Informed Consent and Participant Protection
This domain tests consent as a regulated process rather than a signature. Items ask which elements must appear, who may sign, when re-consent is required, and what extra safeguards apply to children, prisoners, pregnant women and adults with impaired decision-making capacity.
Required elements (21 CFR 50.25)
- Eight basic elements (purpose, duration, procedures; foreseeable risks; benefits; alternatives; confidentiality; compensation and medical treatment for injury; contacts; voluntariness) plus additional elements where applicable (unforeseeable risks, circumstances of termination, costs, consequences of withdrawal, new findings, number of participants).
- No exculpatory language and no wording by which the participant waives legal rights.
Process requirements
- Obtain consent before any study-specific procedure, using the current IRB-approved version; the participant or legally authorised representative signs and dates, and the person obtaining consent signs and dates.
- Give a copy (paper or validated eConsent); the consent discussion, including interpreter use, is documented in the source.
- Children: parental permission plus assent, following the subpart D risk categories. Adults lacking capacity: LAR permission under the IRB-approved framework.
- 21 CFR 50.27(b)(2) short form: oral presentation with an impartial witness, the IRB-approved short form, and a written summary of what was said - for a participant who does not read English.
When re-consent is required
New risk information, a protocol amendment that changes procedures, burden or the risk/benefit ratio, or expiry of the previously approved version. Re-consent the participant before any new procedure is performed under the amended protocol.
Worked example
A new consent version is IRB-approved on Monday; on Tuesday a coordinator has a scheduled screening visit and uses the superseded form still in the cupboard. Reasoning: the consent is invalid for procedures performed after the approval date. The participant must be re-consented with the current version before any further study-specific activity, the event is documented as a deviation, and the corrective action targets version control (removing superseded forms at issuance, checking version at the visit).
Traps that cost marks
- Consent signed after screening tests, or missing signature or date fields.
- Using a witness signature as a substitute for an interpreter's role.
- Assuming re-consent is unnecessary for "administrative" amendments that in fact add procedures or risks.
- eConsent platforms without audit trails, access controls and validated e-signatures.
- Treating a competent adult's relative as an LAR without an IRB-approved basis.