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Welcome to the MED's Ethics Commission!

The state of Upper Austria's Ethics Committee assumes the new JKU Ethics Committee (JKU-EC) in its function as the lead ethics committee, evaluating clinical research projects/studies conducted at the JKU Linz Faculty of Medicine, the Kepler University Hospital, Upper Austrian hospitals, and in the private practice sector.

In accordance with § 30 of the Austrian Universities Act, the JKU-EC assesses the clinical trials for medicinal products and medical devices as well as applying new medical methods and applied medical research on humans. These are conducted by the JKU Linz Faculty of Medicine at the Kepler University Hospital, as well as at other hospitals and institutions, or by physicians in private practice in Upper Austria. As a recognized ethics committee, the JKU-EC evaluates applications for multicenter clinical trials in accordance with Section 41b (1) of the Austrian Medicines Act (AMG as amended by Federal Law Gazette I No. 23/2020) and Section 17 of the Medical Devices Act 2021.
 

The Ethics Committee is also responsible for assessing the implementation of nursing research projects, applying new nursing and treatment concepts, and new nursing and treatment methods. The committee evaluates submitted projects, in particular with regard to their ethical acceptability and in compliance with the principles of the Declaration of Helsinki, the EC-GCP, the ICH-GCP, and in compliance with the legal foundations.
 

As part of the ethical and legal assessment, the JKU-EK primarily examines patient information and consent, the scientific nature of planning as well as conducting the study, the risk-benefit ratio for the patient, the discontinuation criteria, patient information as well as insurance coverage. An assessment is made as to whether the research project complies with the prescribed standards and whether it is ethically unobjectionable.

ETHICS COMMISSION

Faculty of Medicine

LOCATION

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

OFFICE HOURS SECRETARY

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

E-Mail Address
OUR TEAM | Member List
CAMPUS MAP
The Online Submission Portal , opens an external URL

The JKU-EK assesses clinical drug and medical device trials as well as the application of new medical methods and applied medical research on individuals that is carried out in Upper Austria at the Faculty of Medicine (JKU Linz), the Kepler University Hospital, as well as other hospitals and facilities - or by physicians in private practice - that  are covered by the area of responsibility by the (previous) Ethics Committee (State of Upper Austria.

 

Hospitals:

  •  Upper Austria Health and Hospital-AG:
     
    • Kepler Universitätsklinikum
    • Salzkammergut-Klinikum
    • Pyhrn-Eisenwurzen Klinikum
    • Klinikum Freistadt
    • Klinikum Rohrbach
    • Klinikum Schärding
       
  • Klinikum Wels-Grieskirchen
  • Ordensklinikum Linz Elisabethinen
  • Ordensklinikum Linz Barmherzige Schwestern
  • Krankenhaus der Barmherzigen Schwestern Ried
  • Aö. Kankenhaus St. Josef Braunau
  • Konventhospital Barmherzige Brüder Linz
  • Krankenhaus Sierning, Kreuzschwestern Sierning

 

In regard to monocentric clinical trials (in accordance with the AMG) as well as trials in accordace with MPG and other ethical evaluations, responsibility extends to:

  • TFB Kinderwunsch GmbH Wels
  • Klinik Wilhering
  • VITHERA: Vital- und Therapiezentrum Schärding
  • Sonderkrankenanstalten Rehabilitationszentren Bad Schallerbach, Bad Ischl und Weyer der Pensionsversicherungsanstalt
  • Cardiomed Ambulantes Kardiologisches Rehabilitationszentrum, Linz
  • Neurologisches Therapiezentrum Gmundnerberg
  • Sonnenpark Bad Hall, Zentrum für psychosoziale Gesundheit
  • Österreichisches Rotes Kreuz Landesverband Oberösterreich, Linz
  • assista Soziale Dienste GmbH, Altenhof a.H.
  • Magistrat der Landeshauptstadt Linz, Gesundheit und Sport, Abteilung Arbeitsmedizin
  • g.tec medical engineering GmbH, Schiedlberg
  • Institut Zeileis GmbH & Co KG, Valentin-Zeileis-Straße 33, 4713 Gallspach

An Ethics Committee (JKU-EC) was established at the Faculty of Medicine (Johannes Kepler University) in accordance with § 30 para. 1 2002 Austrian Universities Act in conjunction with § 8c KAKuG, § 18 Oö. KAG 1997 and the Guiding Ethics Committee Ordinance acting on the basis of corresponding national and international legal provisions.

The JKU-EC's activities not only extend to areas of enforcement by the federal government, but also to areas of enforcement by the state of Upper Austria.

Download Rules of Procedure (German only)

EC Rules of Procedure , opens a file Rules of Procedure Platform CTR Ethics Committees , opens a file Rules of Procedure CTR Ethics Committee , opens a file

Statutes

Information on clinical trial applications according to Regulation (EU) 536/2014 and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR)

Information about AMG and MPG (German only) , opens a file

Guidelines for differentiating between clinical studies - non-interventional studies - other studies involving medicinal products and medical devices

Guidelines (German only) , opens a file

  • Submissions

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  • FAQs

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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

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Johannes Kepler University Linz

Altenberger Straße 69

4040 Linz, Austria

Telephone +43 732 2468 0
Fax +43 732 2468 4929
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