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

Full board review

Answer

Exempt review

Answer

Continuing review

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

Drug efficacy trial with healthy volunteers

Answer

Study collecting blood samples from pregnant women

Answer

Behavioral intervention study with prisoners

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

To approve new protocol amendments

Answer

To audit the site's financial disclosures

Answer

To review adverse event reports from other sites

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

Notify the sponsor only

Answer

Implement the change immediately and report it at the next continuing review

Answer

Inform participants verbally and document it in their records

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

Ensuring all participants provide written consent

Answer

Minimizing physical risks to participants

Answer

Protecting confidentiality of participant data

Question 6

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

Accepted Answer

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

Answer

Sponsor approval of the informed consent form

Answer

Participant payment above standard compensation rates

Answer

Publication of interim results in a peer-reviewed journal

Question 7

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?

Accepted Answer

45 CFR Part 46

Answer

21 CFR Part 11

Answer

21 CFR Part 312

Answer

45 CFR Part 164