The ethics of psychopharmacological research in legal minors

Child and Adolescent Psychiatry and Mental Health

Volumn 2, Issue , 2008, Pages

  Tan, Jacinta O A ^a   Koelch, Michael ^b  

^a UNIVERSITY OF OXFORD   (United Kingdom)

^b UNIVERSITY HOSPITAL ULM   (Germany)

Author keywords

[No Author keywords available]

Indexed keywords

DRUG; FLUOXETINE; PSYCHOTROPIC AGENT;

ARTICLE; CLINICAL COMPETENCE; CLINICAL TRIAL; DEPRESSION; DRUG COST; DRUG INDUSTRY; DRUG LEGISLATION; HEALTH CARE QUALITY; HUMAN; HUMAN RIGHTS; INFORMED CONSENT; LEGAL LIABILITY; MEDICAL DECISION MAKING; MEDICAL PROFESSION; MEDICAL RESEARCH; PATENT; PATIENT SAFETY; PRIORITY JOURNAL; PROFESSIONAL STANDARD; PSYCHOLOGICAL WELL BEING; PSYCHOPHARMACOLOGY; PSYCHOSIS; PSYCHOTHERAPY; REIMBURSEMENT; RESEARCH ETHICS; SUICIDE;

EID: 58149493576     PISSN: None     EISSN: 17532000     Source Type: Journal    
DOI: 10.1186/1753-2000-2-39     Document Type: Article

References (61)

1. World Medical Association Declaration of Helsinki: Ethical Principles for Medical Research Involving Human Subjects vol. Adopted by the 18th WMA General Assembly, Helsinki, Finland, June 1964 and amended by the 29th WMA General Assembly, Tokyo, Japan, October 1975, 35th WMA General Assembly, Venice, Italy, October 1983 41st WMA General Assembly, Hong Kong, September 1989, 48th WMA General Assembly, Somerset West, Republic of South Africa, October 1996, and the 52nd WMA General Assembly, Edinburgh, Scotland, October 2000 Note of Clarification on Paragraph 29 added by the WMA General Assembly, Washington 2002 Note of Clarification on Paragraph 30 added by the WMA General Assembly, Tokyo 2004 1964 (2000)
2. Bakker MK Kolling P Berg van den PB de Walle HE de Jong van den Berg LT Increase in use of selective serotonin reuptake inhibitors in pregnancy during the last decade, a population-based cohort study from the Netherlands Br J Clin Pharmacol 2008, 65:600-606. Epub 2007 Oct 2022. 10.1111/j.1365-2125.2007.03048.x 17953715
3. Conroy S Choonara I Impicciatore P Mohn A Arnell H Rane A Knoeppel C Seyberth H Pandolfini C Raffaelli MP et al. Survey of unlicensed and off label drug use in paediatric wards in European countries. European Network for Drug Investigation in Children Bmj 2000, 320:79-82. 27251 10625257 10.1136/bmj.320.7227.79
4. Horen B Montastruc JL Lapeyre-Mestre M Adverse drug reactions and off-label drug use in paediatric outpatients Br J Clin Pharmacol 2002, 54:665-670. 1874497 12492616 10.1046/j.1365-2125.2002.t01-3-01689.x
5. Waller DG Off-label and unlicensed prescribing for children: Have we made any progress? Br J Clin Pharmacol 2007, 64:1-2. 2000617 17577389 10.1111/j.1365-2125.2007.02987.x
6. Dell ML Vaughan BS Kratochvil CJ Ethics and the prescription pad Child Adolesc Psychiatr Clin N Am 2008, 17:93-111. 10.1016/j.chc.2007.08.003 18036481
7. Volkers AC Heerdink ER van Dijk L Antidepressant use and off-label prescribing in children and adolescents in Dutch general practice (2001-2005) Pharmacoepidemiol Drug Saf 2007, 16:1054-1062. 10.1002/ pds.1430 17551992
8. Zito JM Safer DJ Valluri S Gardner JF Korelitz JJ Mattison DR Psychotherapeutic medication prevalence in Medicaid-insured preschoolers J Child Adolesc Psychopharmacol 2007, 17:195-203. 10.1089/cap.2007.0006 17489714
9. Schepker R Lippert H-D Kölch M Fegert J Fragwürdigkeit eines Gerichtsurteils zur Antidepressiva- Verordnung bei Jugendlichen/The dilemma of court expertise- commentary on the SSRI- tapering verdict by the saxonian social court Zeitschrift für Kinder- und Jugendpsychiatrie und Psychotherapie 2007, 35:207-212. 10.1024/ 1422-4917.35.3.207
10. Fegert JM Ethical and Legal Problems in Treating Schizophrenic Patients with Neuroleptics During Childhood and Adolescence Child and Adolescent Psychopharmacology News 2003, 8:4-5. 10.1521/capn.8.4.5.23069
11. Grieve J Tordoff J Reith D Norris P Effect of the pediatric exclusivity provision on children's access to medicines Br J Clin Pharmacol 2005, 59:730-735. 1884875 15948940 10.1111/j.1365-2125.2005.02327.x
12. Vitiello B Research in child and adolescent psychopharmacology: Recent accomplishments and new challenges Psychopharmacology (Berl) 2007, 191:5-13. Epub 2006 May 2023. 10.1007/s00213-006-0414-3 16718480
13. Spetie L Arnold LE Ethical issues in child psychopharmacology research and practice: Emphasis on preschoolers Psychopharmacology (Berl) 2007, 191:15-26. Epub 2007 Feb 2006. 10.1007/s00213-006-0685-8 17279378
14. Vitiello B Heiligenstein JH Riddle MA Greenhill LL Fegert JM The interface between publicly funded and industry-funded research in pediatric psychopharmacology: Opportunities for integration and collaboration Biol Psychiatry 2004, 56:3-9. 10.1016/ j.biopsych.2004.03.011 15219466
15. Approved moieties to which FDA has granted pediatric exclusivity for pediatric studies under section 505A of the Federal Food, Drug and Cosmetic Act http://www.fda.gov/cder/pediatric/exgrant.htm accessed July 19, 2006
16. Klein DF The flawed basis for FDA post-marketing safety decisions: The example of anti-depressants and children Neuropsychopharmacology 2006, 31:689-699. 10.1038/sj.npp.1300996 16395296
17. Kölch M Schnoor K Fegert JM The EU-regulation on medicinal products for paediatric use: Impacts on child and adolescent psychiatry and clinical research with minors Eur Child Adolesc Psychiatry 2007, 16:229-235. Epub 2007 Apr 2007. 10.1007/s00787-006-0594-8 17417746
18. National Commission for the Protection of Human to Biomedical and Beavioral Research The Belmont Report Ethical Principles and Guidelines for the protection of human subjects of research Department of Health, Education, and Welfare 1979.
19. European Parliament and of the Council EU Directive 2001/20 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use Official Journal of the European Communities 2001.
20. U.S. Code of Federal Regulations Title 45: Public Welfare Part 46-Protection of Human Subjects Subpart D-Additional Protections for Children Involved as Subjects in Research Research involving greater than minimal risk but presenting the prospect of direct benefit to the individual subjects Department of Health and Human Services 2005.
21. ICH ICH Harmonised Tripartite Guideline, Guideline for Good Clinical Practice E6(R1) International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human use 1996.
22. Hebert-Croteau N Brisson J Lemaire J Latreille J The benefit of participating to clinical research Breast Cancer Research and Treatment 2005, 91:279-281. 10.1007/s10549-005-0320-0
23. Macklin R After Helsinki: Unresolved issues in international research Kennedy Inst Ethics J 2001, 11:17-36. 10.1353/ken.2001.0005 12166444
24. Goodyer I Dubicka B Wilkinson P Kelvin R Roberts C Byford S Breen S Ford C Barrett B Leech A et al. Selective serotonin reuptake inhibitors (SSRIs) and routine specialist care with and without cognitive behaviour therapy in adolescents with major depression: Randomised controlled trial BMJ 2007, 335:142. Epub 2007 Jun 2007. 1925185 17556431 10.1136/ bmj.39224.494340.55
25. Entorf H Fegert JM Kölch M Children in Need of Medical Innovation ZEW Zentrum für Europäische Wirtschaftsforschung GmbH 2004
26. Council of Europe Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine: Convention on Human Rights and Biomedicine Council of Europe 1997.
27. United Nations Convention on the Rights of the Child Office of the High Commissioner for Human Rights 1990.
28. Council of Europe Convention for the Protection of Human Rights and Fundamental Freedoms as amended by Protocol No. 11 1950.
29. Rothärmel S Dippold I Wiethoff K Wolfslast G Patientenaufklärung, Informationsbedürfnis und Informationspraxis in der Kinder- und Jugendpsychiatrie Göttingen 2006.
30. Grisso T Appelbaum PS Abilities related to competence Assessing competence to consent to treatment: A guide for physicians and other health professionals London: Oxford University Press 1998, Chapter 3 31-60.
31. Billick SB Edwards JL Burgert W 3rd Serlen JR Bruni SM A clinical study of competency in child psychiatric inpatients J Am Acad Psychiatry Law 1998, 26:587-594. 9894215
32. 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. 1377517 9650109 10.1136/jme.24.3.158
33. Tan JOA Hope T Stewart A Fitzpatrick R Competence to make treatment decisions in anorexia nervosa: Thinking processes and values Philosophy, Psychology and Psychiatry 2006, 13:267-282. 10.1353/ppp.2007.0032
34. Tan JO Hope T Stewart A Anorexia nervosa and personal identity: The accounts of patients and their parents International Journal of Law and Psychiatry 2003, 26:533-548. 10.1016/S0160-2527(03)00085-2
35. Tan JO Fegert JM Capacity and competence in child and adolescent psychiatry Health Care Analysis 2004, 12:285-294. discussion 265-272. 10.1007/s10728-004-6636-9 15658083
36. Raspe H Hüppe A Steinmann M Empfehlungen zur Begutachtung klinischer Studien durch Ethikkommissionen Köln: Deutscher Ärzteverlag Reihe Medizinethik 2005. http://www.mu-luebeck.de/ fakultaeten/medizinischefakultaet/ethikkommission/ Empfehlungen_Gesamt.pdf (access verified 1st August 2008)
37. Klinkhammer G Medizinische Ethikkommissionen: "Minimale Belastung und minimales Risiko" Deutsches Ärzteblatt 2006:103. 49 A-3310/ B-2885/C-2765.
38. Wesseler I AMG-Novelle und GCP-V Amendment to the German Drug Law and Ordinance on Good Clinical Practice: Consequences for research in emergency medicine when patients are unable to provide consent? Konsequenzen für die Forschung mit einwilligungsunfähigen Patienten in der Notfallmedizin? Notfall & Rettungsmedizin 2006, 9:363-369. 10.1007/s10049-006-0828-9
39. Torpy JM Lynm C Glass RM JAMA patient page. Evidence-based medicine Jama 2006, 296:1192. 10.1001/jama.296.9.1192 16954497
40. Sackett DL Rosenberg WM Gray JA Haynes RB Richardson WS Evidence based medicine: What it is and what it isn't Bmj 1996, 312:71-72. 2349778 8555924
41. Hammad T Laughren T Racoosin J Suicidality in pediatric patients treated with antidepressant drugs Arch Gen Psychiatry 2006, 63:332-339. 10.1001/ archpsyc.63.3.332 16520440
42. Gibbons R Brown C Hur K Marcus S Bhaumik D Erkens J Herings R Mann J Early evidence on the effects of regulators' suicidality warnings on SSRI prescriptions and suicide in children and adolescents Am J Psychiatry 2007, 164:1356-1363. 10.1176/appi.ajp.2007.07030454 17728420
43. Nemeroff C Kalali A Keller M Charney D Lenderts S Cascade E Stephenson H Schatzberg A Impact of publicity concerning pediatric suicidality data on physician practice patterns in the United States Arch Gen Psychiatry 2007, 64:466-472. 10.1001/archpsyc.64.4.466 17404123
44. Safer D Zito J Do antidepressants reduce suicide rates? Public Health 2007, 121:274-277. 10.1016/j.puhe.2006.09.024 17316717
45. DiMasi JA Grabowski HG Should the patent system for new medicines be abolished? Clin Pharmacol Ther 2007, 82:488-490. 10.1038/sj.clpt.6100393 17952100
46. Haefner B Law and research could add up to profitable niche drugs Nature 2007, 446:856. 10.1038/446856b 17443162
47. Ayme S Schmidtke J Networking for rare diseases: A necessity for Europe Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz 2007, 50:1477-1483. 10.1007/s00103-007-0381-9 18026888
48. Whittington CJ Kendall T Fonagy P Cottrell D Cotgrove A Boddington E Selective serotonin reuptake inhibitors in childhood depression: systematic review of published versus unpublished data Lancet 2004, 363:1341-1345. 10.1016/S0140-6736(04)16043-1 15110490
49. Angell M The Truth about the Drug Companies: How. They Deceive Us and What to Do About It New York: Random House 2004.
50. Magno J Derivan A Greenhill LL Making research data available: An ethical imperative demonstrated by the SSRI debacle J Am Acad Child Adolesc Psychiatry 2004, 43:512-514. 10.1097/01.chi.0000122721.57082.ed 15100556
51. Moynihan R Who pays for the pizza? Redefining the relationships between doctors and drug companies. BMJ 31.5.2003 Bmj 2003, 326:1163. 1126044 12775595 10.1136/bmj.326.7400.1163
52. Moynihan R Key opinion leaders: Independent experts or drug representatives in disguise? Br Med J 2008, 336:1402-1403. 10.1136/ bmj.39575.675787.651
53. Melander H Ahlqvist-Rastad J Meijer G Beermann B Evidence b(i)ased medicine - selective reporting from studies sponsored by pharmaceutical industry: Review of studies in new drug applications Bmj 2003, 326:1171-1173. 156459 12775615 10.1136/bmj.326.7400.1171
54. Als-Nielsen B Chen W Gluud C Kjaergard LL Association of funding and conclusions in randomized drug trials: A reflection of treatment effect or adverse events? JAMA 2003, 290:921-928. 10.1001/jama.290.7.921 12928469
55. Lexchin J Bero LA Djulbegovic B Clark O Pharmaceutical industry sponsorship and research outcome and quality: Systematic review Bmj 2003, 326:1167-1170. 156458 12775614 10.1136/bmj.326.7400.1167
56. Jensen PS Hinshaw SP Swanson JM Greenhill LL Conners CK Arnold LE Abikoff HB Elliott G Hechtman L Hoza B et al. Findings from the NIMH Multimodal Treatment Study of ADHD (MTA): Implications and applications for primary care providers J Dev Behav Pediatr 2001, 22:60-73. 11265923
57. Glass RM Fluoxetine, cognitive-behavioral therapy, and their combination for adolescents with depression: Treatment for Adolescents with Depression Study (TADS) randomized controlled trial J Pediatr 2005, 146:145. 15644846
58. Baber NS Tripartite meeting. Paediatric regulatory guidelines: Do they help in optimizing dose selection for children? Br J Clin Pharmacol 2005, 59:660-662. 1884861 15948928 10.1111/j.1365-2125.2005.02427.x
59. March J Silva S Petrycki S Curry J Wells K Fairbank J Burns B Domino M McNulty S Vitiello B Severe J Fluoxetine, cognitive-behavioral therapy, and their combination for adolescents with depression: Treatment for Adolescents With Depression Study (TADS) randomized controlled trial JAMA 2004, 292:807-820. 10.1001/jama.292.21.2578-c 15315995
60. Wendler D Jenkins T Children's and their parents' views on facing research risks for the benefit of others Arch Pediatr Adolesc Med 2008, 162:9-14. 10.1001/archpediatrics.2007.3 18180406
61. McMillan JR Hope T The possibility of empirical psychiatric ethics Empirical Ethics in Psychiatry Oxford: Oxford University Press Widdershoven G, Hope T, McMillan JR, Van der Scheer L 2008, Chapter 2 9-22. International perspectives in philosophy and psychiatry.