Top

Intensive Care Medicine

Published in:

01-01-2012 | Ethics and Regulation of ICU Clinical Research

Factors affecting consent in pediatric critical care research

Authors: Kusum Menon, Roxanne E. Ward, Isabelle Gaboury, Margot Thomas, Ari Joffe, Karen Burns, Deborah Cook

Published in: Intensive Care Medicine | Issue 1/2012

Abstract

Purpose

Consent for research is a difficult and unpredictable process in pediatric critical care populations. The objectives of this study were to describe consent rates in pediatric critical care research and their association with patient, legal guardian, consent process, and study design-related factors.

Methods

A prospective, cohort study was conducted from 2009 to 2010 in six tertiary care pediatric intensive care units (PICU) in Canada with legal guardians of patients who were approached for consent for any ongoing PICU research study. Data were recorded on details of the consent process for all consent encounters.

Results

We recorded 271 consent encounters. The overall consent rate was 80.1% (217/271). We observed higher consent rates when the research assistant was introduced by a member of the clinical team prior to approaching the family (89.7 vs. 77.7%; P = 0.04). Legal guardians of cardiac surgery patients were less likely to provide consent than those of all other patients (75.3 vs. 86.0%; P = 0.03). There was no difference in consent rates between therapeutic (117/145, 80.7%) versus non-therapeutic studies (100/126, 79.4%; P = 0.88).

Conclusion

This study provides future researchers with consent data for determination of recruitment rates, sample sizes, budget estimations, and study timelines. Future pediatric critical care studies should consider incorporating the lower consent rates in cardiac surgery patients and routine introduction of the research assistant to the family by a member of the patient’s care team into their study designs. The potential influence of parental factors on consent rates in pediatric critical care studies requires further research.

Available only for authorised users

Flagel DC (2000) Children as research subjects: new guidelines for Canadian IRBs. IRB 22:1–3PubMedCrossRef

Huckabay LM, Tilem-Kessler D (1999) Patterns of parental stress in PICU emergency admission. Dimens Crit Care Nurs 18:36–42PubMedCrossRef

LaMontagne LL, Hepworth JT, Johnson BD, Deshpande JK (1994) Psychophysiological responses of parents to pediatric critical care stress. Clin Nurs Res 3:104–118PubMedCrossRef

Choong K, Bohn D, Fraser DD, Gaboury I, Hutchison JS, Joffe AR, Litalien C, Menon K, McNamara P, Ward RE (2009) Vasopressin in pediatric vasodilatory shock: a multicenter randomized controlled trial. Am J Respir Crit Care Med 180:632–639PubMedCrossRef

Hutchison JS, Ward RE, Lacroix J, Hebert PC, Barnes MA, Bohn DJ, Dirks PB, Doucette S, Fergusson D, Gottesman R, Joffe AR, Kirpalani HM, Meyer PG, Morris KP, Moher D, Singh RN, Skippen PW (2008) Hypothermia therapy after traumatic brain injury in children. N Engl J Med 358:2447–2456PubMedCrossRef

Lacroix J, Hebert PC, Hutchison JS, Hume HA, Tucci M, Ducruet T, Gauvin F, Collet JP, Toledano BJ, Robillard P, Joffe A, Biarent D, Meert K, Peters MJ (2007) Transfusion strategies for patients in pediatric intensive care units. N Engl J Med 356:1609–1619PubMedCrossRef

Menon K, Ward RE, Lawson ML, Gaboury I, Hutchison JS, Hebert PC, Canadian Critical Care Trials Group (2010) A prospective multi-center study of adrenal function in critically ill children. Am J Respir Crit Care Med 182(2):246–251

Vlasselaers D, Milants I, Desmet L, Wouters PJ, Vanhorebeek I, van den Heuvel I, Mesotten D, Casaer MP, Meyfroidt G, Ingels C, Muller J, Van Cromphaut S, Schetz M, Van den Berghe G (2009) Intensive insulin therapy for patients in paediatric intensive care: a prospective, randomised controlled study. Lancet 373:547–556PubMedCrossRef

Walterspiel JN (1990) Informed consent: influence on patient selection among critically ill premature infants. Pediatrics 85:119–121PubMed

10.

Hoehn KS, Wernovsky G, Rychik J, Gaynor JW, Spray TL, Feudtner C, Nelson RM (2005) What factors are important to parents making decisions about neonatal research? Arch Dis Child Fetal Neonatal Ed 90:F267–F269PubMedCrossRef

11.

Singhal N, Oberle K, Burgess E, Huber-Okrainec J (2002) Parents’ perceptions of research with newborns. J Perinatol 22:57–63PubMedCrossRef

12.

Zupancic JA, Gillie P, Streiner DL, Watts JL, Schmidt B (1997) Determinants of parental authorization for involvement of newborn infants in clinical trials. Pediatrics 99:E6PubMedCrossRef

13.

Hulst JM, Peters JW, van den Bos A, Joosten KF, van Goudoever JB, Zimmermann LJ, Tibboel D (2005) Illness severity and parental permission for clinical research in a pediatric ICU population. Intensive Care Med 31:880–884PubMedCrossRef

14.

Natale JE, Joseph JG, Pretzlaff RK, Silber TJ, Guerguerian AM (2006) Clinical trials in pediatric traumatic brain injury: unique challenges and potential responses. Dev Neurosci 28:276–290PubMedCrossRef

15.

Sturdivant L, Warren NA (2009) Perceived met and unmet needs of family members of patients in the pediatric intensive care unit. Crit Care Nurs Q 32:149–158PubMed

16.

Glickman SW, Anstrom KJ, Lin L, Chandra A, Laskowitz DT, Woods CW, Freeman DH, Kraft M, Beskow LM, Weinfurt KP, Schulman KA, Cairns CB (2008) Challenges in enrollment of minority, pediatric, and geriatric patients in emergency and acute care clinical research. Ann Emerg Med 51:775–780. doi:10.1016/j.annemergmed.2007.11.002 PubMedCrossRef

17.

Simon CM, Siminoff LA, Kodish ED, Burant C (2004) Comparison of the informed consent process for randomized clinical trials in pediatric and adult oncology. J Clin Oncol 22:2708–2717PubMedCrossRef

18.

Breslow NE, Day NE (1987) Statistical methods in cancer research. Volume II: the design and analysis of cohort studies. IARC Sci Publ, Lyon, pp 1–406

19.

Laird NM, Mosteller F (1990) Some statistical methods for combining experimental results. Int J Technol Assess Health Care 6:5–30PubMedCrossRef

20.

Schroeder AR, Axelrod DM, Silverman NH, Rubesova E, Merkel E, Roth SJ (2010) A continuous heparin infusion does not prevent catheter-related thrombosis in infants after cardiac surgery. Pediatr Crit Care Med 11:489–495PubMed

21.

Gruenwald CE, Manlhiot C, Chan AK, Crawford-Lean L, Foreman C, Holtby HM, Van Arsdell GS, Richards R, Moriarty H, McCrindle BW (2010) Randomized, controlled trial of individualized heparin and protamine management in infants undergoing cardiac surgery with cardiopulmonary bypass. J Am Coll Cardiol 56:1794–1802PubMedCrossRef

22.

Huskins WC, Huckabee CM, O’Grady NP, Murray P, Kopetskie H, Zimmer L, Walker ME, Sinkowitz-Cochran RL, Jernigan JA, Samore M, Wallace D, Goldmann DA (2011) Intervention to reduce transmission of resistant bacteria in intensive care. N Engl J Med 364:1407–1418PubMedCrossRef

23.

Sammons HM, Atkinson M, Choonara I, Stephenson T (2007) What motivates British parents to consent for research? A questionnaire study. BMC Pediatr 7:12. doi:10.1186/1471-2431-7-12 PubMedCrossRef

24.

Baren JM, Anicetti JP, Ledesma S, Biros MH, Mahabee-Gittens M, Lewis RJ (1999) An approach to community consultation prior to initiating an emergency research study incorporating a waiver of informed consent. Acad Emerg Med 6:1210–1215PubMedCrossRef

25.

Pierro A, Spitz L (1997) Informed consent in clinical research: the crisis in paediatrics. Lancet 349:1703PubMedCrossRef

26.

Morris MC, Besner D, Vazquez H, Nelson RM, Fischbach RL (2007) Parental opinions about clinical research. J Pediatr 151:532–537. doi:10.1016/j.jpeds.2007.04.032 PubMedCrossRef

27.

Morris MC, Fischbach RL, Nelson RM, Schleien CL (2006) A paradigm for inpatient resuscitation research with an exception from informed consent. Crit Care Med 34:2567–2575PubMedCrossRef

Title: Factors affecting consent in pediatric critical care research
Authors: Kusum Menon
Roxanne E. Ward
Isabelle Gaboury
Margot Thomas
Ari Joffe
Karen Burns
Deborah Cook
Publication date: 01-01-2012
Publisher: Springer-Verlag
Published in: Intensive Care Medicine / Issue 1/2012
Print ISSN: 0342-4642
Electronic ISSN: 1432-1238
DOI: https://doi.org/10.1007/s00134-011-2412-0

Keynote webinar | Spotlight on sleep in brain health

Springer Medicine

Factors affecting consent in pediatric critical care research

Abstract

Purpose

Methods

Results

Conclusion

Keynote webinar | Spotlight on sleep in brain health

Springer Medicine

Abstract

Purpose

Methods

Results

Conclusion

Please log in to get access to this content

Other articles of this Issue 1/2012

Acute kidney injury reduces the hepatic metabolism of midazolam in critically ill patients

How standard is the “S” in SMR?

Early detection of deteriorating ventilation by monitoring bilateral chest wall dynamics in the rabbit

Arterial oxygen tension and mortality in mechanically ventilated patients

Suffering among carers working in critical care can be reduced by an intensive communication strategy on end-of-life practices

Prospective study of the incidence and predictors of thrombus in children undergoing palliative surgery for single ventricle physiology