Food and Drug Administration Public Hearing on the Draft Guidance for Exception from Informed Consent Requirements for Emergency Research: Testimony of Novo Nordisk

2007 ◽  
Vol 14 (4) ◽  
pp. e71-e73 ◽  
Author(s):  
R. B. Weiskopf
2010 ◽  
Vol 20 (6) ◽  
pp. 1125-1131 ◽  
Author(s):  
Werner Brannath ◽  
Hans Ulrich Burger ◽  
Ekkehard Glimm ◽  
Nigel Stallard ◽  
Marc Vandemeulebroecke ◽  
...  

2000 ◽  
Vol 19 (2) ◽  
pp. 261-268
Author(s):  
Deborah R. Barnbaum

In January 2001, the Food and Drug Administration (FDA) proposed annual public disclosure of adverse events during gene therapy and xenotransplantation trials. The proposed policy raises the following questions: (1) Is the reformed policy in accord with the FDA's long-standing informed consent policies? (2) Why pair gene therapy trials and xenotransplantation trials in the revised guidelines? (3) Why single out these trials for public disclosure of adverse events? Each question is examined, and three conclusions are drawn. First, the FDA's own policies on informed consent require prompter public disclosure of adverse events. Second, the coupling of gene therapy and xenotransplantation trials entails a conceptual mistake in the types of communities that are harmed by each therapy's related adverse events. Third, all clinical trials merit such public disclosure of adverse events, not only gene therapy and xenotransplantation trials.


1999 ◽  
Vol 33 (2) ◽  
pp. 224-229 ◽  
Author(s):  
Mark Stuart Kremers ◽  
Diane Roe Whisnant ◽  
Laurie Silvus Lowder ◽  
Linda Gregg

Sign in / Sign up

Export Citation Format

Share Document