Research with human subjects has a long and often troubled history in the United States (U.S.) and throughout the world. Chances are you already have heard of some of the most egregious and well-known examples of unethical research in the biomedical sciences, such as the experiments conducted by Nazi doctors and scientists on concentration camp prisoners during World War II, and the U.S. Public Health Service (PHS) study titled "Tuskegee Study of Untreated Syphilis in the Negro Male" (Tuskegee Study). These abuses led to the creation of codes of research ethics in Europe and the U.S. In the wake of the Second World War, the subsequent Nuremberg Trials on war crimes produced the Nuremberg Code, which outlined ten points for conducting ethical research with human subjects. Nearly two decades later, the World Medical Association (WMA) developed a code of research ethics known as the Declaration of Helsinki, published in 1964 and subsequently revised. This document is built on both the Nuremberg Code and the physician's code of ethics known as the Declaration of Geneva.
In the U.S., news that researchers deceived and withheld treatment from subjects who suffered from syphilis in the Tuskegee Study led to the creation of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (National Commission or "the Commission"). The Commission was charged with establishing a code of research ethics for U.S. research involving human subjects. In 1979, the Commission issued the Belmont Report, the foundational document of the current system of U.S. human subjects protections. The Belmont Report outlines three key ethical principles for conducting research with human subjects: respect for persons, beneficence, and justice. The Belmont Report, in turn, informed the U.S. Department of Health and Human Services (HHS) Code of Federal Regulations