Guidance for MAKE Projects involving human participants and/or personal data

MAKE projects at EPFL are designed for learning and prototyping, not for conducting biomedical or clinical research. If your project involves human participants and/or personal data, it is nevertheless important to ensure the project compliance with the ethical and legal requirements set out in Swiss national laws and EPFL institutional regulations on research with humans.

The Swiss Human Research Act (HRA) applies to research involving human participants, health-related personal data, or human biological material with the aim of generating generalizable knowledge. Specifically, the HRA applies to research on human diseases or the structure and functioning of the human body. Projects falling under the HRA require the authorization of the competent Cantonal ethics committee. The Cantonal ethics authorization must be obtained by the EPFL academic supervisor prior to the project start. This authorization process may take several months and should be carefully planned in advance to ensure the feasibility of your MAKE project.

Projects using anonymized health-related data/human samples do not fall within the scope of the law. It may also be important to specify that human health data/samples are anonymized when it is impossible to trace back the donor, or the donor can only be re-identified with disproportionate effort. While human health data/samples are identifiable (or coded, pseudonymized) if they can be linked to the donor identity (e.g., via a code/pseudonym, or any other direct/indirect identifier).

Examples of projects falling within the scope of the HRA:

• Collecting/Reusing identifiable human biological material or health-related data
• Clinical testing of medicinal products, medical devices, or other health-related interventions
• Research involving embryos, fetuses or deceased persons

For more information, see:

• HRA: Human Research Act
• ClinO: Clinical Trials Ordinance
• ClinO-MD: Ordinance on clinical trials with medical devices
• trialsHRO: Ordinance on human research with the exception of clinical

As stated in the EPFL LEX 1.3.4, projects conducted by EPFL researchers and involving human participants and/or personal data must be approved by the EPFL Human Research Ethics Committee (HREC). These projects do not fall within the scope of the HRA. Engaging with the HREC ensures that EPFL projects outside the HRA are still carried out ethically and in compliance with legal requirements for data protection.

As a general principle the HREC would review MAKE projects conducted in the framework of the student’s academic curriculum and under the academic supervision of an EPFL instructor, when the project appears to raise important ethical and/or legal data protection issues (see the Ethics Checklist for MAKE Student Projects).

The review of students’ projects by the HREC could contribute to raising general awareness of ethical and compliance issues in research. In this sense, the HREC review process itself can be a learning opportunity for both students and their supervisors on the ethical and legal issues raised by the research project.

The HREC review is an on-line process. The entire evaluation takes approximately 4-6 weeks, after submission to the Committee, provided there are no major questions or comments.

Examples of projects that are reviewed by the HREC:

• Interviews, observations, questionnaires involving human participants, including anonymous questionnaires
• Designing/testing prototypes when human participants are involved
• Recordings/tracking of human participants via audio-/video-recordings, sensors, etc.
• Use of data available on social media or publicly available data, which may include personal data

Examples of MAKE projects reviewed by the HREC:

• Assistive Technologies Challenge (as of 2022)
• N-Pulse (as of 2026)
• Campus Motion (as of 2026)

The workflow is designed to ensure that the project can progress effectively from its initial conceptual stage through to obtaining the required ethical approval, which is necessary for the project’s implementation.

• First, you can perform a first assessment with the Ethics Checklist
• Please contact the MAKE coordinator as soon as possible for support with the ethics process (amina.haouala@epfl.ch)
• All projects are different, so timelines can vary from one team to another. The table below shows an “average” timeline, that is flexible

• The MAKE team has examples of filled HREC submission. Feel free to contact amina.haouala@epfl.ch or julien.delisle@epfl.ch for more information
• If needed, you can ask your academic referent to get enroll in the EPFL course on data protection (personal/sensitive, pseudonymized/anonymized, …)
• You can also check the TRAINING AND RESOURCES IN RESEARCH ETHICS EVALUATION, e-modules available to all