BACKGROUND: Obtaining viable informed consent from stroke patients for participation in clinical trials of acute stroke therapies is often problematic because of patients' neurological deficits. Furthermore, obtaining permission from surrogates is often not possible or not legally permissible. SUMMARY OF REVIEW: In 1996 the Food and Drug Administration and Department of Health and Human Services published regulations that allow investigators to conduct emergency research without patient consent under a narrowly defined set of circumstances. We review requirements of these regulations, paying particular attention to how they may be applied in a clinical trial of an acute stroke therapy. CONCLUSIONS: Acute stroke researchers should consider conducting clinical trials with an exception from the informed consent requirement permitted by this law.
BACKGROUND: Obtaining viable informed consent from strokepatients for participation in clinical trials of acute stroke therapies is often problematic because of patients' neurological deficits. Furthermore, obtaining permission from surrogates is often not possible or not legally permissible. SUMMARY OF REVIEW: In 1996 the Food and Drug Administration and Department of Health and Human Services published regulations that allow investigators to conduct emergency research without patient consent under a narrowly defined set of circumstances. We review requirements of these regulations, paying particular attention to how they may be applied in a clinical trial of an acute stroke therapy. CONCLUSIONS: Acute stroke researchers should consider conducting clinical trials with an exception from the informed consent requirement permitted by this law.
Authors: Dawn Kleindorfer; Christopher J Lindsell; Kathleen Alwell; Daniel Woo; Matthew L Flaherty; Jane Eilerman; Pooja Khatri; Opeolu Adeoye; Simona Ferioli; Brett M Kissela Journal: Cerebrovasc Dis Date: 2011-09-15 Impact factor: 2.762
Authors: Kimberly L Feng; Cheryl Person; Jacqueline Phillips-Sabol; Bethany Williams; Chunyan Cai; Amber N Jacobs; Hari Indupuru; Linda Aramburo-Maldonado; Loren Shen; James C Grotta; Andrew D Barreto Journal: Stroke Date: 2014-09-30 Impact factor: 7.914
Authors: Enrique C Leira; Azeemuddin Ahmed; Diane L Lamb; Heena M Olalde; R Charles Callison; James C Torner; Harold P Adams Journal: Stroke Date: 2009-01-08 Impact factor: 7.914
Authors: Chelsea S Kidwell; Reza Jahan; Jeffrey Gornbein; Jeffry R Alger; Val Nenov; Zahra Ajani; Lei Feng; Brett C Meyer; Scott Olson; Lee H Schwamm; Albert J Yoo; Randolph S Marshall; Philip M Meyers; Dileep R Yavagal; Max Wintermark; Judy Guzy; Sidney Starkman; Jeffrey L Saver Journal: N Engl J Med Date: 2013-02-08 Impact factor: 91.245
Authors: Götz Thomalla; Florent Boutitie; Jochen B Fiebach; Claus Z Simonsen; Norbert Nighoghossian; Salvador Pedraza; Robin Lemmens; Pascal Roy; Keith W Muir; Christoph Heesen; Martin Ebinger; Ian Ford; Bastian Cheng; Tae-Hee Cho; Josep Puig; Vincent Thijs; Matthias Endres; Jens Fiehler; Christian Gerloff Journal: Neurology Date: 2017-08-25 Impact factor: 9.910
Authors: Jan Lecouturier; Helen Rodgers; Gary A Ford; Tim Rapley; Lynne Stobbart; Stephen J Louw; Madeleine J Murtagh Journal: BMC Med Ethics Date: 2008-04-29 Impact factor: 2.652