Documenting a Consent Discussion

Part of Sub-Investigator (SUBI) Training: Consent You Take Yourself.

About 2 minutes. Free, in your language, no account needed.

The signature is not the record

A signed form shows a form was signed. The record of consent is your note of the discussion.

What the note should contain

Who was present. What was discussed, including the main risks and the alternatives. What the participant asked. That they had time to consider and a copy of the information sheet. That they were told participation is voluntary. The version of the form used.

And that consent was obtained before any study-specific procedure.

Before any procedure, without exception

Screening bloods, extra imaging, questionnaires. If it is done for the study, it happens after consent.

A procedure performed before consent is one of the most serious findings in a trial, and it is usually the result of an ordinary scheduling assumption rather than anybody deciding to skip anything.

Dates and times both

Consent at 09:40 and the screening blood at 09:15 is a problem that only the times reveal. Recording the time protects you when the order was correct.

The version matters

Consent must be on the version approved and in force at that date. Sites hold superseded copies and they look identical.

Check the version and footer date before the discussion, not afterward.

When someone else translated

If an interpreter was used, record who and how. If a short-form process was used for a language without a translated document, it has its own requirements including a witness.

Do not use a family member as an interpreter for consent if the study provides another route.

Reconsent is a discussion too

A new version notified by letter is not reconsent. A material change needs a conversation and a fresh note.

Your signature means what it says

Signing as the person who conducted the discussion is a statement that you did. Do not sign for a discussion a colleague had.