IRB Administration & Management Flashcards
7 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 7 IRB Administration & Management flashcards as text
An IRB receives a report that a PI conducted research activities before receiving IRB approval. Under most institutional policies, the most appropriate first response is to:
Answer: Halt the unapproved research activities and conduct a protocol deviation review
Research conducted without IRB approval must be stopped and reviewed as a serious protocol deviation, regardless of perceived minimal risk, because prospective review is a regulatory requirement.
Under the 2018 revised Common Rule, broad consent may be obtained for the storage, maintenance, and secondary research use of identifiable private information. Which statement about broad consent is accurate?
Answer: Broad consent must include a description of the types of research that may be conducted
Broad consent under 45 CFR 46.116(d) must describe the types of research, including foreseeable uses, for which identifiable information may be used in the future.
A researcher proposes to use existing de-identified biospecimens from a biobank. Under the 2018 Common Rule, this research:
Answer: Is not research involving human subjects if the specimens cannot be re-identified
Under the 2018 Common Rule, research using de-identified biospecimens that cannot be linked to individuals does not meet the definition of 'research involving human subjects.'
Which scenario requires submission of a continuing review report to the IRB for studies approved under the 2018 Common Rule?
Answer: A study involving greater than minimal risk that has not yet closed to enrollment
Under the 2018 Common Rule, continuing review is no longer required for most minimal-risk studies, but remains required for studies that have not yet closed to enrollment and involve greater than minimal risk.
An IRB administrator is training a new IRB member. Which statement about the role of the primary reviewer in a full-board meeting is CORRECT?
Answer: The primary reviewer presents the protocol to the board but all members vote equally
The primary reviewer leads the discussion and presents the protocol summary, but all board members deliberate and vote with equal weight.
A pregnant researcher wants to enroll herself in a minimal-risk survey study at her own institution. This situation primarily raises concerns about:
Answer: Undue influence and voluntariness of consent given the dual role
When a researcher enrolls themselves in their own study, voluntariness of consent is compromised by the dual role, making this the primary IRB concern.
An IRB is reviewing a study that will compensate participants $500 for a single blood draw. The IRB's primary concern regarding compensation should be:
Answer: Whether the payment amount constitutes undue inducement that compromises voluntary participation
The IRB must evaluate whether compensation is so high that it constitutes undue inducement, impairing participants' ability to make a voluntary, rational decision about enrollment.