CIP Ethical & Regulatory Compliance 3

Question 1

Under the Common Rule, continuing review by the IRB is required at intervals appropriate to the degree of risk, but no less than:

Accepted Answer

Every 12 months

Answer

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.

Question 2

Which of the following best defines 'minimal risk' as used in federal research regulations?

Accepted Answer

The probability and magnitude of harm anticipated are not greater than those ordinarily encountered in daily life

Answer

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.

Question 3

In the context of IRB review, 'assent' differs from 'consent' in that assent:

Accepted Answer

Is the agreement of a minor or cognitively impaired individual who cannot legally consent

Answer

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.

Question 4

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?

Accepted Answer

Report the SAE promptly to the IRB, sponsor, and applicable regulatory authorities per protocol requirements

Answer

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.

Question 5

Which of the following IRB review categories allows for approval by one or more experienced IRB members rather than requiring full board review?

Accepted Answer

Expedited review

Answer

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.

(CIP) Certified Institutional Review Board Professional Practice Test

(CIP) Certified Institutional Review Board Professional Practice Test

CIP Ethical & Regulatory Compliance 3