CPI Informed Consent & Human Subjects Protection 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 & Human Subjects Protection flashcards as text
Which of the following populations is considered 'vulnerable' and requires additional protections under federal regulations?
Answer: Pregnant women, prisoners, and children
Federal regulations specifically identify pregnant women, prisoners, and children as vulnerable populations requiring additional protections.
When obtaining consent from a non-English-speaking participant, what is required?
Answer: A translated consent form or short form with interpreter, approved by the IRB
Non-English speakers must receive consent information in a language they understand, using an IRB-approved translated form or a short form with an interpreter.
What is 'assent' in the context of pediatric research?
Answer: A minor's affirmative agreement to participate, in addition to parental permission
Assent is the child's affirmative agreement to participate in research and is required in addition to parental or guardian permission.
A participant's capacity to provide informed consent becomes impaired during the study. What is the PI's primary obligation?
Answer: Obtain consent from a legally authorized representative and reassess participant's capacity regularly
When a participant loses capacity, the PI must seek consent from a legally authorized representative and continue to respect the participant's preferences and welfare.
What does 'therapeutic misconception' mean in the context of informed consent?
Answer: A participant incorrectly believes the research is designed to benefit them personally rather than generate generalizable knowledge
Therapeutic misconception occurs when a participant conflates research participation with receiving individualized medical treatment.
Which of the following is required when a protocol amendment substantially changes the risks or benefits to current participants?
Answer: Re-consent of currently enrolled participants using an updated form
When an amendment significantly changes risks or benefits, currently enrolled participants must be re-consented using the updated IRB-approved consent form.