SOCRA Ethical Principles in Research 2 — Questions and Answers
Question 1: Which type of IRB review is appropriate for research involving no more than minimal risk that fits specific federally defined categories?
- Full board review
- Expedited review (Correct answer)
- Exempt review
- Continuing review
Correct 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.
Question 2: Under 45 CFR 46, which of the following research activities is most likely to qualify for exemption from IRB review?
- Drug efficacy trial with healthy volunteers
- Survey research involving anonymous adult participants on non-sensitive topics (Correct answer)
- Study collecting blood samples from pregnant women
- Behavioral intervention study with prisoners
Correct 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.
Question 3: What is the primary purpose of continuing review by an IRB?
- To approve new protocol amendments
- To ensure ongoing research remains ethically acceptable and compliant (Correct answer)
- To audit the site's financial disclosures
- To review adverse event reports from other sites
Correct 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.
Question 4: A researcher modifies the study protocol to add a new data collection questionnaire. What must occur before implementing this change?
- Notify the sponsor only
- Obtain IRB approval of the amendment, then implement (Correct answer)
- Implement the change immediately and report it at the next continuing review
- Inform participants verbally and document it in their records
Correct 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.
Question 5: The concept of 'justice' in the Belmont Report is best demonstrated by which research practice?
- Ensuring all participants provide written consent
- Distributing research burdens and benefits equitably across populations (Correct answer)
- Minimizing physical risks to participants
- Protecting confidentiality of participant data
Correct 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.
Question 6: An IRB determines that a study poses greater than minimal risk to participants. Which additional safeguard is MOST likely required?
- Sponsor approval of the informed consent form
- A data safety monitoring board (DSMB) or independent safety monitoring (Correct answer)
- Participant payment above standard compensation rates
- Publication of interim results in a peer-reviewed journal
Correct 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.
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?
- 21 CFR Part 11
- 45 CFR Part 46 (Correct answer)
- 21 CFR Part 312
- 45 CFR Part 164
Correct 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.
SOCRA Ethical Principles in Research 2
Which type of IRB review is appropriate for research involving no more than minimal risk that fits specific federally defined categories?