메뉴 건너뛰기




Volumn 29, Issue 3, 2004, Pages 351-378

Minimal risk as an international ethical standard in research

Author keywords

Ethics; Minimal risk; Minors; Precautionary principle; Regulations; Research; Review boards

Indexed keywords

ETHICS; MEDICAL RESEARCH; MORALITY; REVIEW; RISK ASSESSMENT; SOCIAL ASPECT;

EID: 2542565728     PISSN: 03605310     EISSN: None     Source Type: Journal    
DOI: 10.1080/03605310490500545     Document Type: Review
Times cited : (94)

References (35)
  • 1
    • 0028950350 scopus 로고
    • Guidelines for the ethical conduct of studies to evaluate drugs in pediatric populations
    • 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
  • 5
    • 0035404347 scopus 로고    scopus 로고
    • Learning from the law to address uncertainty in the precautionary principle
    • Cranor, C. (2001). Learning from the law to address uncertainty in the precautionary principle. Science and Engineering Ethics, 7, 313-326.
    • (2001) Science and Engineering Ethics , vol.7 , pp. 313-326
    • Cranor, C.1
  • 6
    • 0027569844 scopus 로고
    • In Loco Parentis: Minimal risk as an ethical threshold for research upon children
    • Freedman, B., Fuks, A., & Weijer, C. (1993). In Loco Parentis: Minimal risk as an ethical threshold for research upon children. Hastings Center Report, 23, 13-19.
    • (1993) Hastings Center Report , vol.23 , pp. 13-19
    • Freedman, B.1    Fuks, A.2    Weijer, C.3
  • 7
    • 0032476883 scopus 로고    scopus 로고
    • Regulations requiring manufactures to assess the safety and effectiveness of new drugs and biological products in pediatric patients: Final rule
    • Food and Drug Administration (FDA). (1998). Regulations requiring manufactures to assess the safety and effectiveness of new drugs and biological products in pediatric patients: Final rule. Federal Register, 63, 66631-66672.
    • (1998) Federal Register , vol.63 , pp. 66631-66672
  • 8
    • 0000967841 scopus 로고    scopus 로고
    • Additional safeguards for children in clinical investigations of FDA-regulated products: Interim rule
    • Food and Drug Administration (FDA). (2001). Additional safeguards for children in clinical investigations of FDA-regulated products: Interim rule. Federal Register, 66, 20589-20600.
    • (2001) Federal Register , vol.66 , pp. 20589-20600
  • 9
    • 10044224948 scopus 로고    scopus 로고
    • Grimes v. Kennedy Krieger Institute, Inc. 782 A. 2d 807, 366 Md. 29 (Court of Appeals of Maryland, 2001)
    • Grimes v. Kennedy Krieger Institute, Inc. 782 A. 2d 807, 366 Md. 29 (Court of Appeals of Maryland, 2001).
  • 10
    • 0019511920 scopus 로고
    • Assessment of risk and research on children
    • Janofsky, J., & Starfield, B. (1981). Assessment of risk and research on children. Journal of Pediatrics, 98, 842-846.
    • (1981) Journal of Pediatrics , vol.98 , pp. 842-846
    • Janofsky, J.1    Starfield, B.2
  • 11
    • 0002259107 scopus 로고
    • When is the risk minimal enough for children to be research subjects?
    • L.M. Kopelman and J.C. Moskop (Eds.), Dordrecht, Netherlands: Kluwer
    • Kopelman, L.M. (1989). When is the risk minimal enough for children to be research subjects? In: L.M. Kopelman and J.C. Moskop (Eds.), Children and health care: Moral and social issues. Dordrecht, Netherlands: Kluwer.
    • (1989) Children and Health Care: Moral and Social Issues
    • Kopelman, L.M.1
  • 12
    • 0031158249 scopus 로고    scopus 로고
    • The best-interests standard as threshold, ideal, and standard of reasonableness
    • Kopelman, L.M. (1997). The best-interests standard as threshold, ideal, and standard of reasonableness. The Journal of Medicine and Philosophy, 22, 271-289.
    • (1997) The Journal of Medicine and Philosophy , vol.22 , pp. 271-289
    • Kopelman, L.M.1
  • 14
    • 0036519078 scopus 로고    scopus 로고
    • Pediatric research segulations under legal scrutiny: Grimes narrows their interpretation
    • Kopelman, L.M. (2002). Pediatric research segulations under legal scrutiny: Grimes narrows their interpretation. Journal of Law, Medicine and Ethics, 30, 38-49.
    • (2002) Journal of Law, Medicine and Ethics , vol.30 , pp. 38-49
    • Kopelman, L.M.1
  • 15
    • 0019395287 scopus 로고
    • Risks of research on children
    • Lascari, A.D. (1981). Risks of research on children. Journal of Pediatrics, 98, 759-760.
    • (1981) Journal of Pediatrics , vol.98 , pp. 759-760
    • Lascari, A.D.1
  • 19
    • 0003811725 scopus 로고
    • 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
  • 20
    • 0004167304 scopus 로고
    • The report to the Secretary of the Department of Health, Education and Welfare
    • National Commission for the Protection of Human Subjects, The Belmont Report. (1979). The report to the Secretary of the Department of Health, Education and Welfare.
    • (1979) The Belmont Report
  • 21
    • 10044268926 scopus 로고    scopus 로고
    • National Institutes of Health (NIH), Human Subjects Research Advisory committee (HSRAC) (2000). Minutes, meeting of November 9 [On-line]. Available: http://ohsr.od.nih.gov/HSRACminutes/110900_HASRAC_minutes.htm
    • (2000) Minutes, Meeting of November 9 [On-line]
  • 23
    • 10044254805 scopus 로고    scopus 로고
    • The Nuremberg Code: Germany (Territory Under Allied Occupation, 1945-1955: U.S. Zone) Military Tribunals. (1947). Permissible Medical Experiments. In vol. 2 of Trials of War Criminals Before the Nuremberg Tribunals Under Control Law. No. 10, 181-183. Washington, DC: U.S. Government Printing Office
    • The Nuremberg Code: Germany (Territory Under Allied Occupation, 1945-1955: U.S. Zone) Military Tribunals. (1947). Permissible Medical Experiments. In vol. 2 of Trials of War Criminals Before the Nuremberg Tribunals Under Control Law. No. 10, 181-183. Washington, DC: U.S. Government Printing Office.
  • 26
    • 85012487629 scopus 로고    scopus 로고
    • Children in clinical research: A conflict of moral values
    • In Focus
    • Sharav, & Hassner, V. (2003). Children in clinical research: A conflict of moral values. The American Journal of Bioethics, 3, In Focus.
    • (2003) The American Journal of Bioethics , vol.3
    • Sharav1    Hassner, V.2
  • 28
    • 0038117616 scopus 로고    scopus 로고
    • Ethical dilemmas in research with children
    • Tauer, C. (2002). Ethical dilemmas in research with children. Accountability in Research, 9, 127-142.
    • (2002) Accountability in Research , vol.9 , pp. 127-142
    • Tauer, C.1
  • 29
    • 10044255707 scopus 로고    scopus 로고
    • T.D. v. N.Y. State Office of Mental Health, 228 A.D. 2d 95 (1996)
    • T.D. v. N.Y. State Office of Mental Health, 228 A.D. 2d 95 (1996).
  • 30
    • 10044223706 scopus 로고    scopus 로고
    • United States Best Pharmaceutical for Children (PL 107-109) Children's Health Act of 2000, enacted October 17, On-line
    • United States Best Pharmaceutical for Children (PL 107-109) Children's Health Act of 2000, enacted October 17, 2000 [On-line]. Available: http:www.fda.gov/opacom/pharmkids/contents.html
    • (2000)
  • 31
    • 0000087571 scopus 로고
    • Additional protections for children involved as subjects in research. (Subpart D)
    • U.S. Code of Federal Regulations, 45 CFR 46: 401-409
    • U.S. Code of Federal Regulations, 45 CFR 46: 401-409. (1983). Additional protections for children involved as subjects in research. (Subpart D.) Federal Register, 48, 9816-9820.
    • (1983) Federal Register , vol.48 , pp. 9816-9820
  • 32
    • 0026427327 scopus 로고
    • Federal policy for the protection of human subjects. (The Common Rule)
    • U.S. Code of Federal Regulations, 45 CFR 46: 101-124
    • U.S. 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
  • 33
    • 0019888803 scopus 로고
    • Final regulations amending basic HHS policy for the protection of human research subjects
    • U.S. Department of Health and Human Services (DHHS). (1981). Final regulations amending basic HHS policy for the protection of human research subjects. Federal Register, 46, 8366-8391.
    • (1981) Federal Register , vol.46 , pp. 8366-8391
  • 34
    • 10044240878 scopus 로고    scopus 로고
    • A Report to Congress in Accord with Section 1003 of P.L. 106-310. Children's Health Act of 2000, May 2001, (2) Additional Findings (a) [On-line]
    • U.S. DHHS Office of Human Research Protections, Protection for Children in Research (May 2001). A Report to Congress in Accord with Section 1003 of P.L. 106-310. Children's Health Act of 2000, May 2001, (2) Additional Findings (a) [On-line]. Available (http://ohrp.osophs.dhhs.gov/reports/ohrp5-02.pdf).
    • (2001) Protection for Children in Research May


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.