메뉴 건너뛰기




Volumn 65, Issue 2, 2010, Pages 71-94

Informed consent form for biomedical research: A tutorial for redaction;Aide à la rédaction du document écrit destiné à l'information du participant à la Recherche BioMédicale et à l'attestation de son consentement éclairé

Author keywords

Biomedical research Redaction; Clinical research; Information; Informed consent; Participant

Indexed keywords

ARTICLE; FRANCE; INFORMED CONSENT; MEDICAL ETHICS; MEDICAL RESEARCH; PATIENT RIGHT; PRIORITY JOURNAL; VALIDATION PROCESS;

EID: 77952763654     PISSN: 00405957     EISSN: None     Source Type: Journal    
DOI: 10.2515/therapie/2010006     Document Type: Article
Times cited : (6)

References (51)
  • 2
    • 85031342674 scopus 로고    scopus 로고
    • Code de la santé publique, L-1122-1131
    • Code de la santé publique, L-1122-1131 http://www.legifrance.gouv. fr
  • 3
    • 33947687647 scopus 로고    scopus 로고
    • Improvement of the comprehension of written information given to healthy volunteers in biomedical research: A single-blind randomized controlled study
    • Paris A, Nogueira da Gama CD, Cornu C, et al. Improvement of the comprehension of written information given to healthy volunteers in biomedical research: a single-blind randomized controlled study. Fundam Clin Pharmacol 2007; 21: 207-214
    • (2007) Fundam Clin Pharmacol , vol.21 , pp. 207-214
    • Paris, A.1    Nogueira Da Gama, C.D.2    Cornu, C.3
  • 4
    • 33645034236 scopus 로고    scopus 로고
    • French adaptation and preliminary validation of a questionnaire to evaluate understanding of informed consent documents in phase i biomedical research
    • Paris A, Cornu C, Auquier P, et al. French adaptation and preliminary validation of a questionnaire to evaluate understanding of informed consent documents in phase I biomedical research. Fundam Clin Pharmacol 2006; 20: 97-104
    • (2006) Fundam Clin Pharmacol , vol.20 , pp. 97-104
    • Paris, A.1    Cornu, C.2    Auquier, P.3
  • 5
    • 20044390814 scopus 로고    scopus 로고
    • Impact of French 'Comites de Protection des Personnes' on the readability of informed consent documents (ICD) in biomedical research: More information, but not better information
    • Paris A, Cracowski JL, Maison P, et al. Impact of French 'Comites de Protection des Personnes' on the readability of informed consent documents (ICD) in biomedical research: more information, but not better information. Fundam Clin Pharmacol 2005; 19: 395-399
    • (2005) Fundam Clin Pharmacol , vol.19 , pp. 395-399
    • Paris, A.1    Cracowski, J.L.2    Maison, P.3
  • 6
    • 55049112208 scopus 로고    scopus 로고
    • Setting up of a Clinical Research Centers Ethics Committee in Rhone-Alpes-Auvergne District
    • Chomel de Varagnes S, Dualé C, Dubray C, et al. Setting up of a Clinical Research Centers Ethics Committee in Rhone-Alpes-Auvergne District. Therapie 2008; 63: 321-325
    • (2008) Therapie , vol.63 , pp. 321-325
    • Chomel De Varagnes, S.1    Dualé, C.2    Dubray, C.3
  • 7
    • 69049091371 scopus 로고    scopus 로고
    • Information sheets and informed consent forms for clinical study participants: Towards standardised recommendations?
    • Chassany O, Bernard-Harlaut M, Guy G, et al. Information sheets and informed consent forms for clinical study participants: towards standardised recommendations? Therapie 2009; 64: 161-166
    • (2009) Therapie , vol.64 , pp. 161-166
    • Chassany, O.1    Bernard-Harlaut, M.2    Guy, G.3
  • 8
    • 53549108038 scopus 로고    scopus 로고
    • Ethical considerations for clinical trials on medicinal products conducted with the paediatric population
    • European Union
    • European Union. Ethical considerations for clinical trials on medicinal products conducted with the paediatric population. Eur J Health Law 2008; 15: 223-250
    • (2008) Eur J Health Law , vol.15 , pp. 223-250
  • 9
    • 0034863892 scopus 로고    scopus 로고
    • Risk perception and communication: Recent developments and implications for anaesthesia
    • Adams AM, Smith AF. Risk perception and communication: recent developments and implications for anaesthesia. Anaesthesia 2001; 56: 745-755
    • (2001) Anaesthesia , vol.56 , pp. 745-755
    • Adams, A.M.1    Smith, A.F.2
  • 10
    • 4844224255 scopus 로고    scopus 로고
    • Informed consent for elective and emergency surgery: Questionnaire study
    • Akkad A, Jackson C, Kenyon S, et al. Informed consent for elective and emergency surgery: questionnaire study. BJOG 2004; 111: 1133-1138
    • (2004) BJOG , vol.111 , pp. 1133-1138
    • Akkad, A.1    Jackson, C.2    Kenyon, S.3
  • 11
    • 33748796357 scopus 로고    scopus 로고
    • Patients' perceptions of written consent: Questionnaire study
    • Akkad A, Jackson C, Kenyon S, et al. Patients' perceptions of written consent: questionnaire study. BMJ 2006; 333: 528
    • (2006) BMJ , vol.333 , pp. 528
    • Akkad, A.1    Jackson, C.2    Kenyon, S.3
  • 12
    • 34047223877 scopus 로고    scopus 로고
    • Longer consent forms for clinical trials compromise patient understanding: So why are they lengthening?
    • Beardsley E, Jefford M, Mileshkin L. Longer consent forms for clinical trials compromise patient understanding: so why are they lengthening? J Clin Oncol 2007; 25: e13-e14
    • (2007) J Clin Oncol , vol.25
    • Beardsley, E.1    Jefford, M.2    Mileshkin, L.3
  • 13
    • 0034267504 scopus 로고    scopus 로고
    • Informed consent
    • Bennett JR. Informed consent. Gut 2000; 47: 455-456
    • (2000) Gut , vol.47 , pp. 455-456
    • Bennett, J.R.1
  • 14
    • 38649136193 scopus 로고    scopus 로고
    • If it's broken, shouldn't it be fixed? Informed consent and initial clinical trials of gene therapy
    • Caplan AL. If it's broken, shouldn't it be fixed? Informed consent and initial clinical trials of gene therapy. Hum Gene Ther 2008; 19: 5-6
    • (2008) Hum Gene Ther , vol.19 , pp. 5-6
    • Caplan, A.L.1
  • 15
    • 41849099696 scopus 로고    scopus 로고
    • Children's views on their involvement in clinical research
    • Chappuy H, Doz F, Blanche S, et al. Children's views on their involvement in clinical research. Pediatr Blood Cancer 2008; 50: 1043-1046
    • (2008) Pediatr Blood Cancer , vol.50 , pp. 1043-1046
    • Chappuy, H.1    Doz, F.2    Blanche, S.3
  • 16
    • 33847381902 scopus 로고    scopus 로고
    • Consent form readability and educational levels of potential participants in mental health research
    • Christopher PP, Foti ME, Roy-Bujnowski K, et al. Consent form readability and educational levels of potential participants in mental health research. Psychiatr Serv 2007; 58: 227-232
    • (2007) Psychiatr Serv , vol.58 , pp. 227-232
    • Christopher, P.P.1    Foti, M.E.2    Roy-Bujnowski, K.3
  • 19
    • 0037365882 scopus 로고    scopus 로고
    • Randomized, controlled trial of an easy-toread informed consent statement for clinical trial participation: A study of the Eastern Cooperative Oncology Group
    • Coyne CA, Xu R, Raich P, et al. Randomized, controlled trial of an easy-toread informed consent statement for clinical trial participation: a study of the Eastern Cooperative Oncology Group. J Clin Oncol 2003; 21: 836-842
    • (2003) J Clin Oncol , vol.21 , pp. 836-842
    • Coyne, C.A.1    Xu, R.2    Raich, P.3
  • 21
    • 0036178499 scopus 로고    scopus 로고
    • Patients' perceptions of information provided in clinical trials
    • Ferguson PR. Patients' perceptions of information provided in clinical trials. J Med Ethics 2002; 28: 45-48
    • (2002) J Med Ethics , vol.28 , pp. 45-48
    • Ferguson, P.R.1
  • 22
    • 33646517939 scopus 로고    scopus 로고
    • A brief measure of perceived understanding of informed consent in a clinical trial was validated
    • Guarino P, Lamping DL, Elbourne D, et al. A brief measure of perceived understanding of informed consent in a clinical trial was validated. J Clin Epidemiol 2006; 59: 608-614
    • (2006) J Clin Epidemiol , vol.59 , pp. 608-614
    • Guarino, P.1    Lamping, D.L.2    Elbourne, D.3
  • 23
    • 33644595938 scopus 로고    scopus 로고
    • Consumer involvement in consent document development: A multicenter cluster randomized trial to assess study participants' understanding
    • Guarino P, Elbourne D, Carpenter J, et al. Consumer involvement in consent document development: a multicenter cluster randomized trial to assess study participants' understanding. Clin Trials 2006; 3: 19-30
    • (2006) Clin Trials , vol.3 , pp. 19-30
    • Guarino, P.1    Elbourne, D.2    Carpenter, J.3
  • 24
    • 0035816024 scopus 로고    scopus 로고
    • Informing patients of uncertainty in clinical trials
    • Halpern SD, Karlawish JH, Weijer C: Informing patients of uncertainty in clinical trials. JAMA 2001; 285: 2713-2714
    • (2001) JAMA , vol.285 , pp. 2713-2714
    • Halpern, S.D.1    Karlawish, J.H.2    Weijer, C.3
  • 25
    • 34248554146 scopus 로고    scopus 로고
    • The role of the consent document in informed consent for pediatric leukemia trials
    • Hazen RA, Drotar D, Kodish E. The role of the consent document in informed consent for pediatric leukemia trials. Contemp Clin Trials 2007; 28: 401-408
    • (2007) Contemp Clin Trials , vol.28 , pp. 401-408
    • Hazen, R.A.1    Drotar, D.2    Kodish, E.3
  • 26
    • 33947244986 scopus 로고    scopus 로고
    • Patient understanding of research: Developing and testing of a new questionnaire
    • Hutchison C, Cowan C, Paul J. Patient understanding of research: developing and testing of a new questionnaire. Eur J Cancer Care (Engl) 2007; 16: 187-195
    • (2007) Eur J Cancer Care (Engl) , vol.16 , pp. 187-195
    • Hutchison, C.1    Cowan, C.2    Paul, J.3
  • 27
    • 0035900908 scopus 로고    scopus 로고
    • Quality of informed consent: A new measure of understanding among research subjects
    • Joffe S, Cook EF, Cleary PD, et al. Quality of informed consent: a new measure of understanding among research subjects. J Natl Cancer Inst 2001; 93: 139-147
    • (2001) J Natl Cancer Inst , vol.93 , pp. 139-147
    • Joffe, S.1    Cook, E.F.2    Cleary, P.D.3
  • 28
    • 0035944839 scopus 로고    scopus 로고
    • Quality of informed consent in cancer clinical trials: A cross-sectional survey
    • Joffe S, Cook EF, Cleary PD, et al. Quality of informed consent in cancer clinical trials: a cross-sectional survey. Lancet 2001; 358: 1772-1777
    • (2001) Lancet , vol.358 , pp. 1772-1777
    • Joffe, S.1    Cook, E.F.2    Cleary, P.D.3
  • 29
    • 38649123009 scopus 로고    scopus 로고
    • Informed consent in human gene transfer clinical trials
    • Kahn J. Informed consent in human gene transfer clinical trials. Hum Gene Ther 2008; 19: 7-8
    • (2008) Hum Gene Ther , vol.19 , pp. 7-8
    • Kahn, J.1
  • 30
    • 33344476296 scopus 로고    scopus 로고
    • Improving comprehension of informed consent
    • Kusec S, Oreskovic S, Skegro M, et al. Improving comprehension of informed consent. Patient Educ Couns 2006; 60: 294-300
    • (2006) Patient Educ Couns , vol.60 , pp. 294-300
    • Kusec, S.1    Oreskovic, S.2    Skegro, M.3
  • 31
    • 33845353426 scopus 로고    scopus 로고
    • Beyond the checklist: Assessing understanding for HIV vaccine trial participation in South Africa
    • Lindegger G, Milford C, Slack C, et al. Beyond the checklist: assessing understanding for HIV vaccine trial participation in South Africa. J Acquir Immune Defic Syndr 2006; 43: 560-566
    • (2006) J Acquir Immune Defic Syndr , vol.43 , pp. 560-566
    • Lindegger, G.1    Milford, C.2    Slack, C.3
  • 32
    • 10844262655 scopus 로고    scopus 로고
    • Study of the quality of information given to patients participating in a clinical trial regarding chronic hemodialysis
    • Lynöe N, Nasström B, Sandlund M. Study of the quality of information given to patients participating in a clinical trial regarding chronic hemodialysis. Scand J Urol Nephrol 2004; 38: 517-520
    • (2004) Scand J Urol Nephrol , vol.38 , pp. 517-520
    • Lynöe, N.1    Nasström, B.2    Sandlund, M.3
  • 33
    • 0034212015 scopus 로고    scopus 로고
    • The extent of written trial information: Preferences among potential and actual trial subjects
    • Madsen SM, Holm S, Riis P. The extent of written trial information: preferences among potential and actual trial subjects. Bull Med Ethics 2000; 13-18
    • (2000) Bull Med Ethics , pp. 13-18
    • Madsen, S.M.1    Holm, S.2    Riis, P.3
  • 34
    • 33845725166 scopus 로고    scopus 로고
    • Informed consent and subject motivation to participate in a large, population-based genomics study: The Marshfield Clinic Personalized Medicine Research Project
    • McCarty CA, Nair A, Austin DM, et al. Informed consent and subject motivation to participate in a large, population-based genomics study: the Marshfield Clinic Personalized Medicine Research Project. Community Genet 2007; 10: 2-9
    • (2007) Community Genet , vol.10 , pp. 2-9
    • McCarty, C.A.1    Nair, A.2    Austin, D.M.3
  • 35
    • 0029745021 scopus 로고    scopus 로고
    • The Deaconess Informed Consent Comprehension Test: An assessment tool for clinical research subjects
    • Miller CK, O'Donnell DC, Searight HR, et al. The Deaconess Informed Consent Comprehension Test: an assessment tool for clinical research subjects. Pharmacotherapy 1996; 16: 872-878
    • (1996) Pharmacotherapy , vol.16 , pp. 872-878
    • Miller, C.K.1    O'Donnell, D.C.2    Searight, H.R.3
  • 36
    • 29544448363 scopus 로고    scopus 로고
    • Informed consent and participant perceptions of influenza vaccine trials in South Africa
    • Moodley K, Pather M, Myer L. Informed consent and participant perceptions of influenza vaccine trials in South Africa. J Med Ethics 2005; 31: 727-732
    • (2005) J Med Ethics , vol.31 , pp. 727-732
    • Moodley, K.1    Pather, M.2    Myer, L.3
  • 37
    • 30644468007 scopus 로고    scopus 로고
    • Volunteer human subjects' understandings of their participation in a biomedical research experiment
    • Morris N, Balmer B. Volunteer human subjects' understandings of their participation in a biomedical research experiment. Soc Sci Med 2006; 62: 998-1008
    • (2006) Soc Sci Med , vol.62 , pp. 998-1008
    • Morris, N.1    Balmer, B.2
  • 40
    • 5144228879 scopus 로고    scopus 로고
    • Consent to the publication of patient information: Incompetent patients may pose a problem
    • Newson AJ. Consent to the publication of patient information: incompetent patients may pose a problem. BMJ 2004; 329: 916
    • (2004) BMJ , vol.329 , pp. 916
    • Newson, A.J.1
  • 41
    • 12544253459 scopus 로고    scopus 로고
    • Readability of informed consent forms for subjects participating in biomedical research: Updating is required
    • Paris A, Cracowski JL, Ravanel N, et al. Readability of informed consent forms for subjects participating in biomedical research: updating is required. Presse Med 2005; 34: 13-18
    • (2005) Presse Med , vol.34 , pp. 13-18
    • Paris, A.1    Cracowski, J.L.2    Ravanel, N.3
  • 42
    • 33747066767 scopus 로고    scopus 로고
    • Evaluate and improve the comprehension of the information in biomedical research
    • Paris A, Cracowski JL. Evaluate and improve the comprehension of the information in biomedical research. Therapie 2006; 61: 85-86
    • (2006) Therapie , vol.61 , pp. 85-86
    • Paris, A.1    Cracowski, J.L.2
  • 43
    • 12444301894 scopus 로고    scopus 로고
    • Are subjects satisfied with the informed consent process? A survey of research participants
    • Pope JE, Tingey DP, Arnold JM, et al. Are subjects satisfied with the informed consent process? A survey of research participants. J Rheumatol 2003; 30: 815-824
    • (2003) J Rheumatol , vol.30 , pp. 815-824
    • Pope, J.E.1    Tingey, D.P.2    Arnold, J.M.3
  • 44
    • 35348837154 scopus 로고    scopus 로고
    • Risk perception and decision processes underlying informed consent to research participation
    • Reynolds WW, Nelson RM. Risk perception and decision processes underlying informed consent to research participation. Soc Sci Med 2007; 65: 2105-2115
    • (2007) Soc Sci Med , vol.65 , pp. 2105-2115
    • Reynolds, W.W.1    Nelson, R.M.2
  • 45
    • 33746920863 scopus 로고    scopus 로고
    • Patient's consent for publication of case report: Need for developing a universal consent form
    • Saxena AK, Ghai B, Makkar JK: Patient's consent for publication of case report: need for developing a universal consent form. Arch Dis Child 2006; 91: 717
    • (2006) Arch Dis Child , vol.91 , pp. 717
    • Saxena, A.K.1    Ghai, B.2    Makkar, J.K.3
  • 46
    • 4544274497 scopus 로고    scopus 로고
    • Consent to the publication of patient information
    • Singer PA. Consent to the publication of patient information. BMJ 2004; 329: 566-568
    • (2004) BMJ , vol.329 , pp. 566-568
    • Singer, P.A.1
  • 47
    • 34248326097 scopus 로고    scopus 로고
    • Informed consent, confidentiality, and subject rights in clinical trials
    • Smith-Tyler J. Informed consent, confidentiality, and subject rights in clinical trials. Proc Am Thorac Soc 2007; 4: 189-193
    • (2007) Proc Am Thorac Soc , vol.4 , pp. 189-193
    • Smith-Tyler, J.1
  • 48
    • 33748331382 scopus 로고    scopus 로고
    • Understanding the decisions of cancer clinical trial participants to enter research studies: Factors associated with informed consent, patient satisfaction, and decisional regret
    • Stryker JE, Wray RJ, Emmons KM, et al. Understanding the decisions of cancer clinical trial participants to enter research studies: factors associated with informed consent, patient satisfaction, and decisional regret. Patient Educ Couns 2006; 63: 104-109
    • (2006) Patient Educ Couns , vol.63 , pp. 104-109
    • Stryker, J.E.1    Wray, R.J.2    Emmons, K.M.3
  • 49
    • 34547559188 scopus 로고    scopus 로고
    • Presenting research information to children: A tale of two methods
    • Tait AR, Voepel-Lewis T, Malviya S. Presenting research information to children: a tale of two methods. Anesth Analg 2007; 105: 358-364
    • (2007) Anesth Analg , vol.105 , pp. 358-364
    • Tait, A.R.1    Voepel-Lewis, T.2    Malviya, S.3
  • 50
    • 33846471617 scopus 로고    scopus 로고
    • Consenting of the vulnerable: The informed consent procedure in advanced cancer patients in Mexico
    • Verastegui EL. Consenting of the vulnerable: the informed consent procedure in advanced cancer patients in Mexico. BMC Med Ethics 2006; 7: E13
    • (2006) BMC Med Ethics , vol.7
    • Verastegui, E.L.1
  • 51
    • 34547219407 scopus 로고    scopus 로고
    • Do cancer patients fully understand clinical trial participation? A pilot study to assess informed consent and patient expectations
    • Wray RJ, Stryker JE,Winer E, et al. Do cancer patients fully understand clinical trial participation? A pilot study to assess informed consent and patient expectations. J Cancer Educ 2007; 22: 21-24
    • (2007) J Cancer Educ , vol.22 , pp. 21-24
    • Wray, R.J.1    Stryker, J.E.2    Winer, E.3


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.