Ethical & Regulatory Compliance 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 Ethical & Regulatory Compliance flashcards as text
Under the Common Rule, continuing review by the IRB is required at intervals appropriate to the degree of risk, but no less than:
Answer: Every 12 months
45 CFR 46.109(e) requires that IRBs conduct continuing review at intervals appropriate to the degree of risk, but not less than once per year.
Which of the following best defines 'minimal risk' as used in federal research regulations?
Answer: The probability and magnitude of harm anticipated are not greater than those ordinarily encountered in daily life
45 CFR 46.102(j) defines minimal risk as the probability and magnitude of harm or discomfort anticipated in the research not being greater than those ordinarily encountered in daily life or routine physical/psychological examinations.
In the context of IRB review, 'assent' differs from 'consent' in that assent:
Answer: Is the agreement of a minor or cognitively impaired individual who cannot legally consent
Assent is the affirmative agreement of a minor or cognitively impaired individual to participate, while legal informed consent must still be obtained from a legally authorized representative.
A researcher discovers that a participant has experienced an unexpected serious adverse event (SAE) possibly related to the study intervention. What is the researcher's primary obligation?
Answer: Report the SAE promptly to the IRB, sponsor, and applicable regulatory authorities per protocol requirements
Unanticipated problems involving risks to subjects or others must be reported promptly to the IRB, and SAEs must also be reported to the sponsor and relevant regulatory bodies per applicable regulations.
Which of the following IRB review categories allows for approval by one or more experienced IRB members rather than requiring full board review?
Answer: Expedited review
Expedited review under 45 CFR 46.110 allows a single experienced IRB member or small subset of the board to review and approve studies that present no more than minimal risk and fit listed categories.
The concept of 'therapeutic misconception' in research ethics refers to:
Answer: Participants mistakenly believing that research procedures are designed to benefit them personally rather than generate generalizable knowledge
Therapeutic misconception occurs when research participants confuse the purpose of research (generating knowledge) with individual medical care, which can impair true informed consent.
Under HIPAA, which of the following is NOT considered Protected Health Information (PHI)?
Answer: De-identified health information that meets Safe Harbor or Expert Determination standards
Information that has been de-identified using either the Safe Harbor method (removing 18 identifiers) or Expert Determination method is no longer PHI and is not subject to HIPAA Privacy Rule protections.