CPI CPI Informed Consent & Subject Rights 2 — Questions and Answers
Question 1: What is the role of a Legally Authorized Representative (LAR) in the informed consent process?
- To sign consent on behalf of a subject who lacks decision-making capacity (Correct answer)
- To witness the investigator obtaining consent from a competent subject
- To review and approve the consent form before IRB submission
- To translate the consent form into the subject's language
Correct answer: To sign consent on behalf of a subject who lacks decision-making capacity
A LAR is an individual authorized under applicable law to consent to research on behalf of a prospective subject who lacks the capacity to provide their own consent.
Question 2: Which core element must be included in ALL informed consent documents under 21 CFR 50.25?
- The investigator's curriculum vitae
- A statement that participation is voluntary and refusal involves no penalty (Correct answer)
- The sponsor's financial interest in the study outcome
- A list of all co-investigators
Correct answer: A statement that participation is voluntary and refusal involves no penalty
A statement confirming that participation is voluntary and that refusal or withdrawal carries no penalty or loss of benefits is a basic required element under 21 CFR 50.25.
Question 3: What is a 'short form' written consent document?
- A one-page summary replacing the full consent form for low-risk studies
- A document stating that required elements were presented orally and the subject agrees (Correct answer)
- An abbreviated consent used for telephone screening
- A consent form approved for use without IRB review
Correct answer: A document stating that required elements were presented orally and the subject agrees
A short form consent document states that the elements of informed consent were orally presented to the subject or LAR, and requires a witness signature and written summary of what was presented.
Question 4: Under which condition is an IRB permitted to waive the requirement for signed informed consent?
- When the study involves a marketed drug with known safety profile
- When the principal risk is a breach of confidentiality and the only link to the subject is the consent form (Correct answer)
- When the sponsor requests a waiver to accelerate enrollment
- When the study is funded by a federal agency
Correct answer: When the principal risk is a breach of confidentiality and the only link to the subject is the consent form
An IRB may waive the signature requirement when the primary risk is a confidentiality breach and the signed consent form itself would be the only record linking the subject to the research.
Question 5: What is 'assent' in the context of pediatric clinical research?
- The parent's legally binding consent for their child to participate
- A minor's affirmative agreement to participate in research, supplementing parental permission (Correct answer)
- An IRB waiver allowing enrollment without full consent
- The FDA's approval of a pediatric study protocol
Correct answer: A minor's affirmative agreement to participate in research, supplementing parental permission
Assent is the child's affirmative agreement to participate, required in addition to parental or guardian permission for research involving minors capable of providing meaningful agreement.
Question 6: What must an investigator do when a research subject decides to withdraw from a study?
- Require the subject to complete current study assessments before withdrawing
- Honor the withdrawal immediately while asking if they consent to use previously collected data (Correct answer)
- Notify the FDA within 15 business days
- Require the subject to provide a written reason for withdrawal
Correct answer: Honor the withdrawal immediately while asking if they consent to use previously collected data
Investigators must respect a subject's right to withdraw at any time without penalty, and may ask—but not require—whether previously collected data may be retained for analysis.
CPI CPI Informed Consent & Subject Rights 2
What is the role of a Legally Authorized Representative (LAR) in the informed consent process?