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Volumn 53, Issue 10, 2008, Pages 1342-1349

Protecting vulnerable subjects in clinical research: Children, pregnant women, prisoners, and employees

Author keywords

Children; Cognitively impaired; Employees; Institutional review board; Pregnant; Prisoners; Research; Residents; Special research populations; Students; Vulnerable subjects; Women

Indexed keywords

CLINICAL RESEARCH; COGNITIVE DEFECT; CONFERENCE PAPER; EMPLOYEE; GOVERNMENT; HUMAN; PEDIATRICS; PRACTICE GUIDELINE; PREGNANT WOMAN; PRISONER; RESPIRATORY THERAPIST; VULNERABLE POPULATION; CHILD; FEMALE; HUMAN EXPERIMENT; LEGAL ASPECT; MEDICAL RESEARCH; ORGANIZATION AND MANAGEMENT; PREGNANCY; PROFESSIONAL STANDARD; REVIEW; UNITED STATES;

EID: 58149148302     PISSN: 00201324     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Conference Paper
Times cited : (27)

References (27)
  • 1
    • 41149152920 scopus 로고
    • Protection of human subjects
    • United States Department of Health and Human Services
    • United States Department of Health and Human Services. Protection of human subjects. Code of Federal Regulations, Title 45, Part 46; 1991.
    • (1991) Code of Federal Regulations, Title 45 , Issue.PART 46
  • 6
    • 0014019552 scopus 로고
    • Ethics and clinical research
    • Beecher HK. Ethics and clinical research. N Engl J Med 1966;274(24):1354-1360.
    • (1966) N Engl J Med , vol.274 , Issue.24 , pp. 1354-1360
    • Beecher, H.K.1
  • 7
    • 0004167304 scopus 로고
    • The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. Washington, DC: OPPR, US Government Printing Office
    • The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The Belmont Report. Washington, DC: OPPR, US Government Printing Office; 1983.
    • (1983) The Belmont Report
  • 8
    • 0001381904 scopus 로고    scopus 로고
    • Changing views of justice after Belmont: AIDS and the inclusion of "vulnerable" subjects
    • Vanderpool H, editor. Frederick, Maryland: University Publishing Group, Inc.
    • Levine C. Changing views of justice after Belmont: AIDS and the inclusion of "vulnerable" subjects. In: The ethics of research involving human subjects. Vanderpool H, editor. Frederick, Maryland: University Publishing Group, Inc.; 1996.
    • (1996) The Ethics of Research Involving Human Subjects
    • Levine, C.1
  • 9
    • 0000087571 scopus 로고
    • Subpart D. Additional protections for children involved as subjects in research code of federal regulations
    • United States Department of Health and Human Services. Washington, DC: March 8
    • United States Department of Health and Human Services. Subpart D. Additional protections for children involved as subjects in research code of federal regulations. Washington, DC: 48 FR 9818, March 8, 1983;
    • (1983) FR , vol.48 , pp. 9818
  • 10
    • 0347137078 scopus 로고
    • 56 FR 28032, 1991.
    • (1991) FR , vol.56 , pp. 28032
  • 11
    • 66949120403 scopus 로고    scopus 로고
    • United States Department of Health and Human Services Section 1003 of P.L. 106-310, May
    • United States Department of Health and Human Services. Protections for children in research, a report to Congress, Section 1003 of P.L. 106-310, May 2001.
    • (2001) Protections for Children in Research, a Report to Congress
  • 12
    • 0037370305 scopus 로고    scopus 로고
    • Do they understand? (Part II): Assent of children participating in clinical anesthesia and surgery research
    • Tait AR, Voepel-Lewis T, Shobha M. Do they understand? (Part II): assent of children participating in clinical anesthesia and surgery research. Respir Care 2003;98(6):609-614.
    • (2003) Respir Care , vol.98 , Issue.6 , pp. 609-614
    • Tait, A.R.1    Voepel-Lewis, T.2    Shobha, M.3
  • 13
    • 0003918497 scopus 로고
    • United States Food and Drug Administration, Department of Health, Education, and Welfare. Washington, DC: Government Printing Office; Report No. HEW 77-3040 United States Food and Washington, DC: Government Printing Office; Report No. HEW 77-3040
    • United States Food and Drug Administration, Department of Health, Education, and Welfare. General Considerations for the Clinical Evaluation of Drugs. Washington, DC: Government Printing Office; Report No. HEW 77-3040; 1977.
    • (1977) General Considerations for the Clinical Evaluation of Drugs
  • 15
    • 0009731165 scopus 로고
    • United States Food and Drug Administration, Department of Health, Education, and Welfare. Washington, DC: Government Printing Office; Report No. HEW 77-3040
    • United States Food and Drug Administration, Department of Health, Education, and Welfare. Guideline for the study and evaluation of gender differences in the clinical evaluation of drugs. Washington, DC: Government Printing Office; Report No. HEW 77-3040, 1993.
    • (1993) Guideline for the Study and Evaluation of Gender Differences in the Clinical Evaluation of Drugs
  • 16
    • 66949168218 scopus 로고
    • NIH guidelines on the inclusion of women and minorities as subjects in clinical research
    • National Institute of Health
    • National Institute of Health. NIH guidelines on the inclusion of women and minorities as subjects in clinical research. 58 Federal Register 39406-39416, 1994.
    • (1994) Federal Register , vol.58 , pp. 39406-39416
  • 17
    • 0000087571 scopus 로고
    • Subpart B: Additional protections for pregnant women, human fetuses and neonates involved in research. Code of Federal Regulations
    • United States Department of Health and Human Services. Washington, DC: US Department of Health and Human Services. March 8
    • United States Department of Health and Human Services. Subpart B: additional protections for pregnant women, human fetuses and neonates involved in research. Code of Federal Regulations. Washington, DC: US Department of Health and Human Services. 48 FR 9818, March 8, 1983;
    • (1983) FR , vol.48 , pp. 9818
  • 18
    • 0347137078 scopus 로고
    • 56 FR 28032, 1991.
    • (1991) FR , vol.56 , pp. 28032
  • 21
    • 0000087571 scopus 로고
    • Subpart C: Additional DHHS protections pertaining to biomedical and behavioral research involving prisoners as subjects. Code of Federal Regulations
    • United States Department of Health and Human Services Washington, DC: US Department of Health and Human Services March 8
    • United States Department of Health and Human Services. Subpart C: Additional DHHS protections pertaining to biomedical and behavioral research involving prisoners as subjects. Code of Federal Regulations. Washington, DC: US Department of Health and Human Services 48 FR 9818, March 8, 1983;
    • (1983) FR , vol.48 , pp. 9818
  • 22
    • 0347137078 scopus 로고
    • 56 FR 28032, 1991.
    • (1991) FR , vol.56 , pp. 28032
  • 23
    • 0022056284 scopus 로고
    • Do medical student research subjects need special protection?
    • Christakis N. Do medical student research subjects need special protection? IRB 1985;7(3):1-4.
    • (1985) IRB , vol.7 , Issue.3 , pp. 1-4
    • Christakis, N.1
  • 24
    • 0344686265 scopus 로고    scopus 로고
    • Research ethics and consent in the intensive care unit
    • DOI 10.1097/00075198-200312000-00013
    • Luce, JM. Research ethics and consent in the intensive care unit. Curr Opin Crit Care 2003;9(6):540-544. (Pubitemid 37518656)
    • (2003) Current Opinion in Critical Care , vol.9 , Issue.6 , pp. 540-544
    • Luce, J.M.1
  • 25
    • 17044390881 scopus 로고    scopus 로고
    • Is clinical research and ethics a zero-sum game?
    • Weijer C. Is clinical research and ethics a zero-sum game? Crit Care Med 2005;33(4):912-913.
    • (2005) Crit Care Med , vol.33 , Issue.4 , pp. 912-913
    • Weijer, C.1
  • 26
    • 0037351813 scopus 로고    scopus 로고
    • Ethical considerations for research in critically ill patients
    • Bigatello LM, George E, Hurford WE. Ethical considerations for research in critically ill patients. Crit Care Med 2003;31(3 Suppl):S178-S181. (Pubitemid 36379564)
    • (2003) Critical Care Medicine , vol.31 , Issue.3 SUPPL.
    • Bigatello, L.M.1    George, E.2    Hurford, W.E.3
  • 27
    • 2142758111 scopus 로고    scopus 로고
    • Ethics, science, and oversight of critical care research: The Office for Human Research Protections
    • Koski G. Ethics, science, and oversight of critical care research: the Office for Human Research Protections. Am J Respir Crit Care Med 2004;169(9):982-986. (Pubitemid 38543634)
    • (2004) American Journal of Respiratory and Critical Care Medicine , vol.169 , Issue.9 , pp. 982-986
    • Koski, G.1


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.