Legibility of the patient information sheet after its review by the clinical research ethics committees;Legibilidad de la hoja de información para el paciente tras su revisión por los comités éticos de investigación clínica

Revista Clinica Espanola

Volumn 210, Issue 10, 2010, Pages 529-530

  Dal Re R ^a,b   Luque Montoro, I ^a   Morejon Bosch E ^a  

^a GLAXOSMITHKLINE   (Spain)

^b UNIVERSIDAD REY JUAN CARLOS   (Spain)

Author keywords

[No Author keywords available]

Indexed keywords

CLINICAL RESEARCH; LETTER; MEDICOLEGAL ASPECT; PATIENT INFORMATION; RESEARCH ETHICS;

ETHICS COMMITTEES, RESEARCH; MEDICAL RECORDS; READING;

EID: 78049432241     PISSN: 00142565     EISSN: 15781860     Source Type: Journal    
DOI: 10.1016/j.rce.2010.04.023     Document Type: Letter

References (11)

1. M.K. Paasche-Orlow, H.A. Taylor, and F.L. Brancati Readability standards for informed-consent forms compared with actual readability N Engl J Med 348 2003 721 726
2. R. Dal-R, R. Ortega, and E. Morejón Multicentre trials review process by Research Ethics Committees in Spain: where do they stand before implementing the new European regulation J Med Ethics 31 2005 744 750
3. W. Burman, P. Breese, S. Weis, N. Bock, J. Bernardo, and A. Vernon The effects of local review on informed consent documents from a multicenter clinical trials consortium Control Clin Trials 24 2003 245 255
4. M.J. Pérez-Elias, M. Sánchez-Conde, V. Soriano, J. Mallolas, I. Luque, F. Rodríguez-Alcntara Fosamprenavir Expanded Access Program Group Fosamprenavir (GW433908)/ritonavir in HIV-infected patients: efficacy and safety results from the Spanish Expanded Access Program Enferm Infecc Microbiol Clin 27 2009 28 32
5. P. Simn, I.M. Barrio, and L. Concheiro Legibilidad de los formularios escritos de consentimiento informado Med Clin (Barc) 107 1997 524 529
6. I. Barrio, and P. Simn Medicin de la legibilidad de textos escritos. Correlacin entre mtodo manual de Flesh y mtodos informticos Aten Primaria 31 2003 104 108
7. G. Rubiera, R. Arbizu, A. Alzueta, J.J. Agndez, and J.R. Riera La legibilidad de los documentos de consentimiento informado en los hospitales de Asturias Gac Sanit 18 2004 153 158
8. C. Jiménez, J.L. Morales, and M.J. Pereira Evaluación de la exhaustividad y legibilidad de documentos de consentimiento informado en cirugía pediátrica Cir Pediatr 14 2000 53 56
9. J.P. Ordovs, E. López, E. Urbieta, R. Torregrosa, and N.V. Jiménez Anlisis de las hojas de información al paciente para la obtencin de su consentimiento informado en ensayos clnicos Med Clin (Barc) 112 1999 90 94
10. G.M. Dresden, and M.A. Levitt Modifying a standard industry clinical trial consent form improves patient information retention as part of the informed consent process Acad Emerg Med 8 2001 246 252
11. E. Beardsley, M. Jefford, and L. Mileshkin Longer consent forms for clinical trials compromise patient understanding: so why are they lengthening? J Clin Oncol 25 2007 e13 e14