Aller au contenu principal

Research data management

Recommandations

  • When processing personal and sensitive data, the HES-SO recommends obtaining the consent of the data subjects in writing before the beginning of data collection

  • In the context of research conducted on humans, informed consent must be given in writing (exceptions possible) and be revocable by the participant at any time without justification

Assessing legal and ethical aspects and issues

If the research project requires the collection of personal and/or sensitive information from individuals, it is imperative to ensure the confidentiality of the data collected. At this stage of the project, researchers are responsible for considering and anticipating the risks of identifying research participants.

See also: Ethics and legal compliance

Personal and sensitive data

In Switzerland, the Federal Data Protection Act (FDPA) and cantonal laws define :

Personal data

Personal data is any information concerning an identified or identifiable natural person

Examples: surname, first name, e-mail address, customer number, telephone number, fingerprint, recorded voice, image

A natural person can be identified:

  • directly (examples: surname, first name)
  • indirectly (e.g. telephone number, e-mail address)

A natural person can be identified:

  • from a single piece of data (e.g. name)
  • by cross-referencing several pieces of data (e.g.: a woman living at such-and-such an address, born on such-and-such a day and a member of such-and-such an association)
Sensitive data

Sensitive means personal data on:

  • Religious, ideological, political or trade union-related views of activities
  • Health, the intimate sphere or the racial origin,
  • Genetic data
  • Biometric data uniquely identifying a natural person
  • Criminal and administrative proceedings and sanctions
  • Social security measures.

Consent forms

"To be able to process personal and sensitive data in the context of scientific research, there needs to be a legal basis for doing so - which is rare - or the consent of the person whose data is being processed... To avoid many of the problems associated with data protection, it is therefore essential to respect the notion of consent. Consent must be obtained before data processing begins, i.e. as soon as the data is collected. 
Although written consent is not obligatory (oral consent is valid), it is strongly recommended in order to document consent and, if necessary, to provide evidence. We strongly advise you to add a specific "data sharing" item to your consent form, if this is not already the case in your template" 1.

"Consent can be revoked at any time. This is an important point to bear in mind when drawing up the data lifecycle plan. It must be possible to delete data when a participant revokes consent (in whole or in part)" 1.

To comply with the law, consent must be 6:

Free Real choice, with no consequences in the event of refusal, without opt-in or opt-out (not pre-set)
Specific Relating to a single treatment and purpose
Informed Includes information
Unambigous Given by a clear statement or act

Informed consent

In the context of research involving human beings (Human research Act, HRA), consent must 3-4: 

  • Be given in writing (exceptions possible)
  • Be informed (see below)
  • Be revocable by the participant at any time without justification

 

The notion of informed consent is of utmost importance. It means that a certain level of information has been provided to participants in a comprehensible manner regarding : 

  • Nature, purpose, duration and progress of the research project 
  • Foreseeable risks and constraints for the participant
  • Expected benefits of the research project, for participants or third parties 
  • Measures taken to protect personal data 
  • Participants' rights (withdrawal of consent, right of access or erasure to the data, etc.)
  • Intended re-use of personal data
  • "The categories of recipients to which personal data is disclosed (+ country if disclosure abroad).
  • ⚠ If you plan to share personal data, it is important to inform people of the categories of recipients (including the repository and other subcontractors such as cloudbased tools)"7

This can also include giving the participants a short period of time to reflect on their decision, so that they thoroughly understand what they are consenting to.

References

  1. Cruchon, B., & Lucas, I. (2023). Ouverture des données de la recherche : Les grands principes juridiques et les recommandations de la HES-SO. HES-SO. https://www.hes-so.ch/fileadmin/documents/HES-SO/Documents_HES-SO/pdf/open-science/liens-utiles/Guide_Principes_Recommandations_Juridiques_HES-SO_2023.pdf

  2. Delamadeleine, C. (2023). Guide rapide de la gestion des données de recherche (p. e0230416). HES-SO. https://www.hes-so.ch/fileadmin/documents/HES-SO/Documents_HES-SO/pdf/open-science/liens-utiles/Brochure_Guide_Rapide_V20240214.pdf

  3. Diaz, P. (2022). Enjeux éthiques de l’Open Research Data : Journées Open science HES-SO 9 et 10 mai 2022 [Présentation PowerPoint]. hes-so. https://www.hes-so.ch/fileadmin/documents/HES-SO/Documents_HES-SO/pdf/open-science/3-b-Diaz_HES_ORD_2022.pptx
  4. Loi fédérale relative à la recherche sur l’être humain (Loi relative à la recherche sur l’être humain) du 30 septembre 2011 (= LRH ; RS 810.30 ; état le 26 mai 2021). https://www.fedlex.admin.ch/eli/cc/2013/617/fr
  5. Loi fédérale sur la protection des données du 25 septembre 2020 (LPD ; RS 235.1 ; état le 1er mars 2023).   https://www.fedlex.admin.ch/eli/cc/2022/491/fr
  6. Lorenzetti, F. (2022). Aspects juridiques de l’Open data : Journées Open science HES-SO 9 et 10 mai 2022 [Présentation PowerPoint]. hes-so. https://www.hes-so.ch/fileadmin/documents/HES-SO/Documents_HES-SO/pdf/open-science/3-a-Lorenzetti-Protection-Donnees.pptx
  7. FORS (2023). Data sharing in the light of the new data protection law Symposium 12 September 2023. Présentation PowerPoint].FORS. https://forscenter.ch/wp-content/uploads/2023/09/symposium_fors_data-sharing-in-the-light-of-the-new-data-protection-laws_12september2023.pdf