-
2
-
-
85031342674
-
-
Code de la santé publique, L-1122-1131
-
Code de la santé publique, L-1122-1131 http://www.legifrance.gouv. fr
-
-
-
-
3
-
-
33947687647
-
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
-
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
-
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
-
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
-
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
-
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
-
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
-
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
-
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
-
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
-
Informed consent
-
Bennett JR. Informed consent. Gut 2000; 47: 455-456
-
(2000)
Gut
, vol.47
, pp. 455-456
-
-
Bennett, J.R.1
-
14
-
-
38649136193
-
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
-
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
-
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
-
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
-
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
-
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
-
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
-
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
-
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
-
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
-
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
-
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
-
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
-
31
-
-
33845353426
-
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
-
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
-
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
-
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
-
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
-
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
-
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
-
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
-
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
-
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
-
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
-
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
-
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
-
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
-
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
-
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
-
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
-
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
-
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
|