Ethical Guidelines in Human Subject Research

• The Advisory Committee was charged with the reconstruction of federal government's rules and policies on human experiments from 1944 through 1974.
• The history of research rules at the Department of Health, Education, and Welfare (DHEW) was well known, at least from 1953 on, when DHEW's National Institutes of Health (NIH) adopted a policy on human subjects research.
• In the 1960s, the DHEW and some other executive branch agencies undertook regulation of research involving human subjects.
• These were early steps of a process that culminated, in 1991, in the comprehensive federal policy known as the "Common Rule."
• The historical background of this process, including a well-publicized series of incidents and scandals that motivated it, was also widely known and much discussed.
• But while scholars have known of the 1953 secretary of defense memorandum, which was declassified in 1975, other relevant Department of Defense documents remained classified or had lain buried in archives.
• Along with the DOD, also created in 1947, the AEC was searching for biomedical information needed to understand the effects of radiation as it prepared for the possibility of atomic warfare.
• In the first years of the Cold War, officials and experts in the AEC and DOD did discuss the requirements for human experiments.
• In 1947, the U.S. government issued a set of guidelines for the use of human subjects in scientific research.
• These guidelines, known as the 1947 Statement on the Use of Human Subjects in Research, were designed to protect human subjects from harm and to ensure that their rights were respected.
• The guidelines were later updated in 1953 to reflect the principles of the Nuremberg Code.
• This memorandum was the first known instance in which a federal agency that sponsored human experiments adopted the Nuremberg Code.
• The memorandum was interpreted and implemented by the military establishment, and it led to a stricter regulation of human subject research.

Explore the historical background and key events leading to the development of federal policies and guidelines for human subject research from 1944 through 1974. Learn about the significant milestones, regulations, and the impact of incidents and scandals that influenced the establishment of ethical standards in research involving human subjects.