domingo, 7 de julio de 2013

Understanding of informed consent by parents of children enrolled in a genetic biobank : Genetics in Medicine : Nature Publishing Group

Understanding of informed consent by parents of children enrolled in a genetic biobank

Genetics in Medicine
(2013)
doi:10.1038/gim.2013.86
Received
Accepted
Published online

Abstract

Purpose:

Prior research suggests that parents undervalue long-term risks associated with their children’s participation in research studies. The primary aim of this study was to evaluate parental understanding of informed consent for a pediatric biobanking study.

Methods:

The study population included parents who provided consent for their child to participate in a study examining the genetic etiology of congenital cardiovascular malformations. Informed consent understanding was measured by adapting the Quality of Informed Consent assessment to our study. We evaluated possible predictors of individual Quality of Informed Consent items using generalized estimating equations.

Results:

A total of 252 individuals representing 188 families completed the study. The Quality of Informed Consent items best understood by parents included consent to participate in research, the main purpose of the study, and the possibility of no direct benefit. The items least understood by parents were those involving the indefinite storage of DNA, the possible risks of participation, and the fact that the study was not intended to treat their child’s heart defect. Parent age and medical decision making by one versus both parents were frequent predictors of individual Quality of Informed Consent items.

Conclusion:

Parents overestimate personal benefit and underestimate the risks associated with their child’s participation in a biobanking study.
Genet Med advance online publication 27 June 2013
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Keywords:

biobank; genetic research; informed consent; informed consent understanding; pediatric biobank

References

  1. Matsui K, Lie RK, Kita Y. Two methods of obtaining informed consent in a genetic epidemiological study: effects on understanding. J Empir Res Hum Res Ethics 2007;2(3):39–48.
  2. Kaufman D, Geller G, Leroy L, Murphy J, Scott J, Hudson K. Ethical implications of including children in a large biobank for genetic-epidemiologic research: a qualitative study of public opinion. Am J Med Genet C Semin Med Genet 2008;148C:31–39.
  3. Haga SB, Beskow LM. Ethical, legal, and social implications of biobanks for genetics research. Adv Genet 2008;60:505–544.
  4. Dixon-Woods M, Ashcroft RE, Jackson CJ, et al. Beyond “misunderstanding”: written information and decisions about taking part in a genetic epidemiology study. Soc Sci Med 2007;65:2212–2222.
  5. Jenkins MM, Rasmussen SA, Moore CA, Honein MA. Ethical issues raised by incorporation of genetics into the National Birth Defects Prevention Study. Am J Med Genet C Semin Med Genet 2008;148C:40–46.
  6. Brisson AR, Matsui D, Rieder MJ, Fraser DD. Translational research in pediatrics: tissue sampling and biobanking. Pediatrics 2012;129:153–162.
  7. Wolf SM, Crock BN, Van Ness B, et al. Managing incidental findings and research results in genomic research involving biobanks and archived data sets. Genet Med 2012;14:361–384.
  8. Brothers KB. Biobanking in pediatrics: the human nonsubjects approach. Per Med 2011;8:79.
  9. Helft PR, Champion VL, Eckles R, Johnson CS, Meslin EM. Cancer patients’ attitudes toward future research uses of stored human biological materials. J Empir Res Hum Res Ethics 2007;2:15–22.
  10. Lockhart NC, Yassin R, Weil CJ, Compton CC. Intersection of biobanking and clinical care: should discrepant diagnoses and pathological findings be returned to research participants? Genet Med 2012;14:417–423.
  11. Ballard HO, Shook LA, Desai NS, Anand KJ. Neonatal research and the validity of informed consent obtained in the perinatal period. J Perinatol 2004;24:409–415.
  12. Joffe S, Cook EF, Cleary PD, Clark JW, Weeks JC. Quality of informed consent: a new measure of understanding among research subjects. J Natl Cancer Inst 2001;93:139–147.
  13. Ormond KE, Cirino AL, Helenowski IB, Chisholm RL, Wolf WA. Assessing the understanding of biobank participants. Am J Med Genet A 2009;149A:188–198.
  14. McCarty CA, Nair A, Austin DM, Giampietro PF. Informed consent and subject motivation to participate in a large, population-based genomics study: the Marshfield Clinic Personalized Medicine Research Project. Community Genet 2007;10:2–9.
  15. Greenley RN, Drotar D, Zyzanski SJ, Kodish E. Stability of parental understanding of random assignment in childhood leukemia trials: an empirical examination of informed consent. J Clin Oncol 2006;24:891–897.
  16. Mortensen MG, Kiyak HA, Omnell L. Patient and parent understanding of informed consent in orthodontics. Am J Orthod Dentofacial Orthop 2003;124:541–550.
  17. Glock RS, Goldim JR. Informed consent in gerontology. Eubios J Asian Int Bioeth 2003;13:6–8.
  18. Kaewpoonsri N, Okanurak K, Kitayaporn D, Kaewkungwal J, Vijaykadga S, Thamaree S. Factors related to volunteer comprehension of informed consent for a clinical trial. Southeast Asian J Trop Med Public Health 2006;37:996–1004.
  19. Appelbaum PS, Lidz CW, Grisso T. Therapeutic misconception in clinical research: frequency and risk factors. IRB 2004;26:1–8.
  20. Criscione LG, Sugarman J, Sanders L, Pisetsky DS, St Clair EW. Informed consent in a clinical trial of a novel treatment for rheumatoid arthritis. Arthritis Rheum 2003;49:361–367.
  21. Larobina ME, Merry CJ, Negri JC, Pick AW. Is informed consent in cardiac surgery and percutaneous coronary intervention achievable? ANZ J Surg 2007;77:530–534.
  22. Whittle J, Conigliaro J, Good CB, Kelley ME, Skanderson M. Understanding of the benefits of coronary revascularization procedures among patients who are offered such procedures. Am Heart J 2007;154:662–668.
  23. Beskow LM, Dean E. Informed consent for biorepositories: assessing prospective participants’ understanding and opinions. Cancer Epidemiol Biomarkers Prev 2008;17:1440–1451.
  24. Cox AC, Fallowfield LJ, Jenkins VA. Communication and informed consent in phase 1 trials: a review of the literature. Support Care Cancer 2006;14:303–309.
  25. Dunn LB, Palmer BW, Keehan M, Jeste DV, Appelbaum PS. Assessment of therapeutic misconception in older schizophrenia patients with a brief instrument. Am J Psychiatry 2006;163:500–506.
  26. Robinson C, Thompson SJ, Woolhead C. Multiple pathways used for the targeting of thylakoid proteins in chloroplasts. Traffic 2001;2:245–251.
  27. Streisand R, Swift E, Wickmark T, Chen R, Holmes CS. Pediatric parenting stress among parents of children with type 1 diabetes: the role of self-efficacy, responsibility, and fear. J Pediatr Psychol 2005;30:513–521.
  28. Thompson SJ, Auslander WF, White NH. Comparison of single-mother and two-parent families on metabolic control of children with diabetes. Diabetes Care 2001;24:234–238.
  29. Varma S, Jenkins T, Wendler D. How do children and parents make decisions about pediatric clinical research? J Pediatr Hematol Oncol 2008;30:823–828.
  30. Wendler D, Jenkins T. Children’s and their parents’ views on facing research risks for the benefit of others. Arch Pediatr Adolesc Med 2008;162:9–14.
  31. Harris ED, Ziniel SI, Amatruda JG, et al. The beliefs, motivations, and expectations of parents who have enrolled their children in a genetic biorepository. Genet Med 2012;14:330–337.
  32. Agre P, Rapkin B. Improving informed consent: a comparison of four consent tools. IRB 2003;25:1–7.
  33. Campbell FA, Goldman BD, Boccia ML, Skinner M. The effect of format modifications and reading comprehension on recall of informed consent information by low-income parents: a comparison of print, video, and computer-based presentations. Patient Educ Couns 2004;53:205–216.
  34. Dunn LB, Lindamer LA, Palmer BW, Schneiderman LJ, Jeste DV. Enhancing comprehension of consent for research in older patients with psychosis: a randomized study of a novel consent procedure. Am J Psychiatry 2001;158:1911–1913.
  35. Eggers C, Obliers R, Koerfer A, et al. A multimedia tool for the informed consent of patients prior to gastric banding. Obesity (Silver Spring) 2007;15:2866–2873.
  36. Migden M, Chavez-Frazier A, Nguyen T. The use of high definition video modules for delivery of informed consent and wound care education in the Mohs Surgery Unit. Semin Cutan Med Surg 2008;27:89–93.
  37. Nwomeh BC, Hayes J, Caniano DA, Upperman JS, Kelleher KJ. A parental educational intervention to facilitate informed consent for emergency operations in children. J Surg Res 2008;152:258–263.
  38. Steffenino G, Viada E, Marengo B, Canale R; Nursing and the Medical Staff of the Cardiac Catheterization Unit. Effectiveness of video-based patient information before percutaneous cardiac interventions. J Cardiovasc Med (Hagerstown) 2007;8:348–353.
  39. Wirshing DA, Sergi MJ, Mintz J. A videotape intervention to enhance the informed consent process for medical and psychiatric treatment research. Am J Psychiatry 2005;162:186–188.
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Author information

Affiliations

  1. Center for Innovation in Pediatric Practice, Nationwide Children’s Hospital, Columbus, Ohio, USA

    • Jennifer Klima,
    • Kelly J. Kelleher &
    • Deena J. Chisolm

  2. Center for Cardiovascular and Pulmonary Research, Nationwide Children’s Hospital, Columbus, Ohio, USA

    • Sara M. Fitzgerald-Butt &
    • Kim L. McBride

  3. Department of Pediatrics, College of Medicine, The Ohio State University, Columbus, Ohio, USA

    • Kelly J. Kelleher,
    • Deena J. Chisolm &
    • Kim L. McBride

  4. College of Public Health, The Ohio State University, Columbus, Ohio, USA

    • Kelly J. Kelleher,
    • Deena J. Chisolm,
    • R. Dawn Comstock &
    • Amy K. Ferketich

  5. Center for Injury Research and Policy, Nationwide Children’s Hospital, Columbus, Ohio, USA

    • R. Dawn Comstock

  6. Present address: OhioHealth Research and Innovations Institute, Columbus, Ohio, USA

    • Jennifer Klima

Corresponding authors

Correspondence to:

Supplementary information

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Understanding of informed consent by parents of children enrolled in a genetic biobank : Genetics in Medicine : Nature Publishing Group
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