Human research



Human research

Human research, the study of human diseases and the human body, requires a lot of personal data. Depending on the type of research, the conditions imposed by the Human Research Act (HRA) on the use of data and biological material differ in their strictness.

Human research, which involves the study of human diseases and the structure and function of the human body, is of major interest to society. At the same time, it requires a lot of personal, often very private, data. The challenge is therefore to give research as much access as necessary, while preserving the privacy of patients as much as possible. The Human Research Act (HRA) - supplemented by the general principles of the Data Protection Act - articulates these two concerns and provides a general framework for research projects. This web page focuses on the HRA. The HRA is supplemented by several ordinances (the Human Research Ordinance (HRO), the Clinical Trials Ordinance (ClinO) and the Ordinance on Clinical Trials with Medical Devices (ClinO-MD) in particular), as well as by several laws or special provisions regulating certain specific aspects (the Stem Cell Research Act (StRA) or certain provisions of the Therapeutic Products Act (TPA) for example).

Informed consent

The HRA is based on the principle - common in medicine - of informed consent: as a general rule, a person - and thus their biological material or data - can only be involved in a human research project if that person understands the process, the risks and the stakes, and on that basis give their consent. The HRA applies this principle to varying degrees depending on the type of project. The HRA distinguishes between two main types of projects: primary and secondary research. The HRO is complementary to the act on this point, providing many explanations.

Primary research

Primary research is the collection of data or biological material directly related to a research project. These are projects primarily involving living persons (Art. 11 ff HRA, which will be discussed here), but also deceased persons (Art. 36 ff HRA) or embryos and foetuses (Art. 39 ff HRA). Secondary research is the re-use of data or biological material collected previously in the context of a therapy or during a previous research project.

Primary research on living people therefore involves actively recruiting participants who are willing to 'make themselves available' for the project in question. These people do not necessarily receive direct benefits or therapy from the project. In this context, the principle of informed consent is a priori absolute, in the sense that it cannot be derogated from. However, the information given may exceptionally be only partial, in the situations referred to in Article 18 HRA.

Re-use of data and biological material (secondary research)

With regard to the re-use (i.e. secondary research) of data or biological material, things are more nuanced. In practice, the researcher will ask doctors or other researchers who may have data or material useful for the project in question to pass it on. The law distinguishes between two types of situations:

  • The re-use of non-genetic personal data (Art. 33 HRA). This is relatively non-specific data relating to an individual. With regard to consent, the HRA has different rules for different situations. If the re-use of data is envisaged in a 'clear' form, where researchers have full, unencrypted access to participants' data, including their names, the rule of informed consent applies. If the use of the data is envisaged only in pseudonymised (or 'coded' as the HRA calls it) form - researchers do not have access to the identifying data of the participants, but a key makes it possible to trace them subject to certain conditions - patients only have a right of objection. The patient is thus informed that their data are to be re-used, that they can object, and that if they do not object, their data will be included in the project. Finally, data in anonymised form - all identifying data are irreversibly deleted - can be freely re-used: patients' consent is not required, nor do they have a right to object. 
  • Re-use of genetic data or biological material (Art. 32 HRA). By their nature, genetic data and biological material involve greater risks from a data protection point of view, which is why the procedure is stricter. The re-use of this data in anonymised form is subject to the right of objection. Re-use in pseudonymised or unencrypted form requires informed consent.

It should be noted that Articles 32 and 33 HRA essentially envisage re-use 'for research purposes': re-use is therefore not limited to a pre-determined project. The HRA thus provides a general authorisation, for multiple projects, even if the projects have not been decided when applying these provisions. The only exception concerns the re-use of unencrypted biological material or genetic data (Art. 32 para. 1 HRA): here, consent is limited to a specific project. In primary research, consent is, by definition, only valid for a specific project.

It should also be noted that when data reused in pseudonymised form has been obtained in accordance with the terms of Article 32 paragraph 2 and 33 paragraph 2 HRA, patients can only be re-identified in specific cases; these are listed in Article 27 of the HRA.

If it is not possible to obtain the consent of the persons whose data is processed (the data subjects), or to inform them of their right to object, Article 34 HRA allows, in certain cases, the re-use of data. Ideally, however, if re-use is envisaged at the time of collection of the material or data, consent or information should be obtained or given at that time (Art. 17 HRA).

Finally, research on human beings is supervised by cantonal ethics committees (Art. 45 ff HRA). Their role is to check that research projects comply with certain requirements, in particular ethical requirements. A research project, or the re-use of data or material in accordance with Article 34 HRA - i.e. without the consent or information of patients - is thus subject to authorisation by an ethics committee.


Further topics


Research (unrelated to health) and data protection

Personal data is important for research. It is important to recall the rules which apply to ensure a fair balance between the interests of the research and the rights of those whose data is processed.

Questions on data protection

Take a look at our FAQ or call our hotline.


Here you can download all documents sorted by topics.

The main provisions

Here you can find out everything about the mains provisions of the Data Protection Act, which comes into force on 1.9.2023.

Last modification 18.04.2023

Top of page