Perception of written and oral information by 50 healthy volunteers from a monocentric study;Perception de l'information orale et écrite par 50 volontaires sains d'une étude monocentrique

Therapie

Volumn 60, Issue 1, 2005, Pages 31-38

  Krupka, Emmanuel ^a   Gendre, David ^a   Lafay, Claire ^a   Le Dez, Odile ^a   Gelineau, Pascale ^a   Perault Pochat, Marie Christine ^a  

^a POITIERS UNIVERSITY HOSPITAL   (France)

Author keywords

Ethical and legal framework; Healthy volunteers; Written and oral information

Indexed keywords

ADULT; AGE; EVIDENCE BASED MEDICINE; FEMALE; GENDER; HUMAN; INFORMED CONSENT; MALE; MEDICAL PERSONNEL; MEDICOLEGAL ASPECT; NORMAL HUMAN; OCCUPATION; PARAMEDICAL PERSONNEL; PRIORITY JOURNAL; QUESTIONNAIRE; REFUSAL TO PARTICIPATE; REVIEW; SATISFACTION; VOLUNTEER;

EID: 16344382758     PISSN: 00405957     EISSN: None     Source Type: Journal    
DOI: 10.2515/therapie:2005004     Document Type: Article

References (23)

1. Loi n° 88-1138 du 20 décembre 1988. Art. L 1121-1 à L 1126-7 du code de la santé publique [online]. Available from URL: http://www.sante.gouv.fr/htm/dossiers/loi_huriet/textes.pdf [Accessed 2004 Dec 16]
2. Loi n° 2002-303 du 4 mars 2002 relative aux droits des malades et à la qualité du système de santé [online]. Available from URL: http://www.legifrance.gouv.fr /WAspad/UnTexteDeJorf?.numjo= MESX0100092L [Accessed 2004 Dec 16]
3. International Conference on Harmonisation topic E6 guideline for good clinical practice. Step 5. Consolidated guideline 1.5.96 [online]. Available from URL: http://www.emea.eu.int/pdfs/human/ich/013595en.pdf [Accessed 2005 Feb 3]
4. Riecken HW, Ravich R. Informed consent to biomedical research in veterans administration hospitals. JAMA 1982; 248 (3): 344-8
5. Lynoe N, Sandlund M, Dahlqvist G, et al. Informed consent: study of quality of information given to participants in a clinical trial. BMJ 1991; 303 (6803): 610-3
6. Howard JM, DeMets D. How informed is informed consent? The BHAT experience. Control Clin Trials 1981; 2 (4): 287-303
7. Gallet M, Aupetit JF, Servan E, et al. Informed consent, what information is left after a therapeutic trial? Arch Mal Coeur Vaiss 1994; 87 (1): 39-45
8. Joffe S, Cook EF, Cleary PD, et al. Quality of informed consent in cancer clinical trials: a cross-sectional survey. Lancet 2001; 358: 1772-7
9. Baker MT, Taub HA. Readability of informed consent forms for research in a veterans administration medical center. JAMA 1983; 250 (19): 2646-8
10. Grossman SA, Piantadosi S, Covahey C. Are informed consent forms that describe clinical oncology research protocols readable by most patients and their families? J Clin Oncol 1994; 12 (10): 2211-5
11. Horng S, Emanuel EJ, Wilfond B, et al. Descriptions of benefits and risks in consent forms for phase I oncology trials. N Engl J Med 2002; 347 (26): 2134-40
12. Olgoff JR, Otto RK. Are research participants truly informed? Readability of informed consent forms used in research. Ethics Behav 1991; 1 (4): 239-52
13. Davis TC, Holcombe RF, Berkel HJ, et al. Informed consent for clinical trials: a comparative study of standard versus simplified forms. J Natl Cancer Inst 1998; 90 (9): 668-74
14. Coyne CA, Xu R, Raich P, et al. Randomized, controlled trial of an easy-to-read informed consent statement for clinical trial participation: a study of the Eastern Cooperative Oncology Group. J Clin Oncol 2003; 21 (5): 836-42
15. Bjorn E, Rossel P, Holm S. Can the written information to research subjects be improved: an empirical study. J Med Ethics 1999; 25 (3): 263-7
16. Frimas V, Chedru-Legros V. Evaluation de la notice d'information au patient dans les essais cliniques. Therapie 2002; 57 (6): 518-23
17. Ferguson PR. Patients' perceptions of information provided in clinical trials. J Med Ethics 2002; 28(1): 45-8
18. Taub HA, Baker MT, Sturr JF. Informed consent for research. Effects of readability, patient age and education. J Am Geriatr Soc 1986; 34 (8): 601-6
19. Wager E, Tooley PJ, Emanuel MB, et al. How to do it: get patients' consent to enter clinical trials. BMJ 1995; 311 (7007): 734-7
20. Sigmon ST, Rohan KJ, Dorhofer D, et al. Effects of consent form information on self-disclosure. Ethics Behav 1997; 7 (4): 299-310
21. Schaeffer MH, Krantz DS, Wichman A, et al. The impact of the disease severity on the informed consent process in clinical research. Am J Med 1996; 100: 261-8
22. Ferguson PR. Information giving in clinical trials: the views of medical researchers. Bioethics 2003; 17 (1): 101-11
23. Petty DR, Zermansky AG, Raynor DK, et al. "No thank you": why elderly patients declined to participate in a research study. Pharm World Sci 2001; 23 (1): 22-7