Minnesota State University, Mankato

ETHN 101

5/6/15 2:13 PM

1)In conducting clinical research, which of the following is the MOST important factor to consider when using human research subjects?

1. 1. Avoiding any potential financial conflicts of interest
   2. Conducting a scientifically sound research trial
   3. Obtaining proper informed consent
   4. Ensuring publication of results regardless of outcomes

 

2. You are conducting a NIH clinical research trial. Which of the following outlines U.S. regulatory requirements for the protection of human subjects and vulnerable populations involved in federally funded research?
   1. U.S. Title 21 Part 11
   2. U.S. Title 21 Part 46
   3. U.S. Title 45 Part 46
   4. U.S. Title 45 Part 56

 

3. The Nuremberg Code is a direct result of which of the following?
   1. Tuskegee experiment
   2. Declaration of Helsinki
   3. German drug law
   4. Nazi war crimes

 

4. Which of the following groups developed and maintains the Declaration of Helsinki?
   1. World Medical Association (WMA)
   2. Food and Drug Administration (FDA)
   3. Office of Human Research Protection (OHRP)
   4. Department of Health and Human Services (HHS)

 

5. According to the Nuremberg Code, the Declaration of Helsinki, and GCP, human clinical experimentation should be conducted only by:
   1. physicians
   2. physicians and nurses
   3. scientifically qualified persons
   4. bioethicists

 

6. Which of the following does NOT describe the ethical obligations outlined in The Declaration of Helsinki for publishing clinical trial results?
   1. Authors are accountable for the completeness and accuracy of their reports
   2. All clinical research should be published regardless of the ethical conduct of the study
   3. Sources of funding should be declared in the publication
   4. Negative and inconclusive as well as positive results should be published or otherwise made publicly available

 

7. The Nuremberg Code and the Declaration of Helsinki outline the importance of voluntary consent of all human research subjects. Which of the following is NOT an acceptable practice for consenting human subjects?
   1. The subject should be made known the nature, duration, and purpose of the experiment
   2. No competent individual may be enrolled in a research study unless he or she freely agrees
   3. The researcher should be cautious if the potential subject is in a dependent relationship with the physician to avoid consent under duress
   4. The research subject cannot discontinue participation if they have signed the IRB-approved informed consent

 

8. What are the 3 basic ethical principles of The Belmont Report?
   1. Respect for Persons, Ethics, and Good Science
   2. Respect for Persons, Beneficence, and Justice
   3. Respect for Persons, Ethics, and Rights
   4. Respect for Persons, Beneficence, and Good Science

 

9. You are a pediatrician conducting a clinical trial in your office. Your first patient arrives and you evaluate him for eligibility in your clinical trial. Which of the following concerns will you need to consider?
   1. Is there sufficient time to review the proposed research with the subject and his parents?
   2. Who is the legally authorized representative for consent?

1. 3. Is assent of the patient required?
   4. All of the above

 

10. Which of the following types of research subjects would be considered a vulnerable population?
    1. Pregnant Women
    2. Prisoners
    3. Children
    4. All of the above

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

5/6/15 2:13 PM