Trial Characteristics That Affect Parental Consent in Neonatal Drug Trials

Abstract

Objective The main purpose of this article is to determine parental consent rates in neonatal drug trials and describe trial characteristics associated with higher rates.

Study Design We included neonatal drug trials published between 2009 and 2014 and compared parental consent rates among the following characteristics: phase type, gestational age, randomization type, drug administration route, drug dosing frequency, blood sampling, control type, length of study, funding source, and length of treatment. We compared characteristics using chi-square, Fisher's exact, one-way analysis of variance or Kruskal–Wallis tests.

Results We identified 52 trials: 38 trials (73%) reported data of parental consent. Median percentage (interquartile range) of parental consent was 79% (62, 89). Higher rates were observed in studies that used active comparators (87%) and shorter study lengths (81% for studies <24 hours).

Conclusion Parental consent rates for neonatal drug trials varied by study characteristics. Information on proportion of parents consented is valuable to assess generalizability of trial results and for preparing trial protocols.

Keywords

newborn - clinical trial - parental consent - informed consent

Authors' Contributions

I.B.H. and S.A. had full access to all the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis. Study concept and design: M.M.L., I.B.H., M.B., S.A., D.T. Acquisition, analysis, or interpretation of data: I.B.H., S.A., M.B., D.T. Drafting of the manuscript: I.B.H. Critical revision of the manuscript for important intellectual content: M.B., M.M.L., S.A., P.B.S., D.T. Statistical analysis: I.B.H. Administrative, technical, or material support: M.B., M.M.L. Study supervision: M.B., M.M.L., P.B.S.

• References

• 1 Betan EJ, Roberts EC, McCluskey-Fawcett K. Rates of participation for clinical child and pediatric psychology research: issues in methodology. J Clin Child Psychol 1995; 24 (02) 227-235
• 2 Hamvas A, Madden KK, Nogee LM. , et al. Informed consent for genetic research. Arch Pediatr Adolesc Med 2004; 158 (06) 551-555
• 3 Hayman RM, Taylor BJ, Peart NS, Galland BC, Sayers RM. Participation in research: informed consent, motivation and influence. J Paediatr Child Health 2001; 37 (01) 51-54
• 4 Stenson BJ, Becher JC, McIntosh N. Neonatal research: the parental perspective. Arch Dis Child Fetal Neonatal Ed 2004; 89 (04) F321-F323
• 5 Rothmier JD, Lasley MV, Shapiro GG. Factors influencing parental consent in pediatric clinical research. Pediatrics 2003; 111 (5 Pt 1): 1037-1041
• 6 Hoehn KS, Wernovsky G, Rychik J. , et al. What factors are important to parents making decisions about neonatal research?. Arch Dis Child Fetal Neonatal Ed 2005; 90 (03) F267-F269
• 7 Maayan-Metzger A, Kedem-Friedrich P, Kuint J. Motivations of mothers to enroll their newborn infants in general clinical research on well-infant care and development. Pediatrics 2008; 121 (03) e590-e596
• 8 McKechnie L, Gill AB. Consent for neonatal research. Arch Dis Child Fetal Neonatal Ed 2006; 91 (05) F374-F376
• 9 Barfield RC, Church C. Informed consent in pediatric clinical trials. Curr Opin Pediatr 2005; 17 (01) 20-24
• 10 Chappuy H, Bouazza N, Minard-Colin V. , et al. Parental comprehension of the benefits/risks of first-line randomised clinical trials in children with solid tumours: a two-stage cross-sectional interview study. BMJ Open 2013; 3 (05) e002733
• 11 Nievaard MA, de Vos R, de Haes JC, Levi M. [Reasons why patients do or do not participate in clinical trials; a systemic review of the literature]. Ned Tijdschr Geneeskd 2004; 148 (04) 186-190
• 12 Swartz MK. The PRISMA statement: a guideline for systematic reviews and meta-analyses. J Pediatr Health Care 2011; 25 (01) 1-2
• 13 Harth SC, Thong YH. Sociodemographic and motivational characteristics of parents who volunteer their children for clinical research: a controlled study. BMJ 1990; 300 (6736): 1372-1375
• 14 Harth SC, Johnstone RR, Thong YH. The psychological profile of parents who volunteer their children for clinical research: a controlled study. J Med Ethics 1992; 18 (02) 86-93
• 15 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 (01) E6
• 16 Tait AR, Voepel-Lewis T, Malviya S. Factors that influence parents' assessments of the risks and benefits of research involving their children. Pediatrics 2004; 113 (04) 727-732
• 17 Schulz KF, Altman DG, Moher D. ; CONSORT Group. CONSORT 2010 statement: updated guidelines for reporting parallel group randomised trials. BMJ 2010; 340: c332
• 18 Hopewell S, Loudon K, Clarke MJ, Oxman AD, Dickersin K. Publication bias in clinical trials due to statistical significance or direction of trial results. Cochrane Database Syst Rev 2009; (01) MR000006