ELKA EXAM (50 QUESTIONS )
1. A research hypothesis states what the researcher expects to find - it is the tentative answer to the research question that guides the entire study. A. True
B. False - Answer- A. True
2. Elements of a clinical research protocol include all but which of the following?
A. Study Rationale
B. Research Objectives
C. Study Design Description
D. Selection and Withdrawal of Subjects E. Requirements and Ethical Approval and Oversight
F. Statistical Analysis Description - Answer- E. Requirements and Ethical Approval and Oversight
3. A planned measurement described in the protocol that is used to determine the effect
of an intervention/treatment on participants is called what? A. An outcome measure
B. A primary objective
C. A hypothesis D. None of the above - Answer- A. An outcome measure
4. When critically analyzing study results, the reader may find flaws or limitations in which of the following areas?
A. Limitations due to the sample size of the population B. Lack of objectivity or presence of bias in the design of the study or interpretation of the results C. Methodological issues in terms of the study design
D. Lack of generalizability of applicability of results E. All of the above
F. A and B only - Answer- E. All of the above
5. One benefit of transparent reporting of trial results is that it enables the reader to judge the reliability of validity of trial results. A. True B. False - Answer- A. True
6. One important distinction between standard of care medical treatment and clinical research is that the intent of medical treatment is to address the needs of an individual parent in the here and now, whereas clinical research is intended to answer questions about whether a treatment or procedure could benefit large groups of people in the future?
A. True
B. False - Answer- A. True
7. Deviations from standard medical practice are considered research. A. True
B. False - Answer- B. False
8. When a potential subject confuses the research study for a proven treatment, that is known as what?
A. Therapeutic Misconception B. Clinical Equipoise
C. The Participant's Dilemma
D. Uncertainty Principle - Answer- A. Therapeutic Misconception
9. Clinical equipoise is considered to be a necessary feature of ethical enrollment of participants into a clinical trial. A. True
B. False - Answer- A. True
Clinical equipoise: the assumption that there is not one "better" intervention present; the
equality regarding probability of benefit that must exist between two or more groups being compared in a study.
10. All of the following are elements or principles of human subject protection EXCEPT: A. Voluntary informed consent B. Respect for persons: Treated as autonomous agents C. The right to end participation in research any time D. Right to safeguard integrity
E. Benefits should outweigh risk
F. Protection from physical, mental, and emotional harm
G. The primary care physician can overrule the subject's decision to participate in a trial H. Access to information regarding research I. Protection of privacy and well-being - Answer- G. The primary care physician can overrule the subject's decision to participate in a trial.
11. Which of the following is an influential document that led the evolution of informed consent practices?
A. The Nuremberg Code
1. A research hypothesis states what the researcher expects to find - it is the tentative answer to the research question that guides the entire study. A. True
B. False - Answer- A. True
2. Elements of a clinical research protocol include all but which of the following?
A. Study Rationale
B. Research Objectives
C. Study Design Description
D. Selection and Withdrawal of Subjects E. Requirements and Ethical Approval and Oversight
F. Statistical Analysis Description - Answer- E. Requirements and Ethical Approval and Oversight
3. A planned measurement described in the protocol that is used to determine the effect
of an intervention/treatment on participants is called what? A. An outcome measure
B. A primary objective
C. A hypothesis D. None of the above - Answer- A. An outcome measure
4. When critically analyzing study results, the reader may find flaws or limitations in which of the following areas?
A. Limitations due to the sample size of the population B. Lack of objectivity or presence of bias in the design of the study or interpretation of the results C. Methodological issues in terms of the study design
D. Lack of generalizability of applicability of results E. All of the above
F. A and B only - Answer- E. All of the above
5. One benefit of transparent reporting of trial results is that it enables the reader to judge the reliability of validity of trial results. A. True B. False - Answer- A. True
6. One important distinction between standard of care medical treatment and clinical research is that the intent of medical treatment is to address the needs of an individual parent in the here and now, whereas clinical research is intended to answer questions about whether a treatment or procedure could benefit large groups of people in the future?
A. True
B. False - Answer- A. True
7. Deviations from standard medical practice are considered research. A. True
B. False - Answer- B. False
8. When a potential subject confuses the research study for a proven treatment, that is known as what?
A. Therapeutic Misconception B. Clinical Equipoise
C. The Participant's Dilemma
D. Uncertainty Principle - Answer- A. Therapeutic Misconception
9. Clinical equipoise is considered to be a necessary feature of ethical enrollment of participants into a clinical trial. A. True
B. False - Answer- A. True
Clinical equipoise: the assumption that there is not one "better" intervention present; the
equality regarding probability of benefit that must exist between two or more groups being compared in a study.
10. All of the following are elements or principles of human subject protection EXCEPT: A. Voluntary informed consent B. Respect for persons: Treated as autonomous agents C. The right to end participation in research any time D. Right to safeguard integrity
E. Benefits should outweigh risk
F. Protection from physical, mental, and emotional harm
G. The primary care physician can overrule the subject's decision to participate in a trial H. Access to information regarding research I. Protection of privacy and well-being - Answer- G. The primary care physician can overrule the subject's decision to participate in a trial.
11. Which of the following is an influential document that led the evolution of informed consent practices?
A. The Nuremberg Code
