MORAL SCIENCE Protecting Participants in Human Subjects Research

Human research serves to ensure the safety of new medicines, establish tolerable exposure levels for environmental and workplace hazards, and determine the effectiveness of new interventions in public health, education, and countless other fields. Without volunteers, these studies would be impossible to conduct. Recognizing society’s responsibility to protect human subjects of research from avoidable harm and unethical treatment, President Barack Obama asked the Presidential Commission for the Study of Bioethical Issues (the Commission) to conduct a thorough review of current regulations and international standards to assess whether they adequately protect human subjects in federally supported scientific studies, no matter where they occur. The Commission’s review confirmed that the federal government supports a diverse and wide-ranging portfolio of research, which includes activities funded directly, or by award or sub-award, throughout the world. Support for medical and public health research predominates, but the federal government also supports a large volume of human subjects research in other fields, including social and behavioral sciences and education.