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

Genetics in Medicine

Volumn 16, Issue 2, 2014, Pages 141-148

  Klima, Jennifer ^a,d   Fitzgerald Butt, Sara M ^a   Kelleher, Kelly J ^a,b,c   Chisolm, Deena J ^a,b,c   Comstock, R Dawn ^a,c   Ferketich, Amy K ^c   McBride, Kim L ^a,b  

^a NATIONWIDE CHILDREN S HOSPITAL   (United States)

^b THE OHIO STATE UNIVERSITY COLLEGE OF MEDICINE   (United States)

^c OHIO STATE UNIVERSITY   (United States)

^d Ohio Health Research and Innovation Institute   (United States)

Author keywords

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

Indexed keywords

DNA;

ARTICLE; CARDIOVASCULAR MALFORMATION; CHILD; FACTUAL DATABASE; FEMALE; HUMAN; INFORMED CONSENT; MAJOR CLINICAL STUDY; MALE; MEDICAL DECISION MAKING; PARENT; PARENT COUNSELING; PARENTAL AGE;

ADULT; BIOLOGICAL SPECIMEN BANKS; CARDIOVASCULAR ABNORMALITIES; FEMALE; HEALTH KNOWLEDGE, ATTITUDES, PRACTICE; HUMANS; INFORMED CONSENT; MALE; PARENTAL CONSENT; PARENTS;

EID: 84898477969     PISSN: 10983600     EISSN: 15300366     Source Type: Journal    
DOI: 10.1038/gim.2013.86     Document Type: Article

References (39)

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 twoparent 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.