ABSTRACT

Violations against human and animal research subjects can result in loss or maiming of life rather than harm an institution such as science. A pharmaceutical company is recruiting healthy volunteers to test a new drug on during phase I trials. During animal testing, two side effects were observed in a small number of animals that were deemed serious: Sleeplessness and diarrhea. The pharmaceutical company sponsoring a drug through the approval process is always the entity that actually carries out and pays for the study. Prisoners represent one of the protected classes of research subjects as it relates to human subjects in research. In some instances, and with the appropriate approvals and oversight, it is appropriate and even necessary to withhold some pieces of information from research subjects. A drug candidate showed unprecedented efficacy in resolving infection with a disease in vitro.