Regulatory Compliance & Ethical Standards Flashcards

An IRB operates under an FDA-approved assurance. What does the IRB's continuing review obligation require?

Answer: Review of ongoing studies at intervals appropriate to the degree of risk, but at least annually

Under 21 CFR 56.109, IRBs must conduct continuing review of approved research at intervals appropriate to risk, but no less than once per year.

A study participant withdraws consent and requests that their already-collected biological samples be destroyed. Under GDPR (applicable to EU sites) and US common law, what is the investigator's obligation?

Answer: The obligation depends on applicable regulations, the consent form terms, and whether data have already been irreversibly anonymized or included in regulatory submissions

The obligation to destroy samples is complex and depends on whether data are identifiable, the original consent terms, applicable law (including GDPR Article 17), and whether data are part of regulatory submissions that cannot be altered.

Under 21 CFR Part 56, which of the following circumstances allows an IRB to conduct expedited review rather than full board review?

Answer: Research involving no more than minimal risk and falling within FDA-designated categories of research

Expedited review is permitted for minimal-risk research that falls within FDA-published categories or for minor changes to previously approved research.

A physician investigator has a financial stake in the company sponsoring the trial they are conducting. Which regulatory framework primarily governs this situation?

Answer: 21 CFR Part 54 — Financial Disclosure by Clinical Investigators

21 CFR Part 54 requires investigators to disclose significant financial interests to sponsors, who must then include this information in marketing application submissions to FDA.

According to ICH E6(R2), an investigator brochure (IB) MUST be updated when which condition occurs?

Answer: Significant new information that may affect subject safety, conduct of the trial, or alter the IRB's approval decision becomes available

The IB must be updated whenever significant new information emerges that could affect subject safety or the conduct of the trial, typically at least annually.

Which of the following BEST describes the concept of 'therapeutic misconception' in clinical research ethics?

Answer: A participant's false belief that research procedures are designed primarily for their individual therapeutic benefit rather than to generate generalizable knowledge

Therapeutic misconception occurs when participants conflate clinical research with clinical care and believe research interventions are personalized to their medical benefit.

Under 21 CFR 312.62, how long must investigators retain study records after the investigation is discontinued or completed, or FDA notifies the investigator the IND application is no longer in effect?

Answer: 2 years

21 CFR 312.62 requires investigators to retain study records for 2 years after the investigation is discontinued or completed, or after FDA notice that the IND is no longer in effect.