for the sake of humanity and the noble traditions of the profession, he should not only be everready 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 incurs in the discharge of his professional duties. In his ministrations, 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 endeavor to add to the comfort of the sick by making his visits at the hour indicated to the patients.Patience, delicacy and secrecyPatience and delicacy should characterize the physicians. 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 confidences to him 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 desire another to act towards one of his own family in like circumstances.PrognosisThe physician should neither exaggerate nor minimize the gravity of a patient’s condition. He should assure 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.The patient must not be neglectedA physician is free to choose whom he will serve. He should, however, respond to any request for his assistance in an emergency or whenever temperate public opinion expects the service. Once having undertaken a case, the physician should not neglect the patient, nor should he withdraw from the case without giving notice to the patient, his relatives or his responsible friends sufficiently long in advance of his withdraw to allow them to secure another medical attendant. No provisionally or fully registered medical practitioner shall willfully commit an act of negligence that may deprive his patient or patients from necessary medical care.DUTIES OF THE PHYSICIAN TO THE PROFESSOIN AT LARGEUpholding the honour of the professionA physician is expected to uphold the dignity and honour of his profession.Membership in medical societyFor the advancement of his profession, a physician should affiliate with medical societies and contribute his time, energy and means so that these societies may represent the ideals of the profession.Safeguarding the professionEvery physician should aid in safeguarding the profession against admission to it of those who are deficient in moral character or education. Physician should not employ, in connection with his professional practice, any attendant, who is neither registered nor enlisted under the Medical Act in force, and should not permit such persons to attend, treat or perform operations upon patients in respect of matters regarding professional discretion or skill, as it is dangerous to public health.Exposure of Unethical ConductA physician should expose, without fear or favour, incompetent or corrupt, dishonest or unethical conduct on the part of members of the profession. Questions of such conduct should be considered, first before proper medical tribunals in executive sessions or by special or duly appointed committees on ethical relations, provided such a course is possible, and provided, also that the law is not hampered thereby. If doubt should arise as to the legality of the physician’s conduct, the situation under investigation may be placed before officers of the law, and the physician investigators may take the necessary steps to enlist the interest of the proper authority.PROFESSIONAL SERVICES OF PHYSICIAN TO EACH OTHERDependence of physicians on each otherThere is no rule that a physician should not charge another physician for his services but a physician should cheerfully and without recompense give his professional service to a physician or his dependents, if they are in his vicinity.Compensation for expensesA physician should consider it as a pleasure and privilege to render gratuitous service to all physicians and their immediate family dependents. When a physician is called from a distance to attend or advise another physician or his dependent, reimbursement should however be made for travelling and other incidental expenses.DUTIES OF PHYSICIAN IN CONSULTATIONConsultation should be encouragedIn case of serious illness, especially in doubtful or difficult conditions, the physician should request consultations.Consultation for Patient’s BenefitsIn every consultation, the benefit to the patient is of first importance. All physicians interested in the case should be candid with the patient, a member of his family or responsible friend.Punctuality in consultationUtmost punctuality should be observed by a physician in meeting for consultation.Conduct in consultationIn consultation, no insincerity, rivalry or envy should be indulged in. All due respect should be observed towards the physician incharge of the case, and no statement, or remarks 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.Statement to patient after consultation(a) All statements of the case to the patient or his representatives should take place in the presence of all the physicians consulting, except as otherwise agreed ; the announcement of the opinion to the patient or his relations or friends shall rest with the medical attendant.(b) Differences of opinion should not be divulged unnecessarily, but when there is an irreconcilable difference of opinion, the circumstances should be frankly and impartially explained to the patient or his friends. It would be open to them to seek further advice should they so desire.Treatment after consultationNo decision should restrain the attending physician from making such subsequent variations in the treatment as any unexpected change may require, but at the next consultation, reasons for the variations should be stated. 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 at any time for the patient the consultant only in case of emergency.Consultant not to take charge of the caseWhen a physician has been called as a consultant none but the rarest and the most exceptional circumstances would justify that consultant taking charge of the case. He should not do so merely on the solicitation of the patient or friends.Patients referred to specialistsWhen a patient is referred to a specialist by the attending physician, a statement of the case should be given to the specialist, who should communicate his opinion in writing in a closed cover direct to the attending physician.DUTIES OF PHYSICIAN IN CASES OF INTEREFERENCEAppointment of a substituteWhenever a physician requests another physician to attend his patient during his temporary absence from his practice, professional courtesy requires the acceptance of such appointment, is consistent with his other duties. The physician acting under such an appointment should give the utmost consideration to the interests and reputation of the absent physician. All such patients should be restored to the care of the latter upon his return.Visiting another physician’s caseA physician called to visit a patient, who has recently been under the care of another physician in the same illness, should not take charge of, nor prescribe for such patient except in a case of emergency when he should communicate to the former explaining the circumstances under which the patient was seen and treatment given, or when the physician has relinquished his case, or when the patient has notified such physician to discontinue his services. 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 should avoid remarks upon the diagnosis or the treatment that has been adopted.Engagement for an Obstetric caseIf a physician agrees to attend a woman during her confinement, he must do so. Inability to do so on an excuse of any other engagement is not tenable, except when he is already engaged on a similar or other serious case. When a physician who has been engaged to attend an obstetric case is absent and another is sent for the 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.DUTIES OF PHYSICIAN TO THE PUBLICPhysicians as CitizensPhysicians, as good citizens, possessed of special training, should advise concerning the health of the community where in they dwell. They should bear their part in enforcing the laws of the community and in sustaining the institutions that advance the interests of humanity. They should cooperate especially with the proper authorities in the administration of sanitary laws and regulations.Public HealthPhysicians, 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 law, rules and regulations of the health authorities. When an epidemic prevails, a physician must continue his labours without regard to the risk to his own health.PharmacistsPhysicians should recognise and promote the practice of pharmacy as a profession and should recognise the cooperation of the pharmacist in education of the public concerning the practice of ethical and scientific medicine.DISCIPLINARY ACTIONThe Medical Council of India desires to bring to the notice of the registered medical practitioners the following statement upon offences and forms of professional misconduct which may be brought before the appropriate Medical Council for disciplinary action in view of the authority conferred upon the Medical Council of India and / or State Medical Councils, as provided under Indian Medical Council Act 1956, or State Medical Council Acts, as may be subsequently amended.The appropriate Medical Council may award such punishment, as deemed necessary. It may direct the removal altogether (professional death sentence) or for a specified period (penal erasure), from the Register the name of any registered practitioner, who has been convicted of any such offence as implies in the opinion of the Medical Council of India and / or State Medical Councils, a defect of character, or who , after an enquiry, at which opportunity has been given to such registered practitioner to be heard in person or by pleader, has been held by the appropriate Medical Council to have been guilty of serious professional misconduct. The appropriate Medical Council may also direct that any name so removed shall be restored.It must be clearly understood that the instances of offences of professional misconduct which are given do not constitute and are not intended to constitute, a complete list of the infamous acts, which may be punished by erasure from the Register, and that by issuing this notice the Medical Council of India and / or State Medical Councils are in no way precluded from considering and dealing with any form of professional misconduct on the part of a registered practitioner. Circumstances may and do arise from time to time in relation to which there may occur questions of professional misconduct which do not come within any of these categories. 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 Indian and / or State Medical Councils have to consider and decide upon the facts brought before the Medical Council of India and / or State Medical Council.Note : A medical practitioner is entitled to appeal to the Central Health Ministry against the decision of the Medical Councils.LISTAdultery or improper Conduct or Association with a patient : Any medical practitioner who abuses his professional position by committing adultery or improper conduct with a patient or by maintaining an improper association with a patient, is liable for disciplinary action, as provided under the Indian Medical Council Act,1956 and / or State Medical Council Acts, as may be subsequently amended.Conviction by Court of Law for offences involving moral turpitude.Professional Certificates, Reports and Other Documents : Registered practitioners are in certain cases bound by law to give, or may from time to time be called upon or requested to give certificates, notifications, reports and other documents, of kindred character, signed by them in their professional capacity for subsequent use in the courts of justice or for administrative purpose etc.(I) Such documents include , among other certificates, notifications, reports :-Under the Acts relating to birth, death or disposal of the dead.Under the Acts relating to Mental Health and Mental Deficiency and the rules made thereunder.Under the Vaccination Acts and the Regulations made thereunder.Under the Factories Acts and the Regulations made thereunder.Under the Education Act.Under the Public Health Acts and the orders made thereunder.Under the Workmen’s Compensation ActUnder the Acts and orders relating to the notification of infections diseases.Under the Employees State Insurance Act.In connection with sick benefit insurance and friendly societies.Under the Merchant Shipping Act.For procuring the issuing of passports.For excusing attendance in courts of justice, in public services, in public offices or in ordinary employments.In connection with rural and Military Matters.In connection with matters under the control of Ministry of the pensions.(ii) Any registered practitioner, who shall be shown to have signed or given under his name and authority and such certificate, notification, report or document of a kindred character, which is untrue, misleading or improper, whetherrelating to the several matters above specified or otherwise, is liable to have his name erased from the Register.(iii) A registered medical practitioner shall maintain a Register of medical certificates, giving full details of the certificates issued. When issuing a medical certificate, always enter the identification marks of the patient and keep a copy of the certificate. Do not omit to note down the signature or thumb mark, address and identification marks of the patient on the medical certificates or reports.Contravening the provisions of the Drugs Act and Regulations made thereunder.Selling Schedule Position to the public under cover of his own qualification, except to his patients.Performing or enabling an unqualified person : to perform an abortion or any illegal operation, for which there is no medical, surgical or psychological indication.A physician should not issue certificates of efficiency in modern medicine to unqualified or non medical persons.(Note : The foregoing does not apply so as to restrict the proper training and instruction of bonafide students, legitimate employees of doctors, midwives, dispensers, surgical attendants, or skilled mechanical and technical assistants under the personal supervision of physicians. )A physician should not contribute to the lay-press articles and give interviews regarding disease and treatments, which may have the effect of advertising himself or soliciting practice ; but it is open to him to write to the lay press under his own name on matter of public health hygienic living or to deliver public lectures, give talks on the radio broadcast for the same purpose and send announcement of the same to the lay press.An institution run by a physician for a particular purpose such as a maternity home, a sanatorium, a house for the crippled or the blind etc. may be advertised in the lay press, but such advertisement should not contain anything more than the name of the institution, type of patients admitted, facilities offered and the residential fees. Name of either the superintendent or the doctors attending should not appear in the advertisement.It is improper for a physician to use an unusually large signboard and write on it anything other than his name, qualifications obtained from a University or a statutory body, titles and name of his speciality. The same should be the contents of his prescription papers. It is improper to affix a board on a chemist’s shop or in place where he does not reside or work.Do not disclose the secrets of a patient that have been learnt in the exercise of your profession. Those may be disclosed only in court of Law under orders of the presiding Judge.Refusal to give Professional Service on Religious Grounds : Refusing on religious grounds alone, to give assistance in or conduct cases of sterility, birth control, craniotomies on living children, and therapeutic abortions, when there is medical indication; unless the medical practitioner feels himself/herself incompetent to do so.Before performing an operation, obtain in writing the consent from the husband or wife, parent or guarding in the case of a minor, or the patient himself, as the case may be. In an operation which may result in sterility, the consent of both husband and wife is needed.Do not publish photographs or case reports of your patients in any medical or other journal in a manner, by which their identity could be made out, without their permission. Should the identity be not disclosed, his consent is not needed.If you are running a nursing home and if you employ assistants to help you, the ultimate responsibility rests on you.No physician must exhibit publicly the scale of fees. But there is no objection to the same being put in the physician’s consulting or waiting rooms. It is not unethical for physician to announce in press, lay or professional, his commencement of practice, interruption or resumption of it after a long interval, or a change of his address, but such announcements containing his address and telephone number shall not appear more than twice.No physician shall use touts or agents for procuring patients.Note : This is also known as canvassing.Do not claim to be a specialist unless you have put in a good few years of study and experience or have a special qualification in that branch. Once you say you are one, do not undertake work outside your speciality even for your friends.Appendix IIHIPPOCRATIC OATHI swear by Apollo the Physician, by Aesculapius, Hygiea and Panacea, and I take to witness all the gods, all the goddesses, to keep according to my ability and my judgment the following Oath :“To consider dear to me as my parents him who taught me this art;to live in common with him and if necessary to share my goods with him ; to look upon his children as my own brothers, to teach them this art if they so desire without fee or written promise; to impart to my sons and the sons of the master who taught me and the disciples who have enrolled themselves and have agreed to the rules of the profession, but to these alone, the precepts and the instruction. I will prescribe regimen for the good of my patients according to my ability and my judgment and never do harm to anyone. To please no one will I prescribe a deadly drug, nor give advice which may cause his death.Nor I will give a woman a pessary to procure abortion. But I will preserve the purity of my life and my art. I will not cut for stone, even for patients in whom the disease is manifest ; I will leave this operation to be performed by practitioners (specialists in this art). In every house where I come I will enter only for the good of my patients, keeping myself far from all intentional ill-doing and all seduction, and especially from the pleasures of love with women or with men, be they free or slaves. All that may come to my knowledge in the exercise of my profession or outside of my profession or in daily commerce with men, which ought not to be spread abroad, I will keep secret and will never reveal. If I keep this oath faithfully, may I enjoy my life and practise my art, respected by all men and in all times ; but if I swerve from it or violate it, may the reverse be my lot”Appendix III DECLARATION OF GENEVA(As amended at Sydney, 1968)At the time of being admitted as a member of the medical profession :I will solemnly pledge myself to consecrate my life to the service of humanity;I will give to my teachers the respect and gratitude which is their due ;I will practise my profession with conscience and dignity ;The health of my patient will be my first consideration ;I will respect the secret which are confided in me, even after the patient has died ;I will maintain by all the means in my power the honour and the noble traditions of the medical profession ;My colleagues will be my brothers ;I will not permit considerations of religion, nationality, race, party politics or social standing to intervene between my duty and my patient ;I will maintain the utmost respect for human life from the time of conception, even under threat. I will not use my medical knowledge contrary to the laws of humanity.I make these promises solemnly, freely and upon my honour.[index]APPENDIX IV DECLARATION OF HELSINKI(Revised 1975)Recommendations guiding medical doctors in biomedical research involving human subjectsINTRODUCTIONIt is the mission of the medical doctor to safeguard the health of the people. His or her knowledge and conscience are dedicated to the fulfillment of this mission.The Declaration of Geneva of the World Medical Association binds the doctor with the words : ‘The health of my patient will be my first consideration ,’ and the International Code of Medical Ethics declares that, ‘ Any act or advice which could weaken physical or mental resistance of a human being may be used only in his interest. ‘The purpose of biomedical research involving human subjects must be to improve diagnostic, therapeutic and prophylactic procedure and the understanding of the aetiology and pathogenesis of disease.In current medical practice most diagnostic, therapeutic or prophylactic procedures involve hazards. This applies a fortiori to biomedical research.Medical progress is based on research which ultimately must rest in part on examination involving human subjects. In the field of biomedical research a fundamental distinction must be recognised between medical research in which the aim is essentially diagnostic or therapeutic for a patient, and medical research the essential object of which is purely scientific and without direct diagnostic or therapeutic value to the person subjected to the research.Special caution must be exercised in the conduct of research which may affect the environment, and the welfare of animals used for research must be respected.Because it is essential that the results of laboratory experiments be applied to human beings to further scientific knowledge and to help suffering humanity, the World Medical Association has prepared the following recommendations as a guide to every doctor in biomedical research involving human subjects. They should be kept under review in the future. It must be stressed that the standards as drafted are only a guide to physicians all over the world. Doctors are not relieved from criminal, civil and ethical responsibilities under the laws of their own countries.I. Basic PrinciplesBiomedical research involving human subjects must conform to generally accepted scientific principles and should be based on adequately accepted scientific principles and should be based on adequately performed laboratory and animal experimentation and on a thorough knowledge of the scientific tradition.The design and performance of each experimental procedure involving human subjects should be clearly formulated in an experimental protocol which should be transmitted to a specially appointed independent committee for consideration, comment and guidance.Biomedical research involving human subjects should be conducted only by scientifically qualified persons and under the supervision of a clinically competent medical person. The responsibility for the human subject must always rest with a medically qualified person and never rest on the subject of the research, even though the subject has given his or her consent.Biomedical research involving human subjects cannot legitimately be carried out unless the importance of the objective is in proportion to the inherent risk to the subject.Every biomedical research project involving human subjects should be preceded by careful assessment of predictable risks in comparison with foreseeable benefits to the subject or to others.Concern for the interests of the subject must always prevail over the interest of science and society.The right of the research subject to safeguard his or her integrity must always be respected. Every precaution should be taken to respect the privacy of the subject and to minimize the impact of the study on the subject’s physical and mental integrity and on the personality of the subject.Doctors should abstain from engaging in research projects involving human subjects unless they are satisfied that the hazards involved are believed to be predictable. Doctors should cease any investigation if the hazards are found to outweigh the potential benefits.In publication of the results of his or her research, the doctor is obliged to preserve the accuracy of the results. Reports of experimentation not in accordance with the principles laid down in this Declaration should not be accepted for publication.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 his or her consent to participation at any time. The doctor should then obtain the subject’s freely given informed consent, preferably in writing.When obtaining informed consent for the research project the doctor should be particularly cautious if the subject is in a dependent relationship to him or her or may consent under duress. In that case the informed consent should be obtained by a doctor who is not engaged in the investigation and who is completely independent of this official relationship.In case of legal incompetence, informed consent should be obtained from the legal guardian in accordance with national legislation. Where physical or mental incapacity makes it impossible to obtain informed consent, or when the subject is a minor,permission from the responsible relative replaces that of the subject in accordance with national legislation.The research protocol should always contain a statement of the ethical considerations involved and should indicate that the principles enunciated in the present Declaration are complied with.II. Medical Research Combined with Professional Care (Clinical Research)In the treatment of the sick person, the doctor must be free to use a new diagnostic and therapeutic measure, if in his or her judgment it offers hope of saving life, re-establishing health or alleviating suffering.The potential benefits, hazards and discomfort of a new method should be weighed against the advantages of the best current diagnostic and therapeutic methods.In any medical study, every patient – including those of a control group, if any – should be assured of the best proven diagnostic and therapeutic method.The refusal of the patient to participate in a study must never interfere with the doctor-patient relationship.If the doctor considers it essential not to obtain informed consent,the specific reasons for this proposal should be stated in the experimental protocol for transmission to the independent committee.The doctor can combine medical research with professional care,the objective being the acquisition of new medical knowledge, only to the extent that medical research is justified by its potential diagnostic of therapeutic value for the patient.III – Non-therapeutic Biomedical Research involving Human Subjects (Non-Clinical Biomedical Research)In the purely scientific application of medical research carried out on a human being, it is the duty of the doctor to remain the protector of the life and health of that person on whom biomedical research is being carried out.The subjects should be volunteers -either healthy persons or patients for whom the experimental design is not related to the patient’s illness.The investigator or the investigating team should discontinue the research if in his / her or their judgment it may, if continued, be harmful to the individual.In research on man, the interest of science and society should never take precedence over considerations related to the wellbeing of the subject.[index]Appendix V INTERNATIONAL CODE OF MEDICAL ETHICSDuties of Doctors in GeneralA DOCTOR MUST always maintain the highest standards of professional conduct.A DOCTOR MUST practise his profession uninfluenced bymotives of profit.THE FOLLOWING PRACTICES are deemed unethical :Any self advertisement except such as is expressly authorised by the national code of medical ethics.Collaboration in any form of medical service in which the does not have professional independence.Receiving any money in connection with services rendered to a patient other than a proper professional care, even with the knowledge of the patient.ANY ACT OR ADVICE which could weaken physical or mental resistance of a human being may be used only in his interest.A DOCTOR IS ADVISED to use great caution in divulging discoveries or new techniques of treatment.A DOCTOR SHOULD certify or testify only to that which he has personally verified.Duties of Doctors to the Sick.A DOCTOR MUST always bear in mind the obligation of preserving human life.A DOCTOR OWES to his patient complete loyalty and all the resources of his science. Whenever an examination or treatment is beyond his capacity he should summon another doctor who has the necessary ability.A DOCTOR SHALL preserve absolute secrecy on all he knows about his patients because of the confidence entrusted in him.A DOCTOR MUST give emergency care as a humanitarian duty unless he is assured that others are willing and able to give such care.Duties of Doctors to Each Other.A DOCTOR OUGHT to behave to his colleagues as he would have them behaved to him.A DOCTOR MUST NOT entice patients from his colleagues.A DOCTOR MUST OBSERVE the principles of ‘The Declaration of Geneva’ approved by the World Medical Association.Appendix VI GUIDELINES FOR STERILIZATION(Issued by the Government of India )Sterilization services are provided free of charge in Government Institutions. Guidelines have been issued from time to time by the Government covering various aspects of sterilization. These are :The age of the husband should not ordinarily be less than 25 years nor should it be over 50 years.The age of the wife should not be less than 20 years or more than 45 years.The motivated couple must have 2 living children at the time of operation.If the couple has 3 or more living children, the lower limit of age of husband or wife may be relaxed at the discretion of the operating surgeon.It is sufficient if the acceptor declares having obtained the consent of his / her spouse to undergo sterilization operation without outside pressure, inducement or coercion, and that he /she knows that for all practical purposes, the operation is irreversible and also that the spouse has not been sterilized earlier.