Introduction au droit et à l'éthique
BIO-455
Media
This file is part of the content downloaded from Introduction au droit et à l'éthique.
General
Tuesday 4:15 pm – 8:00 pm
Classroom: ELD020
TA email : margot.vogelsperger@epfl.ch
- Forum (Forum)
- Course Synopsis and Information (File)
- Instructions for group work (File)
- Forum – Groups (Forum)
- Group composition (Group choice)
- Groups (File)
- Oral Exam Slot Selection (Scheduler)
Bibliography
General links
Swiss Law
https://www.admin.ch/gov/fr/accueil/droit-federal/recueil-systematique.html-
Decisions of the Swiss Federal Supreme Court (ATF)
https://www.bger.ch/fr/index/juridiction/jurisdiction-inherit-template/jurisdiction-recht.htm -
Federal Gazette (FF) (Official Information Bulletin of the Confederation)
https://www.admin.ch/gov/fr/accueil/droit-federal/feuille-federale.html -
Swissmedic
https://www.swissmedic.ch/swissmedic/fr/home.html -
Guidelines of the Swiss Academy of Medical Sciences
http://www.samw.ch/fr/Ethique/Directives/actualite.html -
European Union Law
http://eur-lex.europa.eu/fr/index.htm -
Case Law of the European Court of Human Rights
https://www.echr.coe.int/Pages/home.aspx?p=caselaw/analysis&c=fre -
Training and Resources in Research Ethics and Law (TRREE)
https://elearning.trree.org
September 9
4:15 pm – 6:00 pm: In-person class
6:15 pm – 8:00 pm: No exercise session
Speaker: Elodie Malbois
Course overview:
- Objectives, content, organisation, student work
- Instructions for group work
- Presentation of Modules 1 and 2 of the TRREE online training course: http://elearning.trree.orgSeptembre 16
4:15 pm – 6:00 pm: In-person class
6:15 pm – 8:00 pm: No exercise session
Speaker: Elodie Malbois
Ethical Issues in Experimentation with Humans
- Slides week 2 (File)
- Required reading : What Makes Clinical Research in Developing Countries Ethical? (URL)
- Required reading : Ethical Principles for Medical Research Involving Human Participants (2024) (URL)
- Additional Reading: Deal done over Hela Cell Line - Nature (File)
September 23
4:15 pm – 6:00 pm: In-person class
6:15 pm – 8:00 pm: No exercise session
Speaker: Sandra Hotz
Introduction to Swiss law
- Slides week 3 (File)
- Required reading : Swiss Federal Constitution, 1999 (URL)
- Additional reading : The Confederation in Brief, 2022 (URL)
- Additional reading : Introduction au droit suisse - Celsa Amarelle 2016 (File)
September 30
4:15 pm – 6:00 pm: In-person class
6:15 pm – 8:00 pm: No exercise session
Speaker: Sandra Hotz
Introduction to the Human Research Act
- Slides week 4 (File)
- Lecture of September 30 (URL)
- Required reading : Federal Constitution of the Swiss Confederation of 18 April 1999 (URL)
- Required reading : Federal Act of 30 November 2011 on Research involving Human Beings (Loi relative à la recherche sur l’être humain, LRH) (URL)
- Additional reading (URL)
- Additional reading : World Medical Association, Declaration of Helsinki, 2013 version (URL)
- Additional reading (URL)
- Additional reading : Message on the Federal Act on Research Involving Human Beings, FF 2009 7529 (URL)
- Additional reading (URL)
- Additional reading (URL)
- Additional Reading (File)
- Additional readings : Books (File)
October 7
4:15 pm – 6:00 pm: In-person class
6:15 pm – 8:00 pm: No exercise session
Speaker: Sandra Hotz
Who’s body is it anyway ? (Body, body parts and biological material)
⚠️Deadline for forming groups on Moodle: 7 October 2025 (midnight)⚠️
⚠️Deadline: Students are requested to upload their certificates of completion for Modules 1 and 2 of the TRREE training course to Moodle by 13 October 2025 (midnight)⚠️- Slides week 5 (File)
- Required reading : Federal Constitution of the Swiss Confederation of 18 April 1999, SR 101, Articles 119 and 119a Cst (URL)
- Required reading : Swiss Civil Code of 10 December 1907 (CC), SR 210, Articles 11 to 19d, 27 and 28 et seq., 641 et seq. CC (URL)
- Additional reading - Statut juridique des parties détachées du corps humain (File)
- Additional reading - STEINAUER P.-H., Les droits réels (File)
- Additional reading : books (File)
October 14
4:15 pm – 6:00 pm: In-person class
6:15 pm – 8:00 pm: No exercise session
Speaker: Sandra Hotz
Genetics, Genomics and Law
October 28
4:15 pm – 6:00 pm: In-person class
6:15 pm – 8:00 pm: No exercise session
Speakers: Astrid Pilottin (PhD defense in medical devices) & Sandra Hotz
Intellectual Property Law
- Slides week 7 (File)
- Required reading : Federal Act of 25 June 1954 on Patents for Inventions (Patent Act, PA), SR 232.14 (URL)
- Required reading : Ordinance of 19 October 1977 on Patents for Inventions (Patent Ordinance, PO), SR 232.141 (URL)
- Additional reading : Convention sur le brevet européen du 29 novembre 2000 (File)
- Additional reading : Patent Cooperation Treaty of 19 June 1970 (PCT), SR 0.232.141.1 (URL)
- Addtional reading : WIPO, Understanding Industrial Property (URL)
- Addtional reading : WIPO, General Course on Intellectual Property (DL-101) (URL)
- Additional reading : Books (File)
November 4
4:15 pm – 6:00 pm: In-person class
6:15 pm – 8:00 pm: No exercise session
Speakers: Dr. Sylvain Poitras (Lawyer, Partner and Head of Life Sciences at Appleton Luff, Managing Director of Swiss Peak Technologies) & Sandra Hotz
Introduction to European Biotechnology Law: Medical Devices
- Slides week 8 (File)
- Required reading : Ordinance on Medical Devices, SR 812.213 (URL)
- Required reading: Federal Act on Medicinal Products and Medical Devices (Therapeutic Products Act, TPA), SR 812.21 (URL)
- Required reading : Ordinance on In Vitro Diagnostic Medical Devices, SR 812.219 (URL)
- Required reading : Ordinance on Clinical Trials of Medical Devices, SR 810.306 (URL)
- Additional reading : Swissmedic, introductory video on medical device regulation (URL)
- Additional reading: Swissmedic, medical device regulation (URL)
- Additional reading : FOPH, legislation on medical devices, status as of 3 April 2023 (URL)
- Additional reading : Swiss Medtech, SWISS MEDTECH Code of Ethical Business Practices, 12 June 2017, valid until 31 December 2023 (URL)
- Additional reading : European Union (File)
- Additional reading: medical devices and large language models (File)
- Additional reading : Books (File)
November 11
4:15 pm – 6:00 pm: In-person class
6:15 pm – 8:00 pm: No exercise session
Speaker: Elodie Malbois
Human Enhancement
- Human Enhancement Slides (File)
- Required reading: The ethics of human enhancement: Understanding the debate (File)
- Additional reading: The opposite of human enhancement: Nanotechnology and the blind chicken problem (File)
- Additional reading: Propranolol and the prevention of post-traumatic stress disorder: Is it wrong to erase the “sting” of bad memories? (File)
November 18
4:15 pm – 6:00 pm: In-person class
6:15 pm – 8:00 pm: No exercise session
Speaker: Elodie Malbois
Ethical issues in animal experimentation
- Animal Experimentation Slides (File)
- Required Reading : Swiss academies of arts and science, Weighing of interests for proposed animal experiments. Guidance for applicants (2022) (URL)
- Additional reading: Animal Experimentation in Biomedical Research (URL)
- Additional reading: Beyond the 3 Rs to a More Comprehensive Framework of Principles for Animal Research Ethics (File)
November 25
4:15 pm – 6:00 pm: In-person class
6:15 pm – 8:00 pm: No exercise session
Speaker: Xavier Warot (EPFL animal facility)
The status and protection of animals
⚠️Deadline for writing texts to be sent to other group members: 26 November ⚠️
- Slides week 11 (File)
- Required Reading : Animal Welfare Act (AniWA) (URL)
- Required reading: Ordonnance du 23 avril 2008 sur la protection des animaux (OPAn), (URL)
- Additional reading : Ethical guidelines for animal experiments (2025): (URL)
- Additional reading: The protection of the Dignity of Laboratory Animals in Switzerland (File)
- Additional reading: Legal Protection of Animal Dignity in Switzerland: Status Quo and Future Perspectives (File)
December 2
4:15 pm – 6:00 pm: In-person class
6:15 pm – 8:00 pm: No exercise session
Speaker: Elodie Malbois
Personalized Medicine
⚠️Deadline for submitting comments: 3 December ⚠️
- Personalized Medicine Slides (File)
- Required Reading : The personal is political: Ethics and personalized medicine. Ethical Perspectives (File)
- Additional reading: Ethical implications of epigenetics in the era of personalized medicine (File)
December 9
4:15 pm – 6:00 pm: In-person class
6:15 pm – 8:00 pm: No exercise session
Speakers: Gaia Barazzetti & Elodie Malbois
Scientific fraud and integrity in research
Ethical support at EPFL and the Research Ethics Committee of the Canton of Vaud
⚠️ Deadline for submitting the group report: 10 December ⚠️
- Slides week 13 (File)
- Required reading : Little Nobel comic book - English (File)
- Required reading : Petit Nobel bande dessinée - French (File)
- Required Reading : Directive concerning research integrity and good scientific practice at EPFL (URL)
- Required reading: Code of conduct for scientific integrity (URL)
- Additional reading: Serious games about integrity in research (URL)
December 16
4:15 pm – 6:00 pm: In-person class
6:15 pm – 8:00 pm: No exercise session
Speaker: Sandra Hotz
Students share
what they have learned from group work
Feedback from
teachers on group work
Presentation of the oral exam: procedure and
questions
Swisstranfer link for the exam questions : https://www.swisstransfer.com/d/28db63b0-6bdd-43e6-a7cb-2afc4ebaf86a
- Exam Procedure (File)
- Questions for the oral examination - PDF (File)
- Questions for the oral examination - .doc (File)