Ethical Principles in Research Flashcards

Which type of IRB review is appropriate for research involving no more than minimal risk that fits specific federally defined categories?

Answer: Expedited review

Expedited review is used for research posing no more than minimal risk that falls within one of the nine federally designated categories.

Under 45 CFR 46, which of the following research activities is most likely to qualify for exemption from IRB review?

Answer: Survey research involving anonymous adult participants on non-sensitive topics

Anonymous survey research with adults on non-sensitive topics typically qualifies for exemption under 45 CFR 46.104.

What is the primary purpose of continuing review by an IRB?

Answer: To ensure ongoing research remains ethically acceptable and compliant

Continuing review allows the IRB to periodically reassess whether ongoing research still meets ethical and regulatory standards.

A researcher modifies the study protocol to add a new data collection questionnaire. What must occur before implementing this change?

Answer: Obtain IRB approval of the amendment, then implement

Protocol amendments must be reviewed and approved by the IRB before implementation, except when necessary to eliminate immediate hazard.

The concept of 'justice' in the Belmont Report is best demonstrated by which research practice?

Answer: Distributing research burdens and benefits equitably across populations

Justice requires that the selection of research subjects be fair and that vulnerable groups are not exploited or unfairly burdened.

An IRB determines that a study poses greater than minimal risk to participants. Which additional safeguard is MOST likely required?

Answer: A data safety monitoring board (DSMB) or independent safety monitoring

Greater-than-minimal-risk studies often require an independent safety monitoring committee to protect participant welfare during the trial.

Which federal regulation primarily governs the protection of human subjects in research conducted or supported by the U.S. Department of Health and Human Services?

Answer: 45 CFR Part 46

45 CFR Part 46, also known as the Common Rule, is the primary federal regulation protecting human research subjects under HHS.