Information sheets and informed consent forms for clinical study participants: Towards standardised recommendations?;Note d'information et consentement des patients participant à des essais cliniques: Vers des recommandations standardisées?

Therapie

Volumn 64, Issue 3, 2009, Pages 179-186

  Chassany, Olivier ^a   Bernard Harlaut, Micheline ^b   Guy, Gilles ^c   Billon, Nathalie ^d   Alberola, Bernard ^e   Bergmann, Jean François ^f   Cailliot, Christian ^g   Chappuy, Hélène ^h   Coron, Xavier ⁱ   Cracowski, Jean Luc ^j   Decousus, Hervé ^k   Demonfaucon, Christophe ^l   Fagard, Catherine ^m   Fischer, Hugues ⁿ   Gelpi, Odile ^o   Golinelli, Danielle ^p   Gourlay, Marie Laurence ^q   Juillets, Yves ^r   Le Coent, Rémi ^s   Legrand, Christian ^t   Malchiodi, Monique ^u   Morin, Anne Laure ^v   Nalet, Véronique ^w   Olympie, Alain ^x   Rivaille, François ^y   Sibenaler, Claire ^z   De Gaulle, Isabelle Thizon ⁱ   more..

^a SAINT LOUIS HOSPITAL   (France)

^b CNAFAL   (France)

^c Chemire le Gaudin   (France)

^d SANOFI   (France)

^e Wyeth Pharmaceuticals

^f HÔPITAL LARIBOISIÈRE   (France)

^g AMGEN INC   (United States)

^h HÔPITAL NECKER ENFANTS MALADES   (France)

ⁱ Sanofi Aventis

^j GRENOBLE UNIVERSITY HOSPITAL   (France)

^k SERVICE DE NEUROLOGIE   (France)

^l AFTOC   (France)

^m UNIVERSITÉ DE BORDEAUX   (France)

ⁿ Association de patients   (France)

^o HOSPICES CIVILS DE LYON   (France)

^p Directions Générale de la Santé

^q AFSSAPS   (France)

^r LEEM   (France)

^s GLAXOSMITHKLINE   (United Kingdom)

^t URAEUS   (France)

^u Laboratoires Roche   (France)

^v Avocate   (France)

^w Lilly France   (France)

^x Nature et Culture   (France)

^y INSTITUT DE RECHERCHES INTERNATIONALES SERVIER   (France)

^z La Maison des MICI ^*

more..

Author keywords

Biomedical research; Clinical trials; Information; Informed consent; Patients; Writing

Indexed keywords

ARTICLE; CLINICAL PRACTICE; CLINICAL STUDY; CONFLICT OF INTEREST; HUMAN; INFORMATION; INFORMED CONSENT; LEGAL ASPECT; MEDICAL LITERATURE; MEDICAL RESEARCH; METHODOLOGY; PRIORITY JOURNAL; RISK BENEFIT ANALYSIS;

EID: 69049091371     PISSN: 00405957     EISSN: None     Source Type: Journal    
DOI: 10.2515/therapie/2009034     Document Type: Article

References (9)

1. Groupe de travail sur le document d'information et le consentement éclairé de la Conférence Nationale des Comités de Protection des Personnes. Synthèse des travaux.
2. Paris A, Cracowski JL, Ravanel N, et al. Lisibilité de l'information écrite destinée aux sujets se prêtant à une recherche biomédicale. Presse Med 2005; 34: 13-18
3. Paris A, Cracowski JL, Maison P, et al. Impact of French "Comités 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
4. Sharp SM. Consent documents for oncology trials: does anybody read these things? Am J Clin Oncol 2004; 27: 570-575
5. Wendler D. Can we ensure that all research subjects give valid consent? Arch Intern Med 2004; 164: 2201-2204
6. Flory J, Emanuel E. Interventions to improve research participants' understanding in informed consent for research: a systematic review. JAMA 2004; 292: 1593-1601 (Pubitemid 39314966)
7. Bjørn E, Rossel P, Holm S. Can the written information to research subjects be improved? An empirical study. J Med Ethics 1999; 25: 263-267 (Pubitemid 29273779)
8. Dresden GM, Levitt MA. Modifying a standard industry clinical trial consent form improves patient information retention as part of the informed consent process. Acad Emerg Med 2001; 8: 246-252
9. Paris A, Nogueira da Gama Chaves D, 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 (Pubitemid 46495945)