When Human Experimentation is Criminal
- THE JOURNAL OF CRIMINAL LAW & CRIMINOLOGY Vol. 99, No. I
- Federal Register :: Medical Devices; Exception From General Requirements for Informed Consent
- Human Subject Research: International and Regional Human Rights Standards – Health and Human Rights Journal (hhrjournal.org)
- IDE Approval Process | FDA
- Investigational Medical Devices (hopkinsmedicine.org)
- Investigational Medical Devices | Research (virginia.edu)
- Nuremberg Code – Wikipedia
- Nuremberg Code — United States Holocaust Memorial Museum (ushmm.org)
- Significant Risk and Nonsignificant Risk Medical Device Studies
L. SONG RICHARDSON*
Medical researchers engaged in human experimentation commit criminal acts seemingly without consequence. Whereas other actors who violate bodily integrity and autonomy are routinely penalized with convictions for assault, fraud, and homicide, researchers escape criminal punishment.
This Article begins to scrutinize this under criminalization phenomenon and provides a framework for understanding why researchers are not prosecuted for their crimes.
It argues that their exalted social status, combined with the perceived social benefit of their research, immunizes them from use of the criminal sanction. Whether these constitute
sufficient grounds to give researchers a pass from punishment is a significant question because the state’s failure to act creates expressive harms.
It displays attitudes towards victims and perpetrators that negatively affect the values of autonomy and dignity in medical research.
Moreover, alternative sanctions not only lack the same expressive impact, but may also inadequately police criminal harm. This Article concludes that this implicit immunity is harmful to society and inconsistent with criminal law policy.