The Journal of Pediatrics
Volume 155, Issue 4 , Pages 578-583.e13 , October 2009

Pediatric Biobanks: Approaching Informed Consent for Continuing Research After Children Grow Up

  • Aaron J. Goldenberg, PhD, MPH

      Affiliations

    • Department of Bioethics, Case Western Reserve University, Cleveland, OH
    • Center for Genetic Research Ethics and Law, Case Western Reserve University, Cleveland, OH
    • ,
  • Sara Chandros Hull, PhD

      Affiliations

    • Department of Bioethics, Clinical Center, National Institutes of Health, Bethesda, MD
    • Office of the Clinical Director, National Human Genome Research Institute, National Institutes of Health, Bethesda, MD
    • ,
  • Jeffrey R. Botkin, MD, MPH

      Affiliations

    • University of Utah, Salt Lake City, UT
    • ,
  • Benjamin S. Wilfond, MD

      Affiliations

    • Treuman Katz Center for Pediatric Bioethics, Seattle Children's Hospital, Seattle, WA
    • Department of Pediatrics, University of Washington School of Medicine, Seattle, WA
    • Corresponding Author InformationReprint requests: Benjamin Wilfond, MD, Metropolitan Park West, M/S: MPW 8-2, 1100 Olive Way, Room 876, Seattle WA 98101.

Received 8 July 2008 ,Revised 17 February 2009 ,Accepted 10 April 2009.

References 

  1. Kaiser J. Genetics. US hospital launches large biobank of children's DNA. Science. 2006;312:1584–1585
  2. Winickoff DE, Winickoff RN. The charitable trust as a model for genomic biobanks. N Engl J Med. 2003;349:1180–1184
  3. Geschwind DH, Sowinski J, Lord C, Iversen P, Shestack J, Jones P, et al. The autism genetic resource exchange: a resource for the study of autism and related neuropsychiatric conditions. Am J Hum Genet. 2001;69:463–466
  4. Terry SF, Terry PF, Rauen KA, Uitto J, Bercovitch LG. Advocacy groups as research organizations: the PXE International example. Nat Rev Genet. 2007;8:157–164
  5. Drumm ML, Konstan MW, Schluchter MD, Handler A, Pace R, Zou F, et al. Genetic modifiers of lung disease in cystic fibrosis. N Engl J Med. 2005;353:1443–1453
  6. National Children's Study (homepage on the Internet). Bethesda: The National Children's Study; c2007-2008 (updated Oct 3, 2008). Available at: http://www.nationalchildrensstudy.gov/. Accessed Oct 9, 2008.
  7. Cambon-Thomsen A. The social and ethical issues of post-genomic human biobanks. Nat Rev Genet. 2004;5:866–873
  8. Caulfield T. Tissue banking, patient rights, and confidentiality: tensions in law and policy. Med Law. 2004;23:39–49
  9. Clayton EW. Informed consent and biobanks. J Law Med Ethics. 2005;33:15–21
  10. Clayton EW, Steinberg KK, Khoury MJ, Thomson E, Andrews L, Kahn MJ, et al. Informed consent for genetic research on stored tissue samples. JAMA. 1995;274:1786–1792
  11. Meslin EM, Quaid KA. Ethical issues in the collection, storage, and research use of human biological materials. J Lab Clin Med. 2004;144:229–234discussion 6
  12. Diekema DS. Conducting ethical research in pediatrics: a brief historical overview and review of pediatric regulations. J Pediatr. 2006;149:S3–S11
  13. US Department of Health and Human Services. Code of Federal Regulations. 45 CFR 46, subpart A.
  14. Informed consent, parental permission, and assent in pediatric practice. Committee on Bioethics, American Academy of Pediatrics. Pediatrics. 1995;95:314–317
  15. Wendler DS. Assent in paediatric research: theoretical and practical considerations. J Med Ethics. 2006;32:229–234
  16. Merlo DF, Knudsen LE, Matusiewicz K, Niebroj L, Vahakangas KH. Ethics in studies on children and environmental health. J Med Ethics. 2007;33:408–413
  17. Kettis-Lindblad A, Ring L, Viberth E, Hansson MG. Genetic research and donation of tissue samples to biobanks. What do potential sample donors in the Swedish general public think?. Eur J Public Health. 2006;16:433–440
  18. Wang SS, Fridinger F, Sheedy KM, Khoury MJ. Public attitudes regarding the donation and storage of blood specimens for genetic research. Community Genet. 2001;4:18–26
  19. Wendler D, Emanuel E. The debate over research on stored biological samples: what do sources think?. Arch Intern Med. 2002;162:1457–1462
  20. Hoeyer K, Olofsson BO, Mjorndal T, Lynoe N. Informed consent and biobanks: a population-based study of attitudes towards tissue donation for genetic research. Scand J Public Health. 2004;32:224–229
  21. Schwartz MD, Rothenberg K, Joseph L, Benkendorf J, Lerman C. Consent to the use of stored DNA for genetics research: a survey of attitudes in the Jewish population. Am J Med Genet. 2001;98:336–342
  22. McQuillan GM, Pan Q, Porter KS. Consent for genetic research in a general population: an update on the National Health and Nutrition Examination Survey experience. Genet Med. 2006;8:354–360
  23. Genetic Testing and DNA Biobanks—For Whom, and When? CS Mott Children's Hospital National Poll on Children's Health 2007;1:1–2.
  24. Neidich AB, Joseph JW, Ober C, Ross LF. Empirical data about women's attitudes towards a hypothetical pediatric biobank. Am J Med Genet A. 2008;146:297–304
  25. 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. 2008;148C:31–39
  26. Hull SC, Sharp RR, Botkin JR, Brown M, Hughes M, Sugarman J, et al. Patients' views on identifiability of samples and informed consent for genetic research. Am J Bioeth. 2008;8:62–70
  27. Robison LL, Mertens AC, Boice JD, Breslow NE, Donaldson SS, Green DM, et al. Study design and cohort characteristics of the Childhood Cancer Survivor Study: a multi-institutional collaborative project. Med Pediatr Oncol. 2002;38:229–239
  28. Ronningen KS, Paltiel L, Meltzer HM, Nordhagen R, Lie KK, Hovengen R, et al. The biobank of the Norwegian Mother and Child Cohort Study: a resource for the next 100 years. Eur J Epidemiol. 2006;21:619–625
  29. Stiller CA. Epidemiology and genetics of childhood cancer. Oncogene. 2004;23:6429–6444
  30. Taussig LM, Wright AL, Holberg CJ, Halonen M, Morgan WJ, Martinez FD. Tucson Children's Respiratory Study: 1980 to present. J Allergy Clin Immunol. 2003;111:661–675
  31. Hausman DM. Group risks, risks to groups, and group engagement in genetics research. Kennedy Institute of Ethics journal. 2007;17:351–369
  32. US Department of Health and Human Services. Code of Federal Regulations. 45 CFR 46, subpart D.
  33. Emanuel EJ, Wendler D, Grady C. What makes clinical research ethical?. JAMA. 2000;283:2701–2711
  34. Wendler D, Varma S. Minimal risk in pediatric research. J Pediatr. 2006;149:855–861
  35. Olney RS, Moore CA, Ojodu JA, Lindegren ML, Hannon WH. Storage and use of residual dried blood spots from state newborn screening programs. J Pediatr. 2006;148:618–622

 The study was supported by National Human Genome Research Institute (S.H and B.W.). J.B. received support for the recruitment of subjects. A. G. was supported by the National Institutes of Health (IH P50HG003390, The Center for Genetic Research Ethics and Law). No statement in this article should be construed as an official position of the National Human Genome Research Institute, National Institutes of Health, or Department of Health and Human Services. The authors declare no conflicts of interest.

PII: S0022-3476(09)00381-3

doi: 10.1016/j.jpeds.2009.04.034

The Journal of Pediatrics
Volume 155, Issue 4 , Pages 578-583.e13 , October 2009

Article Tools

* Image Usage & Resolution