Læknablaðið - 15.12.1985, Blaðsíða 58

370
LÆKNABLAÐIÐ
of the objective is in proportion to the inherent risk
to the subject.
(5) 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
interest of the subject must always prevail over the
interests of science and society.
(6) 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.
(7) 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.
(8) 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 accordan-
ce with the principles laid down in this Declaration
should not be accepted for publication.
(9) 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.
(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 independent of this official relationship.
(11) In case of legal incompetence, informed consent
should be obtained from the legal guardian in
accordance with national legislation. Where physi-
cal or mental incapacity makes it impossible to
obtain from the responsible relative replaces that of
the subject in accordance with national legislation.
(12) The research protocol should always contain a
statment 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 judgment it offers hope of
saving life, re-establishing health or alleviating
suffering.
(2) The potential benefits, hazards and discomfort of a
new method should be weighed against the advanta-
ges of the best current diagnostic and therapeutic
methods.
(3) In any medical study, every patient - including
those of control group, if any - should be assured
of the best proven diagnostic and therapeutic
method.
(4) The refusal of the patient to participate in a study
must never interfere with the doctor-patient relati-
onship.
(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 independent com-
mittee (1.2).
(6) 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 diagno-
stic or therapeutic value for the patient.
III. Non-Therapeutic Biomedical Research Involving
Human Subjects (Non-clinical Biomedical Research)
(1) 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.
(2) The subjects should be volunteers - either healthy
persons or patients for whom the experimental
design is not related to the patient’s illness.
(3) The investigator or the investigating team should
discontinue the research if in his/her or their
judgement it may, if continued, be harmful to the
individual.
(4) In research on man, the interest of science and
society should never take precendence over consi-
derations related to the well-being of the subject.