Click on the dot next to the best answer for each question.

1. Autonomy means that participants should be protected from harm.
      True
      False

2. It should be clearly stated if there are no benefits to a study.
      True
      False

3. Adverse events should be reported to the IRB
      immediately.
      within one week.
      within 2 weeks.
      within one month.

4. Justice requires equality in the selection of participants.
      True
      False

5. A participant who is not of legal age can consent to be in a study.
      True
      False

6. The purpose of continuing review is to determine if the risks and benefits:
      are understood by the participants.
      are accurately outlined in the current consent document.
      are permissible to the participants.
      reflect the experience of the subjects.

7. When listing risks, you do not need to list "soft" risks such as embarrassment.
      True
      False

8. Beneficence means that each person has the right to decide not to be in a study.
      True
      False

9. The consent document should be presented to the participant when it is most convenient for the investigators.
      True
      False

10. You will know the terms of continued review when you receive approval from the IRB.
      True
      False

11. A consent document should generally be written to a/an ________ grade reading level.
      third
      fifth
      eighth
      tenth

12. Risks and benefits are better understood by the researcher after the research has begun.
      True
      False

13. The participant can __________ withdraw from the study without penalty.
      never
      occasionally
      usually
      always

14. The University of MN IRB reviews only federally funded research.
      True
      False

15. ____________ is/are not important factor(s) when asking and answering questions.
      Open-ended questions
      Patience and encouragement
      Directive questions
      Preparation

16. No further review is required once the IRB has reviewed a project.
      True
      False

17. A renewal form must be completed annually.
      True
      False

18. The ________________ relationship is not a potentially troublesome one during participant selection.
      doctor/patient
      teacher/student
      parent/child
      employer/employee

19. Changes made in everything except _____________ must be approved by the IRB.
      subject population
      research procedures
      research personnel
      participant's address

20. Researchers with financial interests in the research must inform their participants.
      True
      False

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