Communication and Documentation Flashcards

Under 21 CFR 50.27, what must happen after a participant signs the written consent form?

Answer: The participant is given a copy of the signed form

FDA regulations require that the person signing the consent form receive a copy.

A non-English-speaking participant is consented with the short form method. Who must sign the short form?

Answer: The participant (or legally authorized representative) and a witness

With the short form, the participant and a witness sign the short form, and the witness and the person obtaining consent sign the summary.

The IRB approves a revised consent form with new risk information. What should the site do with participants already enrolled?

Answer: Reconsent them with the newly approved version when the information may affect their willingness to continue

Significant new findings must be shared with enrolled participants, usually documented by reconsenting.

Which consent form version should staff use when enrolling a new participant?

Answer: The most current IRB-approved version

Only the current IRB-approved consent version may be used to enroll participants.

Which communication technique has a participant explain study information back in their own words to confirm understanding?

Answer: Teach-back method

Teach-back confirms comprehension by having participants restate key information.

Before a recruitment flyer can be posted for a study, what must happen?

Answer: The IRB must review and approve it

Recruitment materials are part of the consent process and need IRB approval before use.

Which statement about documenting the informed consent process is accurate?

Answer: A process note should record who obtained consent, when, that questions were answered, and that a copy was given

A consent process note shows that consent was an informed discussion, not just a signature.