메뉴 건너뛰기




Volumn 6, Issue 6, 2000, Pages 9-18

Informed consent and assent in human subject research

Author keywords

Belmont Report; Child assent; Informed consent; Minimal risk; Parental permission; Research ethics; Respect for persons

Indexed keywords

ARTICLE; HUMAN; HUMAN EXPERIMENT; INFORMED CONSENT; STANDARD; UNITED STATES;

EID: 33751578006     PISSN: 10784659     EISSN: 15505022     Source Type: Journal    
DOI: 10.1097/00124784-200006060-00004     Document Type: Article
Times cited : (4)

References (64)
  • 2
    • 85026167339 scopus 로고    scopus 로고
    • 45 Code of Federal Regulations 46
    • Code of Federal Regulations 46.
  • 3
    • 85026160222 scopus 로고    scopus 로고
    • 21 Code of Federa I Regula tions 50,5 6
    • Code of Federa I Regula tions 50,5 6.
  • 4
    • 0013368415 scopus 로고
    • Informed Consent: Consent Issues in Human Research
    • ed. Warren T. Reich. New York: Simon & Schuster Macmillan
    • R.J. Levine, “Informed Consent: Consent Issues in Human Research,” in Encyclopedia of Bioethics, ed. Warren T. Reich. New York: Simon & Schuster Macmillan, 1995.
    • (1995) Encyclopedia of Bioethics
    • Levine, R.J.1
  • 6
    • 0004039952 scopus 로고    scopus 로고
    • Protecting Study Volunteers in Research
    • Boston, MA: Center Watch, Inc
    • C.M. Dunn and G. Chadwick, Protecting Study Volunteers in Research: A Manual for Investigative Sites. Boston, MA: Center Watch, Inc., 1999.
    • (1999) A Manual for Investigative Sites
    • Dunn, C.M.1    Chadwick, G.2
  • 7
    • 0001863026 scopus 로고    scopus 로고
    • Children as Research Subjects
    • ed. J.P. Kahn, et al. New York: Oxford University Press
    • R.M. Nelson, “Children as Research Subjects,” in Beyond Consent: Seeking Justice in Research, ed. J.P. Kahn, et al. New York: Oxford University Press, 1998.
    • (1998) Beyond Consent: Seeking Justice in Research
    • Nelson, R.M.1
  • 8
    • 85026167872 scopus 로고    scopus 로고
    • 45 Code of Federal Regulations 46.116
    • Code of Federal Regulations 46.116.
  • 9
    • 85026184050 scopus 로고    scopus 로고
    • 21 Code of Federal Regulations 50.27
    • Code of Federal Regulations 50.27.
  • 10
    • 85026182687 scopus 로고    scopus 로고
    • 45 Code of Federal Regulations 46.116(d)
    • Code of Federal Regulations 46.116(d).
  • 11
    • 85026175711 scopus 로고    scopus 로고
    • 45 Code of Federal Regulations 46.102(i)
    • Code of Federal Regulations 46.102(i).
  • 12
    • 0026653088 scopus 로고
    • Elements of Informed Consent in Clinical Research with Drugs: A Survey of Spanish Clinical Investigators
    • R. Dal-Re, “Elements of Informed Consent in Clinical Research with Drugs: A Survey of Spanish Clinical Investigators,” Journal of Internal Medicine 231, no. 4 (1992): 375-379.
    • (1992) Journal of Internal Medicine , vol.231 , Issue.4 , pp. 375-379
    • Dal-Re, R.1
  • 13
    • 85026176281 scopus 로고    scopus 로고
    • Differences in Perception of Coals, Expectations and Level of Informed Consent Between Oncologists (Ones) and Patients (pts) Involved in Phase 1 Clinical Trials
    • C. Daugherty, et al., “Differences in Perception of Coals, Expectations and Level of Informed Consent Between Oncologists (ones) and Patients (pts) Involved in Phase 1 Clinical Trials,” Proceedings of the Annual Meeting of the American Society of Clinical Oncology 15 (1996): Al 713.
    • (1996) Proceedings of the Annual Meeting of the American Society of Clinical Oncology , vol.15
    • Daugherty, C.1
  • 14
    • 0018869385 scopus 로고
    • Informed Consent: How Much Does the Patient Understand?
    • J.H. Bergler, et al., “Informed Consent: How Much Does the Patient Understand?” Clinical Pharmacology and Therapeutics 27, no. 4 (1980): 435-440.
    • (1980) Clinical Pharmacology and Therapeutics , vol.27 , Issue.4 , pp. 435-440
    • Bergler, J.H.1
  • 15
    • 0029002997 scopus 로고
    • Perceptions of Cancer Patients and Their Physicians Involved in Phase I Trials
    • C. Daugherty, et al., “Perceptions of Cancer Patients and Their Physicians Involved in Phase I Trials,” Journal of Clinical Oncology 13, no. 5 (1995): 1062-1072.
    • (1995) Journal of Clinical Oncology , vol.13 , Issue.5 , pp. 1062-1072
    • Daugherty, C.1
  • 16
    • 0021252214 scopus 로고
    • Factors Influencing a Person's Reaction to Informed Consent
    • L.L. Gertson and J.R. McNamara, “Factors Influencing a Person's Reaction to Informed Consent,” Psychological Reports 54, no. 1 (1984): 112-114.
    • (1984) Psychological Reports , vol.54 , Issue.1 , pp. 112-114
    • Gertson, L.L.1    McNamara, J.R.2
  • 17
    • 9044245705 scopus 로고    scopus 로고
    • Telephone-Based Nursing Intervention Improves the Effectiveness of the Informed Consent Process in Cancer Clinical Trials
    • N.K. Aaronson, et al., “Telephone-Based Nursing Intervention Improves the Effectiveness of the Informed Consent Process in Cancer Clinical Trials,” Journal of Clinical Oncology 14, no. 3 (1996): 984-996.
    • (1996) Journal of Clinical Oncology , vol.14 , Issue.3 , pp. 984-996
    • Aaronson, N.K.1
  • 18
    • 0018840734 scopus 로고
    • Informed Consent—Why Are Its Goals Imperfectly Realized?
    • B.R. Cassileth, et al., “Informed Consent—Why Are Its Goals Imperfectly Realized?” The New England Journal of Medicine 302 (1980): 896-900.
    • (1980) The New England Journal of Medicine , vol.302 , pp. 896-900
    • Cassileth, B.R.1
  • 19
    • 0021205929 scopus 로고
    • Do Patients Want To Be Informed? A Study of Consent for Cardiac Catheterization
    • A.G. Fraser, “Do Patients Want To Be Informed? A Study of Consent for Cardiac Catheterization,” British Heart Journal 52, no. 4 (1984): 468-470.
    • (1984) British Heart Journal , vol.52 , Issue.4 , pp. 468-470
    • Fraser, A.G.1
  • 20
    • 0030227764 scopus 로고    scopus 로고
    • Trust: The Fragile Foundation of Contemporary Biomedical Research
    • N.E. Kass, etal., “Trust: The Fragile Foundation of Contemporary Biomedical Research,” Hastings Center Report 26, no. 5 (1996): 25-29.
    • (1996) Hastings Center Report , vol.26 , Issue.5 , pp. 25-29
    • Kass, N.E.1
  • 21
    • 0019855992 scopus 로고
    • Disclosure of Information to Patients in Medical Care
    • R.R. Faden, et al., “Disclosure of Information to Patients in Medical Care,” Medical Care 19, no. 7 (1981): 718-33.
    • (1981) Medical Care , vol.19 , Issue.7 , pp. 718-733
    • Faden, R.R.1
  • 22
    • 0029760259 scopus 로고    scopus 로고
    • Offering Patients Entry in Clinical Trials: Preliminary Study of the Views of Prospective Participants
    • F. Corbett, et al., “Offering Patients Entry in Clinical Trials: Preliminary Study of the Views of Prospective Participants,” Journal of Medical Ethics 22 (1996): 227-231.
    • (1996) Journal of Medical Ethics , vol.22 , pp. 227-231
    • Corbett, F.1
  • 23
    • 0030297937 scopus 로고    scopus 로고
    • An Empirical Approach to Informed Consent in Ovarian Cancer
    • D. Feldman-Stewart, et al., “An Empirical Approach to Informed Consent in Ovarian Cancer,” Journal of Clinical Epidemiology 49, no. 11 (1996): 1259-1269.
    • (1996) Journal of Clinical Epidemiology , vol.49 , Issue.11 , pp. 1259-1269
    • Feldman-Stewart, D.1
  • 24
    • 0031968804 scopus 로고    scopus 로고
    • Getting Meaningful Informed Consent from Older Adults: A Structured Literature Review of Empirical Research
    • J. Sugarman, et al., “Getting Meaningful Informed Consent from Older Adults: A Structured Literature Review of Empirical Research,” JAGS 46 (1998): 517-524.
    • (1998) JAGS , vol.46 , pp. 517-524
    • Sugarman, J.1
  • 25
    • 0026542392 scopus 로고
    • The Hopkins Competency Assessment Test: A Brief Method for Evaluating Patients Capacity to Give Informed Consent,”
    • J.S. Janofsky, et al., “The Hopkins Competency Assessment Test: A Brief Method for Evaluating Patients’ Capacity to Give Informed Consent,” Hospital and Community Psychiatry 43, no. 2 (1992): 132-136.
    • (1992) Hospital and Community Psychiatry , vol.43 , Issue.2 , pp. 132-136
    • Janofsky, J.S.1
  • 26
    • 0028600638 scopus 로고
    • Cognitive Deficit and Mental Capacity Evaluation
    • S. Siberfeld, et al., “Cognitive Deficit and Mental Capacity Evaluation,” Canadian Journal of Aging 13 (1994): 539-549.
    • (1994) Canadian Journal of Aging , vol.13 , pp. 539-549
    • Siberfeld, S.1
  • 27
    • 0029165803 scopus 로고
    • Neuropsychologic Predictors of Competency in Alzheimer's Disease Using a Rational Reasons Legal Standard
    • D.C. Marson, et al., “Neuropsychologic Predictors of Competency in Alzheimer's Disease Using a Rational Reasons Legal Standard,” Archives of Neurology 52, no. 10 (1995): 955-959.
    • (1995) Archives of Neurology , vol.52 , Issue.10 , pp. 955-959
    • Marson, D.C.1
  • 28
    • 0028914229 scopus 로고
    • The MacArthur Treatment Competence Study III: Abilities of Patients to Consent to Psychiatric and Medical Treatments
    • T. Grisso and P.S. Appelbaum, “The MacArthur Treatment Competence Study III: Abilities of Patients to Consent to Psychiatric and Medical Treatments,” Law and Human Behavior 19, no. 2 (1995): 149-174.
    • (1995) Law and Human Behavior , vol.19 , Issue.2 , pp. 149-174
    • Grisso, T.1    Appelbaum, P.S.2
  • 29
    • 0026471966 scopus 로고
    • A Study of the Competence to Consent to Treatment in a Psychiatric Hospital
    • B.F. Hoffman and J. Srinivasan, “A Study of the Competence to Consent to Treatment in a Psychiatric Hospital,” Canadian Journal of Psychiatry 37, no. 3 (1992): 179-182.
    • (1992) Canadian Journal of Psychiatry , vol.37 , Issue.3 , pp. 179-182
    • Hoffman, B.F.1    Srinivasan, J.2
  • 30
    • 0029116799 scopus 로고
    • Assessing the Competency of Patients with Alzheimers Disease under Different Legal Standards: A Prototype Instrument,”
    • D.C. Marson, et al.,“Assessing the Competency of Patients with Alzheimer’s Disease under Different Legal Standards: A Prototype Instrument,” Archives of Neurology 52, no. 10 (1995): 949-954.
    • (1995) Archives of Neurology , vol.52 , Issue.10 , pp. 949-954
    • Marson, D.C.1
  • 31
    • 0031749633 scopus 로고    scopus 로고
    • Empirical Examination of the Ability of Children to Consent to Clinical Research
    • N. Ondrusek, et al., “Empirical Examination of the Ability of Children to Consent to Clinical Research,” Journal of Medical Ethics 24 (1998): 158-165.
    • (1998) Journal of Medical Ethics , vol.24 , pp. 158-165
    • Ondrusek, N.1
  • 32
    • 0022591175 scopus 로고
    • Patients Competency to Give Informed Consent to Medication,”
    • J.C. Beck and R.D. Staffin,“Patients’ Competency to Give Informed Consent to Medication,” Hospital and Community Psychiatry 37, no. 4 (1986): 400-402.
    • (1986) Hospital and Community Psychiatry , vol.37 , Issue.4 , pp. 400-402
    • Beck, J.C.1    Staffin, R.D.2
  • 33
    • 0028199948 scopus 로고
    • A Randomized Trial Using Videotape to Present Consent Information for Colonoscopy
    • P. Agre, et al., “A Randomized Trial Using Videotape to Present Consent Information for Colonoscopy,” Gastrointestinal Endoscopy 40, no. 3 (1994): 271-276.
    • (1994) Gastrointestinal Endoscopy , vol.40 , Issue.3 , pp. 271-276
    • Agre, P.1
  • 34
    • 0030917864 scopus 로고    scopus 로고
    • Patient Satisfaction with an Informed Consent Procedure
    • P. Agre, et al., “Patient Satisfaction with an Informed Consent Procedure,” Cancer Practice 5, no. 3 (1997): 162-167.
    • (1997) Cancer Practice , vol.5 , Issue.3 , pp. 162-167
    • Agre, P.1
  • 35
    • 0030847669 scopus 로고    scopus 로고
    • Evaluation of a Video-Supplement to Informed Consent: Injection Drug Users and Preventive HIV Vaccine Efficacy Trials
    • I. Fureman, et al., “Evaluation of a Video-Supplement to Informed Consent: Injection Drug Users and Preventive HIV Vaccine Efficacy Trials,” AIDS Education and Prevention 9, no. 4 (1997): 330-341.
    • (1997) AIDS Education and Prevention , vol.9 , Issue.4 , pp. 330-341
    • Fureman, I.1
  • 36
    • 0022332644 scopus 로고
    • Preparation for Surgery: Information Tapes for the Patient
    • P.A. Baskerville, et al., “Preparation for Surgery: Information Tapes for the Patient,” Practitioner 229 (1985): 677-678.
    • (1985) Practitioner , vol.229 , pp. 677-678
    • Baskerville, P.A.1
  • 37
    • 0027386124 scopus 로고
    • General Information Tapes Inhibit Recall of the Cancer Consultation
    • S.M. Dunn, et al., “General Information Tapes Inhibit Recall of the Cancer Consultation,” Journal of Clinical Oncology 11, no. 11 (1993): 2279-2285.
    • (1993) Journal of Clinical Oncology , vol.11 , Issue.11 , pp. 2279-2285
    • Dunn, S.M.1
  • 38
    • 0030163006 scopus 로고    scopus 로고
    • Educating Patients About Cystic Fibrosis Carrier Screening in a Primary Care Setting
    • B.A. Bernhardt, et al., “Educating Patients About Cystic Fibrosis Carrier Screening in a Primary Care Setting,” Archives of Family Medicine 5, no. 6 (1996): 336-340.
    • (1996) Archives of Family Medicine , vol.5 , Issue.6 , pp. 336-340
    • Bernhardt, B.A.1
  • 39
    • 0025266774 scopus 로고
    • Satisfying Patients Needs for Surgical Information,”
    • M.H. Edwards, “Satisfying Patients’ Needs for Surgical Information,” British Journal of Surgery 77, no. 4 (1990): 463-465.
    • (1990) British Journal of Surgery , vol.77 , Issue.4 , pp. 463-465
    • Edwards, M.H.1
  • 41
    • 85026171914 scopus 로고    scopus 로고
    • Payment to Research Subjects
    • Rockville, MD: FDA
    • Food and Drug Administration, “Payment to Research Subjects,” FDA Information Sheets. Rockville, MD: FDA, September 1998.
    • (1998) FDA Information Sheets
  • 42
    • 0029650014 scopus 로고
    • Informed Versus Randomized Consent to Clinical Trials
    • C. Gallo, et al., “Informed Versus Randomized Consent to Clinical Trials,” Lancet 346, no. 8982 (1995): 1060-1064.
    • (1995) Lancet , vol.346 , Issue.8982 , pp. 1060-1064
    • Gallo, C.1
  • 43
    • 0027491961 scopus 로고
    • Informed Consent: Using a Structured Interview Changes Patients' Attitudes towards Informed Consent
    • P.J.D. Dawes and S. Adcock, “Informed Consent: Using a Structured Interview Changes Patients' Attitudes towards Informed Consent,” Journal of Laryngology and Otology 107, no. 9 (1993): 775-779.
    • (1993) Journal of Laryngology and Otology , vol.107 , Issue.9 , pp. 775-779
    • Dawes, P.J.D.1    Adcock, S.2
  • 44
    • 84988214507 scopus 로고    scopus 로고
    • Is Consent to Participate in Research Voluntary?
    • S.E. Hewlett, “Is Consent to Participate in Research Voluntary?” Arthritis Care and Research 9, no. 5 (1996): 400-404.
    • (1996) Arthritis Care and Research , vol.9 , Issue.5 , pp. 400-404
    • Hewlett, S.E.1
  • 45
    • 2642670291 scopus 로고    scopus 로고
    • Informed Consent for HIV Testing in a South African Hospital: Is It Truly Informed and Truly Voluntary?
    • Q.A. Karim, et al., “Informed Consent for HIV Testing in a South African Hospital: Is It Truly Informed and Truly Voluntary?” American Journal of Public Health 88, no. 4 (1998): 637-640.
    • (1998) American Journal of Public Health , vol.88 , Issue.4 , pp. 637-640
    • Karim, Q.A.1
  • 46
    • 1642465194 scopus 로고
    • The Ethics of Non-Therapeutic Clinical Research on Children
    • (OS) 77-0005. Washington, DC: The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research
    • W.G. Bartholome, “The Ethics of Non-Therapeutic Clinical Research on Children,” in Appendix to Report and Recommendations: Research Involving Children. DHEW Publication No. (OS) 77-0005. Washington, DC: The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, 1977.
    • (1977) Appendix to Report and Recommendations: Research Involving Children. DHEW Publication No
    • Bartholome, W.G.1
  • 47
    • 85026163467 scopus 로고    scopus 로고
    • 45 Code of Federal Regulations 46.402(b)
    • Code of Federal Regulations 46.402(b).
  • 48
    • 85026184663 scopus 로고
    • Report and Recommendations: Research Involving Children. DHEW Publication No. 77-0004
    • The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. Report and Recommendations: Research Involving Children. DHEW Publication No. 77-0004. The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, 1977.
    • (1977) The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research
  • 51
    • 0028959392 scopus 로고
    • Informed Consent, Parental Permission, and Assent in Pediatric Practice (RE9510)
    • American Academy of Pediatrics Committee on Bioethics, “Informed Consent, Parental Permission, and Assent in Pediatric Practice (RE9510),” in Pediatrics 95, no. 2 (1995): 314-317.
    • (1995) Pediatrics , vol.95 , Issue.2 , pp. 314-317
  • 52
    • 85026177833 scopus 로고    scopus 로고
    • 45 Code of Federal Regulations 46.106(i)
    • Code of Federal Regulations 46.106(i).
  • 53
    • 85026156102 scopus 로고    scopus 로고
    • 45 Code of Federal Regulations 46.402(b)
    • Code of Federal Regulations 46.402(b).
  • 54
    • 85026161192 scopus 로고    scopus 로고
    • 45 Code of Federal Regulations 46.404-407
    • Code of Federal Regulations 46.404-407.
  • 55
    • 85026155844 scopus 로고    scopus 로고
    • 45 Code of Federal Regulations 46.408
    • Code of Federal Regulations 46.408.
  • 56
    • 85026178328 scopus 로고
    • Research Involving Those Institutionalized as Mentally Infirm
    • 78-0006. Washington, DC: The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research
    • The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, Research Involving Those Institutionalized as Mentally Infirm. Federal Register Document 78-0006. Washington, DC: The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, 1978.
    • (1978) Federal Register Document
  • 57
    • 0001144134 scopus 로고    scopus 로고
    • Ethical Issues in Pediatric Research
    • ed. H.Y. Vanderpool. Frederick, MD: University Publishing Group
    • W.G. Bartholome, “Ethical Issues in Pediatric Research,” in The Ethics of Research Involving Human Subjects, ed. H.Y. Vanderpool. Frederick, MD: University Publishing Group.
    • The Ethics of Research Involving Human Subjects
    • Bartholome, W.G.1
  • 58
    • 0027571658 scopus 로고
    • Minors Assent, Consent, or Dissent to Medical Research,”
    • Code of Federal Regulations 46.408(a). See also S.L. Leiken, “Minors’ Assent, Consent, or Dissent to Medical Research,” IRB: A Review of Human Subjects Research 15 (1993): 1-7.
    • (1993) IRB: A Review of Human Subjects Research , vol.15 , pp. 1-7
  • 59
    • 0020349163 scopus 로고
    • The Competency of Chil-dren and Adolescents to Make Informed Treatment Decisions
    • L.A. Weithorn and S.B. Campbell, “The Competency of Chil-dren and Adolescents to Make Informed Treatment Decisions,” Child Development 53 (1982): 1589-1598.
    • (1982) Child Development , vol.53 , pp. 1589-1598
    • Weithorn, L.A.1    Campbell, S.B.2
  • 60
    • 0027378150 scopus 로고
    • Maturity of Children to Consent to Medical Research: The Babysitter Test
    • G. Koren, “Maturity of Children to Consent to Medical Research: The Babysitter Test,” Journal of Medical Ethics 19 (1993): 142-147.
    • (1993) Journal of Medical Ethics , vol.19 , pp. 142-147
    • Koren, G.1
  • 61
    • 85026174755 scopus 로고    scopus 로고
    • 45 Code of Federal Regulations 46.408(a)
    • Code of Federal Regulations 46.408(a).
  • 62
    • 85026182905 scopus 로고
    • Public Health: Public Health Methods: Epidemiology and Biostatistics
    • ed. Warren T. Reich. New York: Simon & Schuster Macmillan
    • C.L. Soskolne, “Public Health: Public Health Methods: Epidemiology and Biostatistics,” in Encyclopedia of Bioethics, ed. Warren T. Reich. New York: Simon & Schuster Macmillan 1995.
    • (1995) Encyclopedia of Bioethics
    • Soskolne, C.L.1
  • 63
    • 0029947075 scopus 로고    scopus 로고
    • The Public Health Information Infrastructure: A National Review of the Law on Health Information Privacy
    • L.O. Gostin, et al., “The Public Health Information Infrastructure: A National Review of the Law on Health Information Privacy,” Journal of the American Medical Association 275, no. 24 (1996): 1921-1927.
    • (1996) Journal of the American Medical Association , vol.275 , Issue.24 , pp. 1921-1927
    • Gostin, L.O.1
  • 64
    • 0032109678 scopus 로고    scopus 로고
    • HIV Testing of Infants: Privacy and Public Health
    • A. Etzioni, “HIV Testing of Infants: Privacy and Public Health,” Health Affairs 17, no. 4 (1998): 170-183.
    • (1998) Health Affairs , vol.17 , Issue.4 , pp. 170-183
    • Etzioni, A.1


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.