Guidance for MAKE Projects facing ethical considerations

MAKE projects at EPFL are designed for learning, prototyping, and innovation, not for regulated biomedical or clinical research. To keep your project feasible and legally compliant, it is important to understand the Swiss Human Research Act (HRA) and how to remain outside its scope.

The HRA applies to research involving human participants, health-related personal data, or human biological material with the aim of generating new scientific or medical knowledge. Specifically, the HRA applies to research on human diseases or the structure and functioning of the human body. Projects falling under the HRA (e.g. clinical trials, sampling or reuse of identifiable health data or biological material, work with fetuses/embryos or deceased persons) require formal ethics committee approval and significant administrative resources. This process is not compatible with student MAKE projects.

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).

Scope of the HRA:

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

MAKE projects are educational, which means they are not suited for the heavy administrative and legal responsibilities that come with projects under the Human Research Act. Entering the HRA framework would shift the focus away from learning, prototyping, and creativity. At the same time, your ambition to innovate must be matched with an understanding of ethical and legal requirements. By designing your project outside the scope of the HRA, you keep it feasible, responsible, and fully aligned with EPFL’s educational mission.

To ensure compliance and reduce administrative burden:

• Limit activities to usability, opinion, or demonstration studies that do not involve identifiable health-related data/human samples. Work with simulated, anonymized, or publicly available datasets.
• Frame your objectives clearly as educational exploration, not as medical or scientific studies on humans.
• When in doubt, ask early. If your project idea touches on sensitive areas, consult the MAKE coordinator.

Examples of projects outside the HRA:

• Quality studies or literature reviews
• Opinion or usability surveys without medical/health data
• Anonymous questionnaires
• Research on non-identifiable aggregated data or anonymized data

The EPFL Human Research Ethics Committee (HREC) reviews projects conducted by EPFL researchers that involve human participants and/or personal data. 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 professor, when the project appears to raise prima ethical and/or legal data protection issues.

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.

General advice: when planning your project, it helps to choose a supervising professor with experience submitting HREC applications, as they can guide you more easily through ethical requirements if needed. Whatever your situation, the MAKE coordinator and the Research Office/Ethics Affairs team are here to support you.

1. Submission of an HREC application