Nursing research in the United States: The protection of human subjects

Abstract

In the United States the protection of the rights of human subjects in experimentation has evolved at three levels: professional, public, and private. At the professional level, codes, guidelines and the Patient's Bill of Rights address the issues of protecting the dignity, privacy and autonomy of individuals who serve as research subjects. At the public level, regulations promulgated by the Food and Drug Administration and the Department of Health and Human Services have become the standard for protecting human subjects. At the private level, United States common law regulates the conduct of individual researchers by requiring them to act in a manner consistent with generally accepted standards of care. As professionals, nurses must be actively involved in the formation of public policy regarding the conduct of research and strive to formulate a research agenda that will ensure that the ethics of research in nursing is above question.