Ethical and regulatory oversight of clinical research: The role of the Institutional Review Board.

Abstract

The history of clinical research is, unfortunately, filled with examples of research studies that took advantage of and harmed research participants, to fulfill the research goals of scientists. Over time, we have created a system of ethical codes, principles, and regulations that are designed to prevent these abuses and to ensure that the rights and welfare of research participants are protected and honored. This review article will provide a brief history of clinical research ethics and ethical codes, outlining how those codes developed into the current regulatory requirements for the ethical oversight of clinical research. Understanding the current human subject protection systems will allow researchers to use best practices for planning and conducting rigorous, scientifically valid and ethical clinical studies. Understanding the history, principles, and foundations of the development of this system will equip researchers to understand what resources are available to them and how to make the best decisions when confronted with unique ethical situations in the conduct of their research.