Informed Consent for Case Reports - an Ethical Perspective

Abstract

The case report is a special type of scientific publication that focuses on a single patient, raising problems of confidentiality, as the exposure of the intimacy may facilitate identification of the participants. The legitimacy for the public disclosure derives from the informed consent, ensuring the preservation of patients' self-determination. In this article, we discuss aspects of autonomy as basic ethical principle, framing under the Portuguese Law. In the case reports, as in any clinical investigation, the will of the patient should prevail over the interests of research and researchers, even when he is unable to consent, like the minors, the disabled or the deceased, enforcing the legal rules and addressing to the active involvement of the guardians and the relatives.

¿Por qué publicar Reportes de Casos? Análisis de su aporte a la ciencia

“…Por ello, es fundamental evitar los detalles innecesarios en la descripción de los RC, como fechas, lugares específicos, datos de la familia que no aportan específicamente al caso clínico presentado. Además, se exige contar con consentimiento o asentimiento informado para la publicación del caso y otro específico para el uso de registros fotográficos 19 . AP/RCHP siempre solicita la aprobación del Comité de Ética de la Investigación, que idealmente debería revisar el manuscrito redactado para la publicación.…”

Evaluation of the Research Protocol by Ethical Committee

“…Some researchers think the informed consent is expendable. Others think that informed consent is just a signature in a paper sheet, overlooking the relevance of the information and the explanation to give participants the capacity of accepting consciously and freely [11].…”

“…This potentially jeopardizes the anonymization and confidentiality of the database. Rarely these variables are relevant for research and should be avoided or duly justified[11].…”

Letter in Reply: Leiomyosarcoma of the Vulva Mimicking as Chronic Bartholin Cyst: A Case Report

“…From an ethical point of view and to respect the patients’ autonomy and confidentiality, we submitted only microscopic pictures as the diagnostic criteria of leiomyosarcoma. 3 , 4…”