CCRC CCRC - Certified Clinical Research Coordinator Ethics and Compliance in Clinical Research Questions and Answers 3

Question 1

What is the significance of the Tuskegee Syphilis Study to modern US research ethics?

Accepted Answer

It exposed exploitation of a vulnerable population and directly prompted the National Research Act and Belmont Report

Answer

It led directly to the creation of the FDA

Answer

It was the first US clinical trial to use a placebo control

Answer

It established the requirement for IRB approval of all research

Question 2

Which of the following represents an example of undue inducement in clinical trial recruitment?

Accepted Answer

Offering compensation so large that it impairs participants' ability to assess risks objectively

Answer

Reimbursing participants for parking and travel expenses

Answer

Describing study procedures clearly in the consent form

Answer

Enrolling participants who are also the PI's patients

Question 3

What does the ethical principle of beneficence require of clinical researchers?

Accepted Answer

Maximizing potential benefits and minimizing potential harms to participants

Answer

Treating all participants equitably regardless of background

Answer

Respecting participants' right to withdraw at any time

Answer

Disclosing all financial conflicts of interest

Question 4

A coordinator is aware that the PI has not reported a protocol deviation to the IRB as required. What should the coordinator do?

Accepted Answer

Remind the PI of the reporting obligation and document the interaction

Answer

Do nothing, as reporting is solely the PI's responsibility

Answer

Report the deviation to the IRB directly without informing the PI

Answer

Notify the sponsor and close the study

Question 5

Which group is specifically designated as a 'vulnerable population' requiring additional protections under US federal regulations (45 CFR 46 Subparts B–D)?

Accepted Answer

Prisoners, pregnant women/fetuses, and children

Answer

Healthcare workers enrolled in occupational studies

Answer

Participants over age 65

Answer

Participants with private health insurance

Question 6

What is the primary ethical concern when enrolling patients who have a dependent relationship with the investigator (e.g., the PI's own patients)?

Accepted Answer

Potential undue influence that may compromise voluntary participation

Answer

Increased cost of the clinical trial

Answer

Lack of scientific validity of enrolled data

Answer

Violation of HIPAA authorization requirements