Informed consent

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.

ByCASRAI Editorial Board

· Last updated 21 May 2026

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.

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.

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

Use in your systems

JATS XML <role> element

xml

<role vocab="credit"
      vocab-identifier="https://casrai.org/dictionary/"
      vocab-term="Informed consent"
      vocab-term-identifier="https://casrai.org/dictionary/term/informed-consent" />

Schema.org DefinedTerm (JSON-LD)

json

{
  "@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"
  },
  "dateModified": "2026-05-21T02:22:53",
  "inLanguage": "en"
}