Documentation and Ongoing Consent Requirements

Part of Good Clinical Practice (GCP) — ICH E6(R3): Informed Consent Process.

About 7 minutes. Free, in your language, no account needed.

Why this matters

Consent does not end when the form is signed. New safety information arrives, protocols are amended, and participants change their minds. The most common site findings sit here: a missing date, an old form version, a re-consent that never happened, a withdrawal with no follow-up plan.

What the discussion and the materials must explain

Section 2.8.10 of the International Council for Harmonisation (ICH) guideline ICH E6(R3) lists 22 elements, (a) to (v), that the consent discussion and materials should explain, as applicable. Learn them as five groups.

Group 1, what the trial is. Purpose (a); that it involves research, with a summary of the experimental aspects (b); the investigational product and probability of random assignment (c); the procedures, including all invasive ones (d); what is expected of the participant (e); expected duration (t); approximate number of participants (u).

Group 2, risks, benefits and alternatives. Reasonably foreseeable risks or inconveniences, including where applicable to a partner, embryo, fetus or nursing infant (f); reasonably expected benefits (g); alternative procedures or treatments, with their benefits and risks (h); compensation and treatment for trial-related injury (i). On benefits E6(R3) is explicit: "When there is no intended clinical benefit to the participant, the participant should be made aware of this."

Group 3, money. Any anticipated prorated compensation (j); any anticipated expenses to the participant (k).

Group 4, rights and how to leave. That participation is voluntary and the participant may stop the product or withdraw at any time, without penalty or loss of benefits they are otherwise entitled to (l); follow-up for those who stop, withdraw or are discontinued (m); how their data will be handled, including on withdrawal (n); the circumstances under which participation may be terminated (s); that they will be told in a timely manner of information affecting their willingness to continue (q); who to contact about the trial, their rights and suspected trial-related injury (r).

Group 5, data, privacy and transparency. That taking part allows direct access to source records by regulatory authorities, the sponsor's monitors or auditors and, where applicable, the IRB/IEC, with medical record confidentiality safeguarded (o); that identifying records stay confidential so far as permitted, and the trial may be registered on public databases (p); that trial results and the participant's actual treatment will be made available to them if they want it (v).

Section 2.8.4 adds a prohibition. No consent information may waive, or appear to waive, the participant's legal rights, or release the investigator, institution, sponsor or their service providers from liability for negligence.

Signatures, and what a signature attests

Section 2.8.7 sets out who signs. Before trial participation, the form should be signed and dated by the participant or their legally acceptable representative, where appropriate by an impartial witness, and by the investigator or delegated site staff who conducted the discussion.

The site signature is not a formality. By signing, that person attests that consent was freely given and that the information was accurately explained to, and apparently understood by, the participant. Signatures may be physical or electronic.

Five things must be documented every time:

Add a short note describing what was explained, the questions asked and the time given. A form with a signature and no note is thin evidence that a process happened.

Copies, ongoing consent and re-consent

Section 2.8.11 requires that, before participation, the participant or representative receives a copy of the signed and dated form and any other materials provided, on paper or electronically. Its second half is missed constantly: during participation, the participant should also receive copies of consent form updates. A re-consent is not complete until the participant holds the new version.

Section 2.8.2 governs change. The participant or representative should be informed in a timely manner if new information becomes available that may be relevant to their willingness to continue. That communication, and the confirmed willingness to continue, should be documented.

The information is then assessed to decide whether re-consent is needed. Depending on the stage of the trial, consider whether it is relevant only to new participants or also to existing ones. E6(R3) gives emerging safety concerns as an example where re-consent is needed.

Two requirements follow. New information should be clearly identified in the revised materials. The revised materials should receive the IRB/IEC's approval or favorable opinion in advance of use. Never re-consent from a draft.

End of participation, section 2.9

Section 2.9.1 applies when a participant stops the investigational product, withdraws, is discontinued, or reaches the routine end of the trial. The investigator should follow the protocol. For those who did not reach the routine end, this may include instructions to avoid loss of already collected data. E6(R3) explains why: such loss may bias results and lead to inaccurate conclusions about the safety profile.

Withdrawing from the trial and withdrawing permission to use data already collected are two different decisions. Explain how data are handled at consent, under element (n), not on the day someone leaves.

Section 2.9.2 balances two duties. A participant is not obliged to give a reason. The investigator should still make a reasonable effort to ascertain it, while fully respecting the participant's rights, and may discuss whether the concerns can be addressed. The section then closes the door on pressure: this must not interfere with the decision to refuse or withdraw at any time.

Section 2.9.3 adds that, where relevant, the investigator should inform the participant of the trial results and the treatment they received once the sponsor has that information after unblinding, with due respect to their preference to be informed. Some people do not want to know.

In practice

Kofi is in month seven of a twelve-month trial. He calls the site to say he is stopping.

Layla, the coordinator, confirms that stopping is his right and carries no penalty. She asks, without pressing, whether anything prompted it. He says the Tuesday visits now clash with his work shift. That is solvable, so Layla offers a different day and a shorter visit, and makes clear he may still stop.

Had Kofi confirmed his decision, Layla would arrange the early termination visit and the protocol's safety follow-up, record any reason he chose to give, and confirm what happens to the data already collected.

Two weeks later a safety update adds a new adverse reaction to the consent form. The IRB/IEC approves the revised version on 4 June. Layla re-consents active participants using that version only and gives each of them a copy.

Informed consent is a process, not a signature. That is as true at the exit as at the entrance.

Key takeaways