Regulatory Considerations in Human Subjects Research

Abstract

Biomedical research can be broadly defined as the systemic collection and analysis of data for the purposes of generating new knowledge that will relieve suffering and cure disease. Today, we understand that human subjects research must be conducted in compliance with federal statutes that are in place to ensure that all research activity is conducted ethically and follows the principles articulated in historical treatises such as the Nuremberg Code, the Helsinki Declaration, and the Belmont Report. For research involving drugs or devices, investigators also must comply with all US Food and Drug Administration (FDA) regulations relating to such research. This chapter will review the historical context under which these regulations were developed, provide an overview of the current regulatory requirements that must be met to perform human subjects research, and offer some practical considerations for new academic investigators.