CPI Informed Consent & Subject Rights Flashcards
6 cards from real CPI practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.
Read the first 6 CPI Informed Consent & Subject Rights flashcards as text
What is the role of a Legally Authorized Representative (LAR) in the informed consent process?
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.
Which core element must be included in ALL informed consent documents under 21 CFR 50.25?
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.
What is a 'short form' written consent document?
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.
Under which condition is an IRB permitted to waive the requirement for signed informed consent?
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.
What is 'assent' in the context of pediatric clinical research?
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.
What must an investigator do when a research subject decides to withdraw from a study?
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.