How the Belmont Report clarified informed consent

Sandra Maddock, President & CEO, IMARC Research Imagine being enrolled in a clinical trial without fully understanding the scope or the risks. The Belmont Report marks an important milestone in the history of clinical research. It established guidelines for basic ethical principles, as well as informed consent, the assessment of risks and benefits and subject selection. In this post, we’ll discuss the key principles of the report, and in particular, how it clarified our understanding of informed consent. What is the Belmont Report? The Belmont Report was written in response to the infamous Tuskegee Syphilis Study, in which African Americans with syphilis were lied to and denied treatment for more than 40 years. Many people died as a result, infected others with the disease, and passed congenital syphilis onto their children. Following the Tuskegee study, Congress passed the National Research Act, creating the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. This commission met regularly for nearly four years, culminating in a four-day discussion at the Smithsonian Institution’s Belmont Conference Center in February 1976. The resulting Belmont Report summarized the three ethical principles the commission concluded should guide human research: Respect for persons: All individuals should be treated as autonomous agents, and persons with diminished autonomy are entitled to protection Beneficence: Researchers should m...
Source: Mass Device - Category: Medical Devices Authors: Tags: Blog IMARC Source Type: news