Examples
Worked examples
- Is an instance
A study coordinator reviews the consent form with a prospective participant in a private room, answers all questions, and witnesses the signature only after the participant confirms understanding of the randomisation procedure.
- Is an instance
For a study with non-English-speaking participants, the IRB approves a translated consent and requires a qualified interpreter to be present during the consent discussion.
Counter-examples
Looks similar, but isn't
- Not an instance
A signed form with no documented discussion or comprehension check does not constitute valid informed consent.
- Not an instance
Enrolment after the participant declines further explanation and signs under perceived pressure from the recruiting clinician is not voluntary consent.
Editorial commentary
Informed consent is a continuing process, not a single signature event. Required content under the revised Common Rule includes a concise summary at the start, the purposes and duration of the research, procedures, foreseeable risks, anticipated benefits, alternatives, confidentiality protections, compensation for injury, contacts for questions, and the voluntary nature of participation with the right to withdraw at any time without penalty. The investigator must give the prospective subject sufficient opportunity to consider participation, minimise the possibility of coercion, present information in language understandable to the subject, and avoid exculpatory language. Consent documentation may be waived under specified regulatory conditions.
This entry covers the general Common Rule concept of consenting to a specific study. Two related but distinct consent models sit alongside it: broad consent (a single, one-time consent under §46.116(d) covering an unspecified range of future secondary research uses of stored data or biospecimens) and dynamic consent (a digital-platform model that lets a participant grant, modify, or withdraw consent study-by-study on an ongoing basis, most common in biobanks and longitudinal cohorts) — see the dedicated entries on each for how they differ from the single-study consent described here. Outside the US regulatory context, ICH E6(R3) and the Declaration of Helsinki articulate materially similar disclosure and voluntariness principles, so a multinational or industry-sponsored study commonly satisfies both frameworks through one harmonised consent document rather than two separate processes.
References
- Common Rule 45 CFR §46.116 General requirements for informed consent
- ICH GCP E6(R3) Guideline (2023), Section on Informed Consent of Trial Participants
- Declaration of Helsinki (World Medical Association, 2013 revision), Articles 25-32
Also known as
consent · study consent · voluntary informed consent
Machine-readable encodings
Use in your systems
<role vocab="credit"
vocab-identifier="https://casrai.org/dictionary/"
vocab-term="Informed consent"
vocab-term-identifier="https://casrai.org/dictionary/term/informed-consent" />{
"@context": "https://schema.org",
"@type": "DefinedTerm",
"@id": "https://casrai.org/dictionary/term/informed-consent",
"name": "Informed consent",
"identifier": "https://casrai.org/dictionary/term/informed-consent",
"description": "The voluntary agreement of a prospective research participant, or their legally authorised representative, to take part in a specific research activity, given after disclosure of the information required by the applicable regulation and free from coercion or undue influence.",
"inDefinedTermSet": "https://casrai.org/dictionary/domain/compliance-regulatory#set",
"url": "https://casrai.org/dictionary/term/informed-consent",
"sameAs": [
"consent",
"study consent",
"voluntary informed consent"
],
"license": "https://creativecommons.org/licenses/by/4.0/",
"publisher": {
"@id": "https://casrai.org/#organization"
},
"author": {
"@id": "https://casrai.org/#editorial-team"
},
"datePublished": "2026-05-21T02:22:53",
"dateModified": "2026-08-23T05:31:25",
"inLanguage": "en-GB",
"isAccessibleForFree": true
}
