CIP Ethical & Regulatory Compliance 2

Question 1

Under 45 CFR 46, which of the following populations is considered a 'vulnerable population' requiring additional protections?

Accepted Answer

Prisoners

Answer

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?

Accepted Answer

Nazi medical experiments during World War II

Answer

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?

Accepted Answer

Justice

Answer

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?

Accepted Answer

The signed consent form would be the only record linking the subject to the research

Answer

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?

Accepted Answer

To monitor accumulating data and recommend stopping or modifying a trial if safety concerns arise

Answer

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.

(CIP) Certified Institutional Review Board Professional Practice Test

(CIP) Certified Institutional Review Board Professional Practice Test

CIP Ethical & Regulatory Compliance 2