Assessment of parental decision-making in neonatal cardiac research: a pilot study
- Aruna T Nathan1,
- K Sarah Hoehn2,
- Richard F Ittenbach3,
- J William Gaynor4,5,
- Susan Nicolson1,4,
- Gil Wernovsky4,6,
- Robert M Nelson7
- 1Department of Anesthesiology and Critical Care Medicine, University of Pennsylvania, Pennsylvania, USA
- 2Department of Pediatrics, St Christopher's Hospital for Children, Philadelphia, Pennsylvania, USA
- 3Department of Pediatrics, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, USA
- 4The Cardiac Center, The Children's Hospital of Philadelphia, Pennsylvania, USA
- 5Department of Surgery, The Children's Hospital of Philadelphia and University of Pennsylvania School of Medicine, Pennsylvania, USA
- 6Department of Pediatrics, The Children's Hospital of Philadelphia and University of Pennsylvania School of Medicine, Pennsylvania, USA
- 7Office of Pediatric Therapeutics, Office of the Commissioner, Food and Drug Administration
- Correspondence to Dr Aruna T Nathan, Department of Anesthesiology and Critical Care Medicine, The Children's Hospital of Philadelphia, 12 NW 40, 3400 Civic Center Blvd, Philadelphia, PA, USA;
- Received 16 April 2009
- Revised 13 November 2009
- Accepted 16 November 2009
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.
Study Design Quantitative interviews using study-specific MacCAT-CR tools.
Hypothesis 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.
Participants 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.
- informed consent
- MacArthur competence assessment tool for clinical research
- newborns and minors
- research ethics
- research on special populations
Funding Supported in part by a grant from the Florence RC Murray Program of the Joseph Stokes, Jr Research Institute of The Children's Hospital of Philadelphia.
Competing interests None.
Disclaimer The work reported in this article was performed prior to RMN joining the Food and Drug Administration. The opinions expressed herein do not represent the views of the Food and Drug Administration nor the Department of Health and Human Services.
Ethics approval This study was approved by the Children's Hospital of Philadelphia Institutional Review Board.
Patient consent Obtained.
Provenance and peer review Not commissioned; externally peer reviewed.