CIP Informed Consent Process & Documentation Flashcards
6 cards from real CIP practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.
Read the first 6 CIP Informed Consent Process & Documentation flashcards as text
Which of the following situations requires reconsenting a research participant?
Answer: New information arises that may affect a subject's willingness to continue
Subjects must be reconsented when new information emerges that could materially affect their decision to continue participation.
In an emergency where a subject is unable to consent, research involving greater-than-minimal risk may proceed without consent if:
Answer: The IRB has approved an exception from informed consent (EFIC) and FDA requirements are met
FDA's 21 CFR 50.24 allows exception from informed consent in life-threatening situations when specific IRB approval and community consultation requirements are satisfied.
A subject who does not speak English must be consented using:
Answer: A short form consent document in the subject's language with an interpreter and a witness
When consent cannot be obtained in English, a short form in the subject's language paired with an oral presentation and witness signature is an accepted approach under 45 CFR 46.117(b)(2).
Which additional element of informed consent must be included when a study involves research on biospecimens?
Answer: Whether the research will (if known) or might include whole genome sequencing of the biospecimen
The revised Common Rule added disclosure of the potential for whole genome sequencing of biospecimens as an additional consent element.
What is 'broad consent' as introduced in the 2018 revised Common Rule?
Answer: Consent for future unspecified use of identifiable private information or biospecimens
Broad consent allows institutions to obtain a single consent for future, yet-to-be-specified secondary research use of stored specimens or data.
Under the Common Rule, how long must researchers retain signed consent documents?
Answer: At least 3 years after completion of the research
45 CFR 46.115(b) requires IRBs to retain records, including consent documents, for at least three years after completion of the research.