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Volumn 20, Issue 2-3, 1998, Pages 1-5

The IRB's role in assessing the generalizability of non-NIH-funded clinical trials

Author keywords

[No Author keywords available]

Indexed keywords

NEW DRUG;

EID: 0032009383     PISSN: 01937758     EISSN: None     Source Type: Journal    
DOI: 10.2307/3563554     Document Type: Article
Times cited : (4)

References (19)
  • 1
    • 0001474703 scopus 로고
    • NIH guidelines on the inclusion of women and minorities as subjects in clinical research
    • Department of Health and Human Services, and National Institutes of Health: NIH guidelines on the inclusion of women and minorities as subjects in clinical research. Federal Register 1994; 59:14508-13.
    • (1994) Federal Register , vol.59 , pp. 14508-14513
  • 2
    • 0030159221 scopus 로고    scopus 로고
    • Evolving ethical issues in selection of subjects for clinical research
    • Weijer C: Evolving ethical issues in selection of subjects for clinical research. Cambridge Quarterly of Healthcare Ethics 1996; 5:334-45.
    • (1996) Cambridge Quarterly of Healthcare Ethics , vol.5 , pp. 334-345
    • Weijer, C.1
  • 3
    • 0017099265 scopus 로고
    • Injuries to research subjects: A survey of investigators
    • Cardon PV, Dommel FW, Truble RR: Injuries to research subjects: a survey of investigators. NEJM 1976; 295:650-4.
    • (1976) NEJM , vol.295 , pp. 650-654
    • Cardon, P.V.1    Dommel, F.W.2    Truble, R.R.3
  • 6
    • 0011962384 scopus 로고    scopus 로고
    • Incidence of injury during clinical pharmacology research and indemnification of injured research subjects at the Quincy Research Center
    • President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research.
    • Arnold JD: Incidence of injury during clinical pharmacology research and indemnification of injured research subjects at the Quincy Research Center. In: President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research. Compensating for Research Injuries.
    • Compensating for Research Injuries
    • Arnold, J.D.1
  • 7
    • 0028455540 scopus 로고
    • The impact of HIV infection on society's perception of clinical trials
    • Levine RJ: The impact of HIV infection on society's perception of clinical trials. Kennedy Institute of Ethics Journal 1994; 4:93-8.
    • (1994) Kennedy Institute of Ethics Journal , vol.4 , pp. 93-98
    • Levine, R.J.1
  • 8
    • 0027884905 scopus 로고
    • The exclusion of pregnant, pregnable, and once pregnable people (aka women) from biomedical research
    • Merton V: The exclusion of pregnant, pregnable, and once pregnable people (aka women) from biomedical research. American Journal of Law and Medicine 1994; 19: 369-450.
    • (1994) American Journal of Law and Medicine , vol.19 , pp. 369-450
    • Merton, V.1
  • 10
    • 0027922323 scopus 로고
    • Guidelines for the Study and evaluation of gender differences in the clinical evaluation of drugs
    • Food and Drug Administration: Guidelines for the Study and evaluation of gender differences in the clinical evaluation of drugs. Federal Register 1993; 58:39406-16.
    • (1993) Federal Register , vol.58 , pp. 39406-39416
  • 11
    • 27844435151 scopus 로고    scopus 로고
    • These are outlined in a letter to IRBs by Gary Ellis, Director of the Office for Protection from Research Risk, 25 April 1994
    • These are outlined in a letter to IRBs by Gary Ellis, Director of the Office for Protection from Research Risk, 25 April 1994.
  • 12
    • 27844434046 scopus 로고    scopus 로고
    • 45 CFR 46; Revised 18 June 1991
    • 45 CFR 46; Revised 18 June 1991.
  • 14
    • 0026782559 scopus 로고
    • The exclusion of the elderly and women from clinical trials in acute myocardial infarction
    • Gurwitz JH, Col NF, Avorn J: The exclusion of the elderly and women from clinical trials in acute myocardial infarction. JAMA 1992; 268: 1417-61.
    • (1992) JAMA , vol.268 , pp. 1417-1461
    • Gurwitz, J.H.1    Col, N.F.2    Avorn, J.3
  • 15
    • 0025737883 scopus 로고
    • Analysis and interpretation of treatment effects in subgroups of patients in randomized clinical trials
    • Yusuf S, Wittes J, Probstfield J, Tyroler HA: Analysis and interpretation of treatment effects in subgroups of patients in randomized clinical trials. JAMA 1991; 266:93-8.
    • (1991) JAMA , vol.266 , pp. 93-98
    • Yusuf, S.1    Wittes, J.2    Probstfield, J.3    Tyroler, H.A.4
  • 16
    • 0006006915 scopus 로고
    • Ethics and statistics in clinical research: Towards a more comprehensive examination
    • Freedman B, Shapiro S: Ethics and statistics in clinical research: towards a more comprehensive examination. Journal of Statistical Planning and Inference 1994; 42:223-40.
    • (1994) Journal of Statistical Planning and Inference , vol.42 , pp. 223-240
    • Freedman, B.1    Shapiro, S.2
  • 17
    • 0023452835 scopus 로고
    • Scientific value and validity as ethical requirements for research: A proposed explication
    • Freedman B: Scientific value and validity as ethical requirements for research: a proposed explication. IRB 1987; 9(6):7-10.
    • (1987) IRB , vol.9 , Issue.6 , pp. 7-10
    • Freedman, B.1
  • 18
    • 0027034483 scopus 로고
    • Demarcating research and treatment: A systematic approach for the analysis of the ethics of clinical research
    • Freedman B, Fuks A, Weijer C: Demarcating research and treatment: a systematic approach for the analysis of the ethics of clinical research. Clinical Research 1992; 40:653-60.
    • (1992) Clinical Research , vol.40 , pp. 653-660
    • Freedman, B.1    Fuks, A.2    Weijer, C.3
  • 19
    • 0023185342 scopus 로고
    • Equipoise and the ethics of clinical research
    • Freedman, B: Equipoise and the ethics of clinical research. NEJM 1987; 317:141-5.
    • (1987) NEJM , vol.317 , pp. 141-145
    • Freedman, B.1


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.