(This post also appears on the Penn Wharton Public Policy Initiative)
In December 2011, the Presidential Commission for the Study of Bioethical Issues (the Bioethics Commission) released its report Moral Science: Protecting Participants in Human Subjects Research. In it, the Commission responded to a charge from the President to determine if federal regulations and international standards adequately guard the health and well-being of participants in scientific studies supported by the federal government. Although the Bioethics Commission noted the substantial protections for the health, rights, and welfare of research participants under the existing U.S. system, it also found room for improvement in several areas.
One such area identified by the Bioethics Commission was the treatment and compensation of participants who sustain research-related injuries. Over the last several decades, almost every developed country has instituted policies requiring researchers or sponsors to provide treatment and compensation for research subjects’ injuries. Despite recommendations from the Presidential Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research in 1982, the National Bioethics Advisory Commission (NBAC) in 2001, and the Institute of Medicine (IOM) in 2002 that the federal government either explore the issue further or implement a system of its own, U.S. action has been minimal.
In Moral Science, the Bioethics Commission argued that the absence of such a system was ethically unjustified. Rooted in longstanding ethical principles the Bioethics Commission wrote that “treatment or compensation… is appropriate as an act of benevolent regard for an individual’s willingness to participate in an enterprise of important benefit to the public.”
The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.