Faculty Bibliography

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.

In the last half century, informed consent has become a central tenet of all research involving human subjects. However, even after the worldwide adoption of regulations aimed at ensuring the protection of subjects, some abuses continue. The installation of oversight bodies, such as institutional review boards, has prevented the bulk of deliberate mistreatment; however, unintentional coercion is still a problem. Informed consent is not limited to obtaining a signature on a consent form, but a process of decision making designed to protect the rights of patients and subjects. It is a constant, ongoing exchange of information between researcher and subject. Although research is invaluable to the advancement of medicine and transplantation, researchers have the responsibility to protect their subjects' rights and autonomy. This paper provides an overview of informed consent, principles behind the process, and implications of current regulations to assist readers in their endeavor for sound and ethical research.