메뉴 건너뛰기




Volumn 14, Issue 1, 2007, Pages 19-34

Pediatric research posing a minor increase over minimal risk and no prospect of direct benefit: Challenging 45 CFR 46.406

Author keywords

Disorder or condition clause; Minimal risk; Minor increase over minimal risk; Pediatric research

Indexed keywords

ARTICLE; ETHICS; HUMAN; LEGAL ASPECT; MEDICAL RESEARCH; PEDIATRICS; PRESCHOOL CHILD; RISK ASSESSMENT; UNITED STATES;

EID: 34748878305     PISSN: 08989621     EISSN: 15455815     Source Type: Journal    
DOI: 10.1080/08989620601104782     Document Type: Article
Times cited : (10)

References (21)
  • 1
    • 0019021748 scopus 로고
    • Moral duties of parents and non-therapeutic research procedures involving children
    • Ackerman, T. (1980). Moral duties of parents and non-therapeutic research procedures involving children, Bioethics Quarterly, 2: 94-111.
    • (1980) Bioethics Quarterly , vol.2 , pp. 94-111
    • Ackerman, T.1
  • 2
    • 50449135748 scopus 로고
    • Influence of phenylalanine intake on phenylketonuria
    • Bickel, H., Gerrard J., and Hickmans, E. (1953). Influence of phenylalanine intake on phenylketonuria, The Lancet, 265(6790): 812-813.
    • (1953) The Lancet , vol.265 , Issue.6790 , pp. 812-813
    • Bickel, H.1    Gerrard, J.2    Hickmans, E.3
  • 3
    • 85046202121 scopus 로고
    • Controls
    • Fisher, R. E. W. (1953). Controls, The Lancet, 265 (6793): 993.
    • (1953) The Lancet , vol.265 , Issue.6793 , pp. 993
    • Fisher, R.E.W.1
  • 4
    • 3042558817 scopus 로고    scopus 로고
    • Institute of Medicine (IOM), Washington, D. C.: The National Academies Press
    • Institute of Medicine (IOM). (2004). Ethical Conduct of Clinical Research Involving Children. Washington, D. C.: The National Academies Press.
    • (2004) Ethical Conduct of Clinical Research Involving Children
  • 5
    • 0002259107 scopus 로고
    • When is the risk minimal enough for children to be research subjects?
    • Kopelman L. M. and Moskop, J.C. eds.). Dordrecth: Kluwer
    • Kopelman, L. (1989). When is the risk minimal enough for children to be research subjects? In: Children and Health Care: Moral and Social Issues (Kopelman L. M. and Moskop, J.C. eds.). Dordrecth: Kluwer, pp.89-99.
    • (1989) Children and Health Care: Moral and Social Issues , pp. 89-99
    • Kopelman, L.1
  • 6
    • 13744261108 scopus 로고    scopus 로고
    • What conditions justify risky nontherapeutic or "no benefit" pediatric studies: A sliding scale analysis
    • Kopelman, L. (2004). What conditions justify risky nontherapeutic or "no benefit" pediatric studies: A sliding scale analysis, J Law, Medicine, & Ethics, 32(4):749-58.
    • (2004) J Law, Medicine, & Ethics , vol.32 , Issue.4 , pp. 749-758
    • Kopelman, L.1
  • 8
    • 0017267662 scopus 로고
    • Experimentation in children: Sharing sociality
    • McCormick, R. A. (1976). Experimentation in children: Sharing sociality, Hastings Center Report, 6(6): 41-46.
    • (1976) Hastings Center Report , vol.6 , Issue.6 , pp. 41-46
    • McCormick, R.A.1
  • 9
    • 0003811725 scopus 로고
    • National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, Washington, D.C.: U.S. Government Printing Office
    • National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. (1977). Report and Recommendations on Research Involving Children. Washington, D.C.: U.S. Government Printing Office.
    • (1977) Report and Recommendations On Research Involving Children
  • 10
    • 0004167304 scopus 로고
    • National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, D.C.: U.S. Government Printing Office, Washington
    • National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. (1979). The Belmont Report. Washington, D.C.: U.S. Government Printing Office.
    • (1979) The Belmont Report
  • 11
    • 27744526395 scopus 로고    scopus 로고
    • In defense of a single standard of research risk for all children
    • Nelson, R. M. and Ross, L. F. (2005). In defense of a single standard of research risk for all children, J Pediatrics, 147(5): 565-566.
    • (2005) J Pediatrics , vol.147 , Issue.5 , pp. 565-566
    • Nelson, R.M.1    Ross, L.F.2
  • 12
    • 84880323157 scopus 로고    scopus 로고
    • OHRP, Protections for Children in Research. Available at, Accessed October 11, 2006
    • OHRP. 2001. Protections for Children in Research. Available at http://www.hhs.gov/ohrp/reports/ohrp502.pdf. Accessed October 11, 2006).
    • (2001)
  • 14
    • 0003788092 scopus 로고
    • New Haven, CT.: Yale University Press
    • Ramsey, P. (1970). The Patient as Person. New Haven, CT.: Yale University Press.
    • (1970) The Patient As Person
    • Ramsey, P.1
  • 15
    • 84880280865 scopus 로고    scopus 로고
    • Correspondence: Protecting research subjects
    • Ross, L. F. (2002). Correspondence: Protecting research subjects, N Engl J Med, 346(26): 2094.
    • (2002) N Engl J Med , vol.346 , Issue.26 , pp. 2094
    • Ross, L.F.1
  • 16
    • 0037329681 scopus 로고    scopus 로고
    • Do healthy children deserve greater protection in medical research?
    • Ross, L. F. (2003). Do healthy children deserve greater protection in medical research? J Pediatrics 142(2): 108-112.
    • (2003) J Pediatrics , vol.142 , Issue.2 , pp. 108-112
    • Ross, L.F.1
  • 17
    • 3042604386 scopus 로고    scopus 로고
    • Convening a 407 panel for research not otherwise approvable: "Precursors to diabetes in Japanese American youth" as a Case Study
    • Ross, L. F. (2004a). Convening a 407 panel for research not otherwise approvable: "Precursors to diabetes in Japanese American youth" as a Case Study, Kennedy Institute of Ethics Journal, 14(2): 165-186.
    • (2004) Kennedy Institute of Ethics Journal , vol.14 , Issue.2 , pp. 165-186
    • Ross, L.F.1
  • 18
    • 5644236416 scopus 로고    scopus 로고
    • Children in medical research: Balancing protection and access: Has the pendulum swung too far?
    • Ross, L. F. (2004b). Children in medical research: Balancing protection and access: Has the pendulum swung too far? Perspectives in Biology and Medicine, 47(4): 519-536.
    • (2004) Perspectives In Biology and Medicine , vol.47 , Issue.4 , pp. 519-536
    • Ross, L.F.1
  • 19
    • 33644793601 scopus 로고    scopus 로고
    • Lessons learned from the 407 Process
    • Ross, L. F. (2005). Lessons learned from the 407 Process, Health Matrix, 15(2): 401-421.
    • (2005) Health Matrix , vol.15 , Issue.2 , pp. 401-421
    • Ross, L.F.1
  • 20
    • 79959230017 scopus 로고    scopus 로고
    • The 'subject's condition' requirement: Unjustified exceptionalism in the Federal Regulations
    • Shah, S. (2003). The 'subject's condition' requirement: Unjustified exceptionalism in the Federal Regulations, ASBH Exchange, 6(1): 5-6.
    • (2003) ASBH Exchange , vol.6 , Issue.1 , pp. 5-6
    • Shah, S.1
  • 21
    • 27744441296 scopus 로고    scopus 로고
    • What is a "minor" increase over minimal risk?
    • Wendler, D., Emanuel, E. J. (2005). What is a "minor" increase over minimal risk? J Pediatrics, 147(5): 575-578.
    • (2005) J Pediatrics , vol.147 , Issue.5 , pp. 575-578
    • Wendler, D.1    Emanuel, E.J.2


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.