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Table 1 Individual characteristics of vulnerability to consider by population

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

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  
  1. 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
  2. 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
  3. c“Liable to the authority of others who may have an independent interest in that participation”
  4. Often, conflicts of interest in the investigators may influence participation
  5. d“Given to patterns of deferential behavior that may mask an underlying unwillingness to participate”
  6. eBelongs “to a group whose rights and interests have been socially disvalued”
  7. 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)
  8. g“Lacking in subjectively important social goods that will be provided as a consequence of participation in [the] research”
  9. Adapted from Reference [22]
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