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15 JRE 339 (2007)
Can There Be Exceptions to Fully Informed Consent in Randomized Clinical Trials? The Case of the Randomized Consent (Zelen) Design

handle is hein.journals/jaret15 and id is 351 raw text is: Can there be exceptions to fully informed consent in randomized clinical trials? The case of the randomized consent (Zelen) design Roberto Andorno, Margrit Fdssler, and Nikola Biller-Andomo I. Introduction Since the Nuremberg Code established the ground rules for ethical research more than 50 years ago, researchers have been required to get informed consent from study participants. This requirement, which is currently included in virtually all legal regulations and ethical guidelines on human research, is fundamental for ensuring that subjects are fully respected as persons, that is, as autonomous beings capable of making their own decisions regarding participation in the re- search study. This means they should understand the nature, risks, benefits and alternatives of the research, and be able to make knowledgeable and free decision whether or not to participate in the proposed research. Certainly, informed consent is not enough to legitimate any kind of research on human subjects. This is only the subjective condition for research (respect for autonomy), which should be complemented by an objective requirement (respect for the subject's well-being). This latter element refers to the safety of research participants, and is grounded in the idea that considerations related to the well- being of the human subject should take precedence over the interests of science and society (Declaration of Helsinki, Paragraph 5). This paper will focus on the first condition, the requirement of informed con- sent, and more specifically, on the possibility of allowing some exceptions to a fully informed consent in randomized clinical trials. II. The ethical issue 1. Randomized clinical trials The emphasis on clinical trials to validate a new drug or medical treatment be- fore they are widely used in the clinical setting is one of the most important char- acteristics of research in the past few decades.' The principle of clinical trials is

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