Ethics & legal obligations

The purpose of HRA is to protect the dignity, privacy and health of human beings involved in research (art. 1). It applies to research on human diseases and on the structure and functioning of the human body, carried out (art. 2):

a. on people;

b. on deceased people;

c. on embryos and fetuses;

d. on biological material;

e. on personal data related to health.

It does not apply to the research carried out:

a. on in vitro embryos (within the meaning of the Federal Act of 19 December 2003 on embryonic stem cell research);

b. on anonymous biological material;

c. on health-related data that have been collected anonymously or anonymized.

(Our translation)

The FADP defines what is considered personal and sensitive personal data and general data protection provisions such as: proportionality, correctness of data, possibility of cross-border disclosure, data processing by third parties, etc.

The GDPR regulates data protection and privacy for all individuals within the EU, as well as export of personal data outside the EU. It aims primarly to give control to individuals over their personal data. In human research, this affects all internationally active institutions and companies that collect and process personal data from EU residents, or send data from Swiss citizens in the EU. 

The Loi sur l’Université (LU) gives indication about owership of data in the university context:

" With the exception of copyright on publications, the university owns the intellectual property rights to all intellectual creations and research results—including computer programs—produced in the course of their duties by individuals in an employment relationship with the university " (art. 15)

(Our translation)

This directive specify that (section 2.6 "données de base"):

• good data management and documentation is required
• only individuals participating in the research project may have access to them
• research data should be kept secure for 5 years minimum after the end of the research project

"Les données relatives à l’avancement de la recherche et les résultats des expériences originelles (“données de base”) doivent être documentés de manière claire, complète et précise, selon les règles de chaque discipline, afin d’exclure autant que possible tout dommage, toute perte ainsi que toute manipulation ciblée. Il en va de même pour les données électroniques (sauvegarde des données sur CD-ROM, etc.) et pour la documentation originale des projets de recherche indiquée dans le protocole de recherche.
(...)
Pour chaque projet, il convient également de définir, au préalable, le cercle des participants qui auront encore accès aux données de base au terme de leur collaboration au projet ou de leurs rapports avec l’Université, et de préciser les fins pour lesquelles ils auront le droit d’exploiter ces données.
Le responsable de projet doit veiller à ce que les données de base soient conservées en sécurité pendant cinq ans au moins après le terme de la recherche. Au cas où il quitterait l’Université, le responsable de projet doit s’assurer que les données de base continueront à être conservées de manière appropriée au sein de l’Université."  

Under section 3.2.1, the guidelines also list some infractions linked to research data.

The Animal Protection Act (APA) and Ordonnance sur la protection des animaux (OPAn) aim to protect the dignity and well-being of animals (art. 1). Animal experiments are defined in Article 3c as:

Any procedure during which live animals are used to:

1. Verify a scientific hypothesis;
2. Examine the effects of a specific measure on the animal;
3. Test a substance;
4. Collect or examine cells, organs, or bodily fluids, unless these acts are carried out as part of agricultural production or for diagnostic or therapeutic purposes on the animal, or to verify the health status of animal populations;
5. Obtain or reproduce organisms foreign to the species;
6. Teaching, training, or continuing education.

The Animal Protection Act applies to vertebrates, cephalopods (Cephalopoda), and walking decapods (Reptantia).

With regard to animal experimentation, the Ordonnance sur la protection des animaux (OPAn) specifies the scope of application:

1. Vertebrates;
2. Walking decapods and cephalopods;
3. Mammals, birds, and reptiles from the last third of their gestation or development before hatching;
4. Larval stages of fish and amphibians that are capable of feeding independently.

It does not apply to research conducted on invertebrates (except cephalopods and walking decapods), in particular the following : Drosophila melanogaster, Caenorhabditis elegans, and Galleria mellonella.

Before concluding any collaboration agreement related to research or service mandates, you must contact the competent services of the University. In this news you will find the required procedure, the list of the competent services, as well as an outline of the most common risks.