Section 1: Principles of Research Ethics

1. Which of the following statements define the human research principle of respect for persons?
   a. The capacity and rights of all individuals to make their own decisions
   b. The respect for the autonomy of all human beings
   c. The recognition of the dignity and freedom of all persons
   d. The need to provide special protection to vulnerable persons
   e. All of the above

2. Which of the following statements define the human research principle of beneficence?
   a. Secure the participant's physical, mental and social well-being
   b. Reduce the participant's risks to a minimum
   c. Protection of the participant is more important than the pursuit of new knowledge
   d. Protection of the participant is more important than personal or professional research
            interest
   e. All of the above

3. Which of the following statements define the human research principle of justice?
   a. The selection of participants must be done in an equitable manner
   b. Using research participants for the exclusive benefit of more privileged groups is not 
            permitted
   c. Groups such as minors and pregnant women need special protection
   d. The poor and those with limited access to health care services need special protection
   e. All of the above

Section 2: Foundations of Research Ethics

4. According to the Nuremberg Code:
   a. Military doctors should never conduct medical research
   b. The voluntary consent of the human subject is absolutely essential
   c. Research must not be conducted in times of war
   d. Research should be regulated by an international agency
   e. All of the above

5. The Declaration of Helsinki was revised in 2000.  This revision prohibits the use of placebos:
   a. In psychiatric research where a washout period could prove harmful
   b. In less developed countries where participants cannot afford standard therapy
   c. In research with children
   d. In cases where proven prophylactic, diagnostic or therapeutic method exists
   e. All of the above

6. The Belmont Report, which sets forth the basic ethical principles that govern the conduct of 
    research involving human subjects, was developed in response to:
   a. Nazi experiments on prisoners in concentration camps
   b. Placebo-controlled AZT studies in Africa
   c. Research conducted on pregnant women
   d. The Tuskegee syphilis study
   e. The Common Rule

7. The Common Rule governs:
   a. Research funded by the U.S. government
   b. All research on new drugs
   c. All research conducted in the United States
   d. All of the above
   e. None of the above

8. Published in 1993, the CIOMS guidelines specifically address:
   a. Conflict of interest
   b. The accreditation of research centers
   c. International research
   d. The use of new designs in research
   e. Behavioral research

9. The goal of the International Conference on Harmonisation guidelines is to:
   a. Globally standardize the drug development and approval process
   b. Regulate ethics committees
   c. Encourage the use of pregnant women and children in research
   d. Set standards for non-biomedical research
   e. None of the above

10. ALL guidelines for research involving human subjects require:
   a. Elimination of placebo controls
   b. Benefits for all research participants
   c. Voluntary participation by subjects
   d. Publication of all study findings
   e. Research in animals before research in humans

Section 3: Responsible Conduct of Research

11. Which two of the following statements are essential elements of the definition of research?
   a. A systematic investigation
   b. A protocol approved by a scientific review group
   c. A confirmation of recently obtained new knowledge
   d. Develops or contributes to generalizable knowledge 
   e. Contributes to the advancement of science

12. Which three of the following statements are essential characteristics of informed consent?
   a. The participant has received the necessary information
   b. The provision of information has been made in the presence of a witness
   c. The participant has understood the information
   d. The participant arrived at a decision without undue influence or inducement
   e. The information has been presented in a written document.

13. The Common Rule identifies 8 essential elements of informed consent.  Which element in the 
      following list is not considered essential?
   a. Description of the research and expected participation.
   b. Description of risks.
   c. Description of other alternatives to participation.
   d. Explanation of compensation policy for possible injuries.
   e. Publication plans.
   f.  Explanation that research is voluntary.
   g. Confidentiality.
   h. Benefits
   i.  Contact information.

Section 4: Oversight of Research

18. To be effective, Ethics Committees require:
   a. Members who are unaffiliated with the institution
   b. Members who are qualified scientists
   c. That the institution designates adequate resources
   d. All of the above
   e. None of the above

19. It is important that Ethics Committees include:
   a. Members with relevant scientific expertise
   b. Representatives from the community
   c. Members with a diversity of age, gender and cultural background
   d. Both a and b
   e. All of the above

20. Ethics Committees should be notified of:
   a. Changes to the protocol or consent form
   b. Addition of new research implementation sites
   c. Changes in recruitment procedures
   d. Problems encountered that could impact participant safety
   e. All of the above

21. When reviewing a study, the Ethics Committee does not consider which of the following:
   a. Recruitment methods
   b. Informed consent process
   c. Risks to subjects
   d. Publication plans
   e. Confidentiality of research records

22. In addition to Ethics Committees, research may be monitored by:
   a. Contracted clinical research organizations.
   b. Authorized regulatory agencies.
   c. Sponsor of the study.
   d. All of the above.

Section 5: Special Issues

23. What is included in the definition of scientific misconduct:
   a. Fabrication, falsification, plagiarism or other practices that significantly deviate from 
            accepted standards
   b. Laboratory errors
   c. Differences in interpretation of results
   d. Unexpected results
   e. None of the above

24. Which of the following is not a potential contributor to conflict of interest:
   a. The institution
   b. Peer-reviewed journals
   c. Sponsors
   d. The researcher
   e. All of the above

25. Which three substantial contributions must be met for authorship?
   a. Funding of the project
   b. Conception and design, or analysis and interpretation of data
   c. Drafting or critically revising the article for important intellectual content
   d. Mentorship of young researchers conducting the study
   e. Final approval of the version to be published