Safety and Compliance Flashcards

Which regulation gives an IRB authority to suspend or terminate approval of research that is not being conducted per IRB requirements or that has caused unexpected serious harm?

Answer: 45 CFR 46.113

45 CFR 46.113 authorizes IRBs to suspend or terminate approval and requires a statement of reasons to be reported.

An investigator deviates from the approved protocol to remove an apparent immediate hazard to a participant without prior IRB approval. This is:

Answer: Permitted, but the change must be promptly reported to the IRB

Changes may be made without prior IRB approval only when necessary to eliminate apparent immediate hazards, and must be promptly reported.

A pattern of repeated failures to follow regulations or IRB determinations, suggesting future noncompliance is likely without intervention, is best described as:

Answer: Continuing noncompliance

Continuing noncompliance refers to a repeated pattern that must be reported to institutional officials and OHRP.

A study's IRB approval lapsed last week, but the coordinator continued enrolling new participants. What is the correct characterization?

Answer: Noncompliance; new enrollment must stop until approval is restored

No research activities, including enrollment, may continue after approval expires unless the IRB finds it in the best interest of already-enrolled subjects.

When an IRB suspends or terminates approval, the regulations require that the action:

Answer: Include a statement of reasons and be promptly reported to the investigator, institutional officials, and the agency head

45 CFR 46.113 requires a statement of the reasons and prompt reporting to the investigator, institution, and federal agency.

Following an FDA inspection of a clinical investigator site, inspectional observations of possible violations are documented on which form?

Answer: Form 483

FDA Form 483 lists inspectional observations presented to site management at the close of an inspection.

Which situation would most likely be classified as serious noncompliance?

Answer: Conducting nonexempt human subjects research without obtaining IRB approval

Conducting nonexempt research without IRB approval bypasses a core protection and is a classic example of serious noncompliance.