2005N-0184 Precursor Preference in Surfactant Synthesis of Newborns
FDA Comment Number : EC1
Submitter : Mrs. Alma Britton Date & Time: 06/17/2005 10:06:20
Organization : NIH/NIEHS
Category : Federal Government
Issue Areas/Comments
GENERAL
GENERAL
I fully agree with the Committee (Request for Review by 45 CFR 46.407 Panel-dated 2/7/05). I would also like to say that not only are these very vulnerable subjects but the parents/families are also considered vulnerable as well (seeing your infant in this condition would not allow you to make a judgement call on this proposed research). In this case, possibly a patient advocate should be present, as well as responsible, for assuring that the prospective trial enrolles understand the greater risks and possible benefits to the study and must tell the subject or in this case the parents/families whether it is in their best interest to enroll as well as to inform the families on whatever issues arise druing the course of the entire study. I do not feel this should be approved specifically for the risk of a bloodstream infection from the 24 hour isotope infusion and the extra blood draws.