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  1. Protecting Human Research Participants.pdf




  2. Question 1

    10 Points
    The Tuskegee Syphilis Study, begun in 1932, led directly to the statement of explicit ethical principles in the Nuremberg Code of 1948 and the Declaration of Helsinki in 1964.

  3. Question 2

    10 Points
    The Nuremberg Code emphasized each of the following except:

  4. Question 3

    10 Points
    The declaration of Helsinki expanded on the Nuremberg Code by explicitly stating the duty of a physician/researcher to safeguard patients/research subjects, defining the elements of informed consent, and emphasizing proper research design that is ethical and results in an acceptable risk/benefit ratio

  5. Question 4

    10 Points
    The Belmont Report of 1078 first stated our current primary principles of medical and research ethics, which are:

  6. Question 5

    10 Points
    The researchers in charge of the Tuskegee Study had adequately covered 2 of the 3 ethics principles noted in the Belmont Report, but most of the ethical problems involved issues of autonony

  7. Question 6

    10 Points
    In addition to ensuring the subjects understands the normal elements of informed consent, the researcher has an ethical obligation to ensure that subjects have no misconceptions of the research (for instance, a belief that participation will cure them).

  8. Question 7

    10 Points
    The IRB is concerned with the protection of human subjects, defined as any individual, living or dead, about whom a researcher obtains data through medical intervention, medical records, or obtaining tissue or blood samples.

  9. Question 8

    10 Points
    The IRB requires that each of the human subjects in your study must be completely informed about the study and its procedures and risks, and the consent you obtain must be uncoerced.

  10. Question 9

    10 Points
    The Informed Consent Document should be written in lay terms at the level of a high school graduate

  11. Question 10

    10 Points
    If you provide payments to your subjects, they should be limited to compensation for time and effort and out-of-pocket expenses, so they are not so high they could be considered coercive

  12. Question 11

    10 Points
    An important element of the informed consent document is an explicit statement that participation in research is completely voluntary and that the subject will not be penalized if he or she decides not to participate or withdraws during the study.

  13. Question 12

    10 Points
    Only the principal investigator needs to have a copy of the informed consent document.

  14. Question 13

    10 Points
    Which of the following would likely be of little or no concern to an IRB?

  15. Question 14

    10 Points
    Which of the following is not a normal element of the IRB application that must be reviewed by the IRB?

  16. Question 15

    10 Points
    If you will be doing nothing more to your subjects than would be done in routine physical or psychological evaluations and presents no greater than normal risks of daily living, you should categorize your study as:

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