Læknablaðið : fylgirit - 01.09.1977, Page 24

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and potential hazards of the study ana 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
rersearch).
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-