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Informed Consent in Clinical Trials of in Vitro Diagnostic Devices: Perspectives from the FDA and Manufacturers

¹ Division of Clinical Laboratory Devices, Office of Device Evaluation,
² Division of Bioresearch Monitoring, Office of Compliance, and
³ Program Operations Staff, Office of Device Evaluation, Center for Devices and Radiological Health, US Food and Drug Administration, Rockville, MD 20850.

^aAddress correspondence to this author at: 2098 Gaither Rd., HFZ-440, Rockville, MD 20850. Fax 301-594-5940; e-mail mmm@cdrh.fda.gov.

A Perspective from the Food and Drug Administration

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 ).

Human participants in biomedical research contribute tremendously to our overall societal good. Unfortunately, the history of medical research is checkered with several unethical studies. For example, past atrocities, such as those described at the Doctor’s Trial at Nuremberg, Germany (1) and in the syphilis study at Tuskegee, Alabama (2), showed no respect for the autonomy of human research participants. These and other unethical studies have influenced the rules governing modern biomedical research.

The basic principles underlying the current US federal regulations for human biomedical research can be traced to three landmark documents. The first document was the Nuremberg Code (3), formulated for the Doctor’s Trial at Nuremberg in 1947 and later adopted by the American Medical Association. The first of the 10 principles of the Nuremberg Code is "The voluntary consent of the human subject is absolutely essential". Although the entire Nuremberg Code has not been formally adopted as law by any nation, its basic requirement for informed consent is a universal standard expressed in both international law (4) and international ethical guidelines for conducting human biomedical research (5). This document is often cited as the most important in the history of the ethics . . . [Full Text of this Article]

References

Robert T. McCormack^4b and Paula C. Southwick⁵

⁴ Department of Clinical Affairs, Ortho-Clinical Diagnostics, Inc., Raritan, NJ 08869.

⁵ Department of Clinical Research, Beckman Coulter, Inc., Fullerton, CA 92834.

^bAddress correspondence to this author at: Ortho-Clinical Diagnostics, 1001 US Hwy 202, Raritan, NJ 08869. Fax 908-218-8822; e-mail RMcCorma@OCDUS.JNJ.com.

References