Informed consent: Ethical and legal considerations

Authors

Pablo Diaz

PDF
Publication

FORS Guide Nº 28

DOI
https://doi.org/10.24449/FG-2026-00028
How to cite

Diaz, P. (2026). Informed consent: Ethical and legal considerations FORS Guides, 28, Version 1.0, 1-31.
https://doi.org/10.24449/FG-2026-00028

Keywords

Autonomy, Transparency, Accountability, Data governance, Vulnerability, Consent, Ethics

Abstract

This guide examines the ethical and legal foundations of informed consent in social science research involving human participants. It outlines the criteria for valid consent, discusses how consent can be obtained, documented, and maintained over time, and explores challenges relating to data protection, data sharing and reuse, vulnerable populations, internet research, deception, and other complex research settings. Its aim is to support responsible, transparent, and context-sensitive consent practices.

Recommendations

  • Treat consent as a process, not as a form. Consent should be under-stood as an ongoing practice of communication and decision-making rather than as a docu-ment signed at a single point in time.
  • Build consent around participants’ understanding. The validity of consent depends less on the amount of information provided than on participants’ ability to understand its implications.
  • Say only what you can actually deliver. Information and consent ma-terials should accurately reflect research practices and avoid promises that cannot realistically be fulfilled.
  • Design consent with future data uses in mind. Anticipated sharing, archiving, and reuse of data should be incorporated into the consent process from the outset.
  • Make future uses specific enough to be meaningful. Participants should be able to understand who may access their data, for what purposes, and under what conditions.
  • Revisit consent when circumstances change. Significant modifica-tions to the research, the risks involved, or the intended uses of data should trigger renewed discussion about consent.
  • Pay particular attention to power and dependency. Researchers should actively identify and mitigate situations in which participants may feel unable to refuse, withdraw, or express disagreement.
  • Protect confidentiality without overstating anonymity. Researchers should explain both the safeguards they implement and the limits of protection that can realis-tically be achieved.
  • Adapt consent procedures to the people involved. The form, lan-guage, and documentation of consent should be tailored to participants’ capacities, circum-stances, and vulnerabilities.
  • View consent as part of research accountability. Obtaining consent creates ethical and, often, legal responsibilities that continue throughout the lifecycle of the research and the data it generates.

    • Copyright

    © the author 2026. This work is licensed under a Creative Commons Attribution 4.0 International License (CC BY 4.0)

    Publication year

    2026

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