EXPANDED ACCESS PROGRAMS AS A SOURCE OF COGNITIVE DATA Cover Image

PROGRAMY POSZERZONEGO DOSTĘPU JAKO ŹRÓDŁO DANYCH POZNAWCZYCH
EXPANDED ACCESS PROGRAMS AS A SOURCE OF COGNITIVE DATA

Author(s): Olga Dryla
Subject(s): Health and medicine and law, Welfare services
Published by: Instytut Filozofii Uniwersytetu Jagiellońskiego
Keywords: expanded access; compassionate use; autonomy; cognitive value; justice therapy; research; research experiment; unapproved therapy; hospital exemption; ATMP-HE; experimental treatment;

Summary/Abstract: 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.

  • Issue Year: 20/2023
  • Issue No: 78
  • Page Range: 2-15
  • Page Count: 14
  • Language: Polish