[Readability of informed consent forms for subjects participating in biomedical research: updating is required]

Autor: Paris , Adeline, Cracowski , Jean-Luc, Ravanel , Nadia, Cornu , Catherine, Gueyffier , François, Deygas , Béatrice, Guillot , Karine, Bosson , Jean-Luc, Hommel , Marc
Přispěvatelé: Centre d'Investigation Clinique [Grenoble] (CIC Grenoble), Université Joseph Fourier - Grenoble 1 (UJF)-CHU Grenoble-Hôpital Michallon-Institut National de la Santé et de la Recherche Médicale (INSERM), CIC CHU Lyon (inserm), Université Claude Bernard Lyon 1 (UCBL), Université de Lyon-Université de Lyon-Institut National de la Santé et de la Recherche Médicale (INSERM), Centre d'Investigation Clinique - Epidemiologie Clinique/essais Cliniques Saint Etienne, Université Jean Monnet [Saint-Étienne] (UJM)-Institut National de la Santé et de la Recherche Médicale (INSERM), Paris, Adeline, CIC - Grenoble, Université Joseph Fourier - Grenoble 1 ( UJF ) -Institut National de la Santé et de la Recherche Médicale ( INSERM ), Université Claude Bernard Lyon 1 ( UCBL ), Université de Lyon-Université de Lyon-Institut National de la Santé et de la Recherche Médicale ( INSERM ), Université Jean Monnet [Saint-Étienne] ( UJM ) -Institut National de la Santé et de la Recherche Médicale ( INSERM )
Jazyk: francouzština
Rok vydání: 2005
Předmět:
MESH: Human Experimentation
MESH : Single-Blind Method
MESH: Random Allocation
lisibilité
MESH: Consent Forms
MESH: Comprehension
Consent Forms
Random Allocation
MESH : Child
MESH: Child
MESH: Informed Consent
MESH: Double-Blind Method
Single-Blind Method
Textbooks as Topic
MESH : Consent Forms
MESH: Qualitative Research
Child
Qualitative Research
MESH: Statistics
Nonparametric
Informed Consent
MESH: Research Design
Age Factors
MESH : Comprehension
MESH : Adult
MESH : Research Design
Research Design
MESH: Research Subjects
[ SDV.ETH ] Life Sciences [q-bio]/Ethics
Educational Status
France
Comprehension
Adult
Adolescent
recherche biomédicale
Research Subjects
education
MESH : Textbooks as Topic
Statistics
Nonparametric
MESH : Random Allocation
Double-Blind Method
MESH : Human Experimentation
MESH : Adolescent
MESH : Qualitative Research
MESH : Double-Blind Method
Humans
MESH : France
MESH : Statistics
Nonparametric
MESH: Adolescent
MESH: Age Factors
formulaire d'information et de consentement
MESH: Humans
MESH : Humans
MESH: Adult
[SDV.ETH] Life Sciences [q-bio]/Ethics
MESH: Single-Blind Method
MESH: Textbooks as Topic
[SDV.ETH]Life Sciences [q-bio]/Ethics
MESH: France
MESH : Informed Consent
Human Experimentation
MESH : Age Factors
MESH: Educational Status
MESH : Educational Status
MESH : Research Subjects
Zdroj: La Presse Médicale
La Presse Médicale, Elsevier Masson, 2005, 34 (1), pp.13-8
ISSN: 0755-4982
2213-0276
Popis: National audience; OBJECTIVE: We compared informed consent forms of subjects participating in biomedical research with those of references texts in order to determine the factors that influence readability. METHODS: We assessed the readability of 73 informed consent forms of research protocols conducted in the clinical investigation centres in the Rhone-Alpes area, and then compared them with 33 reference texts corresponding to 5 French school grades (first year infant, primary school, GCS level, high school, and classics aggregation), using the Flesch test and Cordial" analyser. RESULTS: Median Flesch scores were 66 for the first year infant level, 62 for the primary school level, 58 for the GCS level, 42 for the high school level, and 43 for the aggregation level. It was 22 for the informed consent forms. Median Cordial scores were 86 for the first year infant level, 77 for the second, 74 for the third, 49 for the fourth, 43 for the fifth. It was 1 for the informed consent forms. No methodological factor correlated with Flesch and Cordial" results. CONCLUSION: The quantitative readability scores for informed consent forms for subjects participating in biomedical research are low, lower than those proposed to aggregation candidates, whatever the type of protocol. Some thought must be given to the impact of the reduced readability on patients' understanding, and steps should be taken to improve the readability of the forms.
Databáze: OpenAIRE
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