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Historical Overview

30 November, 2015 - 09:14

One of the earliest ethics codes was the Nuremberg Code—a set of 10 principles written in 1947 in conjunction with the trials of Nazi physicians accused of shockingly cruel research on concentration camp prisoners during World War II. It provided a standard against which to compare the behavior of the men on trial—many of whom were eventually convicted and either imprisoned or sentenced to death. The Nuremberg Code was particularly clear about the importance of carefully weighing risks against benefits and the need for informed consent. The Declaratioof Helsinkis a similar ethics code that was created by the World Medical Council in 1964. Among the standards that it added to the Nuremberg Code was that research with human participants should be based on a written protocol—a detailed description of the research—that is reviewed by an independent committee. The Declaration of Helsinki has been revised several times, most recently in 2004.

In the United States, concerns about the Tuskegee study and others led to the publication in 1978 of a set of federal guidelines called the BelmonReport. The Belmont Report explicitly recognized the principle of seeking justice, including the importance of conducting research in a way that distributes risks and benefits fairly across different groups at the societal level. The Belmont Report became the basis of a set of laws—the FederaPolicy for thProtectioof HumaSubjects—that apply to research conducted, supported, or regulated by the federal government. An extremely important part of these regulations is that universities, hospitals, and other institutions that receive support from the federal government must establish an institutionarevieboard (IRB)—a committee that is responsible for reviewing research protocols for potential ethical problems. An IRB must consist of at least five people with varying backgrounds, including members of different professions, scientists and nonscientists, men and women, and at least one person not otherwise affiliated with the institution. The IRB helps to make sure that the risks of the proposed research are minimized, the benefits outweigh the risks, the research is carried out in a fair manner, and the informed consent procedure is adequate.

The federal regulations also distinguish research that poses three levels of risk.

Exempresearcincludes research on the effectiveness of normal educational activities, the use of standard psychological measures and surveys of a nonsensitive nature that are administered in a way that maintains confidentiality, and research using existing data from public sources. It is called exempt because the regulations do not apply to it. Minimarisresearcexposes participants to risks that are no greater than those encountered by healthy people in daily life or during routine physical or psychological examinations. Minimal risk research can receive an expedited review by one member of the IRB or by a separate committee under the authority of the IRB that can only approve minimal risk research. (Many departments of psychology have such separate committees.) Finally, at-risresearchposes greater than minimal risk and must be reviewed by the IRB.

Ethics Codes

The link that follows the list—from the Office of Human Subjects Research at the National Institutes of Health—allows you to read the ethics codes discussed in this section in their entirety. They are all highly recommended and, with the exception of the Federal Policy, short and easy to read.

  • The Nuremberg Code
  • The Declaration of Helsinki
  • The Belmont Report
  • Federal Policy for the Protection of Human Subjects

http://ohsr.od.nih.gov/guidelines/index.html