<< Previous Section | < Previous Page | Next Page > | Next Section >> Case: Phase 1 trials In the absence of human trials it's impossible to know about the safety of drugs in humans that were found to be safe in other animals. Phase I clinical trials involve the dosing of new drugs to tolerance in control subjects and doing pharmacokinetics to determine blood levels, binding, and disposal rates of the drug. Years ago, a large drug company advertised for volunteers for Phase I clinical trials of new agents. They noticed as the weather turned cold, middle-aged persons who were dirty and poorly dressed volunteered, and that the number of volunteers increased yearly. The volunteers were housed in a metabolic unit for 6 months and were given a number of agents in sequence during the winter. Each trial was approved by an "in house" IRB. When it became known that many of the volunteers were homeless alcoholics, screening tests were done to ensure that chemistries were normal or near normal. Each volunteer signed a consent indicating that their compensation would be provided to them at the end of the period of being a control and that they would refrain from alcohol for the duration of their stay. The company believed sincerely that it was helping these individuals. The process was revealed in the media after some years. Questions: Was anything untoward happening here? If you believe so, then what was the range of ethical lapses in drug research? << Previous Section | < Previous Page | Next Page > | Next Section >> Chapter 2 Quick Links Research in Humans History of Rules About Research in Humans Definitions Federal Mandate Respect for Persons Beneficence Justice Common Rule IRB Mission Cases Bibliography Chapter 2 Download (PDF)