The Journal of Pediatrics
Volume 149, Issue 1, Supplement , Pages S25-S30 , July 2006

A developmental approach to child assent for nontherapeutic research

  • Victoria A. Miller, PhD
  • ,
  • Robert M. Nelson, MD, PhD

      Affiliations

    • Corresponding Author InformationReprint requests: Dr Robert M. Nelson, Director, Center for Research Integrity, The Children’s Hospital of Philadelphia, Room 1513 / CHOP North, The Children’s Hospital of Philadelphia, 34th Street and Civic Center Boulevard, Philadelphia, PA 19104.

References 

  1. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research . The Belmont Report (Ethical Principles and Guidelines for the Protection of Human Subjects of Research) . Washington, DC: US Government Printing Office; 1979;
  2. US Department of Health and Human Services . Additional protections for children involved as subjects in research (45 CFR 46.408a) . Federal Register . 1983;48:9814–9820 (March 8)
  3. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research . Report and recommendations (research involving children) . Washington, DC: US Government Printing Office; 1977;
  4. Miller VA , Drotar D , Kodish E . Children’s competence for assent and consent (a review of empirical findings) . Ethics Behav . 2004;14:255–295
  5. Tait AR , Voepel-Lewis T , Malviya S . Do they understand? II (assent of children participating in clinical anesthesia and surgery research) . Anesthesiology . 2003;98:609–614
  6. Nelson RM , Reynolds WW . Child assent and parental permission (a comment on Tait’s “Do they understand?”) . Anesthesiology . 2003;98:1–2
  7. Rossi W , Reynolds WW , Nelson RM . Child assent and parental permission in pediatric research . Theoret Med . 2003;24:131–148
  8. Wendler D , Shah S . Should children decide whether they are enrolled in nonbeneficial research? . Am J Bioeth . 2003;3:1–13
  9. McGee EM . Altruism, children, and nonbeneficial research . AM J Bioeth . 2003;3:21–23
  10. Walker LJ , Taylor JH . Family interactions and the development of moral reasoning . Child Dev . 1991;62:264–283
  11. Denham JE , Nelson RM . Self-determination is not an appropriate model for understanding parental permission and child assent . Anesth Analg . 2002;94:1–3
  12. Kodish E . Informed consent for pediatric research (is it really possible?) . J Pediatr . 2003;142:89–90
  13. Ramsey P . Ethical dimensions of experimental research on children . In:  Van Eys J editors. Research on Children (Medical Imperatives, Ethical Quandaries, and Legal Constraints) . Baltimore: University Park Press; 1978;p. 61–64
  14. Bartholome WG . Parents, children, and the moral benefits of research . Hastings Cent Rep . 1976;6:44–45
  15. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research . Research involving those institutionalized as mentally infirm . Washington, DC: US Government Printing Office; 1978;
  16. Bartholome WG . Ethical issues in pediatric research . In:  Vanderpool HY editors. The ethics of research involving human subjects . Frederick, MD: University Publishing Group; 1996;p. 360–361
  17. Baylis F , Downie J , Kenny N . Children and decisionmaking in health research . IRB . 1999;21:5–10
  18. Steinberg L . Clinical adolescent psychology (what it is, and what it needs to be) . J Consult Clin Psychol . 2002;70:124–128
  19. Drotar D . Relating parent and family functioning to the psychological adjustment of children with chronic health conditions (what have we learned? what do we need to know?) . J Pediatr Psychol . 1997;22:149–165
  20. Wallander J , Varni JW . Effects of pediatric chronic physical disorders on child and family adjustment . J Child Psychol Psychiatry . 1998;39:29–46
  21. Broome ME , Stieglitz KA . The consent process and children . Res Nurs Health . 1992;15:147–152
  22. Dorn L , Susman E , Fletcher J . Informed consent in children and adolescents (age, maturation, and psychological state) . J Adolesc Health . 1995;16:185–190
  23. Rutter M . Age as an ambiguous variable in developmental research (some epidemiological considerations from developmental psychopathology) . Int J Behav Dev . 1989;12:1–34
  24. Nelson RM , Reynolds WW . We should reject passive resignation in favor of requiring the assent of younger children for participation in nonbeneficial research . Am J Bioeth . 2003;3:11–13
  25. Nelson RM , Merz JF . Voluntariness of consent for research (an empirical and conceptual review) . Med Care . 2002;40:V69–V80
  26. Fogas B , Oesterheld J , Shader R . A retrospective study of children’s perceptions of participation as clinical research subjects in a minimal risk study . Dev Behav Pediatr . 2001;22:211–216
  27. Hurley J , Underwood M . Children’s understanding of their research rights before and after debriefing (informed assent, confidentiality, and stopping participation) . Child Dev . 2002;73:132–143
  28. Nannis E . Children’s understanding of their participation in psychological research (implications for issues of assent and consent) . Can J Behav Sci . 1991;23:133–141
  29. Susman E , Dorn L , Fletcher J . Participation in biomedical research (the consent process as viewed by children, adolescents, young adults, and physicians) . J Pediatr . 1992;121:547–552
  30. Abramovitch R , Freedman J , Henry K , Van Brunschot M . Children’s capacity to agree to psychological research (knowledge of risks and benefits and voluntariness) . Ethics Behav . 1995;5:25–48
  31. Scherer D . The capacities of minors to exercise voluntariness in medical treatment decisions . Law Hum Behav . 1991;15:431–449
  32. Hill J , Holmbeck G . Attachment and autonomy during adolescence . Ann Child Dev . 1986;3:145–189
  33. Smetana JG . Adolescents’ and parents’ conceptions of parental authority . Child Dev . 1988;59:321–335
  34. Dornbusch SM , Carlsmith JM , Bushwell S , Ritter PL , Leiderman PH , Hastorf AH , et al.   Single parents, extended households, and the control of adolescents . Child Dev . 1985;56:326–341
  35. Steinberg L , Silverberg S . The vicissitudes of autonomy in early adolescence . Child Dev . 1986;57:841–851
  36. Joffe S . Rethink “affirmative agreement,” but abandon “assent.” . Am J Bioeth . 2003;3:9–11
  37. Bluebond-Langner M , DeCicco A , Belasco J . Involving children with life-shortening illnesses in decisions about participation in clinical research (a proposal for shuttle diplomacy and negotiation) . In:  Kodish E editors. Ethics and Research with Children (A Case-based Approach) . New York: Oxford; 2005;p. 323–343
  38. Geller G , Tambor ES , Bernhardt BA , Fraser G , Wissow L . Informed consent for enrolling minors in genetic susceptibility research (a qualitative study of at-risk children’s and parents’ views about children’s role in decision-making) . J Adolesc Health . 2003;32:260–271
  39. Dunsmore J , Quine S . Information, support, and decision-making needs and preferences of adolescents with cancer (implications for health professionals) . J Psychosocial Oncol . 1995;13:39–56
  40. Dornbusch SM , Ritter PL , Mont-Reynaud R , Chen ZY . Family decision making and academic performance in a diverse high school population . J Adolescent Res . 1990;5:143–160
  41. Liprie ML . Adolescents’ contributions to family decision making . Marriage Family Rev . 1993;18:241–253
  42. White F . Parent-adolescent communication and adolescent decision-making . J Family Studies . 1996;2:41–56
  43. Wills T , Blechman E , McNamara G . Family support, coping, and competence . In:  Hetherington EM ,  Blechman E editor. Stress, Coping, and Resiliency in Children and Families . Mahwah, NJ: Lawrence Erlbaum Associates; 1996;p. 107–133
  44. Brody JL , Scherer DG , Annett RD , Pearson-Bish M . Voluntary assent in biomedical research with adolescents (a comparison of parent and adolescent views) . Ethics Behav . 2003;13:79–95
  45. Ross LF . Children, Families, and Health Care Decision Making . New York: Oxford University Press; 1998;
  46. Steinberg L , Cauffman E . Maturity of judgment in adolescence (psychosocial factors in adolescent decision making) . Law Hum Behav . 1996;20:249–272

PII: S0022-3476(06)00373-8

doi: 10.1016/j.jpeds.2006.04.047

The Journal of Pediatrics
Volume 149, Issue 1, Supplement , Pages S25-S30 , July 2006