Læknablaðið : fylgirit - 01.09.1977, Page 23

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responsibilities under the laws of their own countries.
I. Basic principles
1. Biomedical research involving human subjects must conform to
generally accepted scientific principles and should be based on
adequately performed laboratory and animal experimentation and on
a thorough knowledge of the scientific literature.
2. The design and performance of each experimental procedure in-
volving human subjects should be clearly formulated in an experi-
mental protocol which should be transmitted to a specially app-
ointed independent committee for consideration, canment and
guidance.
3. Biomedical research involving human subjects should be con-
ducted only by scientifically qualified persons and under the
supervision of a clinically competent medical person. The re-
sponsibility for the human subject must always rest with a medi-
cally qualified person and never rest on the subject of the re-
search, even though the subject has given his or her consent.
4. Biomedical research involving human subjects cannot legitinoa-
tely be carried out unless the importance 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.
Concem for the interests 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 in-
tegrity 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 integri-
ty and on the personality of the subject.
7. Doctors should abstain fron engaging in research projects in-
volving 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 po-
tential benefits.
8. In publication of the results of his or her research, the
doctor is obliged to preserve the accuracy of the results. Re-
ports of experimentation not in accordance with the principles
laid down in this Declaration should not be accepted for publi-
cation.
9. In any research on human beings, each potential subject must
be adequately informed of the aims, methods, anticipated benefits