The Journal of Pediatrics
Volume 149, Issue 3 , Pages 285-286.e2 , September 2006

Recent developments in the protection of pediatric research subjects

References 

  1. Sharav VH . The impact of the Food and Drug Administration Modernization Act on the recruitment of children for research . Ethical Hum Sci Serv . 2003;5:83–108
  2. Field MJ , Berman RE . Children CoCRI. The Ethical Conduct of Clinical Research Involving Children . Washington, DC: Institute of Medicine; 2004;
  3. Grimes v. Kennedy Krieger Institute, Inc. . West’s Atl Report . 2001;782:807–862
  4. Roeder KH , Martin SH , Rees JS  Grimes v. Kennedy Krieger Institute, Inc. . Maryland court ruling sets precedent on research involving minors . GHA Today . 2001;45(9):3; 8
  5. 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
  6. McMillan G . What do researchers say? What do subjects hear? Not what they would like to hear. What do subjects need? More information . Prot Hum Subj . 2005;12:10–11
  7. Barfield RC , Church C . Informed consent in pediatric clinical trials . Curr Opin Pediatr . 2005;17:20–24
  8. Friedman LM  Data and Safety Monitoring Boards . In:  Gallin J editors. Principles and practice of clinical research . Burlington, MA: Elsevier; 2002;
  9. Ellenberg SS , Fleming TR , DeMets DL . Data Monitoring Committees in Clinical Trials (Preface ix) . Hoboken, NJ: Wiley; 2003;
  10. National Institutes of Health. NIH Policy for Data and Safety Monitoring. June 10, 1998. Available at: http://grants.nih.gov/grants/guide/notice-files/not98-084.html.
  11. National Institutes of Health. Further Guidance On Data And Safety Monitoring For Phase I AND Phase II Trials. June 5, 2000. Available at: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-038.html
  12. Vaitukaitis JL. Clinical Research and Public Trust. NCRR Reporter Fall 2004. Available at: http://www.ncrr.nih.gov/newspub/Fall04rpt/director.asp. Accessed May 23, 2006.

PII: S0022-3476(06)00359-3

doi: 10.1016/j.jpeds.2006.04.033

The Journal of Pediatrics
Volume 149, Issue 3 , Pages 285-286.e2 , September 2006