Scientific Value and Validity as Ethical Requirements for Research: A Proposed Explication

Abstract

It may be accepted as a maxim that a poorly or improperly designed study involving human subjects one that could not possibly yield scientific facts (that is, reproducible observations) relevant to the question under study-is by definition unethical. Moreover, when a study is in itself scientifically invalid, all other ethical considerations become irrelevant. There is no point in obtaining informed consent to perform a useless study. A worthless study cannot possibly benefit anyone, least of all the experimental subject himself. Any risk to the patient, however small, cannot be justified. In essence, the scientific validity of a study on human beings is in itself an ethical principle.