1. In the purely scientific application of clinical 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 clinical research is being carried out.
2. The nature, the purpose, and the risk of clinical research must be explained
to the subject by the doctor.
3a. Clinical research on a human being cannot be undertaken without his free
consent, after he has been fully informed; if he is legally incompetent the
consent of the legal guardian should be procured.
3b. The subject of clinical research should be in such a mental, physical, and
legal state as to be able to exercise fully his power of choice.
3c. Consent should as a rule be obtained in writing. However, the responsibility
for clinical research always remains with the research worker; it never falls on
the subject, even after consent is obtained.
4a. The investigator must respect the right of each individual to safeguard his
personal integrity, especially if the subject is in a dependent relationship to the
4b. At any time during the course of clinical research the subject or his guardian
should be free to withdraw permission for research to be continued. The
investigator of the investigating team should discontinue the research if in his
or their judgment it may, if continued, be harmful to the individual.