Informed Consent
What a definition is not
A definition is SPEQ’s plain-language decode of how a term is used in practice, cited to the documents that define it. It is a practitioner reference, not legal or regulatory advice, it does not replace the definition in the source, and where a regulator’s wording differs the regulator’s wording governs.
The process by which a trial participant voluntarily confirms their willingness to take part after being informed of all aspects relevant to their decision. Consent process and documentation are among the most-cited GCP inspection findings.
Informed consent is a process, not a signature. The participant must receive information they can understand about the purpose, procedures, risks, benefits, alternatives, and their right to withdraw at any time without penalty; must have adequate time and opportunity to ask questions; and must agree voluntarily, free from coercion or undue influence. The form documents that process — it does not constitute it.
The sequencing rules are strict and are where findings concentrate. Consent must be obtained before any trial-specific procedure, including screening tests done solely for the study. The participant and the person conducting the consent discussion must each personally sign and date, and the participant must be given a copy. Re-consent is required when new safety information emerges or the protocol changes in ways that affect them.
Special situations demand extra structure: legally authorised representatives for participants unable to consent, assent from children alongside parental permission, impartial witnesses for participants who cannot read, and defined provisions for emergency situations. ICH E6(R3) also pushes toward genuine comprehension rather than volume — a consent form so long and dense that nobody reads it fails the purpose even when it is technically complete.
- —A process, not a signature — comprehension, time to consider, and voluntariness are all required.
- —Must precede any trial-specific procedure, including study-only screening.
- —Participant and the person conducting the discussion each personally sign and date; participant keeps a copy.
- —Re-consent when new safety information or a relevant protocol change arises.
- —Special provisions for legally authorised representatives, paediatric assent, and illiterate participants.
- —Consent process and documentation are among the most-cited GCP inspection findings.
ICH E6(R3) Good Clinical Practice; 21 CFR Part 50 (Protection of Human Subjects) and 21 CFR 50.25 for required elements; the Declaration of Helsinki; EU Regulation (EU) No 536/2014 Chapter V.
Frequently asked questions
What is Informed Consent?
The process by which a trial participant voluntarily confirms their willingness to take part after being informed of all aspects relevant to their decision. Consent process and documentation are among the most-cited GCP inspection findings.
Which regulations cover Informed Consent?
ICH E6(R3) Good Clinical Practice; 21 CFR Part 50 (Protection of Human Subjects) and 21 CFR 50.25 for required elements; the Declaration of Helsinki; EU Regulation (EU) No 536/2014 Chapter V.