Informed Consent in Clinical Trials of in Vitro Diagnostic Devices: Perspectives from the FDA and Manufacturers: A Perspective from the Food and Drug Administration (Current Issues in Laboratory Medicine) (Clinical Report‪)‬

Editor's Note: In view of current controversies in the US about informed consent for clinical studies of in vitro diagnostic devices, Associate Editor Fred Apple invited perspectives from the FDA and from two clinical scientists who work for manufacturers. The perspectives were peer-reviewed, revised, edited, and appear here. They add clarity to a topic that affects not only clinical chemists in industry and hospitals, but also the public health and public trust. DEB. The need for informed consent from human subjects whose specimens are used in in vitro diagnostic studies is sometimes questioned. This is especially the case if the research carries only minimal risk to the subject. However, the process of obtaining informed consent recognizes the autonomy of the human subject to decide whether to participate in research regardless of whether there are risks. In this opinion, we will discuss the history of ethics in medical research and how this relates to federal regulations governing informed consent (see Table 1).