RT Journal Article
SR Electronic
T1 When Is Waiver of Consent Appropriate in a Neonatal Clinical Trial?
JF Pediatrics
JO Pediatrics
FD American Academy of Pediatrics
SP 1006
OP 1012
DO 10.1542/peds.2014-0207
VO 134
IS 5
A1 Schreiner, Mark S.
A1 Feltman, Dalia
A1 Wiswell, Thomas
A1 Wootton, Susan
A1 Arnold, Cody
A1 Tyson, Jon
A1 Lantos, John D.
YR 2014
UL http://pediatrics.aappublications.org/content/134/5/1006.abstract
AB It is difficult to do scientifically rigorous research on treatments that must be administered urgently or emergently. Therefore, such treatments are often provided without a strong evidence base. Research would be facilitated if it were permissible to waive the requirement for parental consent. However, that raises a different set of concerns. Federal regulations allow waiver of the requirement for consent but only if studies meet certain conditions. Institutional review boards must decide whether those conditions are met. Sometimes, reasonable people disagree. We present and analyze a protocol for which investigators request a waiver of consent.