OCC OCC Clinical Trials & Evidence-Based Practice 1 — Questions and Answers
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?
- Declaration of Helsinki
- Belmont Report (Correct answer)
- Nuremberg Code
- Common Rule (45 CFR 46)
Correct answer: Belmont Report
The Belmont Report (1979) established the foundational ethical principles of respect for persons, beneficence, and justice for all US federally funded human subjects research.
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?
- To determine the drug's effectiveness in treating the cancer
- To evaluate the drug's safety, tolerability, and maximum tolerated dose in humans (Correct answer)
- To compare the new drug with the current standard of care
- To confirm the drug's benefit in a large population
Correct answer: To evaluate the drug's safety, tolerability, and maximum tolerated dose in humans
Phase I trials primarily establish safety, tolerability, pharmacokinetics, and maximum tolerated dose in a small group of patients, not efficacy.
Question 3: Which element is REQUIRED for a patient to provide valid informed consent for clinical trial participation?
- Physician presence is required and the nurse cannot witness consent
- Voluntary participation, disclosure of all risks and benefits, and patient comprehension (Correct answer)
- Written consent obtained within 24 hours of enrollment
- Presence of a family member to co-sign the consent form
Correct answer: Voluntary participation, disclosure of all risks and benefits, and patient comprehension
Valid informed consent requires voluntary participation free from coercion, full disclosure of risks and benefits, and confirmation that the patient understands the information.
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?
- Tell the patient which arm they are in if they sincerely want to know
- Explain the concept of blinding and that this information is protected to maintain trial integrity (Correct answer)
- Unblind the patient only with physician approval
- Withdraw the patient from the trial if they continue to ask
Correct answer: Explain the concept of blinding and that this information is protected to maintain trial integrity
In blinded trials, the nurse must explain that blinding protects scientific integrity and that the information cannot be shared without compromising the trial's validity.
Question 5: A nurse notes an unexpected serious adverse event in a patient on a clinical trial. What is the MOST important immediate action?
- Report the adverse event to the IRB within 10 business days
- Document the event in the chart, report to the principal investigator immediately, and complete the adverse event report per protocol (Correct answer)
- Withdraw the patient from the study before reporting
- Report directly to the FDA without involving the PI
Correct answer: Document the event in the chart, report to the principal investigator immediately, and complete the adverse event report per protocol
Serious adverse events must be documented, immediately reported to the PI, and captured in the adverse event reporting system per the protocol's safety monitoring plan.
Question 6: A patient on a clinical trial wants to withdraw from the study. What does the nurse explain about their rights?
- The patient must complete the study since they signed the consent form
- The patient can withdraw at any time without penalty or loss of standard care benefits (Correct answer)
- Withdrawal requires a 30-day notice period per protocol
- Withdrawal is only permitted if the PI approves the reason
Correct answer: The patient can withdraw at any time without penalty or loss of standard care benefits
Patients have the right to withdraw from any clinical trial at any time without penalty, coercion, or loss of access to standard care, as guaranteed by federal research ethics regulations.
OCC OCC Clinical Trials & Evidence-Based Practice 1
Which document outlines the ethical principles for conducting research involving human subjects and forms the foundation of clinical trial ethics in the US?