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Volumn 16, Issue 4, 2010, Pages 675-691

Statistical Power, the Belmont Report, and the Ethics of Clinical Trials

Author keywords

Belmont Report; Ethical frameworks; Ethical reasoning; Ethical thinking; Ethics of clinical trials; RCR; Research compliance; Research oversight; Statistical power

Indexed keywords

ARTICLE; CLINICAL TRIAL (TOPIC); ETHICS; HISTORY; HUMAN; HUMAN EXPERIMENT; INFORMED CONSENT; METHODOLOGY; PATIENT SELECTION; RESEARCH ETHICS; RISK; SAFETY; STANDARD; STATISTICS;

EID: 78650049337     PISSN: 13533452     EISSN: 16605454     Source Type: Journal    
DOI: 10.1007/s11948-010-9244-0     Document Type: Article
Times cited : (22)

References (17)
  • 1
    • 27544482422 scopus 로고    scopus 로고
    • The declaration of Helsinki: An update on paragraph 30
    • Blackmer, J., & Haddad, H. (2005). The declaration of Helsinki: An update on paragraph 30. Canadian Medical Association Journal, 173, 1052-1053.
    • (2005) Canadian Medical Association Journal , vol.173 , pp. 1052-1053
    • Blackmer, J.1    Haddad, H.2
  • 3
    • 0028860181 scopus 로고
    • Reporting of power and sample size in randomized controlled trials
    • Burdick, C. (1995). Reporting of power and sample size in randomized controlled trials. Journal of the American Medical Association, 273, 22.
    • (1995) Journal of the American Medical Association , vol.273 , pp. 22
    • Burdick, C.1
  • 4
    • 3242667914 scopus 로고    scopus 로고
    • When experiments go wrong: The U.S. perspective
    • Capron, A. (2004). When experiments go wrong: The U. S. perspective. The Journal of Clinical Ethics, 15, 22-29.
    • (2004) The Journal of Clinical Ethics , vol.15 , pp. 22-29
    • Capron, A.1
  • 6
    • 11944272254 scopus 로고
    • A power primer
    • Cohen, J. (1992). A power primer. Psychological Bulletin, 112, 155-159.
    • (1992) Psychological Bulletin , vol.112 , pp. 155-159
    • Cohen, J.1
  • 7
    • 0018076475 scopus 로고
    • The importance of beta, the type II error, and sample size in the design and interpretation of the randomized controlled trial: Survey of 71 'negative' trials
    • Frieman, J. A., Chalmers, T. C., Smith, H., & Kuebler, R. R. (1978). The importance of beta, the type II error, and sample size in the design and interpretation of the randomized controlled trial: Survey of 71 'negative' trials. New England Journal of Medicine, 299, 690-694.
    • (1978) New England Journal of Medicine , vol.299 , pp. 690-694
    • Frieman, J.A.1    Chalmers, T.C.2    Smith, H.3    Kuebler, R.R.4
  • 9
    • 0018398230 scopus 로고
    • Ethical considerations in clinical trials
    • Levine, R. (1979). Ethical considerations in clinical trials. Clinical Pharmacology and Therapeutics, 25(5), 728-774.
    • (1979) Clinical Pharmacology and Therapeutics , vol.25 , Issue.5 , pp. 728-774
    • Levine, R.1
  • 10
    • 78650047501 scopus 로고    scopus 로고
    • Center for ethical deliberation, Accessed 15 October 2010
    • Matchett, N. J. (2007). Frameworks. Center for ethical deliberation. http://mcb. unco. edu/ced/frameworks/. Accessed 15 October 2010.
    • (2007) Frameworks
    • Matchett, N.J.1
  • 11
    • 0028276374 scopus 로고
    • Statistical Power, sample size, and their reporting in randomized controlled trials
    • Moher, D., Dulberg, C. S., & Wells, G. A. (1994). Statistical Power, sample size, and their reporting in randomized controlled trials. Journal of the American Medical Association, 272, 122-124.
    • (1994) Journal of the American Medical Association , vol.272 , pp. 122-124
    • Moher, D.1    Dulberg, C.S.2    Wells, G.A.3
  • 13
    • 0038241932 scopus 로고
    • National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, Washington, DC: U.S. Government Printing Office, II
    • National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. (1975). Appendix: The Belmont report: Ethical principles and guidelines for the protection of human subjects of research (Vol. I and II). Washington, DC: U. S. Government Printing Office.
    • (1975) Appendix: The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research , vol.I
  • 14
    • 78650053972 scopus 로고
    • Office of human subjects research
    • National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, The Belmont report, Accessed 15 October 2010
    • National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. (1979). The Belmont report. Office of human subjects research. National http://ohsr. od. nih. gov/guidelines/belmont. html. Accessed 15 October 2010.
    • (1979) National
  • 15
    • 0003710205 scopus 로고
    • Office for Human Research Protections (first edition 1981; revised, updated, and expanded by Robin Penslar), Accessed 15 October 2010
    • Office for Human Research Protections (first edition 1981; revised, updated, and expanded by Robin Penslar). (1993). Institutional Review Board Guidebook. http://www. hhs. gov/ohrp/irb/irb_guidebook. htm. Accessed 15 October 2010.
    • (1993) Institutional Review Board Guidebook
  • 16
    • 0035893302 scopus 로고    scopus 로고
    • What are the effects of the fifth revision of the declaration of Helsinki?
    • Tollman, S., Bastian, H., Doll, R., Hirsch, L. J., & Guess, H. A. (2001). What are the effects of the fifth revision of the declaration of Helsinki? British Medical Journal, 323, 1417-1423.
    • (2001) British Medical Journal , vol.323 , pp. 1417-1423
    • Tollman, S.1    Bastian, H.2    Doll, R.3    Hirsch, L.J.4    Guess, H.A.5
  • 17
    • 78650071350 scopus 로고    scopus 로고
    • Declaration of Helsinki
    • Accessed 15 October 2010, World Medical Association.
    • World Medical Association. (2004). Declaration of Helsinki. Office of Human Subjects Research. http://ohsr. od. nih. gov/guidelines/helsinki. html. Accessed 15 October 2010.
    • (2004) Office of Human Subjects Research


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.