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The Journal of Pediatrics
Volume 149, Issue 3
, Pages 285-286.e2
, September 2006
Recent developments in the protection of pediatric research subjects
References
-
.
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
-
.
Children CoCRI. The Ethical Conduct of Clinical Research Involving Children
. Washington, DC: Institute of Medicine; 2004;
-
.
West’s Atl Report
. 2001;782:807–862
- . Maryland court ruling sets precedent on research involving minors . GHA Today . 2001;45(9):3; 8
- . Quantifying the federal minimal risk standard (implications for pediatric research without a prospect of direct benefit) . JAMA . 2005;294:826–832
-
.
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
- . Informed consent in pediatric clinical trials . Curr Opin Pediatr . 2005;17:20–24
-
.
In:
Gallin J
editors.
Principles and practice of clinical research
. Burlington, MA: Elsevier; 2002;
-
.
Data Monitoring Committees in Clinical Trials
(Preface ix)
. Hoboken, NJ: Wiley; 2003;
-
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.
-
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
-
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
© 2006 Mosby, Inc. All rights reserved.
« Previous
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The Journal of Pediatrics
Volume 149, Issue 3
, Pages 285-286.e2
, September 2006
