Examples
Worked examples
- Is an instance
A trial participant notifies the coordinator that they wish to withdraw; the site stops further visits and follows the protocol's pre-specified plan to retain anonymised data already collected.
- Is an instance
A biobank participant uses the dynamic-consent portal to withdraw consent for future use of stored specimens; the biobank flags the sample identifier so no further releases occur.
Counter-examples
Looks similar, but isn't
- Not an instance
A participant declining a single study visit while remaining enrolled is not a withdrawal of consent.
- Not an instance
Loss to follow-up where the participant cannot be contacted is not a withdrawal and does not by itself trigger destruction of collected data.
Editorial commentary
Withdrawal is a fundamental right under all major human-subjects frameworks and must be available without penalty or loss of benefits. Protocols should specify at consent whether previously collected data and samples will be destroyed, retained in identifiable form, or retained in coded/anonymised form on withdrawal, and the consent form must accurately describe these choices. Under the GDPR, withdrawal of consent under Article 7(3) does not by itself require deletion of data already lawfully processed for research purposes where another lawful basis or a research-purposes safeguard under Article 89 applies, but the institution must clearly explain this distinction in the consent process.
References
- Common Rule 45 CFR §46.116(b)(8) statement of right to withdraw
- GDPR Regulation (EU) 2016/679 Article 7(3) withdrawal of consent
- ICH GCP E6(R3) Guideline (2023), provisions on withdrawal of trial participants
Also known as
consent withdrawal · revocation of consent · withdrawal from research
Machine-readable encodings
Use in your systems
<role vocab="credit"
vocab-identifier="https://casrai.org/dictionary/"
vocab-term="Withdrawal of consent"
vocab-term-identifier="https://casrai.org/dictionary/term/withdrawal-of-consent" />{
"@context": "https://schema.org",
"@type": "DefinedTerm",
"name": "Withdrawal of consent",
"identifier": "https://casrai.org/dictionary/term/withdrawal-of-consent",
"description": "The exercise by a research participant of the right to revoke their consent to ongoing participation in research, after which the investigator must cease prospective collection of data or biospecimens from that participant and apply the protocol-specified handling of data already collected.",
"inDefinedTermSet": "https://casrai.org/dictionary/domain/compliance-and-regulatory/",
"url": "https://casrai.org/dictionary/term/withdrawal-of-consent",
"sameAs": [
"consent withdrawal",
"revocation of consent",
"withdrawal from research"
],
"license": "https://creativecommons.org/licenses/by/4.0/"
}
