Informed consent

What does Informed consent mean in clinical research?

ICH E6(R3) defines informed consent as a process by which a participant or their legally acceptable representative voluntarily confirms their willingness to participate in a trial, after having been informed and given the opportunity to discuss all aspects of the trial relevant to that decision.^⁠[1] The consent discussion is conducted by the investigator or site staff the investigator delegates.^⁠[1]

In the US, FDA regulations require legally effective informed consent before a person takes part in FDA-regulated research, sought in circumstances that give the person enough time to consider participation and that minimize coercion or undue influence, in language the person can understand.^⁠[2]

Consent is where interest turns into participation, and where some of it is lost. In an audit of 15 randomized oncology studies at a cancer center in India, declining treatment was the second most common reason for screen failure, accounting for 22.2% of failures.^⁠[3] Practical note: give patients the consent document before the visit and a way to ask questions early. Consent supports that step with plain-language explanations and patient Q&A, with escalation to staff; the site still obtains consent.