Declaration of Helsinki of 1964

 

  • World Medical Association adopted guiding principles for conducting human subject research.
     

  • The physician must be free to use a new diagnostic and therapeutic measure, if in his or her judgement 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.
     

  • 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 physician-patient relationship.
     

  • No experiment should be conducted where there is an a priori reason to believe that death or disabling injury will occur.
     

  • If the physician 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 objective being the acquisition of new medical knowledge, only to the extent that medical research is justified by its potential diagnostic or therapeutic value for the patient.
     

  • It is the duty of the physician 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 well-being of the subject.

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