메뉴 건너뛰기




Volumn 32, Issue 2, 2003, Pages 161-169

Randomized, controlled evaluation of a prototype informed consent process for HIV vaccine efficacy trials

Author keywords

High risk populations; HIV; HIV vaccines; Informed consent; Randomized trial

Indexed keywords

HUMAN IMMUNODEFICIENCY VIRUS VACCINE;

EID: 0037321668     PISSN: 15254135     EISSN: None     Source Type: Journal    
DOI: 10.1097/00126334-200302010-00008     Document Type: Article
Times cited : (57)

References (43)
  • 1
    • 0014019552 scopus 로고
    • Ethics and clinical research
    • Beecher HK. Ethics and clinical research. N Engl J Med 1966;274:1354-60.
    • (1966) N Engl J Med , vol.274 , pp. 1354-1360
    • Beecher, H.K.1
  • 3
    • 0013037561 scopus 로고
    • Washington, DC: US Government Printing Office
    • Ad Hoc Advisory Panel. Final report on the Tuskeegee Syphilis Study. Washington, DC: US Government Printing Office, 1973:5-15.
    • (1973) Final Report on the Tuskeegee Syphilis Study , pp. 5-15
  • 4
    • 0019838828 scopus 로고
    • How informed is informed consent? The BHAT experience
    • Howard JM, DeMets D, the BHAT Research Group. How informed is informed consent? The BHAT experience. Control Clin Trials 1981;2:287-303.
    • (1981) Control Clin Trials , vol.2 , pp. 287-303
    • Howard, J.M.1    DeMets, D.2
  • 5
    • 0020681945 scopus 로고
    • Informed consent: Ethical, legal, and medical implications for doctors and patients who participate in randomised clinical trials
    • Cancer Research Campaign Working Party in Breast Conservation. Informed consent: ethical, legal, and medical implications for doctors and patients who participate in randomised clinical trials. BMJ 1983;286:1117-21.
    • (1983) BMJ , vol.286 , pp. 1117-1121
  • 7
    • 0025772201 scopus 로고
    • Informed consent: Study of the quality of information given to participants in a clinical trial
    • Lynöe N, Sandlund M, Dahlqvist G, et al. Informed consent: study of the quality of information given to participants in a clinical trial. BMJ 1991;303:610-3.
    • (1991) BMJ , vol.303 , pp. 610-613
    • Lynöe, N.1    Sandlund, M.2    Dahlqvist, G.3
  • 8
    • 0023319217 scopus 로고
    • False hopes and best data: Consent to research and the therapeutic misconception
    • Applebaum PS, Roth LH, Lidz CW, et al. False hopes and best data: consent to research and the therapeutic misconception. Hastings Cent Rep 1987;April:20-4.
    • (1987) Hastings Cent Rep , vol.APRIL , pp. 20-24
    • Applebaum, P.S.1    Roth, L.H.2    Lidz, C.W.3
  • 9
    • 0014530749 scopus 로고
    • Obtaining informed consent: Form or substance
    • Epstein LC, Lasagna L. Obtaining informed consent: form or substance. Arch Intern Med 1969;123:682-8.
    • (1969) Arch Intern Med , vol.123 , pp. 682-688
    • Epstein, L.C.1    Lasagna, L.2
  • 10
    • 0003632150 scopus 로고
    • Washington, DC: US Government Printing Office
    • Advisory Committee on Human Radiation Experiments. Final report. Washington, DC: US Government Printing Office, 1995.
    • (1995) Final Report
  • 11
    • 0022391484 scopus 로고
    • Informed consent in psychiatric research: Preliminary findings from an ongoing investigation
    • Benson PR, Roth LH, Winslade WJ. Informed consent in psychiatric research: preliminary findings from an ongoing investigation. Soc Sci Med 1985;20:1331-41.
    • (1985) Soc Sci Med , vol.20 , pp. 1331-1341
    • Benson, P.R.1    Roth, L.H.2    Winslade, W.J.3
  • 12
    • 0022636079 scopus 로고
    • Ethical problems in clinical research: The need for empirical research studies of the clinical trials process
    • MacKillop WJ, Johnston P. Ethical problems in clinical research: the need for empirical research studies of the clinical trials process. J Chron Dis 1986;39:177-88.
    • (1986) J Chron Dis , vol.39 , pp. 177-188
    • MacKillop, W.J.1    Johnston, P.2
  • 13
    • 0022804977 scopus 로고
    • Comprehension of informed consent for research: Issues and directions for future studies
    • Taub HA. Comprehension of informed consent for research: issues and directions for future studies. IRB 1986;November-December:7-10.
    • (1986) IRB , vol.NOVEMBER-DECEMBER , pp. 7-10
    • Taub, H.A.1
  • 14
    • 0023370291 scopus 로고
    • Empirical studies of ethical issues in research: A research agenda
    • Stanley B, Sieber JE, Melton GB. Empirical studies of ethical issues in research: a research agenda. Am Psychol 1987;42:735-41.
    • (1987) Am Psychol , vol.42 , pp. 735-741
    • Stanley, B.1    Sieber, J.E.2    Melton, G.B.3
  • 15
    • 0027374794 scopus 로고
    • Preparing for HIV vaccine efficacy trials: Partnerships and challenges
    • Vermund SH, Fischer RD, Hoff R, et al. Preparing for HIV vaccine efficacy trials: partnerships and challenges. AIDS Res Hum Retroviruses 1993;10(suppl 1):127-32.
    • (1993) AIDS Res Hum Retroviruses , vol.10 , Issue.SUPPL. 1 , pp. 127-132
    • Vermund, S.H.1    Fischer, R.D.2    Hoff, R.3
  • 16
    • 0029069554 scopus 로고
    • Trial objectives and end points for measuring the efficacy of HIV vaccines
    • Hoff R, Barker L. Trial objectives and end points for measuring the efficacy of HIV vaccines. Infect Agents Dis 1995;4:95-101.
    • (1995) Infect Agents Dis , vol.4 , pp. 95-101
    • Hoff, R.1    Barker, L.2
  • 17
    • 0030682523 scopus 로고    scopus 로고
    • Intermediate-size trials for the evaluation of HIV vaccine candidates: A workshop summary
    • Rida W, Fast P, Hoff R, et al. Intermediate-size trials for the evaluation of HIV vaccine candidates: a workshop summary. J Acquir Immune Defic Syndr Hum Retrovirol 1997;16:195-203.
    • (1997) J Acquir Immune Defic Syndr Hum Retrovirol , vol.16 , pp. 195-203
    • Rida, W.1    Fast, P.2    Hoff, R.3
  • 19
    • 0028805546 scopus 로고
    • Preventing discrimination against volunteers in preventive HIV vaccine efficacy trials: Conference summary
    • Sheon AR. Preventing discrimination against volunteers in preventive HIV vaccine efficacy trials: conference summary. AIDS Hum Retrovir 1995;11:1309-11.
    • (1995) AIDS Hum Retrovir , vol.11 , pp. 1309-1311
    • Sheon, A.R.1
  • 23
    • 0032534846 scopus 로고    scopus 로고
    • Preventing discrimination against volunteers in prophylactic HIV vaccine trials: Lessons from the phase II trial
    • Sheon AR, Wagner L, McElrath MJ, et al. Preventing discrimination against volunteers in prophylactic HIV vaccine trials: lessons from the phase II trial. J Acquir Immune Defic Syndr Hum Retrovirol 1998;19:519-26.
    • (1998) J Acquir Immune Defic Syndr Hum Retrovirol , vol.19 , pp. 519-526
    • Sheon, A.R.1    Wagner, L.2    McElrath, M.J.3
  • 24
    • 0030819266 scopus 로고    scopus 로고
    • Risk behavior for HIV infection in preventive HIV vaccine trials: A cautionary note
    • Chesney MA, Chambers DB, Kahn JO. Risk behavior for HIV infection in preventive HIV vaccine trials: a cautionary note. J Acquir Immune Defic Syndr 1997;16:266-71.
    • (1997) J Acquir Immune Defic Syndr , vol.16 , pp. 266-271
    • Chesney, M.A.1    Chambers, D.B.2    Kahn, J.O.3
  • 25
    • 0028126719 scopus 로고
    • HIV preventive vaccine efficacy trials in the US: Overview of target communities concerns
    • Hodel D. HIV preventive vaccine efficacy trials in the US: overview of target communities concerns. AIDS Res Hum Retroviruses 1994;10(suppl 2):S255-6.
    • (1994) AIDS Res Hum Retroviruses , vol.10 , Issue.SUPPL. 2
    • Hodel, D.1
  • 26
    • 0028090129 scopus 로고
    • Behavioral studies relevant to vaccine trial preparation: An introduction
    • Turner CF, Sheon AR. Behavioral studies relevant to vaccine trial preparation: an introduction. AIDS Res Hum Retroviruses 1994;10 (suppl 2):S273-6.
    • (1994) AIDS Res Hum Retroviruses , vol.10 , Issue.SUPPL. 2
    • Turner, C.F.1    Sheon, A.R.2
  • 27
    • 0028138936 scopus 로고
    • Behavioral research contributions to planning and conducting HIV vaccine efficacy studies
    • Temoshok LR. Behavioral research contributions to planning and conducting HIV vaccine efficacy studies. AIDS Res Hum Retroviruses 1994;10(suppl 2):S277-80.
    • (1994) AIDS Res Hum Retroviruses , vol.10 , Issue.SUPPL. 2
    • Temoshok, L.R.1
  • 28
    • 0028673707 scopus 로고
    • Toward achieving meaningful informed consent in AIDS vaccine trials with injection-drug users
    • Sugarman J. Toward achieving meaningful informed consent in AIDS vaccine trials with injection-drug users. AIDS Public Policy Journal 1994;9:167-72.
    • (1994) AIDS Public Policy Journal , vol.9 , pp. 167-172
    • Sugarman, J.1
  • 29
    • 84942949575 scopus 로고
    • Ethical, behavioral, and social aspects of HIV vaccine trials in developing countries
    • Lurie P, Bishaw M, Chesney M, et al. Ethical, behavioral, and social aspects of HIV vaccine trials in developing countries. JAMA 1994;271:295-301.
    • (1994) JAMA , vol.271 , pp. 295-301
    • Lurie, P.1    Bishaw, M.2    Chesney, M.3
  • 30
    • 0023007738 scopus 로고
    • Randomised comparison of procedures for obtaining informed consent in clinical trials of treatment for cancer
    • Simes RJ, Tattersall MHN, Coates AS, et al. Randomised comparison of procedures for obtaining informed consent in clinical trials of treatment for cancer. BMJ 1986;293:1065-8.
    • (1986) BMJ , vol.293 , pp. 1065-1068
    • Simes, R.J.1    Tattersall, M.H.N.2    Coates, A.S.3
  • 31
    • 0022978579 scopus 로고
    • Informing the elderly: A comparison of four methods
    • Tymchuk AJ, Ouslander JG, Rader N. Informing the elderly: a comparison of four methods. J Am Geriatr Soc 1986;34:818-22.
    • (1986) J Am Geriatr Soc , vol.34 , pp. 818-822
    • Tymchuk, A.J.1    Ouslander, J.G.2    Rader, N.3
  • 32
    • 0025428929 scopus 로고
    • Informed consent documents: Increasing comprehension by reducing reading level
    • Young DR, Hooker DT, Freeberg FE. Informed consent documents: increasing comprehension by reducing reading level. IRB 1990;May-June:1-5.
    • (1990) IRB , vol.MAY-JUNE , pp. 1-5
    • Young, D.R.1    Hooker, D.T.2    Freeberg, F.E.3
  • 33
    • 0026955501 scopus 로고
    • Improving readability of consent forms: What the computers don't tell you
    • Peterson BT, Clancy SJ, Champion K, et al. Improving readability of consent forms: what the computers don't tell you. IRB 1992;November-December:6-8.
    • (1992) IRB , vol.NOVEMBER-DECEMBER , pp. 6-8
    • Peterson, B.T.1    Clancy, S.J.2    Champion, K.3
  • 34
    • 0018776441 scopus 로고
    • Written informed consent in patients with breast cancer
    • Muss HB, White DR, Michielutte R, et al. Written informed consent in patients with breast cancer. Cancer 1979;43:1549-56.
    • (1979) Cancer , vol.43 , pp. 1549-1556
    • Muss, H.B.1    White, D.R.2    Michielutte, R.3
  • 35
    • 0020017629 scopus 로고
    • More on making consent forms readable
    • Levine RJ. More on making consent forms readable [editorial]. IRB 1982;January-February:8-9.
    • (1982) IRB , vol.JANUARY-FEBRUARY , pp. 8-9
    • Levine, R.J.1
  • 36
    • 0013224148 scopus 로고
    • More on making consent forms readable
    • Meisel A. More on making consent forms readable [editorial]. IRB 1982;January-February:9.
    • (1982) IRB , vol.JANUARY-FEBRUARY , pp. 9
    • Meisel, A.1
  • 37
    • 0018141691 scopus 로고
    • A simple technique for increasing cancer patients' knowledge of informed consent to treatment
    • Morrow G, Gootnick J, Schmale A. A simple technique for increasing cancer patients' knowledge of informed consent to treatment. Cancer 1978;42:793-9.
    • (1978) Cancer , vol.42 , pp. 793-799
    • Morrow, G.1    Gootnick, J.2    Schmale, A.3
  • 39
    • 77649173768 scopus 로고
    • Longitudinal data analysis using generalized linear models
    • Liang K-Y, Zeger SL. Longitudinal data analysis using generalized linear models. Biometrika 1986;73:13-22.
    • (1986) Biometrika , vol.73 , pp. 13-22
    • Liang, K.-Y.1    Zeger, S.L.2
  • 40
    • 0028788544 scopus 로고
    • Medical eligibility, comprehension of the consent process, and retention of injection drug users recruited for an HIV vaccine trial
    • Harrison K, Vlahav D, Jones K, et al. Medical eligibility, comprehension of the consent process, and retention of injection drug users recruited for an HIV vaccine trial. JAIDS 1995;10:386-90.
    • (1995) JAIDS , vol.10 , pp. 386-390
    • Harrison, K.1    Vlahav, D.2    Jones, K.3
  • 41
    • 0023842099 scopus 로고
    • Enhancing comprehension of information for informed consent: A review of empirical research
    • Silva MC, Sorrell JM. Enhancing comprehension of information for informed consent: a review of empirical research. IRB 1988;January-February:1-5.
    • (1988) IRB , vol.JANUARY-FEBRUARY , pp. 1-5
    • Silva, M.C.1    Sorrell, J.M.2
  • 42
    • 0035341521 scopus 로고    scopus 로고
    • Safety and immunogenicity of a canarypox-vectored human immunodeficiency virus type 1 vaccine with or without gp120: A phase 2 study in higher- and lower-risk volunteers
    • Belshe RB, Stevens C, Gorse GJ, et al. Safety and immunogenicity of a canarypox-vectored human immunodeficiency virus type 1 vaccine with or without gp120: a phase 2 study in higher- and lower-risk volunteers. J Infect Dis 2001;183:1343-52.
    • (2001) J Infect Dis , vol.183 , pp. 1343-1352
    • Belshe, R.B.1    Stevens, C.2    Gorse, G.J.3
  • 43
    • 0018240061 scopus 로고
    • Videotape aids informed consent decision
    • Barbour GL, Blumenkrantz MJ. Videotape aids informed consent decision. JAMA 1978;240:2741-2.
    • (1978) JAMA , vol.240 , pp. 2741-2742
    • Barbour, G.L.1    Blumenkrantz, M.J.2


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.