Informed Consent: Ethical and Legal Issues


Informed consent from research participants is a necessary legal and ethical requirement for research involving human subjects. Valid informed consent relies on giving full information and on the capacity of research participants to consent.

The article describes the historical development of the concept of informed consent in biomedical research and explores its current embedding in international legal documents. It discusses the specific problems of informed consent in fast‐moving research areas and possible solutions in ‘broad’ or ‘dynamic’ consent. The specific issues raised in relation to consent from minors and other incompetent persons are discussed, as are the secondary research use of routine clinical data and the research use of old tissue samples and other historical materials and data obtained without consent.

Key Concepts

  • Informed consent is a central concept in modern research ethics and law.
  • Valid consent can only be obtained if the prospective research participant is fully informed, is competent to consent and not subject to coercion or undue pressure. In fast‐moving research fields where future research use is difficult to predict, ‘broad’ or ‘dynamic’ consent may be used in certain circumstances.
  • For persons who are incompetent to consent, researchers must often rely on proxy consent (e.g. parents consenting for small children).
  • A proxy must make a decision to consent based solely on considerations of the best interest of the incompetent person.

Keywords: consent; informed consent; genetic research; secondary use of data, tissue samples; incompetent persons


Council of Europe (1997) Convention for the Protection of Human Rights and Dignity of the Human Being with Regard to the Application of Biology and Medicine: Convention on Human Rights and Biomedicine Oviedo, 4.IV.1997. European Treaty Series no. 164. Strassbourg: Council of Europe.

Kaye J, Whitley EA, Lund D, et al. (2014) Dynamic consent: a patient interface for twenty‐first century research networks. European Journal of Human Genetics. DOI: 10.1038/ejhg.2014.71.

UNESCO (2005) Universal Declaration on Bioethics and Human Rights, 19 October 2005 Paris: UNESCO.

World Medical Association (2013) World Medical Association Declaration of Helsinki: Ethical Principles for Medical Research Involving Human Subjects. Fortaleza, Brazil: WMA.

Further Reading

Buchanan AE and Brock DW (1989) Deciding for Others: The Ethics of Surrogate Decision‐Making. Cambridge, UK: Cambridge University Press.

Corrigan O, McMillan J, Liddell K, Richards M and Weijer C (eds) (2009) The Limits of Consent – A Socio‐Ethical Approach to Human Subject Research in Medicine. Oxford, UK: Oxford University Press.

Doyal L (ed.) (2001) Informed Consent in Medical Research. London: British Medical Journal Publishers.

Elger B, Biller‐Andorno N, Mauron A and Capron AM (eds) (2008) Ethical Issues in Governing Biobanks – Global Perspectives. Aldershot, UK: Ashgate.

Faden RR and Beauchamp TL (eds) (1986) A History and Theory of Informed Consent. Oxford, UK: Oxford University Press.

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How to Cite close
Holm, Søren(Feb 2015) Informed Consent: Ethical and Legal Issues. In: eLS. John Wiley & Sons Ltd, Chichester. [doi: 10.1002/9780470015902.a0005198.pub3]