Running the Consent Process and Documenting It

Part of Human Subjects Protection for Clinical Research Staff: Informed Consent.

About 5 minutes. Free, in your language, no account needed.

Why this matters

A signature does not prove that consent happened, but a missing or wrong one can show it did not. Consent is a process with a record at the end. This lesson covers both.

ICH E6(R3) sets the international baseline for the consent process and its content. The US rules (HHS 45 CFR 46 and FDA 21 CFR 50) are taught as the detailed worked example, and passages naming them are US law. Outside the United States, follow your national law and ethics committee requirements, which may add to or differ from what you read here.

Before the conversation starts

ICH E6(R3) section 2.8.1 sets out these points:

• The IRB/IEC must have documented its approval of the consent materials and process before consenting begins.
• Information should be as clear and concise as possible, in simple language, and varied approaches (text, images, video) are allowed.
• Remote consent may be considered, with identity assured in person or remotely. A paper alternative should be an option when computerized systems are used.

Consent is obtained by the investigator or delegated site staff (2.8.6). Check the delegation log first. If your name is not on it for consent, do not do it.

During the conversation

ICH E6(R3) calls for ample time unless there is a justified reason otherwise, and an opportunity to ask questions, with the questions answered to the participant's satisfaction (2.8.5, 2.8.6).

Neither the investigator nor site staff should coerce or unduly influence a participant to join or to continue (2.8.3). A good habit: ask the participant to describe, in their own words, what will happen and what the main risks are.

The record: the signed form

Under the Common Rule (45 CFR 46.117(a)), consent is documented with a written form that the IRB has approved. The form is signed, including electronically, by the subject or the legally authorized representative, and a written copy is given to the person signing. FDA (21 CFR 50.27(a)) adds that the form is signed and dated by the subject or representative at the time of consent.

ICH E6(R3) section 2.8.7 adds that the form is signed and dated by the participant or representative and, where appropriate, by an impartial witness and by the investigator or delegated staff, before participation. Signing attests that consent was freely given and the information accurately explained and apparently understood.

If the participant or representative cannot read, an impartial witness is present throughout the consent discussion and signs the form (2.8.9).

The participant receives a copy of the signed and dated form before participation, and copies of updates during participation (2.8.11).

The short form

The regulations also allow a short form route (46.117(b)(2); 50.27(b)(2)). A written short form states that the required elements were presented orally (under the Common Rule, also that key information was presented first). The IRB approves a written summary of what will be said, and a witness attends the oral presentation. Only the short form is signed by the subject or representative. The witness signs the short form and a copy of the summary, the person obtaining consent signs a copy of the summary, and the subject or representative receives a copy of both.

Do not improvise: the summary must be IRB-approved first.

When signed documentation may be waived

An IRB may waive the requirement for a signed form in limited circumstances (46.117(c)(1); 21 CFR 56.109(c)(1)). Under the Common Rule these are: the only record linking subject and research would be the consent form and the principal risk is harm from a breach of confidentiality (the subject's wishes govern); minimal risk research with no procedures that normally require written consent outside research; or minimal risk research with a cultural group in which signing forms is not the norm and an alternative documentation mechanism. FDA allows a similar waiver for minimal risk research. The IRB may require a written statement about the research when documentation is waived (46.117(c)(2); 56.109(d)). Waiving a signature is the IRB's decision, never the site's.

Other points worth knowing

• For each federally conducted or supported clinical trial, one IRB-approved consent form used to enroll subjects must be posted on a public federal website no later than 60 days after the last study visit by any subject (46.116(h)).
• Consent requirements do not preempt federal, state or local laws that require additional disclosure (46.116(i); 50.25(d)).

In practice

Before a consent visit, a coordinator checks that the form version matches the IRB-approved one, that her name is on the delegation log for consent, and that the participant has had the form for a few days. She asks the participant to describe the study back to her. They both sign and date, and the participant leaves with a copy.

What this looks like when it goes wrong

A participant signs the consent form, but nobody dates it. Later, a monitor sees a screening procedure recorded on the same day, and the form cannot show whether consent came first.

A missing date turned a normal visit into a question the file cannot answer.

Key takeaways

• IRB/IEC approval of consent materials comes before consenting begins.
• Consent is obtained by the investigator or delegated staff, with ample time and questions answered to the participant's satisfaction.
• The signed form is signed and dated before participation, and the participant gets a copy.
• An impartial witness is present throughout if the participant or representative cannot read.
• The short form needs an IRB-approved summary and a witness. Waiving signed documentation is an IRB decision.
• Neither investigator nor staff should coerce or unduly influence a participant to join or continue.