Ethical Principles

Background and Historical Perspective

The need for adequate protection of the individual participant and the adoption of stricter ethical principles in practice has been shaped by several historical events. One of the worst cases of ethical misconduct [Page 244]by researchers in the United States was the Tuskegee Syphilis Study (1932–1972) conducted by the U.S. Public Health Service with 399 black men in Macon County, Alabama, to study the natural history of syphilis. Following incidents of research malpractice such as the Tuskegee Study and the increased concerns of the public, the Nuremberg Code, the Belmont Report, and the Declaration of Helsinki were adopted. The Nuremberg Code declares the need for voluntary consent by human subjects, disclosure of study procedures, and protection for vulnerable populations. The Belmont Report, released in 1979 by the U.S. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, emphasizes three basic ethical principles to guide practice: (1) respect for persons, (2) beneficence, and (3) justice. The principle of respect for persons emphasizes that researchers acknowledge autonomy (an individual's ability to independently make decisions) and the protection of those with diminished or restricted autonomy (individuals who are not capable of self-determination) to enter into research participation informed and voluntarily. Beneficence exemplifies the ethical treatment of persons by securing their protection from harm or risk involved with participation and the disclosure of benefits associated with study involvement. The third principle, justice, encourages equal treatment and provision of advantages and access associated with research to all persons. The Declaration of Helsinki, adopted in 1964, was designed to guide physicians in biomedical research involving human subjects to safeguard the health of people.

Respondent/Participant