Información del artículo
El Texto completo está disponible en PDF
Bibliografía
[1.]
J. Katz.
The Nuremberg Code and the Nuremberg trial. A reappraisal.
JAMA, 276 (1996), pp. 1662-1666
[2.]
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 1993, in Hong Kong in 1989, in South Africa in 1996, and in Edinburgh, Scotland in October, (2000),
[3.]
Food and Drug Administration: Clinical investigations: Proposed establishment of regulations on obligations of sponsors and monitors. Fed Reg, 42 (Sept 27, 1977):49612-49630.
[4.]
CPMP Working Party of Efficacy of Medicinal Products.
EEC Note for guidance: Good Clinical Practice for trials on medicinal products in the European Community.
Pharmacol Toxicol, 67 (1990), pp. 361-372
[5.]
Ley 25/1990, de 20 de diciembre, del Medicamento. BOE, 22 diciembre 1990.
[6.]
Real decreto 561/1993.
de 16 de abril, por el que se establecen los requisitos para la realización de ensayos clínicos con medicamentos.
Ministerio de Sanidad y Consumo. BOE n.°, 114 (1993),
[7.]
ICH Topic E 11.
Note for guidance on clinical investigation of medicinal products in the paediatric population (CPMP/ ICH/2711/99).
The European Agency for the Evaluation of Medicinal Products. London, 27 July, (2000),
[8.]
F.J. De Abajo.
Ensayos clínicos en niños: aspectos éticos.
Rev Esp Pediatr, 56 (2000), pp. 27-38
[9.]
Special article: American Pediatric Society/Society for Pediatric Research code of responsible conduct of research..
Pediatr Res, 45 (1999), pp. 613-614
[10.]
L.F. Ross, J.W. Newburger, S.P. Sanders.
Ethical issues in pediatric trials.
Am Heart J, 142 (2001), pp. 233-236
[11.]
Sauer PJJ.
Research in children. A report of the Ethics Working Group of the CESP.
Eur J Pediatr, 161 (2002), pp. 1-5
[13.]
Committee on Bioethics.
Informed consent, parental permission, and assent in pediatric practice.
Pediatrics, 95 (1995), pp. 314-317
[14.]
International Committee of Medical Journal Editors.
Protection of patients’ rights to privacy.
BMJ, 311 (1995), pp. 1272
[15.]
D. Rennie, V. Yank.
Disclosure to the reader of institutional review board approval and informed consent.
JAMA, 277 (1997), pp. 922-923
[16.]
R.J. Amdur, C. Biddle.
Institutional Review Board Approval and Publication of Human Research Results.
JAMA, 277 (1997), pp. 909-914
[17.]
H. Bauchner, J. Sharfstein.
Failure to report ethical approval in child health research: Review of published papers.
BMJ, 323 (2001), pp. 318-319
[18.]
M.G.M. Rikkert, H.A.M. Have.
Hoefnagels WHL. Informed consent in biomedical studies on aging: Survey of four journals.
BMJ, 313 (1996), pp. 1117
[19.]
Ley orgánica 15/1999.
de 13 de diciembre, de Protección de Datos de Carácter Personal.
BOE, 14 diciembre, (1999),
[20.]
M. Nylenna.
Details of patients’ consent in studies should be reported.
BMJ, 314 (1997), pp. 1127
[23.]
J.S. Tobias, R.L. Souhami.
Fully informed consent can be needlessly cruel.
BMJ, 307 (1993), pp. 1199-1201
[24.]
R. Smith.
Informed consent: The intricacies Should the BMJ reject all studies that do not include informed consent?.
BMJ, 314 (1997), pp. 1059-1060
Copyright © 2002. Asociación Española de Pediatría
