Informed consent in research and practice involving human subjects: History, theory and problems concerning contemporary practice

Abstract

Obtaining informed consent is both a legal and moral requirement in scientific and clinical practice involving human subjects. However, the answer to the question of what it means for informed consent to be valid is not self-evident. First, we will consider the historical roots of informed consent and its philosophical assumptions as well as the implications of these assumptions for a theory of informed consent. Second, we will review a theory of informed consent using a principle-based approach. And third, we will discuss the status of informed consent using a principle-based approach in contemporary literature, along with the limitations and problems in translating theory into practice. It is stressed that subjective interpretation of relevant contextual factors necessarily remains an element in the process of obtaining valid informed consent.