Abstract

In the twentieth century, ethical evaluation of human subject research was dependent on various guidelines, each developed in response to unethical behavior to avoid repetition of past misdeeds. This piecemeal system left gaps that continued to permit ethical flaws and failure in research. In 2001, Emanuel et al. proposed a set of requirements that now serves as the “gold standard” for ethical conduct of human subject research. These guidelines apply to all forms of investigation, including surgical interventions. Investigators must be familiar with these guidelines and the context in which they arose to prevent future ethical violations.