Fast track to disaster? Considerations raised by the current recruitment techniques for clinical research subjects.
Efforts to obtain Food and Drug Administration (FDA) approval of new drugs on a "fast track" are not without hazards for physicians and other providers involved in conducting clinical research. Increasingly, research sponsors have implemented competitive subject recruitment techniques that encourage investigators and their staffs to move studies along rapidly, but may also raise concerns about subject safety. The purpose of this article is to examine competitive recruitment practices and to examine the ethical and legal issues related to obtaining information consent for clinical research within this current framework.
Isidor
John M
JM
Schulman Associates Institutional Review Board, Inc.
Kaltman
Sandra P
SP
D002986:Clinical Trials as Topic / Q000941:ethics; D003068:Coercion; D003163:Competitive Behavior; D004345:Drug Industry; D006805:Human Experimentation / Q000941:ethics; D006801:Humans; D007258:Informed Consent / Q000941:ethics; D016365:Liability, Legal; D012108:Research Personnel / Q000331:legislation & jurisprudence; D035842:Research Subjects / Q000600:supply & distribution*; D012109:Research Support as Topic / Q000191:economics; D014481:United States