The Journal of Pediatrics
Volume 152, Issue 1 , Pages 9-14 , January 2008

Research Involving Wards of the State: Protecting Particularly Vulnerable Children

  • Sumeeta Varma, BS
    • ,
  • David Wendler, PhD

      Affiliations

    • Corresponding Author InformationReprint requests: David Wendler, Department of Bioethics, NIH Clinical Center, Building 10, Room 1C118, Bethesda, MD 20892.

Received 19 March 2007 ,Revised 2 July 2007 ,Accepted 19 July 2007.

References 

  1. Solomon J. AIDS drugs tested on foster kids without advocate protection. Associated Press State & Local Wire; 2005;May 4
  2. Montero D. AIDS tots used as “guinea pigs.”. New York Post. 2004;February 29; section 005
  3. Otto M. Drugs tested on HIV-positive foster children; Hill investigates ethical questions raised by 1990s trials in Md, elsewhere. Washington Post. 2005;May 19;section B.01
  4. Scott J, Kaufman L. Belated charge ignites furor over AIDS drug trial. New York Times. 2005;July 17
  5. OHRP determination letter of May 23, 5005. http://www.hhs.gov/ohrp/detrm_letrs/YR05/may05c.pdfAccessed June 18, 2006
  6. Hearing on protecting foster children in clinical trials. In: Human Resources Subcommittee, House Ways and Means Committee. 2005;109th Congress, 1st Session ed. Washington, DC
  7. US Code of Federal Regulations. Title 45CFR46 Subpart D, §46.409. Department of Health and Human Services. Revised June 18, 1991.
  8. US Code of Federal Regulations. Title 2CFR50 Subpart D, §50.56. Department of Health and Human Services.
  9. US Code of Federal Regulations. Title 21 CFR 50 §50.3(q).
  10. American Academy of Pediatrics Task Force on Health Care for Children in Foster Care. Fostering health: health care for children and adolescents in foster care. 2nd ed.. New York: American Academy of Pediatrics District II, New York State; 2005;
  11. Data adapted from Child Welfare League of America national data analysis system. http://ndas.cwla.orgAccessed June 19, 2006
  12. Hearing on protecting foster children in clinical trials. In: Human Resources Subcommittee, House Ways and Means Committee. 2005;109th Congress, 1st Session ed. Washington, DC; (Testimony of Donald Young)
  13. Hearing on protecting foster children in clinical trials. In: Human Resources Subcommittee, House Ways and Means Committee. 2005;109th Congress, 1st Session ed. Washington, DC; (Testimony of Moira Ann Szilagyi).
  14. Emanuel EJ, Wendler D, Grady C. What makes clinical research ethical?. JAMA. 2000;283:2701–2711
  15. 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;April 18
  16. US Code of Federal Regulations. Title 45 CFR 46 §46.102(i).
  17. Wendler D, Belsky L, Thompson KM, Emanuel EJ. Quantifying the federal minimal risk standard: implications for pediatric research without a prospect of direct benefit. JAMA. 2005;294:826–832
  18. Hearing on protecting foster children in clinical trials. In: Human Resources Subcommittee, House Ways and Means Committee. 2005;109th Congress, 1st Session ed. Washington, DC; (Testimony of Alan Fleischman)
  19. World Medical Association. Declaration of Helsinki: ethical priniciples for medical research involving human subjects. 2000;Edinburgh, Scotland
  20. Council for International Organizations of Medical Sciences (CIOMS). International ethical guidelines for biomedical research involving human subjects. 2002;Geneva
  21. Bilchik S. Pediatricians should ensure foster children get needed care. AAP News. 2005;26:19–20
  22. Hearing on protecting foster children in dlinical trials. In: Human Resources Subcommittee, House Ways and Means Committee. 2005;109th Congress, 1st Session ed. Washington, DC; (Submission of John Mattingly)
  23. Institute of Medicine. Ethical conduct of clinical research involving children. Washington, DC: National Academies Press; 2004;
  24. Martin JM, Sacks HS. Do HIV-infected children in foster care have access to clinical trials of new treatments?. AIDS Public Policy J. 1990;5:3–8
  25. Nolan K. AIDS and pediatric research. Eval Rev. 1990;14:464–481

 The opinions expressed are the authors’ own. They do not represent any position or policy of the National Institutes of Health, Public Health Service, or Department of Health and Human Services. This work was completed as part of the authors’ official duties as employees of the NIH Clinical Center. The NIH had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; and preparation, review, or approval of the manuscript. The authors have no financial conflicts of interest with respect to this manuscript or its contents.

PII: S0022-3476(07)00701-9

doi: 10.1016/j.jpeds.2007.07.039

The Journal of Pediatrics
Volume 152, Issue 1 , Pages 9-14 , January 2008

Article Tools