What is informed consent?
Informed consent is one of the founding principles of research ethics. Its intent is that human participants can enter research freely (voluntarily) with full information about what it means for them to take part, and that they give consent before they enter the research.
Consent should be obtained before the participant enters the research (prospectively). The minimum requirements for consent to be informed are that the participant understands what the research is and what they are consenting to.
There are two distinct stages to a standard consent process for competent adults:
- Stage 1 (giving information): the person reflects on the information given; they are under no pressure to respond to the researcher immediately.
- Stage 2 (obtaining consent): the researcher reiterates the terms of the research, often as separate bullet points or clauses; the person agrees to each term (giving explicit consent) before agreeing to take part in the project as a whole. Consent has been obtained.
Researchers should ensure that they comply with the General Data Protection Regulation (GDPR) during and after the consent process, especially if they will be collecting 'special category' (ie sensitive) data or personal data in the course of their research (also refer to the advice on consent in research involving children). See also the guidance on data protection and research and the data protection checklist for use when preparing an application for ethical review.