Assessment of parental decision-making in neonatal cardiac research: a pilot study.
OBJECTIVE
To assess parental permission for a neonate's research participation using the MacArthur competence assessment tool for clinical research (MacCAT-CR), specifically testing the components of understanding, appreciation, reasoning and choice.


METHODS
Quantitative interviews using study-specific MacCAT-CR tools.


OBJECTIVE
Parents of critically ill newborns would produce comparable MacCAT-CR scores to healthy adult controls despite the emotional stress of an infant with critical heart disease or the urgency of surgery. Parents of infants diagnosed prenatally would have higher MacCAT-CR scores than parents of infants diagnosed postnatally. There would be no difference in MacCAT-CR scores between parents with respect to gender or whether they did or did not permit research participation.


METHODS
Parents of neonates undergoing cardiac surgery who had made decisions about research participation before their neonate's surgery.


METHODS
The MacCAT-CR.


RESULTS
35 parents (18 mothers; 17 fathers) of 24 neonates completed 55 interviews for one or more of three studies. Total scores: magnetic resonance imaging (mean 36.6, SD 7.71), genetics (mean 38.8, SD 3.44), heart rate variability (mean 37.7, SD 3.30). Parents generally scored higher than published subject populations and were comparable to published control populations with some exceptions.


CONCLUSIONS
The MacCAT-CR can be used to assess parental permission for neonatal research participation. Despite the stress of a critically ill neonate requiring surgery, parents were able to understand study-specific information and make informed decisions to permit their neonate's participation.
Department of Anesthesiology and Critical Care Medicine, University of Pennsylvania, Pennsylvania, USA. nathan@email.chop.edu
Aruna T
AT
Nathan
K Sarah
KS
Hoehn
Richard F
RF
Ittenbach
J William
JW
Gaynor
Susan
S
Nicolson
Gil
G
Wernovsky
Robert M
RM
Nelson
D000328:Adult; D035843:Biomedical Research / Q000941:ethics*; D003657:Decision Making / Q000941:ethics*; D005260:Female; D006330:Heart Defects, Congenital / Q000523:psychology*; D006801:Humans; D007231:Infant, Newborn; D008297:Male; D033282:Parental Consent / Q000941:ethics* / Q000523:psychology; D010290:Parents / Q000523:psychology*; D010358:Patient Participation; D010865:Pilot Projects