The institutional review board and protecting human subjects: 10 frequently asked questions

Abstract

It is essential that anyone involved in research involving human subjects be familiar with the purpose and role of institutional review boards. Institutional review boards are designed, first and foremost, to protect human research subjects by overseeing the implementation of federal regulations regarding protection of human subjects. The federal government requires institutional review board approval for any human subject research that receives federal funding, and many scholarly journals require proof of institutional review board approval of the research before publication. In this article, the answers to 10 frequently asked questions about the role of institutional review boards highlight the important contributions made by institutional review boards to the conduct of ethically sound research. The aim is to generate a working knowledge of the institutional review board's function that can be used by every researcher contemplating working with human research subjects. This is the first in a series of 3 articles examining common issues in research ethics.

Coming in the November/December 2008 Issue

“…2 The IRB must take measures to review research proposals to determine that ethical guidelines are followed. An IRB functions under the guidelines and regulation of the FDA.…”

“…[1][2][3] Exempt review is one that does not necessitate regular IRB review. These are (1) exempt, (2) expedited, and (3) full.…”

“…[1][2][3] In many cases, the Bproposal may be reviewed and approved without a meeting of the IRB. [1][2][3] In many cases, the Bproposal may be reviewed and approved without a meeting of the IRB.…”

“…2 However, since the formation of the Food and Drug Administration (FDA) in the early 1960s, many efforts have been made to protect the rights of humans in clinical trials. The war crimes of World War II come to mind first, but the United States is not without blame concerning unethical research.…”