Risk in Drug Trials
Barnes, Michael R.
Feild, John A.
Searls, David B.
Lancet 2006 December 23-2007 January 5; 368(9554): 2205-2206
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Califf, Robert M.; Morse, Michael A.; Wittes, Janet; Goodman, Steven N.; Nelson, Daniel K.; DeMets, David L.; Iafrate, R. Peter; Sugarman, Jeremy (2003-06)
Emanuel, Ezekiel J.; Wood, Anne; Fleischman, Alan; Bowen, Angela; Getz, Kenneth A.; Grady, Christine; Levine, Carol; Hammerschmidt, Dale E.; Faden, Ruth; Eckenwiler, Lisa; Muse, Carianne Tucker; Sugarman, Jeremy (2004-08-17)The oversight of research involving human participants is widely believed to be inadequate. The U.S. Congress, national commissions, the Department of Health and Human Services, the Institute of Medicine, numerous professional ...
Levine, Carol; Faden, Ruth; Grady, Christine; Hammerschmidt, Dale; Eckenwiler, Lisa; Sugarman, Jeremy (Consortium to Examine Clinical Research Ethics, 2004-02-03)Research participants require ongoing protection of the kind already established in law and regulation. However, "special scrutiny" for certain types of research is also needed. Three criteria for special scrutiny are 1) ...