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.
Two different things “withdrawal” can mean
Research administrators and IRBs distinguish withdrawal from further participation (the subject stops undergoing study procedures or providing new data going forward) from withdrawal of already-collected identifiable data or specimens (the subject asks for what has already been collected to be removed or destroyed). The first is always available and must involve no penalty. The second is often only partially achievable: once data has been de-identified, aggregated, analysed, or already incorporated into a locked dataset or a publication, it may not be practicable — or, once results are published, even meaningful — to retroactively remove it. A well-written consent form sets this expectation up front rather than implying an unqualified right to have already-used data erased.
What a protocol must specify at consent
Because the two forms of withdrawal have different practical limits, the consent process should specify, before data collection begins, what will happen to already-collected material on withdrawal: whether it will be destroyed, retained in identifiable form with the subject’s permission, or retained only in coded/de-identified form. This is a required element of an adequate consent process under the Common Rule’s general 46.116 disclosure standard, not a separate optional add-on.
ICH GCP and clinical trial withdrawal
ICH GCP (E6) treats participant withdrawal in a clinical trial as always permissible without justification or penalty, but distinguishes it from investigator-initiated discontinuation (removing a participant for safety, non-compliance, or protocol reasons) — the two are recorded and reported differently, and a sponsor’s safety and efficacy analyses must account for withdrawals consistently with the trial’s pre-specified statistical analysis plan rather than simply dropping withdrawn participants’ existing data from an ongoing safety assessment.
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
Related: Informed consent · Broad consent · Dynamic consent · Common Rule (45 CFR 46).
Also known as
consent withdrawal · revocation of consent · withdrawal from research
Machine-readable encodings
Use in your systems
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