The impact of escalating regulatory requirements on the conduct of clinical research.
A discussion of the impact of escalating regulatory requirements is provided, from the point of view of the administration of the institutional review board of an academic institution, and from clinical investigators who conduct studies at that same institution. Current and anticipated future issues are discussed.
Gordon
B G
BG
Department of Pediatrics, University of Nebraska Medical Center, Omaha, NE 68198-7680, USA.
Kessinger
A
A
Mann
S L
SL
Prentice
E D
ED
D016907:Adverse Drug Reaction Reporting Systems / Q000458:organization & administration / Q000592:standards; D035843:Biomedical Research / Q000941:ethics / Q000331:legislation & jurisprudence / Q000592:standards*; D026661:Clinical Trials Data Monitoring Committees / Q000458:organization & administration / Q000592:standards; D002986:Clinical Trials as Topic / Q000941:ethics / Q000331:legislation & jurisprudence / Q000592:standards; D016265:Conflict of Interest / Q000191:economics / Q000331:legislation & jurisprudence; D033161:Government Regulation; D017408:Guidelines as Topic / Q000592:standards; D006805:Human Experimentation / Q000941:ethics / Q000331:legislation & jurisprudence / Q000592:standards; D006801:Humans; D007258:Informed Consent / Q000941:ethics / Q000331:legislation & jurisprudence / Q000592:standards; D014481:United States; D014483:United States Dept. of Health and Human Services; D014486:United States Food and Drug Administration