Ethical issues in adolescent and parent informed consent for pediatric asthma research participation

Journal of Asthma

Volumn 44, Issue 7, 2007, Pages 489-496

  Scherer, David G ^a,d   Annett, Robert D ^b   Brody, Janet L ^c  

^a UNIVERSITY OF MASSACHUSETTS   (United States)

^b UNIVERSITY OF NEW MEXICO HEALTH SCIENCES CENTER   (United States)

^c OREGON RESEARCH INSTITUTE   (United States)

^d UNIVERSITY OF MASSACHUSETTS   (United States)

Author keywords

Adolescent assent; Biomedical research ethics; Informed consent; Pediatric asthma research; Research participation decision making

Indexed keywords

ADOLESCENT; ASTHMA; COMPENSATION; COMPETENCE; DECISION MAKING; HUMAN; INFORMED CONSENT; KNOWLEDGE; MEDICAL RESEARCH; PARENT; PATIENT PARTICIPATION; PHYSICIAN; PSYCHOLOGICAL ASPECT; RESEARCH ETHICS; REVIEW; RISK FACTOR;

ADOLESCENT; ADOLESCENT PSYCHOLOGY; ASTHMA; BIOMEDICAL RESEARCH; CHILD; DECISION MAKING; ETHICS, RESEARCH; HUMANS; INFORMED CONSENT; MENTAL COMPETENCY; PARENTAL CONSENT; PATIENT PARTICIPATION; PERCEPTION; RISK ASSESSMENT; VOLITION;

EID: 34548860415     PISSN: 02770903     EISSN: 15324303     Source Type: Journal    
DOI: 10.1080/02770900701247137     Document Type: Review

References (93)

1. Abramovitch R, Freedman JL, Henry K, Van BM. Children's capacity to agree to psychological research: knowledge of risks and benefits and voluntariness. Ethics Behav 1995; 5(1):25-48.
2. Kopelman LM. Children as research subjects: A dilemma. Journal of Medicine and Philosophy 2000;25:745-764.
3. Levine RJ. Adolescents as research subjects without permission of their parents or guardians: ethical considerations. J Adolesc Health 1995; 17:287-297.
4. Weithorn LA, Scherer DG. Children's involvement in research participation decisions: Psychological considerations. In: Grodin, Glanz, eds. Children as research subjects: Science, ethics and law.Oxford, New York: Oxford University Press; 1994; 133-179.
5. U.S. Department of Health and Human Services. Centers for Disease Control and Prevention. Summary health statistics for U.S. Children: National Health Interview Survey, 2002. Vital and Health Statistics 2004; 10(221):1-87.
6. Recruitment of participants in the childhood Asthma Management Program (CAMP). I. Description of methods: Childhood Asthma Management Program Research Group. J Asthma 1999; 36:217-237.
7. Sorkness CA, Ford JG, Lemanske RF Jr. Recruitment strategies in the Asthma Clinical Research Network. Control Clin Trials 2001 Dec; 22(6 suppl):222S-235S.
8. Bender BG, Annett RD, Ikle D, DuHamel TR, Rand C, Strunk RC. Relationship between disease and psychological adaptation in children in the Childhood Asthma Management Program and their families. CAMP Research Group. Arch Pediatr Adolesc Med 2000; 154:706-713.
9. Bender BG, Ikle DN, DuHamel T, Tinkelman D. Retention of asthmatic patients in a longitudinal clinical trial. J Allergy Clin Immunol 1997 Feb; 99:197-203.
10. Scott ES, Reppucci ND, Woolard JL. Evaluating adolescent decision-making in legal contexts. Law Hum Behav 1995; 19:224-243.
11. Steinberg L, Cauffman E. Maturity of judgement in adolescence: psychosocial factors in adolescent decision making. Law Hum Behav 1996; 20:249-272.
12. Abramovitch R, Freedman JL, Thoden K, Nikolich C. Children's capacity to consent to participation in psychological research: empirical findings. Child Development 1991; 62:1100-1109.
13. Gardner W, Scherer D, Tester M. Asserting scientific authority. Cognitive development and adolescent legal rights. Am Psychol 1989 Jun; 44:895-902.
14. Grisso T. Minors' assent to behavioral research without parental consent. In: Stanley B, Seiber JE, eds. Social Research on Children and Adolescents. Newbury Park, California: Sage Publications; 1992; 109-127.
15. Scherer DG. The capacities of minors to exercise voluntariness in medical treatment decisions. Law Hum Behav 1991; 15:431-449.
16. Scherer DG. (Chair). Parents' and children's informed consent to pediatric research and treatment. Symposium conducted at the APA Annual Convention, San Francisco, CA 2001.
17. Thompson RA. Vulnerability in research: a developmental perspective on research risk. Child Dev 1990; 61:1-16.
18. Woolard JL, Reppucci ND, Redding RE. Theoretical and methodological issues in studying children's capacities in legal contexts. Law Hum Behav 1996; 20:219-228.
19. Annett RD, Brody JL, Scherer DG, Perkett EA. Perception of risk associated with asthma research procedures among adolescents, parents, and pediatricians. J Allergy Clin Immunol 2004; 114:1138-1145.
20. Brody JL, Annett RD, Scherer DG, Perryman ML, Cofrin KM. Comparisons of adolescent and parent willingness to participate in minimal and above-minimal risk pediatric asthma research protocols. J Adolesc Health 2005; 37:229-235.
21. 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.
22. Brody JL, Scherer DG, Annett RD, Turner C, Dalen J. Family and physician influence on asthma research-participation decisions for adolescents: the effects of adolescent gender and research risk. Pediatrics 2006.
23. Scherer DG, Brody JL, Annett RD, Hetter J, Roberts LW, Cofrin KM. Financial compensation to adolescents for participation in biomedical research: adolescent and parent perspectives in seven studies. J Pediatr 2005; 146:552-558.
24. Broome ME. Consent (assent) for research with pediatric patients. Semin Oncol Nurs 1999; 15:96-103.
25. Broome ME, Richards DJ. The influence of relationships on children's and adolescents' participation in research. Nurs Res 2003; 52:191-197.
26. Broome ME, Richards DJ, Hall J. Children in research: the experiences of ill children and adolescents. J Fam Nurs 2001; 7:32-49.
27. Kodish ED, Pentz RD, Noll RB, Ruccione K, Buckley J, Lange BJ. Informed consent in the Childrens Cancer Group: results of preliminary research. Cancer 1998; 82: 2467-2481.
28. Olechnowicz JQ, Eder M, Simon C, Zyzanski S,Kodish E. Assent observed: children's involvement in leukemia treatment and research discussions. Pediatrics 2002; 109:806-814.
29. Hochhauser M. Concepts, categories, and value judgments in informed consent forms. IRB 2003; 25:7-10.
30. Lawson SL, Adamson HM. Informed consent readability: subject understanding of 15 common consent form phrases. IRB 1995; 17(5-6):16-19.
31. Paasche-Orlow MK, Taylor HA, Brancati FL. Readability standards for informedconsent forms as compared with actual readability. N Engl J Med 2003; 348:721-726.
32. Ogloff JR, Otto RK. Are research participants truly informed? Readability of informed consent forms used in research. Ethics Behav 1991; 1:239-252.
33. Cohn LD, Schydlower M, Foley J, Copeland RL. Adolescents' misinterpretation of health risk probability expressions. Pediatrics 1995; 95:713-716.
34. Fogas BS, Oesterheld JR, Shader RI. A retrospective study of children's perceptions of participation as clinical research subjects in a minimal risk study. J Dev Behav Pediatr 2001; 22:211-216.
35. Tates K, Meeuwesen L. 'Let mum have her say': turntaking in doctor-parent-child communication. Patient Educ Couns 2000; 40:151-162.
36. Tates K, Meeuwesen L. Doctor-parent-child communication. A (re)view of the literature. Soc Sci Med 2001; 52:839-851.
37. Young RA, Lynam MJ, Valach L, Novak H, Brierton I, Christopher A. Joint actions of parents and adolescents in health conversations. Qual Health Res 2001; 11:40-57.
38. Responsible research: A systems approach to protecting research participants. Washington, DC: Institute of Medicine; 2003.
39. Fisher CB.Arelational perspective on ethics-in-science decisionmaking for research with vulnerable populations. IRB: A Review of Human Subjects Research 1997; 19:1-4.
40. Fisher CB. Participant consultation: Ethical insights into parental permissions and confidentiality procedures for policy-relevant research with youth. In: Lerner RM, Jacobs F,Wertlieb D, eds. Handbook of applied developmental science: promoting positive child, adolescent, and family development through research, policies, and programs.Imprint Thousand Oaks, California: Sage Publications; 2003; 371-396.
41. Geller G, Tambor ES, Bernhardt BA, Fraser G, Wissow LS. 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.
42. Field MJ, Behrman RE. Institute of Medicine. Ethical conduct of clinical research involving children. Washington, DC: National Academies; 2004.
43. Mccabe MA, Rushton CH, Glover J, Murray MG, Leikin S. Implications of the Patient Self-Determination Act: guidelines for involving adolescents in medical decision making. J Adolesc Health 1996; 19:319-324.
44. Burke TM, Abramovitch R, Zlotkin S. Children's understanding of the risks and benefits associated with research. J Med Ethics 2005; 31:715-720.
45. Weithorn LA, Campbell SB. The competency of children and adolescents to make informed treatment decisions. Child Dev 1982; 53:1589-1598.
46. Halpern-Felsher BL, Caufmann E. Costs and benefits of a decision: Decisionmaking competence in adolescents and adults. Appl Devel Psychol 2001; 22:257-273.
47. 56 Federal Register 28003 (codified at 45 CFR 46). Washington DC: US Government Printing Office; 1991.
48. Weijer C. The ethical analysis of risk. J Law, Med Ethics 2000; 28:344-361.
49. Office for Human Research Protections. IRB Guidebook (Chapter VI, Special Classes of Subjects) 2001Available from: URL: Available: at http://ohrp.osophs.dhhs.gov/irb/irb_guidebook.htm
50. Cohn LD, Macfarlane S, Yanez C, Imai WK. Risk-perception: differences between adolescents and adults. Health Psychol 1995; 14:217-222.
51. Quadrel MJ, Fischhoff B, Davis W. Adolescent (in)vulnerability. Am Psychol 1993; 48:102-116.
52. Susman EJ, Dorn LD, Fletcher JC. Participation in biomedical research: the consent process as viewed by children, adolescents, young adults, and physicians. J Pediatr 1992; 121:547-552.
53. Kaser-Boyd N, Adelman HS, Taylor L. Minors' ability to identify risks and benefits of therapy. Prof Psychol Res Pr 1985; 16:411-417.
54. Arnold LE, Stoff DM, Cook E Jr, Cohen DJ, Kruesi M, Wright C, et al. Ethical issues in biological psychiatric research with children and adolescents. J Am Acad Child Adolesc Psychiatry 1995; 34:929-939.
55. Fradet C, McGrath PJ, Kay J, Adams S, Luke B. A prospective survey of reactions to blood tests by children and adolescents. Pain 1990; 40:53-60.
56. Ondrusek N, Abramovitch R, Pencharz P, Koren G. Empirical examination of the ability of children to consent to clinical research. J Med Ethics 1998; 24:158-165.
57. Michaels TF, Oetting ER. The informed consent dilemma: an empirical approach. J Soc Psychol 1979; 109:223-230.
58. Sullivan DS, Deiker TE. Subject-experimenter perceptions of ethical issues in human research. Am Psychol 1973; 28:587-591.
59. Kupst MJ. Clinical trials in pediatric cancer: Parental perspectives on informed consent. In D G Scherer (Chair), Parents' and children's informed consent to pediatric research and treatment 2001;Symposium conducted at the APA Annual Convention, San Francisco, CA.
60. Skinner LJ, Berry KK, Biro M, Jackson T. Research ethicality: the perceptions of participants and their participation willingness. Curr Psychol 1991; 10(1-2):79-91.
61. Holder AR, Veatch RM. Can teenagers participate in research without parental consent? IRB 1981; 3(2):5-8.
62. English A, Kenney KE. State Minor Consent Laws: A Summary, 2nd ed. Chapel Hill, NC. Center for Adolescent Health & the Law 2003.
63. Mammel KA, Kaplan DW. Research consent by adolescent minors and institutional review boards. J Adolesc Health 1995; 17:323-330.
64. Society for Adolescent Medicine. Guidelines for adolescent health research. J Adoles Health 2003; 33:396-409.
65. McGee G. Children's participation in nonbeneficial research: should they decide? Open peer commentaries. Am J Bioeth 2003; 3:8-40.
66. Wendler D, Shah S. Should children decide whether they are enrolled in nonbeneficial research? Am J Bioeth 2003; 3:1-7.
67. Milgram S. Behavioral study of obedience. J Abnorm Psychol 1963; 67:371-378.
68. Scherer DG, Reppuci ND. Adolescents' capacities to provide voluntary informed consent: the effects of parental influence and medical dilemmas. Law Hum Behav 1988; 12:123-141.
69. Lidz CW, Meisel A, Zerubavel E, Carter M, Sestak RM, Roth LH. Informed Consent: A Study of Decisionmaking in Psychiatry. New York: Guilford Press; 1984.
70. Ong LM, de Haes JC, Hoos AM, Lammes FB. Doctor-patient communication: a review of the literature. Soc Sci Med 1995; 40:903-918.
71. Nucci L, Smetana JG. Mothers' concepts of young children's areas of personal freedom. Child Dev 1996; 67:1870-1886.
72. Pomerantz EM, Ruble DN. The role of maternal control in the development of sex differences in child self-evaluative factors. Child Dev 1998; 69:458-478.
73. Smetana JG, Daddis C. Domain-specific antecedents of parental psychological control and monitoring: the role of parenting beliefs and practices. Child Dev 2002; 73:563-580.
74. Kaminsky A, Roberts LW, Brody JL. Influences upon willingness to participate in schizophrenia research: an analysis of narrative data from 63 people with schizophrenia. Ethics Behav 2003; 13:279-302.
75. Aby JS, Pheley AM, Steinberg P. Motivation for participation in clinical trials of drugs for the treatment of asthma, seasonal allergic rhinitis, and perennial nonallergic rhinitis. Ann Allergy Asthma Immunol 1996; 76:348-354.
76. Dickert N, Grady C. What's the price of a research subject? Approaches to payment for research participation. N Engl J Med 1999; 341:198-203.
77. Dresser R. Payments to research participants: the importance of context. Am J Bioeth 2001; 1:47.
78. Kuczewski M. Is informed consent enough? Monetary incentives for research participation and the integrity of biomedicine. Am J Bioeth 2001; 1:49-51.
79. Vere DW. Payments to healthy volunteers-ethical problems. Br J Clin Pharmacol 1991; 32:141-142.
80. Viens AM. Socio-economic status and inducement to participate. Am J Bioeth 2001; 1:1f-2f.
81. Erlen JA, Sauder RJ, Mellors MP. Incentives in research: ethical issues. Orthop Nurs 1999; 18:84-87.
82. Grady C. Money for research participation: does in jeopardize informed consent? Am J Bioeth 2001; 1:40-4.
83. Savulescu J. The fiction of "undue inducement": Why researchers should be allowed to pay participants any amount of money for any reasonable research project. Am J Bioeth 2001; 1:1g-3g.
84. Siminoff LA. Money and the research subject: A comment on Grady. Am J Bioeth 2001; 1:65-66.
85. Wilkenson M, Moore A. Inducement in research. Bioethics 1997; 11:373-389.
86. Zink S. Maybe we should pay them more. Am J Bioeth 2001; 1:1h.
87. Fernhoff PM. Paying for children to participate in research: a slippery slope or an enlightened stairway? J Pediatr 2002; 141:153-154.
88. Weise KL, Smith ML, Maschke KJ, Copeland HL. National practices regarding payment to research subjects for participating in pediatric research. Pediatrics 2002; 110:577-582.
89. Wendler D, Rackoff JE, Emanuel EJ, Grady C. The ethics of paying for children's participation in research. J Pediatr 2002; 141:166-171.
90. Lidz, CW, Appelbaum, PS, Grisso, T. Therapeutic misconception and the appreciation of risks in clinical trials. Soc Sci & Med 2004; 58:1689-1697.
91. Vitiello B, Aman MG, Scahill L, McCracken JT, McDougle CJ, Tierney E, Davies M, Arnold LE. Research knowledge among parents of children participating in a randomized clinical trial. JAm Acad Child Adol Psych 2005; 44:145-149.
92. Lemanek KL. Adherence. In: Brown RT, ed. Handbook of Pediatric Psychology in School Settings.Mahwah, NJ: Lawrence Erlbaum Associates; 2004; 149-168.
93. Brody JL, Gluck JP, Aragon AS. Participants' understanding of the process of psychological research: informed consent. Ethics Behav 1997; 7:285-298.