SOCRA Ethical Principles in Research 2

Question 1

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

Accepted Answer

Expedited review

Answer

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

Question 2

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

Accepted Answer

Survey research involving anonymous adult participants on non-sensitive topics

Answer

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

Question 3

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

Accepted Answer

To ensure ongoing research remains ethically acceptable and compliant

Answer

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

Question 4

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

Accepted Answer

Obtain IRB approval of the amendment, then implement

Answer

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

Question 5

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

Accepted Answer

Distributing research burdens and benefits equitably across populations

Answer

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

(SOCRA) Society of Clinical Research Associates Practice Test