Emedinews:Insights on Medicolegal Issues:World Medical Association (WMA) guidelines for medical doctors in biomedical research involving human subjects

• 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 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 consideration involved and should indicate that the principles enunciated in the present Declaration are complied with.

(Ref: 18th World Medical Assembly, Helsinki, Finland, 1964 and revised by the 29th World Medical Assembly, Tokyo, Japan, 1975).

World Medical Association Declaration on Principle-Undergraduate Medical Education & Faculty

The goal of medical education is to educate physicians who are entitled and consistent with their training to practice the profession without limitation. Medical Education leading to the first professional degree must be conducted by an organized faculty and the faculty must possess the appropriate academic qualifications that can only be achieved through formal training and experience

• The first professional degree should represent completion of a curriculum that qualifies the student for a spectrum of career choices, including patient care, public health, clinical or basic research or medical education. Each career choice will require additional education beyond that required for the first professional degree.
• The research to advance medical knowledge and the provision of the highest quality of care must occur in academic settings to demonstrate the highest medical standards.
• The content, format and evaluation of the educational experience provided are the responsibility of the faculty with participation of National Medical Associations.
• The faculty is responsible for providing its own obligatory basic curriculum in an academic environment of freedom in which learning and inquiry can thrive in a maximal way.
• Frequent reviews of the curriculum, allowing for the needs of the community and for input from practicing physicians should be conducted by the faculty,
• The proper administrative structure and academic records must be maintained. When the necessary elements are available the clinical education of practitioner and specialist can be sponsored by either a university or a hospital.

(Adopted by the 39th World Medical Assembly Madrid Spain, October 1987)

Emedinews:Insights on Medicolegal Issues:World Medical Association (WMA) guidelines for medical doctors in biomedical research involving human subjects

• 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 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 consideration involved and should indicate that the principles enunciated in the present Declaration are complied with.

(Ref: 18th World Medical Assembly, Helsinki, Finland, 1964 and revised by the 29th World Medical Assembly, Tokyo, Japan, 1975).

Emedinews:Insights on Medicolegal Issues:World Medical Association (WMA) guidelines for medical doctors in biomedical research involving human subjects

• 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 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 consideration involved and should indicate that the principles enunciated in the present Declaration are complied with.

(Ref: 18th World Medical Assembly, Helsinki, Finland, 1964 and revised by the 29th World Medical Assembly, Tokyo, Japan, 1975).

Emedinews:Insights on Medicolegal issues:What is the World Medical Association Declaration on Terminal Illness?

On October 1983, the 35th World Medical Assembly in Venice, Italy adopted as below:

• The duty of the physician is to heal and, where possible, relieve suffering and act to protect the best interests of his patients.
• There shall be no exception to this principle even in the case of incurable disease or malformation.
• This principle does not preclude application of the following rules
• The physician may relieve suffering of a terminally ill patient by withholding treatment with the consent of the patient or his immediate family if unable to express his will.
• Withholding of treatment does not free the physician from his obligation to assist the dying person and give him the necessary medicaments to mitigate the terminal phase of his illness.
• The physician shall refrain from employing any extraordinary means which would prove of no benefit for the patient.
• The physician may, when the patient cannot reverse the final process of cessation of vital functions, apply such artificial means as are necessary to keep organs active for transplantation provided he acts in accordance with the laws of the country or by virtue of a formal consent given by the responsible person.
• The certification of death or the irreversibility of vital activity had been made by physicians unconnected with the transplantation and the patient receiving treatment.
• These artificial means shall not be paid for by the donor or his relatives. Physicians treating the donor shall be totally independent of those treating the recipient and of the recipient himself.