SOCRA CCRP Informed Consent 2 — Questions and Answers

Question 1: Under ICH-GCP, which of the following must be included in the informed consent form?

The sponsor's total budget for the trial
A statement that participation is voluntary and that the subject may withdraw at any time without penalty (Correct answer)
The names of all other participants in the study
A guarantee of therapeutic benefit

Correct answer: A statement that participation is voluntary and that the subject may withdraw at any time without penalty

ICH-GCP Section 4.8.10 requires that the informed consent form include a statement that participation is voluntary and that the subject may refuse to participate or withdraw at any time without penalty or loss of benefits.

ICH-GCP Section 4.8.10 lists the required elements of informed consent. Among the most fundamental is the statement that participation is entirely voluntary and that the subject (or legally acceptable representative) may refuse to participate or may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled. Other required elements include: description of the trial, risks, benefits, alternative treatments, confidentiality provisions, compensation information, and contact persons. The consent document must be written in language understandable to the subject and must not include language that waives any of the subject's legal rights or releases the investigator or sponsor from liability.

Question 2: What must occur before any trial-related procedures are performed on a potential study subject?

The subject must complete all screening assessments
Written informed consent must be obtained (Correct answer)
The subject must receive the investigational product
The site must submit the first enrollment report

Correct answer: Written informed consent must be obtained

ICH-GCP requires that freely given written informed consent must be obtained from each subject before any trial-specific procedures are performed, including screening tests.

ICH-GCP Section 4.8.8 states that before a subject's participation in the trial, the written informed consent form should be signed and personally dated by the subject (or legally acceptable representative) and by the person who conducted the informed consent discussion. No trial-related procedures, including screening assessments, can be performed prior to obtaining consent. This is a fundamental ethical principle derived from the Declaration of Helsinki and the Belmont Report. If screening procedures are part of standard of care, they may not require separate research consent, but any procedure performed specifically for the trial requires prior consent.

Question 3: How should the informed consent process be handled for a subject who cannot read?

The subject cannot participate in clinical trials
An impartial witness must be present during the entire consent discussion and must sign the consent form (Correct answer)
The investigator may waive the consent requirement
A family member can sign without the subject's involvement

Correct answer: An impartial witness must be present during the entire consent discussion and must sign the consent form

When a subject cannot read, ICH-GCP requires that an impartial witness be present during the entire informed consent discussion. The witness must sign and date the consent form to attest that the information was accurately explained and apparently understood.

ICH-GCP Section 4.8.9 specifically addresses informed consent for subjects who cannot read. In such cases, an impartial witness should be present during the entire informed consent discussion. After the consent document and any other written information are read and explained to the subject, the subject must provide oral consent if able (or mark the form, such as a thumbprint), and the witness must sign and date the consent form. The witness should not be part of the trial team or otherwise unduly influenced by those involved in the trial. This process ensures that illiteracy does not prevent subjects from exercising their right to participate in research while maintaining appropriate protections.

Question 4: When a significant new finding arises during a clinical trial that could affect a subject's willingness to continue, what action is required?

No action is needed until the trial ends
The subject must be informed promptly and re-consent must be obtained with a revised consent form (Correct answer)
The finding should be reported only to the sponsor
Only new subjects need to be informed

Correct answer: The subject must be informed promptly and re-consent must be obtained with a revised consent form

ICH-GCP Section 4.8.2 requires that when new information becomes available that may be relevant to the subject's willingness to continue, the subject must be informed in a timely manner and a revised consent form must be signed.

Informed consent is not a one-time event but rather an ongoing process. ICH-GCP Section 4.8.2 states that neither the investigator nor the trial staff should coerce or unduly influence a subject's decision to participate, and that any new information that may affect a subject's willingness to continue participation should be communicated in a timely manner. When significant new safety information, protocol amendments affecting subjects, or other relevant findings emerge, a revised informed consent form must be prepared, approved by the IRB/IEC, and signed by currently enrolled subjects. This process, often called re-consent, ensures subjects remain fully informed throughout their participation.

Question 5: What is the role of a legally acceptable representative (LAR) in the informed consent process?

To replace the subject entirely in making treatment decisions
To provide informed consent on behalf of a subject who is unable to provide consent themselves (Correct answer)
To serve as the study monitor
To verify the accuracy of the case report forms

Correct answer: To provide informed consent on behalf of a subject who is unable to provide consent themselves

A legally acceptable representative may provide informed consent on behalf of a subject who is unable to do so (e.g., due to incapacity, age), according to applicable laws and regulations.

ICH-GCP defines a legally acceptable representative (LAR) as an individual or juridical or other body authorized under applicable law to consent, on behalf of a prospective subject, to the subject's participation in the clinical trial. This applies to subjects who cannot provide consent themselves, such as minors, adults with cognitive impairment, or those who are unconscious. The LAR must be provided with the same information and opportunity to ask questions as would be provided to a competent subject. In some jurisdictions, assent from the subject (particularly from older minors) is also required in addition to LAR consent. The specific individuals who can serve as LARs vary by jurisdiction and must comply with local laws.

Question 6: Which of the following statements about informed consent language is correct according to ICH-GCP?

Technical medical terminology should be used to demonstrate scientific rigor
The consent form should be written in language that is understandable to the subject or the subject's legally acceptable representative (Correct answer)
Legal disclaimers must be prominently featured
The consent form should be available only in English for standardization

Correct answer: The consent form should be written in language that is understandable to the subject or the subject's legally acceptable representative

ICH-GCP requires that the informed consent form be written in language that is non-technical and understandable to the subject or the subject's legally acceptable representative.

ICH-GCP Section 4.8.6 specifies that the language used in the oral and written information about the trial, including the consent form, should be as non-technical as practical and should be understandable to the subject or the subject's LAR. This requirement reflects the ethical principle that true informed consent requires genuine understanding. The form should typically be written at an 8th-grade reading level or below. Medical terms should be defined or explained. The consent form must be available in the subject's native language when needed. Both the IRB/IEC and the investigator share responsibility for ensuring that the consent documents are clear, complete, and comprehensible.

SOCRA CCRP Informed Consent 2

Under ICH-GCP, which of the following must be included in the informed consent form?

Select your answer

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