The following analysis of ethical issues in the testing of new drugs is located in a broader discussion of ethical issues in medical experimentation with human subjects generally. Major ethical principles which have emerged from the recent debate concerning biomedical and behavioral research are examined, special attention being given to the meaning and theological/philosophical basis of the consent requirement. Two models of medical ethics are examined, one beginning with the primacy of the “benefits to society” and the other with the primacy of the subject as person. The development and testing of a vaccine for the prevention of viral hepatitis type B is considered as a test case in the development and testing of a new drug.
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