CIP Ethical & Regulatory Compliance 2 — Questions and Answers
Question 1: Under 45 CFR 46, which of the following populations is considered a 'vulnerable population' requiring additional protections?
- Healthy adult volunteers
- Prisoners (Correct answer)
- Graduate students
- Hospital staff
Correct answer: Prisoners
Prisoners are explicitly identified in Subpart C of 45 CFR 46 as a vulnerable population requiring additional IRB protections due to potential coercion in the prison environment.
Question 2: The Nuremberg Code was primarily developed in response to which historical event?
- Tuskegee Syphilis Study
- Nazi medical experiments during World War II (Correct answer)
- Willowbrook hepatitis studies
- Guatemala syphilis inoculation experiments
Correct answer: Nazi medical experiments during World War II
The Nuremberg Code was established in 1947 following the Nuremberg Doctors' Trial, which prosecuted Nazi physicians who conducted unethical experiments on concentration camp prisoners.
Question 3: Which ethical principle from the Belmont Report requires that researchers distribute the burdens and benefits of research fairly across society?
- Respect for Persons
- Beneficence
- Justice (Correct answer)
- Non-maleficence
Correct answer: Justice
Justice requires equitable selection of research subjects so that no single group bears an unfair burden of research risks or is excluded from its benefits.
Question 4: An IRB may waive the requirement for written documentation of informed consent if which condition is met?
- The study involves more than minimal risk
- The signed consent form would be the only record linking the subject to the research (Correct answer)
- The research is federally funded
- The PI requests a waiver in writing
Correct answer: The signed consent form would be the only record linking the subject to the research
Under 45 CFR 46.117(c)(1), an IRB may waive written documentation if the consent document would be the only record linking the subject to the research and the principal risk is a breach of confidentiality.
Question 5: What is the primary purpose of a Data Safety Monitoring Board (DSMB) in clinical research?
- To approve the initial study protocol
- To monitor accumulating data and recommend stopping or modifying a trial if safety concerns arise (Correct answer)
- To audit financial compliance of the research study
- To review IRB applications for completeness
Correct answer: To monitor accumulating data and recommend stopping or modifying a trial if safety concerns arise
A DSMB periodically reviews accumulating safety and efficacy data during a trial and can recommend early termination if harm, clear benefit, or futility is identified.
Question 6: Which regulation specifically governs FDA-regulated research involving human subjects?
- 45 CFR 46
- 21 CFR Parts 50 and 56 (Correct answer)
- HIPAA Privacy Rule (45 CFR 164)
- ICH E6 GCP Guidelines
Correct answer: 21 CFR Parts 50 and 56
21 CFR Parts 50 (informed consent) and 56 (IRB regulations) govern FDA-regulated clinical investigations involving human subjects, including drug, device, and biologic studies.
Question 7: A researcher wants to use leftover biological specimens collected during routine clinical care for a new research study. Which of the following best describes when this would qualify for IRB exemption?
- The specimens were collected fewer than 5 years ago
- The specimens are not labeled with identifiers that could link them to subjects (Correct answer)
- The PI obtained verbal consent from all donors
- The specimens are stored at the research institution
Correct answer: The specimens are not labeled with identifiers that could link them to subjects
Under 45 CFR 46.104(d)(4), research involving existing specimens qualifies for exemption when sources cannot be identified by investigators directly or through coded identifiers.
CIP Ethical & Regulatory Compliance 2
Under 45 CFR 46, which of the following populations is considered a 'vulnerable population' requiring additional protections?