The ethical justification for inclusion of neonates in pragmatic randomized clinical trials for emergency newborn care

Table 1 Individual characteristics of vulnerability to consider by population

Population	^aSituational	^bIncapacitational	^cJuridic	^dDeferential	^eSocial	^fMedical	^gAllocational
Children	X	X	X	X	X	X	X
Disadvantaged persons	X			X	X		X
Human fetuses	X
Neonates	X	X
Persons with mental/physical disability	X	X	X	X	X	X	X
Pregnant women	X			X
Prisoners	X		X	X	X		X
Ethnic or racial minorities	X			X	X
Critically ill patients	X	X		X	X	X

^a“In a situation in which medical exigency prevents the education and deliberation needed to decide whether to participate in the study.” For instance, newborns with neonatal emergency conditions
^bLacks “the capacity to deliberate about and decide whether to participate in the study.” For instance, parents of newborns may not have enough time for deliberations on whether to participate
^c“Liable to the authority of others who may have an independent interest in that participation”
Often, conflicts of interest in the investigators may influence participation
^d“Given to patterns of deferential behavior that may mask an underlying unwillingness to participate”
^eBelongs “to a group whose rights and interests have been socially disvalued”
^fHas “been selected, in part, because of the presence of a serious health-related condition for which there are no satisfactory remedies.” This is situation common in severe neonatal emergencies where viability is doubtful (need to rescue)
^g“Lacking in subjectively important social goods that will be provided as a consequence of participation in [the] research”
Adapted from Reference [22]

ISSN: 1471-2431