-
1
-
-
0002293794
-
Historical overview: Pediatric experimentation
-
Grodin MA, Glantz LH, editors. Children as research subjects: science, ethics, and law. New York: Oxford University Press
-
(1994)
, pp. 3-25
-
-
Lederer, S.E.1
Grodin, M.A.2
-
2
-
-
85007181575
-
-
Permissible medical experiments: trials of war criminals before the Nuremberg Military Tribunals under Control Council Law No. 10, Nuremberg, October 1946-April 1949. Volume 2. Washington (DC): US Government Printing Office (n.d.); p. 181-2
-
-
-
-
3
-
-
85007159551
-
-
World Medical Assembly, Declaration of Helsinki. Adopted by the 18th World Medical Assembly, Helsinki, Finland, 1964, and amended in Tokyo in 1975, in Venice in 1983, in Hong Kong in 1989, in South Africa in 1996, and in Edinburgh, Scotland in October, 2000. Available from: http://www.wits.ac.za/bioethics/helslnki.htm
-
-
-
-
4
-
-
85007260227
-
-
US Department of Health, Education and Welfare. 45 CFR 46. Protection of human subjects: proposed regulations on research involving children. 43 FR 31786-94. July 21, 1978
-
-
-
-
5
-
-
85007159542
-
-
US Department of Health and Human Services. 45 CFR 46. Protections for children involved as subjects in research. 48 FR 9814-20. March 8, 1983
-
-
-
-
6
-
-
85007159536
-
-
US Department of Health and Human Services. 45 CFR 46. Addtional DHHS protections for children involved as subjects in research. 56 FR 28032. June 18, 1991
-
-
-
-
8
-
-
85007146744
-
-
US Food and Drug Administration, Department of Health and Human Services. Food and Drug Administration Modernization Act of 1997. Public Law 105-115
-
-
-
-
9
-
-
85007272681
-
-
Regulations requiring manufacturers to assess the safety and effectiveness of new drugs and biological products in pediatric patients; final rule. (Proposal 62 FR 43900; August 15, 1997.) Fed Reg 1998;63. No.: 231 (December 2, 1998); 21 CFR 201, 312, 314, and 601
-
-
-
-
11
-
-
0028950350
-
Guidelines for the ethical conduct of studies to evaluate drugs in pediatric populations
-
(1995)
Pediatrics
, vol.95
, pp. 286-294
-
-
-
13
-
-
0019021748
-
Moral duties of parents and non-therapeutic research procedures involving children
-
(1980)
Bioethics Q
, vol.2
, pp. 94-111
-
-
Ackerman, T.1
-
15
-
-
0028959392
-
Informed consent, parental permission, and assent in pediatric practice
-
(1995)
Pediatrics
, vol.95
, pp. 314-317
-
-
-
17
-
-
0018624247
-
Fooling ourselves with child autonomy and assent in non-therapeutic clinical research
-
(1979)
Clin Res
, vol.27
, pp. 345
-
-
Ackerman, T.F.1
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