OCC OCC Clinical Trials & Evidence-Based Practice 1

Question 1

Which document outlines the ethical principles for conducting research involving human subjects and forms the foundation of clinical trial ethics in the US?

Accepted Answer

Belmont Report

Answer

Declaration of Helsinki

Answer

Nuremberg Code

Answer

Common Rule (45 CFR 46)

Question 2

A patient enrolled in a Phase I clinical trial asks the nurse what the primary goal of this phase is. What is the correct response?

Accepted Answer

To evaluate the drug's safety, tolerability, and maximum tolerated dose in humans

Answer

To determine the drug's effectiveness in treating the cancer

Answer

To compare the new drug with the current standard of care

Answer

To confirm the drug's benefit in a large population

Question 3

Which element is REQUIRED for a patient to provide valid informed consent for clinical trial participation?

Accepted Answer

Voluntary participation, disclosure of all risks and benefits, and patient comprehension

Answer

Physician presence is required and the nurse cannot witness consent

Answer

Written consent obtained within 24 hours of enrollment

Answer

Presence of a family member to co-sign the consent form

Question 4

What is the nurse's role when a patient enrolled in a blinded randomized controlled trial asks which treatment arm they are in?

Accepted Answer

Explain the concept of blinding and that this information is protected to maintain trial integrity

Answer

Tell the patient which arm they are in if they sincerely want to know

Answer

Unblind the patient only with physician approval

Answer

Withdraw the patient from the trial if they continue to ask

Question 5

A nurse notes an unexpected serious adverse event in a patient on a clinical trial. What is the MOST important immediate action?

Accepted Answer

Document the event in the chart, report to the principal investigator immediately, and complete the adverse event report per protocol

Answer

Report the adverse event to the IRB within 10 business days

Answer

Withdraw the patient from the study before reporting

Answer

Report directly to the FDA without involving the PI

Question 6

A patient on a clinical trial wants to withdraw from the study. What does the nurse explain about their rights?

Accepted Answer

The patient can withdraw at any time without penalty or loss of standard care benefits

Answer

The patient must complete the study since they signed the consent form

Answer

Withdrawal requires a 30-day notice period per protocol

Answer

Withdrawal is only permitted if the PI approves the reason