The Patient Information Sheet (PIS) and Informed Consent (IC) for case reports and case series: Proposal for a standard model for presentations in congresses and other scientific publications
Reumatol Clin (Engl Ed). 2018 Jul-Aug;14(4):215-223.
doi: 10.1016/j.reuma.2018.07.001.
[Article in
English,
Spanish]
Affiliations
- 1 Comité Autonómico de Ética de la Investigación de Galicia, Santiago de Compostela, A Coruña, España; Comité Territorial de Ética de la Investigación de A Coruña-Ferrol, A Coruña, España; Secretaría Técnica Xeral da Consellería de Sanidade, Santiago de Compostela, A Coruña, España.
- 2 Comité Territorial de Ética de la Investigación de A Coruña-Ferrol, A Coruña, España; Unidad de Farmacia de Atención Primaria. Centro de Salud San José-A, A Coruña, España.
- 3 Comité Autonómico de Ética de la Investigación de Galicia, Santiago de Compostela, A Coruña, España; Servicio de Reumatología. Complexo Hospitalario Universitario de Pontevedra, Pontevedra, España. Electronic address: susana.maria.romero.yuste@sergas.es.
Abstract
A standard model of the Patient Information Sheet (PIS) and Informed Consent (IC) would facilitate compliance with the guaranteed rights of the patient when their health data is used in any form for purposes other than medical assistance, like the release of case reports and case series. This model would be suitable for the presentation of case reports in a congress in any form (verbal communication, poster or presentation), for its publication in a journal that does not require the completion of its own model, or even for teaching practice. A standard model of the PIS and IC would facilitate the application of the current regulations and good clinical practices in clinical research: it would guarantee the compliance of the professionals' duty of protection of the patient's privacy against the use of their health data for purposes other than medical assistance.
Keywords:
Autonomía personal; Case Reports; Consentimiento informado; DeCS: Derechos del paciente; Informed Consent; Informes de casos; MeSH: Patient Rights; Personal Autonomy.
Copyright © 2018. Publicado por Elsevier España, S.L.U.
MeSH terms
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Congresses as Topic
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Epidemiologic Studies
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Humans
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Informed Consent / standards*
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Models, Theoretical
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Patient Education as Topic / methods
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Patient Education as Topic / standards*
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Patient Rights / standards*
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Periodicals as Topic
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Publishing / standards
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Research Report / standards*