How to Obtain and Document Informed Consent
Run consent as a process a monitor can reconstruct, not a signature on a form.
What a how-to is not
A how-to is SPEQ’s practitioner method, not a procedure. It does not replace your own SOP, it is not a validated approach, and the judgement calls in it belong to your quality unit.
Consent is the one procedure in a trial where the regulatory obligation and the ethical obligation are the same thing, and it is also the most frequently cited deficiency in clinical inspections. The failures are almost never about the form itself. They are about what happened around the signature: who explained it, when, whether the participant could still have declined, and whether any of that was written down.
- 1
Confirm the form was approved before it was used
The version used must be the version the review board approved, and it must have been approved before the participant signed. Consent taken on a superseded version is not a documentation defect that can be corrected later — it is consent obtained under a description of the trial that no longer applied.
- 2
Allow time and a setting for questions
The participant must have the opportunity to consider and to ask questions without pressure, in language they understand. Consent obtained in the same encounter as a screening procedure invites the finding that the decision was not free, so record that the opportunity existed rather than assuming it is implied.
- 3
Have the participant sign and personally date before any trial procedure
The dating must be by the participant, not entered for them, and it must precede every activity performed for the trial rather than for care. A procedure performed before the signature is unconsented research, whatever the clinical justification.
- 4
Have the person conducting the discussion sign as well
The signature of whoever conducted the discussion is what turns a form into evidence that a conversation occurred. Where local rules require an impartial witness, the witness attests to the process, not to the medical content.
- 5
Write the process note in the participant record
Record who conducted the discussion, when, what was provided, what was asked, and that a copy was given to the participant. This note, not the form, is what a monitor reconstructs the process from, and it is the single most useful thing a site can do to survive a consent review.
- 6
Re-consent when the information changes
New safety information, an amended protocol, or a new procedure requires re-consent of participants still in follow-up, on the approved updated version. Track who has been re-consented and who is still outstanding — partial re-consent with no tracking is how a site discovers the gap during an inspection.
- !A superseded form version used after an amendment was approved, so the description consented to no longer matches the trial.
- !The date entered by site staff rather than personally by the participant.
- !A screening procedure performed before the signature because it was also clinically indicated.
- !Re-consent after a safety update tracked informally, so nobody can say who is outstanding.
How to Obtain and Document Informed Consent: frequently asked questions
Common questions on obtain and document informed consent.
Is a signed form sufficient evidence of consent?
No. The form evidences agreement; the process note evidences that an informed decision was possible — who explained the trial, when, what was asked, and that the participant kept a copy. Inspections that find consent deficiencies usually find a complete form and no record of the conversation around it.
What if a procedure is both standard care and a trial procedure?
If it is being performed for the trial, or its result will be used as trial data, it requires consent first. The fact that a clinician would have ordered it anyway does not convert research use into care, and this is one of the most common ways a pre-consent procedure is rationalised.
Who must be re-consented after an amendment?
Participants still in follow-up whose experience or decision the change could affect — new risks, new procedures, a changed duration. Track it as a list with a closure date rather than as an intention, because the participants who slip through are the ones seen least often.