Informed consent & ethical issues in paediatric psychopharmacology

Indian Journal of Medical Research

Volumn 129, Issue 1, 2009, Pages 19-32

  Malhotra, Savita ^a   Subodh, B N ^a  

^a POSTGRADUATE INSTITUTE OF MEDICAL EDUCATION AND RESEARCH   (India)

Author keywords

Assent; Children; Informed consent; Mature minor; Psychopharmacology

Indexed keywords

CHILD PSYCHOLOGY; CHILD WELFARE; ETHICAL DECISION MAKING; INDIA; INFORMED CONSENT; LEGAL ASPECT; MEDICAL ETHICS; MEDICAL RESEARCH; PARENTAL CONSENT; PRACTICE GUIDELINE; PROFESSIONAL STANDARD; PSYCHOPHARMACOLOGY; RESEARCH ETHICS; REVIEW;

AGE FACTORS; CHILD; CHILD WELFARE; HUMANS; INDIA; INFORMED CONSENT; PEDIATRICS; PSYCHOPHARMACOLOGY; RISK ASSESSMENT;

EID: 65949098882     PISSN: 09715916     EISSN: 09715916     Source Type: Journal    
DOI: None     Document Type: Review

References (52)

1. Committee on Bioethics. Ethics and the care of critically ill infants and children. Pediatrics 1996; 98: 149-52.
2. Mary R, Stanley Z. The ethical boundaries of drug research in pediatrics. Pediatr Clin North Am 1997; 44: 27-40.
3. Boris B, David A. Pediatric psychopharmacology. In: Benjamin JS, Virginia AS, editors. Comprehensive text book of psychiatry. 8th ed. Philadelphia: Lippincott Williams & Wilkins; 2005. p. 3363-76.
4. Nottelmann ED, Jensen PS. Bipolar affective disorder in children and adolescents: Introduction to Special Section. J Am Acad Child Adolesc Psychiatry 1995; 34: 705-8.
5. Arnold LE, Stoff DM, Cook E Jr, Cohen DJ, Kruesi M, Wright C, et al. Ethical issues in biological psychiatry research with children and adolescents. J Am Acad Child Adolesc Psychiatry 1995; 34: 929-39.
6. Benedetto V, Petert SJ. Medication development and testing in children and adolescents. Arch Gen Psychiatry 1997; 54: 871-6.
7. Benedetto V. Psychopharmacology for young children: clinical needs and research opportunities. Pediatrics 2001; 108: 983-9.
8. Part 46-Protection of human subjects. Federal Register 1974; 39: 914
9. The Nuremberg Code. Trials of War Criminals before the Nuremberg Military Tribunals under Control Council Law No. 10, Washington DC: US Government Printing Office; 1949; 2: 181-2.
10. World Medical Association: Declaration of Helsinki: Recommendations guiding physicians in biomedical research involving human subjects. JAMA 1997; 277: 925-6.
11. National Commission for the Protection of Human Subjects. Belmont report: Ethical and guidelines for the protection of human subjects of research. Washington DC: US Government Printing Office, 1978 (Summary and 2 volumes of appendices).
12. The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, Department of Health, The Belmont report: Ethical principles and guidelines for the protection of human subjects of research. Education and Welfare, April 18, 1979; 44: 23192-7.
13. Policy Statement on Ethical Considerations involved in Research on Human Participants. New Delhi: Indian Council of Medical Research; 1980.
14. Ethical guidelines for biomedical research on human subjects. New Delhi: Indian Council of Medical Research; 2000. p. 1-77.
15. Ethical guidelines for biomedical research on human participants. New Delhi: Indian Council of Medical Research; 2006. p. 1-120.
16. American Academy of Pediatrics, Committee on Drugs. Guidelines for the ethical conduct of studies to evaluate drugs in pediatric populations. Pediatrics 1977; 60: 91-101.
17. Protection of human subjects - proposed regulations on research involving children. Federal Register 1978; 43: 786.
18. Additional protections for children involved as subjects in research. Federal Register 1983; 48: 114-7.
19. Laura WR. Ethical and mental illness research. Psych Clin North Am 2002; 25: 525-45.
20. Appelbaum PS, Lidz CW, Meisel A. Informed consent: Legal theory legal practice. New York: Oxford University Press; 1987.
21. Mishkin B. Determining the capacity for making health care decisions. In: Bilig N, Robins PV, editors. Issues in geriatric psychiatry (Advances in Psychosomatic Medicine, Vol 19). Switzerland: Krager S; 1989. p. 151-66.
22. Robert IS. The law and psychiatry. In: Robert EH, Staurt GY, editors. Text book of clinical psychiatry. 4th ed. Washington: American Psychiatric Publishing; 2003. p. 1585-628.
23. Canterbury V. Spence, 464 F2d 772 (DC Cir), cert denied, Canterbury v. Spence, 409 US 1064 (1972).
24. Committee on Medical Liability. Consent by proxy for nonurgent pediatric care. Pediatrics 2003; 112: 1186-95.
25. Malcom JG. Informed consent in the practice of psychiatry. In: Simon RI, editor. American psychiatric press review of clinical psychiatry and the law, vol. 3. Washington: American Psychiatric Press; 1992. p. 223-81.
26. Philip JG. Children: problems in pediatrics. In: Jocelyn YH, editor. Ethics and child mental health. Jerusalem: Gefen Publishing House; 1994. p. 186-98.
27. Piaget J, Inhelder B. The growth of logical thinking from childhood to adolescence. New York: Basic Books; 1958.
28. Lewis C, Lewis M, Ifekwunigue M. Informed consent by children and participation in an influenza vaccine trial. Am J Public Health 1978; 68: 1079-82.
29. Leiken S. Minors assent, consent, or dissent to medical research. IRB Rev Hum Subj Res 1993; 15: 1-7.
30. Weithorn L, Campbell S. The competency of children and adolescents to make informed decisions. Child Dev 1982; 53: 1589-98.
31. Loar N. Toward liberal guidelines for clinical research with children. Med Law 1987; 6: 127-37.
32. Helmut R. Ethical aspects and treatment in child psychiatry. In: Jocelyn YH, editor. Ethics and child mental health. Jerusalem: Gefen Publishing House; 1994. p. 150-60.
33. Dresser R. Mentally disabled research subjects: the enduring policy issues. JAMA 1996; 276: 67-72.
34. David IS, Elizabeth GM, David W. The accuracy of the surrogate decision makers. Arch Intern Med 2006; 166: 493-7.
35. Emanuel EJ, Emanuel LL. Proxy decision making for incompetent patients: an ethical and empirical analysis. JAMA 1992; 267: 2067-71.
36. Santelli JS, Smith Rogers A, Rosenfeld WD, DuRant RH, Dubler N, Morreale M, et al. Guidelines for adolescent health research: a position paper of the Society for Adolescent Medicine. J Adolesc Health 2003; 33: 396-409.
37. Sanci LA, Sawyer SM, Weller PJ, Bond LM, Patton GC. Youth health research ethics: time for a mature-minor clause? Med J Aust 2004; 180: 336-8.
38. Gillick v West Norfolk and Wisbech Area Health Authority. 1986 AC 112.
39. Esbensen F-A, Deschenes EP, West J. Active parental consent in schoolbased research: an examination of ethical and methodological issues. Eval Rev 1996; 20: 737-53.
40. Wyn J, Lumley J, Daly J. Women's health: methods and ethics. In: Daly J, editor. Ethical intersections: health research, methods and researcher responsibility. Sydney: Allen and Unwin; 1996. p. 166-79.
41. Caller BS. The newly dead as research subjects. Clin Res 1989; 37: 487-94.
42. Fost N. Research on brain dead. J Pediatr 1980; 96: 54-6.
43. Stephen JC, Glen CC, Mina KD. Treatment of children and adolescents. In: Robert EH, Staurt GY, editors. Text book of clinical psychiatry, 4th ed. Washington: American Psychiatric Publishing; 2003. p. 1399-451.
44. Mark D. Residential and inpatient treatment. 8th ed. In: Benjamin JS, Virginia AS, editors. Comprehensive text book of psychiatry. Philadelphia: Lippincott Williams & Wilkins; 2005. p. 3384-90.
45. Spetie L, Arnold E. Ethical issues in child psychopharmacology research and practice: emphasis on preschoolers. Psychopharmacology 2007; 191: 15-26.
46. Hodges FM, Svoboda JS, Van Hove RS. Prophylactic interventions on children: balancing human rights with public health. J Med Ethics 2002; 28: 10-6.
47. Ghaziuddin N, Kutcher SP, Knapp P, Bernet W, Arnold V, Beitchman J, et al. Practice parameter for use of electroconvulsive therapy with adolescents. J Am Acad Child Adolesc Psychiatry 2004; 43: 1521-39.
48. Registrar General and Census Commissioner of India. Census of India. Provisional population atlas. New Delhi: Government of India; 2001.
49. Smith Rogers A, D' Angelo L, Futterman D. Guidelines for adolescents participation in research: current realities and possible resolutions. IRB: A Review of Human Subjects Research 1994; 16: 1-6.
50. NHS Central Office for Research Ethics Committees. Multicentre research ethics committees guidance notes, 2000. Research on children (Manual 11.7 & V27.1). Available at: www.mrc.ac.uk.
51. Jane FK, Margaret AD, Ronald AF, Barry WH, Steven EK, Deborah Mulligan-Smith, et al. Consent for emergency medical services for children and adolescents. Pediatrics 2003; 111: 703-6.
52. Santelli J. Human subjects protection and parental permission in adolescent health research. J Adolesc Health 1997; 21: 384-7.