Expanded access programs as a source of cognitive data

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Olga Dryla


The presented article is devoted to the question of whether extended access therapy can or should be accompanied by research activity. It consists of three parts. The first lists the tasks that can be used for medical information regarding extended access programs, which leads to the conclusion that even taking into account the specific limitations of their cognitive value, this type of data can be meaningfully used. The second part is devoted to the limited regulations in European law concerning the discussed issue, and the Polish Act on the Professions of Physician and Dentist which grants physicians/researchers broader powers. In the last part of the article, two arguments are presented to ethically justify the granting of such broad powers to researchers, and thus limiting the autonomy of patients.


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Dryla, Olga. 2023. “Expanded Access Programs As a Source of Cognitive Data”. Diametros 20 (78):2-15. https://doi.org/10.33392/diam.1941.
“Normative problems of innovative therapies, Part 1” – articles
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