The Social Filter Effect of Informed Consent in Clinical Research

Abstract

Few would disagree with the moral principle of respect for individual autonomy in the conduct of clinical research.1-3 After all, self-determination and informed choice are the cultural norms of free societies. Rather, it is the legal and regulatory provisions of the informed consent doctrine that have caused the most difficulties. Some 25 years after the promulgation of this doctrine,4,5 many problems remain with its practical implementation. The doctrine of informed consent has four essential components. 6-8First, there must be full disclosure of risks and benefits and the therapeutic alternatives. Second, the information must be provided in writing in an easily comprehensible form, but given the intermix of medical terminology and legal jargon, this is easier said than done.9