Abstract
Objective:
To assess the impact of time on parental decision-making for research participation for neonates with congenital heart disease.
Study Design:
Interviews were conducted with 37 parents of 19 neonates with congenital heart disease who were eligible for three different studies: genetic etiology of congenital heart disease, heart rate variability (HRV) and structural and functional cranial magnetic resonance imaging (MRI). All parents were asked the same questions: (1) ‘Did you have adequate time to make a decision about research?’ and (2) ‘Why?’ Differences between groups (reporting adequate and inadequate time) were evaluated using Fisher's exact tests; central themes were examined using qualitative analysis.
Result:
Of those parents who reported having adequate time to make their decision (22 of 37), the majority chose to participate when compared to those who reported inadequate time (genetics study, P<0.01; HRV, P=0.05; MRI, P<0.01). For the parents reporting inadequate time, consistent themes emerged: insufficient time to make an educated choice (n=10), consideration of study logistics (n=8), spouse not present at the time of decision (n=7) and insufficient time to discuss the studies (n=4).
Conclusion:
Parental perception of adequate time to decide about research participation was associated with parental willingness to enroll the child in research. Despite any time limitations, parents were satisfied with the decisions they made. Optimizing the time available for the parental permission process could enhance research participation in the neonatal period.
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References
Allmark P, Mason SA, Gill AB, Megone C . Obtaining consent for neonatal research. Arch Dis Child Fetal Neonatal Ed 2003; 88: F166–F167.
Mason SA, Allmark PJ . Obtaining informed consent to neonatal randomised controlled trials: interviews with parents and clinicians in the Euricon study. Lancet 2000; 356 (9247): 2045–2051.
Burgess E, Singhal N, Amin H, McMillan DD, Devrome H . Consent for clinical research in the neonatal intensive care unit: a retrospective survey and a prospective study. Arch Dis Child Fetal Neonatal Ed 2003; 88: F280–F286.
Kraybill EN . The challenge of informed consent in neonatal research. J Perinatol 2004; 24: 407–408.
Hoehn KS, Wernovsky G, Rychik J, Tian ZY, Donaghue D, Alderfer MA et al. Parental decision-making in congenital heart disease. Cardiol Young 2004; 14: 1–6.
Hoehn KS, Wernovsky G, Rychik J, Gaynor JW, Spray TL, Feudtner C et al. What factors are important to parents making decisions about neonatal research? Arch Dis Child Fetal Neonatal Ed 2005; 90: 3.
Zakay D . The impact of time perception processes on decision making under time stress, in time pressure and stress in human judgment and decision making. In: Svenson, Maule AJ (eds). Plenum Press: New York, 1993, pp 59–72.
Licht DJ, Wang J, Silvestre DW, Nicolson SC, Monetenegro LM, Wernovsky G et al. Preoperative cerebral blood flow is diminished in neonates with severe congenital heart defects. J Thorac Cardiovasc Surg 2004; 128 (6): 841–849.
Richard L . Using NVivo in Qualitative Research, 2nd edn. QSR International: Melbourne, 2000.
United States Department of Health and Human Services. Code of Federal Regulations. 45 CFR 46.408. Federal Policy for the Protection of Human Subjects (Subpart D). In: United States Department of Health and Human Services; 1991.
Zupancic JA, Gillie P, Streiner DL, Watts JL, Schmidt B . Determinants of parental authorization for involvement of newborn infants in clinical trials. Pediatrics 1997; 99 (1): e6.
Hulst JM, Peters JW, van den Bos A, Joosten KF, van Goudouever JB, Zimmerman LJ et al. Illness severity and parental permission for clinical research in the pediatric ICU population. Intensive Care Med 2005; 31: 880–884.
Eder ML, Yamokoski AD, Wittmann PW, Kodish ED . Improving informed consent: suggestions from parents of children with leukemia. Pediatrics 2007; 119 (4): e849–e859.
Miller VA, Drotar D, Burant C, Kodish E . Clinician-parent communication during informed consent for pediatric leukemia trials. J Pediatr Psychol 2005; 30 (3): 219–229.
Hall MA, Camacho F, Lawlor JS, Depuy V, Sugarman J, Weinfurt K . Measuring trust in medical researchers. Med Care 2006; 44 (11): 1048–1053.
Truog RD . Increasing the participation of children in clinical research. Intensive Care Med 2005; 31: 760–761.
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Hoehn, K., Nathan, A., White, L. et al. Parental perception of time and decision-making in neonatal research. J Perinatol 29, 508–511 (2009). https://doi.org/10.1038/jp.2009.5
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DOI: https://doi.org/10.1038/jp.2009.5
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