Informed consent from research participants is a necessary legal and ethical requirement for human genetics research. 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 the possible solution in the so-called ‘broad’ consent. The specific issues raised in relation to consent from minors and other incompetent persons are discussed, as is the research use of old tissue sample and other materials 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 and is competent to consent.
  
• In fast-moving research fields where future research use is difficult to predict, ‘broad’ 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.