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Volumn 25, Issue 2, 2010, Pages 145-150

Informed consent issues in traumatic brain injury research: Current status of capacity assessment and recommendations for safeguards

Author keywords

[No Author keywords available]

Indexed keywords

CLINICAL ASSESSMENT; CLINICAL RESEARCH; COGNITION; HUMAN; INFORMED CONSENT; POPULATION RESEARCH; REVIEW; TRAUMATIC BRAIN INJURY;

EID: 77949591046     PISSN: 08859701     EISSN: None     Source Type: Journal    
DOI: 10.1097/HTR.0b013e3181d8287d     Document Type: Review
Times cited : (20)

References (32)
  • 1
    • 0013368415 scopus 로고
    • Consent issues in human research
    • Reich WT, ed. New York, NY: Macmillan
    • Levine RJ. Consent issues in human research. In: Reich WT, ed. Encyclopedia of Human Ethics. Vol 2. New York, NY: Macmillan; 1995:1241-1250.
    • (1995) Encyclopedia of Human Ethics , vol.2 , pp. 1241-1250
    • Levine, R.J.1
  • 2
    • 0023319217 scopus 로고
    • False hopes and best data: Consent to research and the therapeutic misconception
    • Applebaum PS, Loren H, Roth C, Lidz W. False hopes and best data: consent to research and the therapeutic misconception.Hastings Cent Rep. 1987;17(2):20-24.
    • (1987) Hastings Cent Rep , vol.17 , Issue.2 , pp. 20-24
    • Applebaum, P.S.1    Loren, H.2    Roth, C.3    Lidz, W.4
  • 5
    • 0035576795 scopus 로고    scopus 로고
    • Racial/ethnic disparities in mortality by stroke subtype in the United States 1995-1998
    • Ayala C, Greenlund KJ, Croft JB, et al. Racial/ethnic disparities in mortality by stroke subtype in the United States 1995-1998. Am J Epidemiol. 2001;154:1057-1063.
    • (2001) Am J Epidemiol , vol.154 , pp. 1057-1063
    • Ayala, C.1    Greenlund, K.J.2    Croft, J.B.3
  • 6
    • 26444596581 scopus 로고    scopus 로고
    • Informed consent for medical treatment and research: A review
    • del Carmen M, Joffe S. Informed consent for medical treatment and research: a review. Oncologist. 2005;10(8):636-641.
    • (2005) Oncologist , vol.10 , Issue.8 , pp. 636-641
    • Del Carmen, M.1    Joffe, S.2
  • 9
    • 77949643560 scopus 로고
    • The Belmont Report: Ethical principles and guidelines for the protection of human subjects of research
    • Paper presented at: April 18, Washington, DC
    • The Belmont Report: ethical principles and guidelines for the protection of human subjects of research. Paper presented at: the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research; April 18, 1979;Washington, DC.
    • (1979) The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research
  • 10
    • 77949392212 scopus 로고
    • Declaration of Helsinki: Recommendations guiding medical doctors in biomedical research involving human subjects
    • Paper presented at: June, Helsinki, Finland
    • Declaration of Helsinki: recommendations guiding medical doctors in biomedical research involving human subjects. Paper presented at: 18th World Medical Assembly; June 1964; Helsinki, Finland.
    • (1964) 18th World Medical Assembly
  • 11
    • 0007002676 scopus 로고
    • 45 CFR 46
    • 45 CFR 46. Fed Regist; 1991;56:28012.
    • (1991) Fed Regist , vol.56 , pp. 28012
  • 12
    • 0018108013 scopus 로고
    • Racism and research: The case of the Tuskegee Syphilis Study
    • Brandt AM. Racism and research: the case of the Tuskegee Syphilis Study. Hastings Center Rep. 1978;8:21-29.
    • (1978) Hastings Center Rep , vol.8 , pp. 21-29
    • Brandt, A.M.1
  • 13
    • 77949642143 scopus 로고
    • Reprinted in Leavitt J, Numbers R, eds. 2nd ed. Madison: University of Wisconsin Press
    • Reprinted in Leavitt J, Numbers R, eds. Sickness and Health in America. 2nd ed. Madison: University of Wisconsin Press; 1985:331-346.
    • (1985) Sickness and Health in America , pp. 331-346
  • 14
    • 35448956727 scopus 로고    scopus 로고
    • The association of specific neuropsychological deficits with capacity to consent to research treatment
    • Palmer BW, Savla GN. The association of specific neuropsychological deficits with capacity to consent to research treatment. J Int Neuropsychol Soc. 2007;13:1047-1059.
    • (2007) J Int Neuropsychol Soc , vol.13 , pp. 1047-1059
    • Palmer, B.W.1    Savla, G.N.2
  • 15
    • 61749084080 scopus 로고    scopus 로고
    • Request for information and comments on research that involves adult individuals with impaired decision-making capacity
    • US Department of Health and Human Services
    • US Department of Health and Human Services. Request for information and comments on research that involves adult individuals with impaired decision-making capacity. Fed Regist. 2007;72(171):50966-50970.
    • (2007) Fed Regist , vol.72 , Issue.171 , pp. 50966-50970
  • 16
    • 26444525945 scopus 로고    scopus 로고
    • National Bioethics Advisory Commission. Washington, DC: National Bioethics Advisory Commission
    • National Bioethics Advisory Commission. Guidelines for Research Involving Cognitively Impaired Subjects. Washington, DC: National Bioethics Advisory Commission; 1999:1-25.
    • (1999) Guidelines for Research Involving Cognitively Impaired Subjects , pp. 1-25
  • 17
    • 0036082190 scopus 로고    scopus 로고
    • Involving decisionally impaired subjects in research: The need for legislation
    • Applebaum PS. Involving decisionally impaired subjects in research: the need for legislation. Am J Geriatr Psychiatry. 2002;10: 120-124.
    • (2002) Am J Geriatr Psychiatry , vol.10 , pp. 120-124
    • Applebaum, P.S.1
  • 18
    • 0038148155 scopus 로고    scopus 로고
    • Informed consent for Alzheimer's disease clinical trials: A survey of clinical investigators
    • Karlawish J, Knopman D, Clark CM, et al. Informed consent for Alzheimer's disease clinical trials: a survey of clinical investigators. IRB. 2002;24(5):1-5.
    • (2002) IRB , vol.24 , Issue.5 , pp. 1-5
    • Karlawish, J.1    Knopman, D.2    Clark, C.M.3
  • 19
    • 39549100354 scopus 로고    scopus 로고
    • Cognitive models of medical decision-making capacity in patients with mild cognitive impairment
    • Okonkwo OC, Griffith HR, Belue K, et al. Cognitive models of medical decision-making capacity in patients with mild cognitive impairment. J Int Neuropsychol Soc. 2008;14:287-308.
    • (2008) J Int Neuropsychol Soc , vol.14 , pp. 287-308
    • Okonkwo, O.C.1    Griffith, H.R.2    Belue, K.3
  • 21
    • 57749099326 scopus 로고    scopus 로고
    • Cognitive predictors of medical decision-making capacity in traumatic brain injury
    • Dreer LE, DeVivo MJ, Novack TA, Krywanski S, Marson DC. Cognitive predictors of medical decision-making capacity in traumatic brain injury. Rehabil Psychol. 2008;53(4):486-497.
    • (2008) Rehabil Psychol , vol.53 , Issue.4 , pp. 486-497
    • Dreer, L.E.1    Devivo, M.J.2    Novack, T.A.3    Krywanski, S.4    Marson, D.C.5
  • 22
    • 0030096941 scopus 로고    scopus 로고
    • Do you understand? An ethical assessment of researchers' description of the consenting process
    • Titus SL, Keane MA. Do you understand? An ethical assessment of researchers' description of the consenting process. J Clin Ethics. 1996;7(1):60-68.
    • (1996) J Clin Ethics , vol.7 , Issue.1 , pp. 60-68
    • Titus, S.L.1    Keane, M.A.2
  • 23
    • 0035025349 scopus 로고    scopus 로고
    • Enhancing informed consent for research and treatment
    • Dunn LB, Jeste DV. Enhancing informed consent for research and treatment. Neuropsychopharmacology. 2001;24:595-607.
    • (2001) Neuropsychopharmacology , vol.24 , pp. 595-607
    • Dunn, L.B.1    Jeste, D.V.2
  • 24
    • 14744283614 scopus 로고    scopus 로고
    • Evaluating the quality of informed consent
    • Sugarman J, Lavori PW, Boeger M, et al. Evaluating the quality of informed consent. Clin Trials. 2005;2:34-41.
    • (2005) Clin Trials , vol.2 , pp. 34-41
    • Sugarman, J.1    Lavori, P.W.2    Boeger, M.3
  • 25
    • 16644366054 scopus 로고    scopus 로고
    • Research with brain-injured subjects
    • Winslade WJ, Tovino SA. Research with brain-injured subjects. J Head Trauma Rehabil. 2004;19(6):513-515.
    • (2004) J Head Trauma Rehabil , vol.19 , Issue.6 , pp. 513-515
    • Winslade, W.J.1    Tovino, S.A.2
  • 26
    • 1842433689 scopus 로고    scopus 로고
    • Research on minimally conscious patients: Innovation or Exploitation?
    • Winslade WJ. Research on minimally conscious patients: innovation or exploitation? J Head Trauma Rehabil. 2004;19(2):178-179.
    • (2004) J Head Trauma Rehabil , vol.19 , Issue.2 , pp. 178-179
    • Winslade, W.J.1
  • 27
    • 0037417244 scopus 로고    scopus 로고
    • Research involving cognitively impaired adults
    • Karlawish J. Research involving cognitively impaired adults. N Engl JMed. 2003;348:1389-1392.
    • (2003) N Engl JMed , vol.348 , pp. 1389-1392
    • Karlawish, J.1
  • 28
    • 0029116799 scopus 로고
    • Assessing the competency of patients with Alzheimer's disease under different legal standards
    • Marson DC, Ingram KK, Cody HA, Harrell LE. Assessing the competency of patients with Alzheimer's disease under different legal standards. Arch Neurol. 1995;52:949-954.
    • (1995) Arch Neurol , vol.52 , pp. 949-954
    • Marson, D.C.1    Ingram, K.K.2    Cody, H.A.3    Harrell, L.E.4
  • 29
    • 25144511970 scopus 로고    scopus 로고
    • The capacity to consent to treatment and research: A review of standardized assessment tools
    • Sturman ED. The capacity to consent to treatment and research: a review of standardized assessment tools. Clin Psychol Rev. 2005;25(7):954-974.
    • (2005) Clin Psychol Rev , vol.25 , Issue.7 , pp. 954-974
    • Sturman, E.D.1
  • 30
    • 0024166188 scopus 로고
    • Assessing patients' capacity to consent to treatment
    • Applebaum PS, Grisso T. Assessing patients' capacity to consent to treatment. N Engl JMed. 1988;319:1635-1638.
    • (1988) N Engl JMed , vol.319 , pp. 1635-1638
    • Applebaum, P.S.1    Grisso, T.2
  • 31
    • 34547787224 scopus 로고    scopus 로고
    • A new brief instrument for assessing decisional capacity for clinical research
    • JesteDV, PalmerBW, Appelbaum PS, et al. A new brief instrument for assessing decisional capacity for clinical research. Arch Gen Psychiatry. 2007;64(8):966-974.
    • (2007) Arch Gen Psychiatry , vol.64 , Issue.8 , pp. 966-974
    • Jeste, D.V.1    Palmer, B.W.2    Appelbaum, P.S.3
  • 32
    • 0035797938 scopus 로고    scopus 로고
    • Core safeguards for clinical research with adults who are unable to consent
    • Wendler D, Prasad K. Core safeguards for clinical research with adults who are unable to consent. Ann Intern Med. 2001;135(7): 514-523.
    • (2001) Ann Intern Med , vol.135 , Issue.7 , pp. 514-523
    • Wendler, D.1    Prasad, K.2


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.