Skip to main content
PMC home page
Archives of Disease in Childhood logoLink to Archives of Disease in Childhood
. 1998 Aug;79(2):120–125. doi: 10.1136/adc.79.2.120

Informed consent, parental awareness, and reasons for participating in a randomised controlled study

M van Stuijvenberg 1, M Suur 1, S de Vos 1, G Tjiang 1, E Steyerberg 1, G Derksen-Lubsen 1, H Moll 1
PMCID: PMC1717659  PMID: 9797591

Abstract

BACKGROUND—The informed consent procedure plays a central role in randomised controlled trials but has only been explored in a few studies on children.
AIM—To assess the quality of the informed consent process in a paediatric setting.
METHODS—A questionnaire was sent to parents who volunteered their child (230 children) for a randomised, double blind, placebo controlled trial of ibuprofen syrup to prevent recurrent febrile seizures.
RESULTS—181 (79%) parents responded. On average, 73% of parents were aware of the major study characteristics. A few had difficulty understanding the information provided. Major factors in parents granting approval were the contribution to clinical science (51%) and benefit to the child (32%). Sociodemographic status did not influence initial participation but west European origin of the father was associated with willingness to participate in future trials. 89% of participants felt positive about the informed consent procedure; however, 25% stated that they felt obliged to participate. Although their reasons for granting approval and their evaluation of the informed consent procedure did not differ, relatively more were hesitant about participating in future. Parents appreciated the investigator being on call 24 hours a day (38%) and the extra medical care and information provided (37%) as advantages of participation. Disadvantages were mainly the time consuming aspects and the work involved (23%).
CONCLUSIONS—Parents' understanding of trial characteristics might be improved by designing less difficult informed consent forms and by the investigator giving extra attention and information to non-west European parents. Adequate measures should be taken to avoid parents feeling obliged to participate, rather than giving true informed consent.



Full Text

The Full Text of this article is available as a PDF (104.6 KB).

Selected References

These references are in PubMed. This may not be the complete list of references from this article.

  1. Aaronson N. K., Visser-Pol E., Leenhouts G. H., Muller M. J., van der Schot A. C., van Dam F. S., Keus R. B., Koning C. C., ten Bokkel Huinink W. W., van Dongen J. A. Telephone-based nursing intervention improves the effectiveness of the informed consent process in cancer clinical trials. J Clin Oncol. 1996 Mar;14(3):984–996. doi: 10.1200/JCO.1996.14.3.984. [DOI] [PubMed] [Google Scholar]
  2. Autret E., Dutertre J. P., Barbier P., Jonville A. P., Pierre F., Berger C. Parental opinions about biomedical research in children in Tours, France. Dev Pharmacol Ther. 1993;20(1-2):64–71. doi: 10.1159/000457542. [DOI] [PubMed] [Google Scholar]
  3. Baker M. T., Taub H. A. Readability of informed consent forms for research in a Veterans Administration medical center. JAMA. 1983 Nov 18;250(19):2646–2648. [PubMed] [Google Scholar]
  4. Balslev T. Parental reactions to a child's first febrile convulsion. A follow-up investigation. Acta Paediatr Scand. 1991 Apr;80(4):466–469. doi: 10.1111/j.1651-2227.1991.tb11883.x. [DOI] [PubMed] [Google Scholar]
  5. Baumer J. H., David T. J., Valentine S. J., Roberts J. E., Hughes B. R. Many parents think their child is dying when having a first febrile convulsion. Dev Med Child Neurol. 1981 Aug;23(4):462–464. doi: 10.1111/j.1469-8749.1981.tb02019.x. [DOI] [PubMed] [Google Scholar]
  6. Bergler J. H., Pennington A. C., Metcalfe M., Freis E. D. Informed consent: how much does the patient understand? Clin Pharmacol Ther. 1980 Apr;27(4):435–440. doi: 10.1038/clpt.1980.60. [DOI] [PubMed] [Google Scholar]
  7. Camfield P. R., Camfield C. S., Shapiro S. H., Cummings C. The first febrile seizure--antipyretic instruction plus either phenobarbital or placebo to prevent recurrence. J Pediatr. 1980 Jul;97(1):16–21. doi: 10.1016/s0022-3476(80)80122-3. [DOI] [PubMed] [Google Scholar]
  8. Cassileth B. R., Lusk E. J., Miller D. S., Hurwitz S. Attitudes toward clinical trials among patients and the public. JAMA. 1982 Aug 27;248(8):968–970. [PubMed] [Google Scholar]
  9. Daugbjerg P., Brems M., Mai J., Ankerhus J., Knudsen F. U. Intermittent prophylaxis in febrile convulsions: diazepam or valproic acid? Acta Neurol Scand. 1990 Jul;82(1):17–20. doi: 10.1111/j.1600-0404.1990.tb01581.x. [DOI] [PubMed] [Google Scholar]
  10. Fallowfield L. Questionnaire design. Arch Dis Child. 1995 Jan;72(1):76–79. doi: 10.1136/adc.72.1.76. [DOI] [PMC free article] [PubMed] [Google Scholar]
  11. Fell J. M., Rylance G. W. Parental permission, information, and consent. Arch Dis Child. 1991 Aug;66(8):980–981. doi: 10.1136/adc.66.8.980. [DOI] [PMC free article] [PubMed] [Google Scholar]
  12. Grunder T. M. Two formulas for determining the readability of subject consent forms. Am Psychol. 1978 Aug;33(8):773–775. doi: 10.1037//0003-066x.33.8.773. [DOI] [PubMed] [Google Scholar]
  13. Harth S. C., Thong Y. H. Parental perceptions and attitudes about informed consent in clinical research involving children. Soc Sci Med. 1995 Jun;40(11):1573–1577. doi: 10.1016/0277-9536(94)00412-m. [DOI] [PubMed] [Google Scholar]
  14. Harth S. C., Thong Y. H. Sociodemographic and motivational characteristics of parents who volunteer their children for clinical research: a controlled study. BMJ. 1990 May 26;300(6736):1372–1375. doi: 10.1136/bmj.300.6736.1372. [DOI] [PMC free article] [PubMed] [Google Scholar]
  15. Howard J. M., DeMets D. How informed is informed consent? The BHAT experience. Control Clin Trials. 1981 Dec;2(4):287–303. doi: 10.1016/0197-2456(81)90019-2. [DOI] [PubMed] [Google Scholar]
  16. Knudsen F. U. Effective short-term diazepam prophylaxis in febrile convulsions. J Pediatr. 1985 Mar;106(3):487–490. doi: 10.1016/s0022-3476(85)80688-0. [DOI] [PubMed] [Google Scholar]
  17. Kramer M. S., Naimark L. E., Roberts-Bräuer R., McDougall A., Leduc D. G. Risks and benefits of paracetamol antipyresis in young children with fever of presumed viral origin. Lancet. 1991 Mar 9;337(8741):591–594. doi: 10.1016/0140-6736(91)91648-e. [DOI] [PubMed] [Google Scholar]
  18. Lynn M. R. Determination and quantification of content validity. Nurs Res. 1986 Nov-Dec;35(6):382–385. [PubMed] [Google Scholar]
  19. Lynöe N., Sandlund M., Dahlqvist G., Jacobsson L. Informed consent: study of quality of information given to participants in a clinical trial. BMJ. 1991 Sep 14;303(6803):610–613. doi: 10.1136/bmj.303.6803.610. [DOI] [PMC free article] [PubMed] [Google Scholar]
  20. Morrow G. R. How readable are subject consent forms? JAMA. 1980 Jul 4;244(1):56–58. [PubMed] [Google Scholar]
  21. Rosman N. P., Colton T., Labazzo J., Gilbert P. L., Gardella N. B., Kaye E. M., Van Bennekom C., Winter M. R. A controlled trial of diazepam administered during febrile illnesses to prevent recurrence of febrile seizures. N Engl J Med. 1993 Jul 8;329(2):79–84. doi: 10.1056/NEJM199307083290202. [DOI] [PubMed] [Google Scholar]
  22. Tarnowski K. J., Allen D. M., Mayhall C., Kelly P. A. Readability of pediatric biomedical research informed consent forms. Pediatrics. 1990 Jan;85(1):58–62. [PubMed] [Google Scholar]
  23. Uhari M., Rantala H., Vainionpä L., Kurttila R. Effect of acetaminophen and of low intermittent doses of diazepam on prevention of recurrences of febrile seizures. J Pediatr. 1995 Jun;126(6):991–995. doi: 10.1016/s0022-3476(95)70231-8. [DOI] [PubMed] [Google Scholar]
  24. Wager E., Tooley P. J., Emanuel M. B., Wood S. F. How to do it. Get patients' consent to enter clinical trials. BMJ. 1995 Sep 16;311(7007):734–737. doi: 10.1136/bmj.311.7007.734. [DOI] [PMC free article] [PubMed] [Google Scholar]

Articles from Archives of Disease in Childhood are provided here courtesy of BMJ Publishing Group

RESOURCES