Ethical Issues in Psychiatric Research on Children and Adolescents

Child and Adolescent Psychiatric Clinics of North America

Volumn 17, Issue 1, 2008, Pages 127-148

  Hoop, Jinger G ^a   Smyth, Angela C ^b   Roberts, Laura Weiss ^a  

^a MEDICAL COLLEGE OF WISCONSIN   (United States)

^b UNIVERSITY OF CHICAGO   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

CHILD PSYCHIATRY; CLINICAL PRACTICE; CLINICAL RESEARCH; CONFIDENTIALITY; CONFLICT OF INTEREST; EVIDENCE BASED PRACTICE; HUMAN; INFORMED CONSENT; METHODOLOGY; PATIENT SELECTION; PEER REVIEW; PRACTICE GUIDELINE; PRIORITY JOURNAL; PROFESSIONAL STANDARDS REVIEW ORGANIZATION; PSYCHIATRIST; RANDOMIZED CONTROLLED TRIAL; RESEARCH ETHICS; RESEARCH SUBJECT; REVIEW; RISK BENEFIT ANALYSIS;

ADOLESCENT; ADOLESCENT PSYCHIATRY; CHILD; CHILD PSYCHIATRY; ETHICS, MEDICAL; ETHICS, RESEARCH; HUMANS; INFORMED CONSENT; PRACTICE GUIDELINES AS TOPIC; RANDOMIZED CONTROLLED TRIALS AS TOPIC; RESEARCH SUBJECTS; UNITED STATES;

EID: 36248982138     PISSN: 10564993     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.chc.2007.07.003     Document Type: Review

References (83)

1. Angold A., Messer S.C., Stangl D., et al. Perceived parental burden and service use for child and adolescent psychiatric disorders. Am J Public Health 88 1 (1998) 75-80
2. Blanchard L.T., Gurka M.J., and Blackman J.A. Emotional, developmental, and behavioral health of American children and their families: a report from the 2003 national survey of children's health. Pediatrics 117 6 (2006) e1202-e1212
3. Laughren T.P. Regulatory issues in pediatric psychopharmacology. J Am Acad Child Adolesc Psychiatry 35 10 (1996) 1276-1282
4. NIH policy and guidelines on the inclusion of children as participants in research involving human subjects. Available at: http://grants.nih.gov/grants/guide/notice-files/not98-024.html. Accessed March 6, 1998.
5. Greenhill L., Jensen P., Abikoff H., et al. Developing strategies for psychopharmacological studies in preschool children. J Am Acad Child Adolesc Psychiatry 42 4 (2003) 406-414
6. Hepper F., and Fellow-Smith E. Off-label prescribing in a community child and adolescent mental health service: implications for information giving and informed consent. Clinician in Management 13 1 (2005) 29-34
7. Vitiello B., Jensen P., and Hoagwood K. Integrating science and ethics in child and adolescent psychiatry research. Biol Psychiatry 46 (1999) 1044-1049
8. Dooley J., Camfield P., Gordon K., et al. Lamotrigine-induced rash in children. Neurology 46 1 (1996) 240-242
9. Simon G. The antidepressant quandary-considering suicide risk when treating adolescent depression. N Engl J Med 355 26 (2006) 2722-2723
10. Bridge J.A., Iyengar S., Salary C.B., et al. Clinical response and risk for reported suicidal ideation and suicide attempts in pediatric antidepressant treatment: a meta-analysis of randomized controlled trials. JAMA 297 15 (2007) 1683-1696
11. Ryan N.D., and Varma D. Child and adolescent mood disorders-experience with serotonin-based therapies. Biol Psychiatry 44 5 (1998) 336-340
12. Plomin R. Finding genes in child psychology and psychiatry: when are we going to be there?. J Child Psychol Psychiatry 46 10 (2005) 1030-1038
13. Abou-Saleh M.T. Neuroimaging in psychiatry: an update. J Psychosom Res 61 3 (2006) 289-293
14. National Institutes of Health. Regulations and ethical guidelines. The Nuremberg Code. Available at: http://ohsr.od.nih.gov/guidelines/nuremberg.html. Accessed May 1, 2007.
15. Annas G.J., and Grodin M.A. The Nazi doctors and the Nuremberg Code (1992), Oxford University Press, New York
16. The World Medical Association. Declaration of Helsinki, 1964. Available at: http://www.wma.net/e/policy/b3.htm. Accessed April 27, 2007.
17. Krugman S. The Willowbrook hepatitis studies revisited: ethical aspects. Rev Infect Dis 8 1 (1986) 157-162
18. The President's Advisory Committee on Human Radiation Experiments. The human radiation experiments (1996), Oxford University Press, New York
19. 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, 1979. Available at: http://www.hhs.gov/ohrp/humansubjects/guidance/belmont.htm. Accessed June 12, 2006.
20. Roberts L.W. Informed consent and the capacity for voluntarism. Am J Psychiatry 159 5 (2002) 705-712
21. U.S. Department of Health and Human Services: Code of Federal Regulations: Title 45 public welfare, Department of Health and Human Services part 46 protection of human subjects, 2005. Available at: http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm. Accessed April 27, 2007.
22. U.S. Department of Health and Human Services: Code of Federal Regulations: title 21 Food and Drug Administration, Department of Health and Human Services. Part 50 protection of human subjects and Part 56 institutional review boards, 2001. Available at: http://www.access.gpo.gov/nara/cfr/waisidx_01/21cfrv1_01.html. Accessed April 27, 2007.
23. Levine R.J. Respect for children as research subjects. In: Lewis M. (Ed). Child and adolescent psychiatry (1991), Williams and Wilkins, Baltimore, MD 1229-1238
24. Roberts LW, Hoop JG, Anderson TT, et al. Professionalism and ethics: a self-assessment guide for medical professionals. Washington, DC: American Psychiatric Press, Inc.; in press.
25. U.S. Department of Health and Human Services: Code of Federal Regulations: title 45 public welfare, Department of Health and Human Services, part 46 protection of human subjects, Subpart D, additional protections for children involved as subjects in research, 2005. Available at: http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm#subpartd. Accessed April 27, 2007.
26. Levine C., Faden R., Grady C., et al. The limitations of "vulnerability" as a protection for human research participants. Am J Bioeth 4 3 (2004) 44-49
27. Emanuel E., Wendler D., and Grady C. What makes clinical research ethical?. JAMA 283 20 (2000) 2701-2711
28. Roberts L. Ethical dimensions of psychiatric research: a constructive, criterion-based approach to protocol preparation. The research protocol ethics assessment tool (RePEAT). Biol Psychiatry 46 (1999) 1106-1119
29. Munir K., and Earls F. Ethical principles governing research in child and adolescent psychiatry. J Am Acad Child Adolesc Psychiatry 31 (1992) 408-414
30. President's Commission for the Protection of Human Subjects in Biomedical and Behavioral Research. Protecting human subjects (1981), Government Printing Office, Washington, DC
31. Brody B.A. The ethics of biomedical research: an international perspective (1998), Oxford University Press, London
32. Levine R.J. Clinical trials and physicians as double agents. Yale J Biol Med 65 2 (1992) 65-74
33. Morin K., Rakatansky H., Riddick Jr. F.A., et al. Managing conflicts of interest in the conduct of clinical trials. JAMA 287 1 (2002) 78-84
34. Appelbaum P.S. Rethinking the conduct of psychiatric research. Arch Gen Psychiatry 54 2 (1997) 117-120
35. Chen D., Miller F., and Rosenstein D. Ethical aspects of research into the etiology of autism. Research Reviews 9 (2003) 48-53
36. United States Department of Health and Human Services. Code of Federal Regulations, title 45 public welfare, Department of Health and Human Services, part 160 and Subparts A and E of part 164, privacy rule 2000. Available at: http://www.hhs.gov/ocr/regtext.html. Accessed April 27, 2007.
37. National Institutes of Health. Certificates of confidentiality: background information, 2003. Available at: http://grants1.nih.gov/grants/policy/coc/background.htm. Accessed April 27, 2007.
38. Beecher H.K. Ethics and clinical research. N Engl J Med 274 (1966) 1354-1360
39. Dresser R. Wanted: single, white male for medical research. Hastings Cent Rep 22 (1992) 24-29
40. Institute of Medicine. Guidance for national healthcare disparities report (2002), National Academy Press, Washington, DC
41. United States Department of Health and Human Services. Healthy people 2010: understanding and improving health. 2nd edition (2000), Government Printing Office, Washington, DC
42. Miller V.A., and Nelson R.M. A developmental approach to child assent for nontherapeutic research. J Pediatr 149 (2006) S25-S30
43. Faden R.R., Beauchamp T.L., and King N. A history and theory of informed consent (1986), Oxford University Press, New York
44. Roberts L.W., Geppert C., McCarty T., et al. Evaluating medical students' skills in obtaining informed consent for HIV testing. J Gen Intern Med 18 (2003) 112-119
45. Appelbaum P., Roth L., and Lidz C. The therapeutic misconception: informed consent in psychiatric research. Int J Law Psychiatry 5 3-4 (1982) 319-329
46. Appelbaum P.S., and Grisso T. The MacArthur competence study I, II, III. Law Hum Behav 19 (1995) 105-174
47. Oesterheld J., Fogas B., and Rutten S. Ethical standards for research on children. J Am Acad Child Adolesc Psychiatry 37 7 (1998) 684-685
48. Gaylin W. The competence of children: no longer all or none. Hastings Cent Rep 12 2 (1982) 33-38
49. Arnold L.E., Stoff D.M., Cook Jr. E., et al. Ethical issues in biological psychiatric research with children and adolescents. J Am Acad Child Adolesc Psychiatry 34 (1995) 929-939
50. Rosato J. The ethics of clinical trials: a child's view. J Law Med Ethics 28 (2000) 362-378
51. Dresser R. Mentally disabled research subjects. The enduring policy issues. JAMA 276 (1996) 67-72
52. Levine R.J. Ethics and regulation of clinical research (1981), Urban & Schwartzenberg, Baltimore (MD)
53. Scherer D.G., Brody J.L., Annett R.D., et al. Financial compensation to adolescents for participation in biomedical research: adolescent and parent perspectives in seven studies. J Pediatr 146 4 (2005) 552-558
54. Carandang C., Santor D., Gardner D., et al. Data safety monitoring boards and other study methodologies that address subject safety in "high-risk" therapeutic trials in youths. J Am Acad Child Adolesc Psychiatry 46 4 (2007) 489-490
55. Horton R. Trial registers: protecting patients, advancing trust. Lancet 367 9523 (2006) 1633-1635
56. International Committee of Medical Journal Editors. Uniform requirements for manuscripts submitted to biomedical journals: writing and editing for biomedical publication. 2005. Available at: http://www.icmje.org/icmje.pdf. Accessed May 1, 2007.
57. Lader E.W., Cannon C.P., Ohman E.M., et al. The clinician as investigator: participating in clinical trials in the practice setting: appendix 1: fundamentals of study design. Circulation 109 (2004) e302-e304
58. Leber P. The placebo control in clinical trials (a view from the FDA). Psychopharmacol Bull 22 (1986) 30-32
59. Schaefer A. The ethics of the randomized clinical trial. N Engl J Med 307 (1982) 719-725
60. Rothman K.J., and Michels K.B. The continuing unethical use of placebo controls. N Engl J Med 331 (1994) 394-398
61. O'Leary K.D., and Borkovec T.D. Conceptual, methodological, and ethical problems of placebo groups in psychotherapy research. Am Psychol 33 (1978) 821-830
62. Levine R.J., and Schafer A. The use of placebos in randomized clinical trials. IRB 7 2 (1985) 1-6
63. Bok S. The ethics of giving placebos. Sci Am 231 5 (1974) 17-23
64. Klerman G.L. Scientific and ethical considerations in the use of placebo controls in clinical trials in psychopharmacology. Psychopharmacol Bull 22 (1986) 25-29
65. Derivan A., Lventhal B., March J., et al. The ethical use of placebo in clinical trials involving children. J Child Adolesc Psycholpharmacol 14 2 (2004) 169-174
66. Freedman B. Equipoise and the ethics of clinical research. N Engl J Med 317 3 (1987) 141-145
67. Caldwell P., Butow P., and Craig J. Parents' attitudes to children's participation in randomized controlled trials. J Pediatr 142 5 (2003) 554-559
68. Aman M., and Wolford P. Consumer satisfaction with involvement in drug research: a social validity study. J Am Acad Child Adolesc Psychiatry 34 7 (1995) 940-945
69. Bukstein O.G. Satisfaction with treatment for attention-deficit-hyperactivity disorder. Am J Manag Care 10 4 Suppl (2004) S107-S116
70. Tierney E., Aman M., Stout D., et al. Parent satisfaction in a multi-site acute trial of risperidone in children with autism: a social validity study. Psychopharmacology (Berl) 191 (2007) 149-157
71. Melton G.B. Parents and children: legal reform to facilitate children's participation. Am Psychol 54 (1999) 935-944
72. Belitz J. Caring for children. In: Roberts L.W., and Dyer A.R. (Eds). Concise guide to ethics in mental health care (2004), American Psychiatric Publishing, Washington, DC 119-135
73. Dorn L.D., Susman E.J., and Fletcher J.C. Informed consent in children and adolescents: age, maturation and psychological state. J Adolesc Health 16 3 (1995) 185-190
74. Brody J.L., Scherer D.G., Annett R.D., et al. Family and physician influence on asthma research participation decisions for adolescents: the effects of adolescent gender and research risk. Pediatrics 118 (2006) 356-362
75. Brody J.L., Annett R.D., Scherer D.G., et al. Comparisons of adolescent and parent willingness to participate in minimal and above-minimal risk pediatric asthma research protocols. J Adolesc Health 37 3 (2005) 229-235
76. Harth S., and Thong Y. Parental perceptions and attitudes about informed consent in clinical research involving children. Soc Sci Med 40 11 (1995) 1573-1577
77. Appelbaum P.S., and Grisso T. Assessing patients' capacities to consent to treatment. N Engl J Med 319 (1988) 1635-1638
78. Lidz C.W., Appelbaum P.S., Grisso T., et al. Therapeutic misconception and the appreciation of risks in clinical trials. Soc Sci Med 58 (2004) 1689-1697
79. Roberts L.W., Warner T.D., Anderson C.T., et al. Schizophrenia research participants' responses to protocol safeguards: recruitment, consent, and debriefing. Schizophr Res 67 (2004) 283-291
80. Roberts L.W., Hammond K.A., Warner T.D., et al. Influence of ethical safeguards on research participation: comparison of perspectives of people with schizophrenia and psychiatrists. Am J Psychiatry 161 (2004) 2309-2311
81. Rodriguez A., Tuvemo T., and Hansson M. Parents' perspectives on research involving children. Ups J Med Sci 111 1 (2006) 73-86
82. Fleischman A., and Klein J. Clinical research in the private office setting-ethical issues. Trans Am Clin Climatol Assoc 113 (2002) 126-136
83. Roa J.N., and Cassia L.J. Ethics of undisclosed payments to doctors recruiting patients in clinical trials. BMJ 325 (2002) 36-37