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Helsinki Agreement Research Ethics

A person who agrees to participate in a randomized controlled blind study agrees not to receive information that most people wish to receive; i.e. know what treatment they are receiving at any time. This agreement not to know such information is not only for studies with placebo controls. Placebo controls are not considered unethical per se in paragraph 29. What is called into question is the potential harm to researchers who, in a controlled versus placebo study, may not receive otherwise proven treatment. 13. Reasonable caution should be exercised when conducting harmful medical examinations. In 1983, four minor changes were made to the DoH text [10]: in the 16 cases where the word was used in the 1975 version, the word “doctor (s)” was changed to “doctor.” In the introduction, the quotation from the introduction of the International Code of Medical Ethics changed slightly because the text of the code had changed. Also in the introduction, the Latin expression a forteriori was changed in the statement “In current medical practice, most diagnostic, therapeutic or prophylactic methods associated with hazards” has been modified. This is especially true for biomedical research. Finally, in the “Fundamental Principles” section, the requirement to add to paragraph I.11, which deals with situations of legal incapacity, if a minor can give “agreement” to obtain such consent. Physicians should abandon research projects on human subjects unless they are satisfied that the associated dangers are considered foreseeable. Physicians should terminate any examination if the risks are determined to outweigh the potential benefits.

Prior to the Nuremberg Code of 1947, there was no commonly accepted code of conduct on the ethical aspects of human research, although some countries, notably Germany and Russia, have adopted national policies [3a]. The declaration developed the ten principles that first appeared in the Nuremberg Code and linked them to the Geneva Declaration (1948), a statement on the ethical duties of physicians. The statement focused specifically on clinical research, which reflects changes in medical practice from the term “Human Experiences in the Nuremberg Code.” A notable change to the Nuremberg code was a relaxation of the conditions of approval, which was “absolutely necessary” under Nuremberg.

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