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The Patient Information Sheet (PIS) and Informed Consent (IC) for case reports and case series: Proposal for a
Juana Cruz Del Río1, Isabel Sastre Gervás2, Susana Romero Yuste3
1Comité 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.
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.
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