Assignment:
True or False Questions
1. True or False? In a truly ethical study the benefits should outweigh the risks.
2. True or False? Nuremberg code of 1947 was established to protect the right and well being of human subjects in research.
3. True or False? Consent forms should be obtained from legal minors for participation inthe study.
4. True or False? Both assent and consent forms are needed from legal minors and their authorized personnel to participate in the study.
5. True or False? Pregnant women, human fetuses, neonates, prisoners, and children are considered as special need population.
Multiple Choice Questions
6. According to the Belmont Report, what are the basic ethical principles to consider when planning a research study?
A. Respect, beneficence, and justice
B. Respect and justice
C. Respect, beneficence, and incentives
7. Researcher wants to test the efficacy of drug "X" in children. This drug has not previously tested in animals or any in vivo or in vitro studies. What decision will IRB take in respect to this proposed study?
A. Approve
B. Reject
8. A research group is interested in studing the "psychological impacts of sexual abuse in young adults". They plan to conduct one-on-one interviews with individuals who have been sexually abused as children. The research group has put together an excellent application packet for IRB, however they have not included a consent form. The authors believe that they do not need to use consent forms for this study as most of the individuals are patients/ clients at their medical practice. In your understanding, does this proposed study need a consent form?
A. Yes
B. No
9. What are the 4 relevant criteria for IRB approval?
10. State and explain 4 essential elements of informed consent.
Short-Answer Questions
1. Explain why it is necessary to use survival analysis techniques to estimate a measure of association in a case-cohort study.
2. Discuss "built-in-bias" and explain how it affects the relationship between the odds ratio and the relative risk.
3. Define "attributable risk" and explain the interpretation of this measure of association.
4. Explain the "rarity assumption" and why it is necessary to estimate the relative risk in casecontrol studies.
5. Discuss one (analytical) advantage of using a case-cohort approach to measure an association.