Læknablaðið : fylgirit - 01.09.1977, Blaðsíða 24

Læknablaðið : fylgirit - 01.09.1977, Blaðsíða 24
18 and potential hazards of the study and the discomfort it may en- tail. 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. 10. 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 in- dependent of this official relationship. 11. In case of legal incompetence, informed consent should be ob- tained from the legal guardian in accordance with national legi- slation. Where physical or mental incapacity makes it impossible to obtain informed consent, or when the subject is a minor, per- mission from the responsible relative replaces that of the sub- ject in accordance with national legislation. 12. 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). 1. 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 judgement it offers hope of saving life, reestablishing health or alleviating suffering. 2. The potential benefits, hazards and discomfort of a new met- hod should be weighed against the advantages of the best current diagnostic and terapeutic methods. 3. In any medical study, every patient - including those of a control group, if any - should be assured of the best proven dia- gnostic and therapeutic method. 4. The refusal of the patient to participate in a study must never interfere with the doctor-patient relationship. 5. 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 in- dependence committee (1,2) 6. The doctor can combine medical research with professional care, the objective being the acquisition of new medical know-

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