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Managing Ethics in Europe and Austria

Christiane Druml

christiane.druml@meduniwien.ac.at

Vienna, September 18, 2018

To Clarify:A Constant Confusion -

3 Types of Ethics Committees

• Bioethics Committees (advice Government, Parliament, … questions of the life sciences)

• Research Ethics Committees (IRBs, review clinical research protocols)

• Clinical Ethics Committees (consult on individual cases, end of life, organ allocation,…)

The Landscape

(Research) Ethics Committees

- the Beginning in Austria

1966

1964/1975 1979

2001 2002

Selection of Historical Highlights

19961947

20062000

Research Ethics in Austria

• University of Vienna – Medical Faculty:

Establishment of an Ethics Committee 1978

• For all research projects at the Medical Faculty (from 2004 onwards: University) and the Vienna General Hospital-AKH – long before legally required (Hospital Act, Drug Act)

(Research-) Ethics Committees

• 1978 at Medical Faculty, Vienna

• Established according to the Declaration of Helsinki version 1975;

• Legal basis: law of the EU, Austrian Medicines Act, Medical Devices Act, Hospital Act & „soft law“

• „Forum of Austrian Ethics Committees“ established 1997 (27 institutional members)

Number of Ethics Committees in the EU Member StatesThe Heterogeneity

Druml C. et al. Intensive Care Med 2009; 35: 1636

Change of Paradigm

• Not only in medicine, but general evolution of society: Shift from paternalism to autonomy and self determination

• Today, much higher percentage of low risk and big data research projects than invasive human experiments

• Greater awareness of including ethics in all national and international research projects,

• Internal and external (ethics advisory board)

(Bio-) Ethics Committees

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Bioethics Committeeswhy and since when?

Since the Nuremberg Code:

• Rapid advances in science: transplantation, procreation, genetics and cell therapy

• Change from paternalism to autonomy (informed consent)

• In the 1980ies: Quest to map the human genome

• HIV pandemic in Sub Sahara-Africa

• International research & globalization, biobanking & big data

• Therefore: Necessity to include interdisciplinary professional advice in the “big” discussions: Beginning of life, end of life, genome editing, research

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www.bka.gv.at/bioethik

Austrian Bioethics Commission

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• Advisory body

• 25 members with different professional background: law, medicine, philosphy, theology, genetics, political science

• 13 men /12 women

• 22 Recommendations since 2001 --- 15 unanimous

www.bundeskanzleramt.at

Austrian Bioethics Commission

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Recommendation of theAustrian Bioethics Commission 2011

Austrian Bioethics Commission

Recommendations since October 2007• Cord blood banking 2008

• Recommendations with gender reference for ethicscommittees and clinical studies 2008

• Research on human embryonic stem cell research 2009

• Ethical aspects on the development and use of assistivetechnologies 2009

• Genetic and genome wide testing on the internet 2010

• Codification of legislation medical research 2011

• Biobanks for medical research 2011

1

Austrian Bioethics Commission

• Recommendation for terminology of medical decisions in end-of-life situations 2011

• Reform of the reproductive medicine act 2012

• Research on persons without the capacity to consent 2013

• Dying with dignity 2015

• Vaccination – ethical aspects 2015

• Participatory medicine and the internet 2015

• Intersexualität & Transidentität 2017

• Medizin und Ökonomie 2017

• Robotik in der Pflege 2017

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Bioethics Advisory BodiesEurope & international

National Committees (examples)

• UK, Nuffield Council of Bioethics 1991

• CCNE, France 1993 (President Mitterrand - Birth of first test tube baby

• Austria 2001 (same year as Germany, Switzerland)

Supranational Committees (examples)

• EGE European Union, former GAEIB 1991; by Commission Decision

• IBC UNESCO 1993, members worldwide recruited

Initiatives (examples)

• DH-BIO, 1992 Council of Europe

• WHO, Global Health Ethics

• NEC Forum, reg. assembly of national ECs incl. CoE, UNESCO,…

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Bioethics in Austria• Institut für Ethik und Recht, established 1993

as “Senatskommission” including 8 Faculties of the Vienna University,

Günter Virt, professor of theology, Chair (1993 – 2001)

now structure as platform

Ulrich Körtner, professor of theology, Chair (since 2001)

• Austrian Bioethics Commission, established 2001

“Bioethikkommission beim Bundeskanzleramt”

established by Austrian Chancellor Wolfgang Schüssel,

Johannes Huber, professor of gynecology, Chair from 2001-2007,

Christiane Druml, Chair since 2007

• UNESCO Chair on Bioethics at the Medical University of Vienna, established 2016

Current Situation

• Various initiatives and courses• Bioethik Netzwerk Ethics Ethucation (Haifa)

Program at the MedUni Innsbruck • UNESCO Chair of Bioethics of the MedUni

Wien since 2016• IERM, platform at the Univ. Wien

but:• No integration in university education on a

regular and proactive basis compared withother EU Member States like Germany (included in the „Regelcurriculum)

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“There is a clear need forphysicians being trained to understand the social, cultural and environmental contexts within which they will practice—in much the same way they are taught anatomy, physiology and biochemistry.”

In a resolution on the Inclusion of Medical Ethics and HumanRights in the Curriculum of Medical Schools World-Wide, the World Medical Association urged in 2015that medical ethics and human rights be taught at every medical school as obligatory and examined partof the university curriculum [11].

ÖKZ, 10/2016

But…. „normative Kraft des

Faktischen“• Ethics – included in training of physicians

(Basisausbildung)• Clinical research – Ethics Committees• Training of investigators – Qualification of clinical

investigator must be documented when submitting a research proposal

• All EU – research projects etc. require a fundamental „Ethics Section“ as integrated part of the submission

• „ethical review“ – ethics board – etc.• Nomination in Ethics committees etc.

Therefore – my pledge:

• Establishment of publicly financed and funded „real“ Chairs/Institutes for Ethics in Medicine at public medical universities

• Proactive and sustainable garanty of training and education of young researchers (Assistents, „Habilitationen“, Publicationen)

• Potential bringing up of (future) members of supervising ethics committees

• Integration in the regular curriculum & • Prüfungsrelevant – obligatory and examined

Thank you for your attention!

www.josephinum.ac.athttps://www.meduniwien.ac.at/web/en/unesco-chair-on-

bioethics/