Tutorial Chapter 2: What are the basic elements of the research code of ethics?

In reaction to experiments conducted by the Nazis during World War II, the Nuremberg Code was issued by the Nazi War Crimes Tribunal in 1947. This was the first internationally recognized code of research ethics. It stressed the importance of "voluntariness" of the subject and prevention of unnecessary physical or mental suffering.

In 1964, the 18th World Medical Assembly developed the Declaration of Helsinki which laid out the basic principles for biomedical research. A clear distinction was drawn between medical research combined with clinical care and nontherapeutic research involving human subjects.

In 1979, the United States Department of Health, Education, and Welfare issued the Belmont Report, which remains the standard set of ethical principles for US researchers today.

The Belmont Report sets forth three basic ethical principles:

• Respect for persons: This principle incorporates the dual notion that individuals should be treated as autonomous agents and that persons with diminished autonomy are entitled to protection.
• Beneficence: This term is used to convey the obligation that researchers should "do good." Subjects must be protected from harm, but researchers are also obliged to maximize possible benefits.
• Justice: Who ought to receive the benefits of research and bear its burdens? The selection process of research subjects needs to ensure that criteria are not based on gender, race, easy availability, manipulability, or compromised position. The notion of justice also requires that studies providing advantages should be offered not only to the wealthy or better educated, but also to the poor and less advantaged.

Chapter Review

Next Chapter: What are the current regulations concerning human subjects research?