-
1
-
-
0028950350
-
Guidelines for the ethical conduct of studies to evaluate drugs in pediatric populations
-
American Academy of Pediatrics (AAP) Committee on Drugs
-
American Academy of Pediatrics (AAP) Committee on Drugs (1995). Guidelines for the ethical conduct of studies to evaluate drugs in pediatric populations. Pediatrics 95: 286-294.
-
(1995)
Pediatrics
, vol.95
, pp. 286-294
-
-
-
2
-
-
0030002694
-
Unapproved uses of approved drugs: The physician, the package insert, and the Food and Drug Administration
-
American Academy of Pediatrics (AAP) Committee on Drugs
-
American Academy of Pediatrics (AAP) Committee on Drugs (1996). Unapproved uses of approved drugs: The physician, the package insert, and the Food and Drug Administration. Pediatrics 98: 143-145.
-
(1996)
Pediatrics
, vol.98
, pp. 143-145
-
-
-
3
-
-
0023319217
-
False hopes and best data: Consent to research and the therapeutic misconception
-
Appelbaum, P.S., Roth, L.H., Lidz, C.W., Benson, P. and Winslade, W. (1987). False hopes and best data: Consent to research and the therapeutic misconception. Hastings Center Report 17, 2: 20-24.
-
(1987)
Hastings Center Report
, vol.17
, Issue.2
, pp. 20-24
-
-
Appelbaum, P.S.1
Roth, L.H.2
Lidz, C.W.3
Benson, P.4
Winslade, W.5
-
4
-
-
84882856691
-
Code of Federal Regulations
-
Food and Drug Administration: Institutional Review Boards
-
Code of Federal Regulations, 21 CFR 56 (1999). Food and Drug Administration: Institutional Review Boards, (http://frwebgatel.access.gpo.gov).
-
(1999)
CFR
, vol.21
, Issue.56
-
-
-
5
-
-
0026427327
-
Federal policy for the protection of human subjects
-
Code of Federal Regulations, 45 CFR 46: 101-124, (The Common Rule.)
-
Code of Federal Regulations, 45 CFR 46: 101-124 (1991). Federal policy for the protection of human subjects. (The Common Rule.) Federal Register 56: 28003-28016.
-
(1991)
Federal Register
, vol.56
, pp. 28003-28016
-
-
-
6
-
-
0000087571
-
Additional protections for children involved as subjects in research
-
Code of Federal Regulations, 45 CFR 46: 401-109
-
Code of Federal Regulations, 45 CFR 46: 401-109 (1983). Additional protections for children involved as subjects in research. Federal Register 48: 9816-9820.
-
(1983)
Federal Register
, vol.48
, pp. 9816-9820
-
-
-
7
-
-
0002537087
-
Vulnerable children
-
In M.A. Grodin and L.H. Glantz (eds.)., New York: Oxford University Press
-
Cooke, R.E. (1994). Vulnerable children. In M.A. Grodin and L.H. Glantz (eds.). Children as Research Subjects: Science, Ethics, and Law, pp. 193-214. New York: Oxford University Press.
-
(1994)
Children as Research Subjects: Science, Ethics, and Law
, pp. 193-214
-
-
Cooke, R.E.1
-
8
-
-
0029946834
-
Is the "therapeutic orphan" about to be adopted?
-
Cote C.J., Kauffman, R.E., Troendle, G.J. and Lambert, G.H. (1996). Is the "therapeutic orphan" about to be adopted? Pediatrics 98: 118-123.
-
(1996)
Pediatrics
, vol.98
, pp. 118-123
-
-
Cote, C.J.1
Kauffman, R.E.2
Troendle, G.J.3
Lambert, G.H.4
-
9
-
-
0038613935
-
Regulations requiring manufacturers to assess the safety and effectiveness of new drugs and biological products in pediatric patients; Proposed rule
-
Food and Drug Administration (FDA)
-
Food and Drug Administration (FDA) (1997). Regulations requiring manufacturers to assess the safety and effectiveness of new drugs and biological products in pediatric patients; Proposed rule. Federal Register 62, 158: 43900-43916.
-
(1997)
Federal Register
, vol.62
, Issue.158
, pp. 43900-43916
-
-
-
10
-
-
0032476883
-
Regulations requiring manufacturers to assess the safety and effectiveness of new drugs and biological products in pediatric patients; Final rule
-
Food and Drug Administration (FDA)
-
Food and Drug Administration (FDA) (1998). Regulations requiring manufacturers to assess the safety and effectiveness of new drugs and biological products in pediatric patients; Final rule. Federal Register 63, 231: 66631-66672.
-
(1998)
Federal Register
, vol.63
, Issue.231
, pp. 66631-66672
-
-
-
11
-
-
0023185342
-
Equipoise and the ethics of clinical research
-
Freedman, B. (1987). Equipoise and the ethics of clinical research. New England Journal of Medicine 317, 3: 141-145.
-
(1987)
New England Journal of Medicine
, vol.317
, Issue.3
, pp. 141-145
-
-
Freedman, B.1
-
12
-
-
0027569844
-
In loco parentis: Minimal risk as an ethical threshold for research upon children
-
Freedman, B., Fuks, A. and Weijer, C. (1993). In loco parentis: Minimal risk as an ethical threshold for research upon children. Hastings Center Report 23, 2: 13-19.
-
(1993)
Hastings Center Report
, vol.23
, Issue.2
, pp. 13-19
-
-
Freedman, B.1
Fuks, A.2
Weijer, C.3
-
13
-
-
0027897587
-
A policy regarding research in healthy children
-
Gidding, S.G., Camp, D., Flanagan, M.H., Kowalski, J.A., Lingl, L.L., Silverman, B.L. and Langman, C.B. (1993). A policy regarding research in healthy children. Journal of Pediatrics 123: 852-855.
-
(1993)
Journal of Pediatrics
, vol.123
, pp. 852-855
-
-
Gidding, S.G.1
Camp, D.2
Flanagan, M.H.3
Kowalski, J.A.4
Lingl, L.L.5
Silverman, B.L.6
Langman, C.B.7
-
14
-
-
0242315033
-
The law of human experimentation with children
-
In M.A. Grodin and L.H. Glantz (eds.)., New York: Oxford University Press
-
Glantz, L.H. (1994). The law of human experimentation with children. In M.A. Grodin and L.H. Glantz (eds.). Children as Research Subjects: Science, Ethics, and Law, pp. 103-130. New York: Oxford University Press.
-
(1994)
Children as Research Subjects: Science, Ethics, and Law
, pp. 103-130
-
-
Glantz, L.H.1
-
16
-
-
0019511920
-
Assessment of risk in research on children
-
Janofsky, B.A. and Starfield, B. (1981). Assessment of risk in research on children. Journal of Pediatrics 98: 842-846.
-
(1981)
Journal of Pediatrics
, vol.98
, pp. 842-846
-
-
Janofsky, B.A.1
Starfield, B.2
-
17
-
-
0027654735
-
"Ethics and clinical research" revisited
-
Katz, J. (1993). "Ethics and clinical research" revisited. Hastings Center Report 23, 5: 31-39.
-
(1993)
Hastings Center Report
, vol.23
, Issue.5
, pp. 31-39
-
-
Katz, J.1
-
18
-
-
0012827818
-
Scientific issues in biomedical research with children
-
In M.A. Grodin and L.H. Glantz (eds.)., New York: Oxford University Press
-
Kauffman, R.E. (1994). Scientific issues in biomedical research with children. In M.A. Grodin and L.H. Glantz (eds.). Children as Research Subjects: Science, Ethics, and Law, pp. 29-45. New York: Oxford University Press.
-
(1994)
Children as Research Subjects: Science, Ethics, and Law
, pp. 29-45
-
-
Kauffman, R.E.1
-
19
-
-
0032525837
-
Informed consent in the Children's Cancer Group
-
Kodish, E.D. et al. (1998). Informed consent in the Children's Cancer Group. Cancer 82, 12: 2467-2481.
-
(1998)
Cancer
, vol.82
, Issue.12
, pp. 2467-2481
-
-
Kodish, E.D.1
-
20
-
-
0002259107
-
When is the risk minimal enough for children to be used as research subjects?
-
In L.M. Kopelman and J.C. Moskop (eds.)., Dordrecht: Kluwer Academic Publishers
-
Kopelman, L.M. (1989). When is the risk minimal enough for children to be used as research subjects? In L.M. Kopelman and J.C. Moskop (eds.). Children and Health Care: Moral and Social Issues, pp. 89-99. Dordrecht: Kluwer Academic Publishers.
-
(1989)
Children and Health Care: Moral and Social Issues
, pp. 89-99
-
-
Kopelman, L.M.1
-
21
-
-
0019395287
-
Risks of research in children
-
Lascari, A.D. (1981). Risks of research in children. Journal of Pediatrics 98: 759-760.
-
(1981)
Journal of Pediatrics
, vol.98
, pp. 759-760
-
-
Lascari, A.D.1
-
22
-
-
0002047566
-
Children as research subjects
-
In L.M. Kopelman and J.C. Moskop (eds.)., Dordrecht: Kluwer Academic Publishers
-
Levine, R.J. (1989). Children as research subjects. In L.M. Kopelman and J.C. Moskop (eds.). Children and Health Care: Moral and Social Issues, pp. 73-87. Dordrecht: Kluwer Academic Publishers.
-
(1989)
Children and Health Care: Moral and Social Issues
, pp. 73-87
-
-
Levine, R.J.1
-
23
-
-
0018025199
-
Research on children: National Commission says Yes, if
-
McCartney, J.J. (1978). Research on children: National Commission says "Yes, if. " Hastings Center Report 8, 5: 26-31.
-
(1978)
Hastings Center Report
, vol.8
, Issue.5
, pp. 26-31
-
-
McCartney, J.J.1
-
24
-
-
0003811725
-
-
National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, Washington, DC: Department of Health, Education, and Welfare (DHEW Publication No. (OS) 77-0004)
-
National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (1977). Report and Recommendations: Research Involving Children. Washington, DC: Department of Health, Education, and Welfare (DHEW Publication No. (OS) 77-0004).
-
(1977)
Report and Recommendations: Research Involving Children
-
-
-
25
-
-
0001863026
-
Children as research subjects
-
In J.P. Kahn, A.C. Mastroianni and J. Sugarman (eds.)., New York: Oxford University Press
-
Nelson, R.M. (1998). Children as research subjects. In J.P. Kahn, A.C. Mastroianni and J. Sugarman (eds.). Beyond Consent: Seeking Justice in Research, pp. 47-66. New York: Oxford University Press.
-
(1998)
Beyond Consent: Seeking Justice in Research
, pp. 47-66
-
-
Nelson, R.M.1
-
27
-
-
0010524236
-
President to order drug makers to conduct pediatric studies
-
August
-
Pear, R. (1997). President to order drug makers to conduct pediatric studies. New York Times, August 13: A17.
-
(1997)
New York Times
, vol.13
-
-
Pear, R.1
-
28
-
-
0032576259
-
FDA will require companies to test drugs on children
-
November
-
Pear, R. (1998). FDA will require companies to test drugs on children. New York Times, November 28: A1 and A10.
-
(1998)
New York Times
, vol.28
-
-
Pear, R.1
-
29
-
-
0024355582
-
Can children be enrolled in a placebo-controlled randomized clinical trial of synthetic growth hormone?
-
Prentice, E.D., Antonson, D.L., Jameton, A. et al. (1989). Can children be enrolled in a placebo-controlled randomized clinical trial of synthetic growth hormone? IRB 11, 1: 6-10.
-
(1989)
IRB
, vol.11
, Issue.1
, pp. 6-10
-
-
Prentice, E.D.1
Antonson, D.L.2
Jameton, A.3
-
30
-
-
84880300038
-
-
(Director, Human Subject Protections, Office of Protection from Research Risks), Personal communication, January 4
-
Puglisi, J.T. (Director, Human Subject Protections, Office of Protection from Research Risks) (1999). Personal communication, January 4.
-
(1999)
-
-
Puglisi, J.T.1
-
31
-
-
0014244852
-
Editorial comment: Therapeutic orphans
-
Shirkey, H. (1968). Editorial comment: Therapeutic orphans. Journal of Pediatrics 72: 119-120.
-
(1968)
Journal of Pediatrics
, vol.72
, pp. 119-120
-
-
Shirkey, H.1
-
32
-
-
0028440119
-
The NIH trials of growth hormone for short stature
-
Tauer, C.A. (1994). The NIH trials of growth hormone for short stature. IRB 16, 3: 1-9.
-
(1994)
IRB
, vol.16
, Issue.3
, pp. 1-9
-
-
Tauer, C.A.1
-
33
-
-
0030920199
-
Pediatric phase II cancer chemotherapy trials: A pediatric oncology group study
-
Weitman, S., Ochoa, S., Sullivan, A., Shuster, J., Winick, N., Pratt, C., Vietti, T. and Harris, M. (1997). Pediatric phase II cancer chemotherapy trials: A pediatric oncology group study. Journal of Pediatric Hematology/Oncology 19, 3: 187-191.
-
(1997)
Journal of Pediatric Hematology/Oncology
, vol.19
, Issue.3
, pp. 187-191
-
-
Weitman, S.1
Ochoa, S.2
Sullivan, A.3
Shuster, J.4
Winick, N.5
Pratt, C.6
Vietti, T.7
Harris, M.8
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