[Introduction of an accreditation system for hospital informed consent forms].
OBJECTIVE
To describe an accreditation system for informed consent forms (ICF) in a tertiary hospital, as an intervention to improve their quality, and to check the improvements achieved.


METHODS
Following an external evaluation of the ICF quality in a public hospital in Murcia (Spain), an accreditation committee set the ICF requirements and associated procedures. Effectiveness is assessed by comparing two external evaluations carried out by the EMCA Program (2011 and 2013) and based on 19 criteria and a sample of 60 ICF for every public hospital in Murcia Region.


RESULTS
To be accredited, every ICF must meet the 19 external criteria plus 5 based on legibility, readability and scientific and technical validity. A form to fill in the contents of every ICF was agreed, which would be reviewed, approved and validated for five years. Before the implementation, 8.2 defects/ICF were detected. The accreditation system obtained an 89% improvement (0.9 defects/ICF) and achieved significant improvements in 18 criteria, 16 of which are benchmarked.


CONCLUSIONS
The accreditation system achieved a substantial improvement in the ICF (obtaining a better result in external evaluations) and guarantees their contents, legibility and readability. This system needs to be extended to other hospitals, since it is not clear whether common ICFs would be suitable. However, this improvement is structural and does not guarantee that the overall information/consent procedure is done properly, thus complementary strategies for measurement and improvement are required.
Unidad de Calidad Asistencial, Hospital Clínico Universitario Virgen de la Arrixaca, Área 1 Murcia-Oeste, Murcia, España. Electronic address: julioj.lopez-picazo@carm.es.
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López-Picazo
Unidad de Calidad Asistencial, Hospital Clínico Universitario Virgen de la Arrixaca, Área 1 Murcia-Oeste, Murcia, España.
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Tomás-Garcia
Consejería de Sanidad y Política Social de Murcia, Subdirección General de Calidad Asistencial, Programa EMCA, Murcia, España.
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Calle-Urra
Consejería de Sanidad y Política Social de Murcia, Subdirección General de Calidad Asistencial, Programa EMCA, Murcia, España.
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Parra-Hidalgo
Comité de Ética Asistencial, Hospital Clínico Universitario Virgen de la Arrixaca, Área 1 Murcia-Oeste, Murcia, España.
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Valverde-Iniesta
D000068:Accreditation; D032882:Comprehension; D032962:Consent Forms / Q000592:standards*; D005568:Forms and Records Control; D006779:Hospitals, Public; D006801:Humans; D015397:Program Evaluation; D058996:Quality Improvement
Accreditation; Acreditación; Consent forms; Estudios de evaluación; Evaluation studies; Formularios de consentimiento; Normas; Standards