Human Subjects.

Human subjects in medical research
by Arthur L. Caplan, Glenn McGee

In 1966 Henry Beecher, a prominent physician at the Harvard Medical School, published an important paper reporting a variety of abuses of human subjects in medical research at major universities and medical centers in the United States. The ethical violations he cited included the use of subjects without their consent and the participation in medical research of subjects who have not been offered the option of standard treatment. Beecher’s article triggered discussions and debate inside and outside of medicine about the importance and practicality of obtaining consent from research subjects or surrogates if the subjects could not provide consent for themselves.

Concerns about research ethics were further heightened by a research project called the Tuskegee Study, sponsored by the United States Public Health Service to assess the clinical course of syphilis. Public health researchers conducting the study, which began in 1932 and was ended at the direction of the Congress of the United States in 1972, withheld both diagnostic information and effective treatment from black men enrolled in the study in order to retain their ongoing participation. The abuses of the Tuskegee Study prompted the formulation of a national commission to examine ethical issues in research, and eventually led Congress to enact regulations requiring informed consent from participants and the review of all federally funded health research by appointed review boards. In 1997 United States President Bill Clinton issued a formal apology to the survivors of the Tuskegee Study and their families.