When, Why, and How to Conduct Research in Child and Adolescent Psychiatry: Practical and Ethical Considerations

Psychiatric Clinics of North America

Volumn 32, Issue 2, 2009, Pages 361-380

  Chen, Donna T ^a   Shepherd, Lois L ^a,b  

^a UNIVERSITY OF VIRGINIA   (United States)

^b UNIVERSITY OF VIRGINIA SCHOOL OF LAW   (United States)

Author keywords

Children and adolescents; Mental health; Practical clinical trials; Practice based research; Research ethics

Indexed keywords

ADOLESCENT; ATTENTION DEFICIT DISORDER; CHILD; CHILD PSYCHIATRY; CLINICAL DECISION MAKING; CLINICAL PRACTICE; CLINICAL RESEARCH; CONFLICT; DOCTOR PATIENT RELATION; HUMAN; INFORMATION DISSEMINATION; INFORMED CONSENT; INTERPERSONAL COMMUNICATION; MEDICAL FEE; MEDICAL PRACTICE; MEDICAL PROFESSION; MENTAL HEALTH CARE; PATIENT SELECTION; PHYSICIAN ATTITUDE; PRESCHOOL CHILD; PRIORITY JOURNAL; PROFESSIONAL SECRECY; PROFESSIONALISM; RESEARCH ETHICS; RESEARCH SUBJECT; REVIEW; RISK ASSESSMENT; SCHOOL CHILD;

ADOLESCENT; ADOLESCENT PSYCHIATRY; BIOMEDICAL RESEARCH; CHILD; CHILD PSYCHIATRY; CONFIDENTIALITY; CONFLICT OF INTEREST; DECISION MAKING; FORMS AND RECORDS CONTROL; GENETIC RESEARCH; GOVERNMENT REGULATION; HUMANS; INFORMED CONSENT; PATIENT SELECTION; PHYSICIAN-PATIENT RELATIONS; RISK ASSESSMENT; THIRD-PARTY CONSENT;

EID: 66249111128     PISSN: 0193953X     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.psc.2009.03.003     Document Type: Review

References (84)

1. Geddes J., and Carney S. Recent advances in evidence-based psychiatry. Can J Psychiatry 46 5 (2001) 403-406
2. Essock S.M., Goldman H.H., Van Tosh L., et al. Evidence-based practices: setting the context and responding to concerns. Psychiatr Clin North Am 26 4 (2003) 919-938
3. March J.S., Silva S.G., Compton S., et al. The case for practical clinical trials in psychiatry. Am J Psychother 162 (2005) 836-846
4. March J.S., Silva S.G., Compton S., et al. The Child and Adolescent Psychiatry Trials Network (CAPTN). J Am Acad Child Adolesc Psychiatry 43 5 (2004) 515-518
5. On December 5, 2008, ClinicalTrials.gov has 65,543 trials listed with locations in 161 countries. Listed studies include phases I- IV as well as observational studies. A search on the term "child AND mental health" finds 865 studies of which 360 studies are open to recruitment. 23 of these open studies are sponsored by industry, 213 are sponsored by NIH, 17 are sponsored by other federal agencies, and 152 studies are sponsored by universities/organizations/other. Two of these studies are part of the Child and Adolescent Psychiatry Trials Network (CAPTN). Available at:. http://www.cliwwwnicaltrials.gov Accessed December 5, 2008
6. Chen D.T., Miller F.G., and Rosenstein D.L. Clinical research and the physician-patient relationship. Ann Intern Med 138 8 (2003) 669-672
7. Hoop J.G., Smyth A.C., and Roberts L.W. Ethical issues in psychiatric research on children and adolescents. Child Adolesc Psychiatr Clin N Am 17 1 (2008) 127-148
8. Arnold L.E. Turn-of-the-century ethical issues in child psychiatric research. Curr Psychiatry Rep 3 2 (2001) 109-114
9. Hotopf M., Churchill R., and Lewis G. Pragmatic randomised controlled trials in psychiatry. Br J Psychiatry 175 (1999) 217-223
10. Wasserman R.C., Slora E.J., Bocian A.B., et al. Pediatric research in office settings (PROS): a national practice-based research network to improve children's health care. Pediatrics 102 6 (1998) 1350-1357
11. Green L.A., Wood M., Becker L., et al. The Ambulatory Sentinel Practice Network: purpose, methods, and policies. J Fam Pract 18 2 (1984) 275-280
12. For up-to-date information and examples, see homepage of AHRQ Practice-Based Research Networks. Available at:. http://pbrn.ahrq.gov/portal/server.pt Accessed December 10, 2008
13. For up-to-date information about contract/clinical research organizations, see the website for the Association of Clinical Research Organizations. Available at:. http://www.acrohealth.org/ Accessed December 10, 2008
14. Rettig R.A. The industrialization of clinical research. Health Aff (Millwood) 19 2 (2000) 129-146
15. Wadman M. The quiet rise of the clinical contractor. Nature 441 7089 (2006) 22-23
16. Shuchman M. Commercializing clinical trials-risks and benefits of the CRO boom. N Engl J Med 357 14 (2007) 1365-1368
17. Chen D.T., and Worrall B.B. Practice-based clinical research and ethical decision making-Part I: deciding whether to incorporate practice-based research into your clinical practice. Semin Neurol 26 1 (2006) 131-139
18. Chen D.T., and Worrall B.B. Practice-based clinical research and ethical decision making-Part II: deciding whether to host a particular research study in your practice. Semin Neurol 26 1 (2006) 140-147
19. Wolf L.E., Walden J.F., and Lo B. Human subjects issues and IRB review in practice-based research. Ann Fam Med 3 Suppl 1 (2005) S30-S37
20. Graham D.G., Spano M.S., and Manning B. The IRB challenge for practice-based research: strategies of the American Academy of Family Physicians National Research Network (AAFP NRN). J Am Board Fam Med 20 2 (2007) 181-187
21. Excellent overviews and educational materials are available at the Clinical Trials Networks Best Practices website. Available at:. https://www.ctnbestpractices.org/ Accessed December 10, 2008
22. Beach J.E. Clinical trials integrity: a CRO perspective. Account Res 8 3 (2001) 245-260
23. Snyder L., and Mueller P.S. Research in the physician's office: navigating the ethical minefield. Hastings Cent Rep 38 2 (2008) 23-25
24. Gray T. Getting the most out of community-based research. ACP Observer (2004). http://www.acpinternist.org/archives/2004/04/cbr.htm . Accessed December 10, 2008
25. Klein J.E., and Fleischman A.R. The private practicing physician-investigator: ethical implications of clinical research in the office setting. Hastings Cent Rep 32 (2002) 22-26
26. Eichenwald K., and Kolata G. Drug trials hide conflicts for doctors. New York Times (print) 1 (1999) 34. Available at: http://www.nytimes.com/1999/05/16/business/drug-trials-hide-conflicts-fo r-doctors.html%sec=health Accessed February 24, 2009
27. Zuckerman G. Biovail is paying physicians prescribing new heart drug. Wall St J (July 21, 2003). Available at: http://wsj.com/article/SB105874152264f463400.html?med=americas_business_ whats_news Accessed February 24, 2009
28. Harris G., Carey B., and Roberts J. Psychiatrists, children, and drug industry's role. New York Times (May 10, 2007). http://www.nytimes.com/2007/05/10psyche.html Accessed February 24, 2009
29. Harris G., and Carey B. Researchers fail to reveal full drug pay. New York Times (June 8 2008). http://www.nytimes.com Accessed February 24, 2009
30. CEJA Report 2 - I-94, Finder's fees: payment for the referral of patients to clinical research Studies. Available at:. http://www.ama-assn.org/ama1/pub/upload/mm/369/ceja_2i94.pdf Accessed December 10, 2008
31. American Academy of Child and Adolescent Psychiatry. AACAP guidelines on conflict of interest for child and adolescent psychiatrists. Available at:. http://www.aacap.org/galleries/transparency-portal/Council%20Approved%20 COI%20Guidelines%20for%20Practitioners%201-30-2009.pdf Accessed February 24, 2009
32. 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
33. Werhane P., and Doering J. Conflicts of interest and conflicts of commitment. Prof Ethics 4 (1995) 47-81
34. Miller F.G., Rosenstein D.L., and DeRenzo E.G. Professional integrity in clinical research. JAMA 280 16 (1998) 1449-1454
35. Roberts L.W., Geppert C.M., and Brody J.L. A framework for considering the ethical aspects of psychiatric research protocols. Compr Psychiatry 42 5 (2001) 351-363
36. Emanuel E.J., Wendler D., and Grady C. What makes clinical research ethical?. JAMA 283 20 (2000) 2701-2711
37. Noah B.A. Bioethical malpractice: risk and responsibility in human research. J Health Care Law Pol 7 2 (2004) 175-241
38. Joffe S., and Truog R.D. Equipoise and randomization. In: Emanuel E.J., Grady C., Crouch R.A., et al (Eds). The Oxford textbook of clinical research ethics (2008), Oxford University Press, New York 245-252
39. Coleman C.H. Duties to subjects in clinical research. Vanderbilt Law Rev 58 (2005) 387-449
40. World Medical Association. Declaration of Helsinki. 2008. Available at: http://www.wma.net/e/policy/b3.htm. Accessed December 10, 2008.
41. Kimmelman J. The therapeutic misconception at 25: treatment, research, and confusion. Hastings Cent Rep 37 6 (2007) 36-42
42. Dresser R. The ubiquity and utility of the therapeutic misconception. Soc Philos Policy 19 2 (2002) 271-294
43. Henderson G.E., Churchill L.R., Davis A.M., et al. Clinical trials and medical care: defining the therapeutic misconception. PLoS Med 4 11 (2007) e324
44. Appelbaum P.S., Roth L.H., Lidz C.W., et al. False hopes and best data: consent to research and the therapeutic misconception. Hastings Cent Rep 17 2 (1987) 20-24
45. Miller F.G., and Joffe S. Benefit in phase 1 oncology trials: therapeutic misconception or reasonable treatment option?. Clin Trials 5 6 (2008) 617-623
46. Emanuel L.L., and Richter J. The consultant and the patient-physician relationship. A trilateral deliberative model. Arch Intern Med 154 (1994) 1785-1790
47. Stoeckle J.D., Ronan L.J., Emanuel L.L., et al. A manual on manners and courtesies for the shared care of patients. J Clin Ethics 8 (1997) 22-33
48. Department of Health and Human Services. 45 CFR §46.116 and 45 CFR §46.117. Available at:. http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm Accessed April 9, 2009
49. Department of Health and Human Services. 45 CFR §46.408 (2008). Available at:. http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm Accessed April 9, 2009
50. Committee on Bioethics, American Academy of Pediatrics. Informed consent, parental permission, and assent in pediatric practice. Pediatrics 95 2 (1995) 314-317
51. Department of Health and Human Services. 45 CFR §46.408(b) and (d) (2008). Available at: http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm. Accessed April 9, 2009.
52. Department of Health and Human Services. 45 CFR §46.408(a). Available at: http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm. Accessed April 9, 2009.
53. Kuther T.L., and Posada M. Children and adolescents' capacity to provide informed consent for participation in research. Adv Psychol Res 32 (2004) 163-173
54. Food and Drug Administration, Department of Health and Human Services, 21 C.F.R. §50.55.
55. In brief, waivers are only permitted when the research could not practically be carried out without a waiver (45 C.F.R. §46.116(c) & (d)), or when parental permission is not a reasonable requirement to protect the subjects (for example, neglected or abused children) and an appropriate mechanism for protecting the children is substituted (45 C.F.R. §46.408(c)).
56. Collagan L.K., and Fleischman A.R. Adolescent research and parental permission. In: Kodish E. (Ed). Ethics and research with children (2005), Oxford University Press, New York 77-99
57. Campbell A.T. State regulations of medical research with children and adolescents: an overview and analysis. In: Field M.J., and Behrman R.E. (Eds). Ethical conduct of clinical research involving children. a report of the Institute of Medicine (2004), National Academies Press, Washington, DC 320-387
58. Children are defined in the regulations as "persons who have not attained the legal age for consent to treatments or procedures involved in the research, under the applicable law of the jurisdiction in which the research will be conducted." 45 CFR §46.402(a) (2008).
59. Katzman D.K. Guidelines for adolescent health research. J Adolesc Health 33 5 (2003) 410-415
60. Santelli J.S., Rogers A.S., Rosenfeld W.D., et al. Guidelines for adolescent health research: a position paper of the Society for Adolescent Medicine. J Adolesc Health 33 5 (2003) 396-409
61. Glantz L.H. Research with children. Am J Law Med 24 (1998) 213-244
62. Department of Health and Human Services, Office for Human Research Protections, OHRP Research Involving Children Frequently Asked Questions, Question 17. Available at:. http://www.hhs.gov/ohrp/researchfaq.html Accessed April 9, 2009
63. Campbell A.T. Consent, competence, and confidentiality related to psychiatric conditions in adolescent medicine practice. Adolesc Med Clin 17 1 (2006) 25-47
64. See, e.g., Cal Fam Code §6924 (2008) (psychotropic drugs); Florida Stat §394.4784 (2008) (any medication); Ohio Rev Code Ann (2008) §5122.04 (any medication). See generally Vukadinovich DM. Minors' rights to consent to treatment: navigating the complexity of state laws. J Health Law 2004;37(4):667-91.
65. Nuffield Council on Bioethics. Mental disorders and genetics: the ethical context (1998), Nuffield Council on Bioethics, London
66. Farmer A.E., Owen M.J., and McGuffin P. Bioethics and genetic research in psychiatry. Br J Psychiatry 176 (2000) 105-108
67. Appelbaum P.S. Ethical issues in psychiatric genetics. J Psychiatr Pract 10 6 (2004) 343-351
68. 23andMe Home Page. Available at:. https://www.23andme/.com Accessed on December 12, 2008 when the cost was $399, and a "family special" was being offered with a savings of $200
69. Burke W., Pinsky L.E., and Press N.A. Categorizing genetic tests to identify their ethical, legal, and social implications. Am J Med Genet 106 3 (2001) 233-240
70. Ravitsky V., and Wilfond B.S. Disclosing individual genetic results to research participants. Am J Bioeth 6 6 (2006) 8-17
71. Bloch M.H., Landeros-Weisenberger A., Sen S., et al. Association of the serotonin transporter polymorphism and obsessive-compulsive disorder: systematic review. Am J Med Genet B Neuropsychiatr Genet 147B 6 (2008) 850-858
72. Caspi A., Sugden K., Moffitt T.E., et al. Influence of life stress on depression: moderation by a polymorphism in the 5-HTT gene. Science 301 5631 (2003) 386-389
73. Prasad H.C., Steiner J.A., Sutcliffe J.S., et al. Enhanced activity of human serotonin transporter variants associated with autism. Philos Trans R Soc Lond B Biol Sci 364 1514 (2009) 163-173
74. Camilleri M., Busciglio I., Carlson P., et al. Candidate genes and sensory functions in health and irritable bowel syndrome. Am J Physiol Gastrointest Liver Physiol 295 2 (2008) G219-G225
75. Kronenberg S., Frisch A., Rotberg B., et al. Pharmacogenetics of selective serotonin reuptake inhibitors in pediatric depression and anxiety. Pharmacogenomics 9 11 (2008) 1725-1736
76. Lavieri R.R., and Garner S.A. Ethical considerations in the communication of unexpected information with clinical implications. Am J Bioeth 6 6 (2006) 46-48
77. American Society of Human Genetics Board of Directors, American College of Medical Genetics Board of Directors. Points to consider: ethical, legal, and psychosocial implications of genetic testing in children and adolescents. Am J Hum Genet 57 5 (1995) 1233-1241
78. Nelson R.M., Botkjin J.R., Kodish E.D., et al., Committee on Bioethics. Ethical issues with genetic testing in pediatrics. Pediatrics 107 6 (2001) 1451-1455
79. Stevenson D.A., and Strasburger V.C. Advise or consent? Issues in genetic testing of adolescents. Adolesc Med 13 2 (2002) 213-221
80. Cho M.K. Understanding incidental findings in the context of genetics and genomics. J Law Med Ethics 36 2 (2008) 280-285
81. Ensenauer R.E., Michels V.V., and Reinke S.S. Genetic testing: practical, ethical, and counseling considerations. Mayo Clin Proc 80 1 (2005) 63-73
82. Lucassen A., and Parker M. Revealing false paternity: some ethical considerations. Lancet 357 9261 (2001) 1033-1035
83. Lilani A. Ethical issues and policy analysis for genetic testing: Huntington's disease as a paradigm for diseases with a late onset. Hum Reprod Genet Ethics 11 2 (2005) 28-34
84. Public Law 110-233 (2008).