Research on human participants

Ethical research with human participants is not only a matter of legal compliance and institutional approval;  it reflects a deeper responsibility toward the dignity, rights, and well‑being of participants, as well as a commitment to scientific integrity and social trust. Good Research Data Management (RDM) and ethical practice go hand in hand: by planning data collection, storage, sharing and deletion carefully (documenting consent, anonymising data when possible, limiting access, and ensuring secure and transparent archiving) researchers not only protect participants, but also produce data that are reliable, reproducible, and ethically shareable. Embedding ethics and data quality at the very start of a project helps create research that is robust, respectful, and fit for future reuse.

In some cases, the nature of the participants or the research methods calls for stricter ethical controls. This includes research involving:

• Vulnerable individuals: such as minors, patients, people facing discrimination, those unable to give informed consent, individuals in institutional settings, minority groups, or sex workers.

• Sensitive topics: such as trauma, identity, sexuality, religion, or political views, which may cause stress, anxiety, or discomfort.

• Deceptive methods: including misleading information or withholding the full purpose of the research from participants.

• Use of online recruitment: especially via social media or when using identifiable images or engaging with sensitive issues online.

Two essential requirements in this context are:

• Compliance with the General Data Protection Regulation (GDPR – 2016/679)

• Ethical approval from a recognised Ethics Committee, when required, and often before beginning data collection.

Medical and health-related studies

Relevant Belgian Legislation:

Clinical Trial Regulation (CTR) – Regulation (EU) 536/2014
Medical Device Regulation (MDR) – Regulation (EU) 2017/745
In Vitro Diagnostic Regulation (IVDR) – Regulation (EU) 2017/746

Relevant Belgian Legislation:

Human Experiments Act (7 May 2004): Governs experiments on human beings
Human Body Material Act: Regulates the collection and use of human bodily materials for research or medical purposes

International ethical standards: 

Research involving human participants must also align with internationally recognized ethical principles, including:

The CIOMS/WHO International Ethical Guidelines for Health-Related Research Involving Humans (2016), that provide a globally recognised framework for conducting ethically sound research involving human participants.
The Declaration of Helsinki
The Oviedo Convention on Human Rights and Biomedicine
Good Clinical Practice (GCP) guidelines

Non-medical Research on Humans

Informed Consent

In all non-medical research involving human participants, obtaining informed consent is essential. Researchers must ensure that participants clearly understand the nature of the research, their rights, and any potential risks involved.

Key requirements:

• Provide a participant information sheet and a consent form (see templates or institutional guidelines).
  The consent form must state the participant’s rights, including the voluntary nature of participation and the right to withdraw at any time without consequence.
• Consent should be written in clear, accessible language. In certain cases, verbal consent may be acceptable, provided it is documented appropriately.
• Online surveys: The welcome or introduction page must contain key study information and a consent statement. A screenshot of this page may serve as evidence of consent.

Note: When collecting data in external organisations or institutions (e.g., schools, NGOs, companies), verify whether local ethical approval is required. For EU-funded projects, consult the EU Grants Guide: How to complete your ethics self-assessment.

Data protection

If your research involves the collection of personal or sensitive data, you must comply with the General Data Protection Regulation (GDPR). Always consult your institution’s Data Protection Officer (DPO) and Research Data Officer to ensure compliance with institutional policies and funder requirements on data protection and data management.

Research Involving Minors (Under 18)

Minors are considered a particularly vulnerable group in research ethics. When conducting research involving participants under the age of 18, additional ethical safeguards must be applied.

• Parental or legal guardian consent is required in most cases.

• Assent from the child must also be obtained in an age-appropriate way, giving the child the chance to express their willingness to participate.

• In certain cases, the minor’s own consent may suffice, depending on maturity and local legislation.

• If a child dissents, even with parental consent, their wishes must be respected.

• Researchers should maintain open communication with parents or guardians throughout the study.

Non-Written Consent

• If written consent isn’t possible (e.g., due to illiteracy), verbal consent must be documented and independently witnessed by someone with no ties to the research.

• In sensitive contexts (e.g., marginalised groups, personal or risky topics), alternative consent methods (such as oral consent) may be used with appropriate ethical approval.

For further guidance, see EU Grants: How to complete your ethics self-assessment.

Institutional Ethics Committees

Ethical procedures and requirements may vary across institutions. Researchers are responsible for ensuring that their project complies with the ethical standards and review processes of their own institution. For project-specific guidance or to determine whether ethics approval is required, please contact your local ethics committee.

• Université catholique de Louvain (UCLouvain)

• Université de Liège (ULiège)

• Université libre de Bruxelles (ULB)

• Université de Mons (UMons)

• Université de Namur (UNamur)

Please refer to your university’s research office or ethics committee for detailed procedures, templates, and contacts.