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Welcome to the MED's Ethics Commission!

The JKU Faculty of Medicine's Ethics Committee assesses clinical research projects involving human subjects in accordance with § 30 para. 1 2002 Austrian Universities Act in conjunction with § 8c KAKuG, § 18 Oö. KAG 1997, opens an external URL in a new window and as a recognized CTR Ethics Commission in accordance with Regulation (EU) 536/2014 (Clinical Trial Regulation "CTR"), opens an external URL in a new window. The JKU Ethics Committee operates based on the corresponding national and international legal stipulations and is responsible for all projects involving patients and test subjects recruited at the JKU Faculty of Medicine, the Kepler University Hospital, and all other hospitals, facilities and medical branches in Upper Austria, as well as all research projects within the jurisdiction of the (former) Upper Austrian Ethics Committee.

This includes:

 

  • Clinical trials for pharmaceuticals (submitted before January 31, 2023)

  • Clinical trials of pharmaceuticals for use in humans in accordance with Regulation (EU) 536/2014

  • Clinical trials for in vitro diagnostic medical devices (IVDR) Regulation (EU) 2017/746

  • Clinical trials for medical devices in accordance with Regulation (EU) 2017/745

  • Applying new medical methods

  • And applied clinical research on humans

The Ethics Committee is also responsible for assessing long-term care research projects, new care and treatment concepts, and new care and treatment methods. The committee assesses the submitted projects' ethical safety and integrity, particularly in compliance with The Declaration of Helsinki, EC-GCP, ICH-GCP and the legal requirements.

When carrying out an ethical and a legal assessment, the JKU-EC primarily examines the patient's information and consent, a study's scientific approach and feasibility in regard to planning and implementation, the patient's risk-benefit ratio, the discontinuation criteria, patient information, and insurance coverage. The assessment is based on whether or not the research proposal meets the stipulated standards and if it is ethically sound.

ETHICS COMMISSION.

Faculty of Medicine

LOCATION

Johannes Kepler University Linz
MED Ethics Commission
Med Campus I
ADM Building, 7th Floor
Krankenhausstraße 5
4020 Linz

OFFICE HOURS

Monday - Thursday: 9:00 AM to 12:00 PM

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The cover features philosophers Ludwig Wittgenstein, Immanuel Kant, and Martin Heidegger.

 

Kant developed the principle of free will into the categorical imperative in the “Grundlegung zur Metaphysik der Sitten” (Foundations of the Metaphysics of Morals). Based on the autonomy of reason and free will, hs ethical imperative is arguably – and to some extent - the only ethical system to date that manages to derive universal human rights.

In contrast, Wittgenstein believes a rational basis of ethics is impossible and a confusion of language. It is impossible to provide a rationale for ethics that everyone can understand. "An ethical proposition is a personal act" and, he believes, it is almost identical with aesthetics. Ethical argumentation requires persuasion by means of a language game and changing the terms.

While Heidegger rejects ethics as a philosophical discipline, he understands, however, that the basic structure of human existence is to worry. As a form of existence throughout the world, worry spans globe, along with man’s relationship to himself. Caring about others, worrying about the practical things, and being consciously aware of being worried means that man is the caretaker and resigned to worrying about the state of being.

Stefan M. Fischer