Skip to main content
SpringerLink
Log in

Protection of Children and Adolescents in Psychiatric Research: An Unfinished Business

  • Published:
HEC Forum Aims and scope Submit manuscript

This is a preview of subscription content, log in via an institution to check access.

Access this article

Log in via an institution

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Institutional subscriptions

References

  1. Jellinek MS. Mirror, mirror on the wall: Are we prescribing the right psychotropic medications to the right children using the right treatment plan? Arch Pediat Adol Med, 2003; 157: 14–16.

    Google Scholar 

  2. Zito JM, Safer DJ, DosReis S, Gardner JF, Magder L, Soeken K, Boles M, Lynch F, Riddle MA. Psychotropic practice patterns for youth. A 10-year perspective. Arch Pediat Adol Med, 2003; 157: 17–25.

    Google Scholar 

  3. Zito JM, Derivan AT, Greenhill LL. Making research data available: An ethical imperative demonstrated by the SSRI debacle. J Amer Acad Child Adol Psychiat, 2004; 43(5): 512–514.

    Article  Google Scholar 

  4. Greenhill LL, et al. Review of safety assessment methods used in pediatric psychopharmacology. J Amer Acad Child Adol Psychiat, 2003; 42: 627–633.

    Article  Google Scholar 

  5. Sharav VH. Children in clinical research: A conflict of moral values. Amer J Bioethics, 2003; 3(1): InFocus. www.bioethics.net/journal/infocus.php?vol=3&issue=1&articleID=52

  6. Solyom AE. Letter to editor: Efficacy of sertraline in the treatment of children and adolescents with major depressive disorder. Journal of the American Medical Association, 2004; 291: 41–42.

    Article  Google Scholar 

  7. Bodenheimer T. Uneasy alliance - Clinical investigators and the pharmaceutical industry. New England Journal of Medicine, 2000; 342: 1539–1544.

    Article  PubMed  Google Scholar 

  8. Klein JE, Fleischman AR. The private practicing physician-investigator: Ethical implications of clinical research in the office setting. Hastings Center Report, 2002; 32(4): 22–26.

    Google Scholar 

  9. Shamoo AE, Moreno J; eds. Business and research. New York: Taylor & Francis; 2002.

    Google Scholar 

  10. Public Law No. 105–115, 111 Stat. 2296; 1997.

  11. Public Law No. 107–109, 115 Stat. 1408; 2002.

  12. Institute of Medicine. Committee on Clinical Research Involving Children. Field MJ, Behrman RE, eds. The ethical conduct of clinical research involving children. Washington D.C.: The National Academies Press; 2004.

    Google Scholar 

  13. Solyom AE. Omitted considerations and populations: A response to ‘Should children decide whether they are enrolled in nonbeneficial research?’ by David Wendler and Seema Shah. Amer J Bioethics, 2004; 4(1): W39. www.bioethics.net/journal/correspondence.php?vol=4&issue=1&articleID=152

  14. Thompson RA. Developmental changes in risk and benefit: A changing calculus of concerns. In: Stanley B, Sieber JE; eds. Social research on children and adolescents: Ethical issues. Newbury Park, London, New Delhi: Sage Publications; 1992: 31–64.

    Google Scholar 

  15. Cooke RE. Vulnerable children. In: Grodin MA, Glantz LH; eds. Children as research subjects. New York, Oxford: Oxford University Press; 1994: 194–195.

    Google Scholar 

  16. Broome ME, Kodish E, Geller G, Siminoff LA. Children in research: New perspectives and practices for informed consent. IRB: Ethics & Human Res, Suppl, 2003; 25(5): S20-S25.

    Google Scholar 

  17. Wendler D, Shah S. Should children decide whether they are enrolled in nonbeneficial research? Amer J Bioethics, 2003; 3(4): 1–7.

    Article  Google Scholar 

  18. Moreno JD. Convenient and captive populations. In: Kahn JP, Mastroianni AC, Sugarman J; eds. Beyond consent. New York, NY: Oxford University Press; 1998: 111–130.

    Google Scholar 

  19. National Commission for Protection of Human Subjects of Biomedical and Behavioral Research. Report and recommendations: Research involving children. Washington D.C.: Department of Health, Education and Welfare, Pub. No. (OS) 770004; 1977.

    Google Scholar 

  20. Food and Drug Administration. Additional safeguards for children in clinical investigations of FDA-regulated products. Fed Regist 2001; 66: 20589–20600.

    Google Scholar 

  21. American Academy of Pediatrics. Committee of Drugs. Guidelines for the ethical conduct of studies to evaluate drugs in pediatric populations (RE9503). Pediatrics, 1995; 95: 286–294.

    Google Scholar 

  22. Federal Policy for the Protection of Human Subjects. 56 Fed. Reg. 28,003; 1991. http://www.ohrp.osophs.dhhs.gov/humansubjects/guidance/45cfr46.htm (updated 2001).

  23. National Bioethics Advisory Commission. Research involving persons with mental disorders that may affect decisionmaking capacity. Volume I. Report and recommendations. Rockville, MD; 1998.

  24. FDA Pediatric Ethics Working Group. Consensus statement on Pediatric Advisory Subcommittee’s September 11, 2000 meeting regarding placebo-controlled trials. www.fda.gov/cder/pediatric/index.htm#advisory.

  25. Orr RD. Guidelines for the use of placebo controls in clinical trials of psychopharmacologic agents. Psychiat Serv, 1996; 47: 1262–1264.

    Google Scholar 

  26. Kupfer DJ, Frank E. Placebo in clinical trials for depression - Complexity and necessity. Journal of the American Medical Association, 2002; 287:1853–1854.

    Article  PubMed  Google Scholar 

  27. Kim SYH, Holloway RG. Burdens and benefits of placebos in antidepressant clinical trials: A decision and cost-effectiveness analysis. Amer J Psychiat, 2003; 160: 1272–1276.

    Article  PubMed  Google Scholar 

  28. Moreno JD. Regulation of Research on the Decisionally Impaired: History and Gaps in the Current Regulatory System. J Health Care Law & Pol, 1998; 1: 1–21.

    Google Scholar 

  29. Koren G, Kearns GL, Reed M, Pons G. Use of healthy children as volunteers in drug Studies: The ethical debate. Clin Pharm & Ther, 2003; 73: 147–152.

    Google Scholar 

  30. FDA Ethics Working Group. Consensus statement on the Pediatric Advisory Subcommittee’s November 15, 1999 meeting regarding clinical trials involving ‘normal volunteers.’ www.fda.gov/cder/pediatric/index.htm#advisory.

  31. American Psychiatric Association. Guidelines for assessing the decision-making capacities of potential research subjects with cognitive impairment. Amer J Psychiat, 1998; 155: 1649–1650.

    Google Scholar 

  32. Kumra S, Briguglio C, Lenane M, Goldhar L, Bedwell J, Venuchekov J, Jacobsen LK, Rapaport JL. Including children and adolescents with schizophrenia in medication-free research. Amer J Psychiat, 1999; 156: 1065–1068.

    PubMed  Google Scholar 

  33. Shirkey H. Editorial comment: Therapeutic orphans. Pediatrics, 1968; 72: 119.

    Google Scholar 

  34. Wilson JT. An update on the therapeutic orphan. Pediatrics, 1999; 104: 585–586.

    PubMed  Google Scholar 

Download references

Author information

Consortia

Antal E. Solyom, M.D., Ph.D., M.A.

Jonathan D. Moreno, Ph.D.

Rights and permissions

Reprints and permissions

About this article

Cite this article

Antal E. Solyom, M.D., Ph.D., M.A.., Jonathan D. Moreno, Ph.D.. Protection of Children and Adolescents in Psychiatric Research: An Unfinished Business. HEC Forum 17, 210–226 (2005). https://doi.org/10.1007/s10730-005-2548-9

Download citation

  • Issue Date:

  • DOI: https://doi.org/10.1007/s10730-005-2548-9

Keywords

Search

Navigation