Ethical & Regulatory Compliance Flashcards

A researcher proposes a study involving deception where participants are not told the true purpose of the research. The IRB may approve this only if:

Answer: The study cannot be conducted without deception, the risks are minimal, and subjects are debriefed as soon as possible

Under 45 CFR 46.116(c), the IRB may waive or alter informed consent elements for deceptive research only if the study cannot practicably be conducted otherwise, risks are minimal, and subjects are debriefed after participation.

Which of the following scenarios represents a conflict of interest that an IRB member must disclose?

Answer: The IRB member holds stock in the company sponsoring the study under review

A financial relationship with the sponsor, such as holding company stock, creates a conflict of interest requiring disclosure and recusal from IRB deliberation and voting on that study.

The principle of 'respect for persons' in the Belmont Report encompasses which two moral requirements?

Answer: Autonomy of individuals and protection of those with diminished autonomy

Respect for Persons requires acknowledging individual autonomy and providing additional protections for those with diminished autonomy, forming the ethical basis for informed consent requirements.

A Certificate of Confidentiality (CoC) protects researchers from being compelled to disclose which type of information?

Answer: Identifiable, sensitive research data that could harm subjects if disclosed

A CoC, authorized under 42 USC 241(d), protects researchers from compelled disclosure of identifiable, sensitive research data through legal demands such as subpoenas or court orders.

When research involves greater than minimal risk to children but offers the prospect of direct benefit, the IRB must determine that:

Answer: The risk is justified by the anticipated benefit to the subjects and the relation of risk to benefit is at least as favorable as alternative approaches

Under 45 CFR 46.405 (Subpart D), research with greater than minimal risk that offers direct benefit to child subjects may be approved if the risk-benefit ratio is at least as favorable as available alternatives.

Which document formally defines an IRB's operating procedures, membership requirements, and review processes?

Answer: IRB Written Procedures and Standard Operating Procedures (SOPs)

Written procedures and SOPs document how the IRB operates, including membership composition, meeting quorum requirements, review categories, and reporting procedures, as required by 45 CFR 46.108(a).

In research, 'equipoise' refers to:

Answer: Genuine uncertainty in the scientific community about which treatment arm is superior

Clinical equipoise is the genuine uncertainty that exists in the expert medical community about the comparative merits of the treatments being tested, which ethically justifies randomization in clinical trials.