3. Jeopardy Rules Game show host will divide the room into two teams When you know the answer, raise your hand and wait to be called on Your answer must be in the form of a question You may refer to handouts or notes Once you have answered one question, you may not answer another (whether or not your answer was correct) Scorekeeping –Correct answers are added to your team’s score. –Incorrect answers are subtracted from your team’s score If you answer correctly you choose the next category, but if you answer incorrectly the other team chooses the next category A correct answer for Double Jeopardy doubles the dollar value

4. Do The Right Thing Guess Who?I Do, I Do, I Do Tick Tock, Tick Tock Step 1,2,3 5 pts 10 pts 15 pts 20 pts 25 pts

5. Equal distribution of burdens and benefits

6. What is justice?

7. Treating individuals as autonomous agents

8. What is respect for persons?

9. Providing psychiatric research subjects with tokens

10. What is undue influence?

11. Ensuring risks to subjects are reasonable in relation to anticipated benefits

12. What is one of the IRB approval criteria?

13. Time frame required for reporting an unanticipated serious adverse event to the IRB

14. What is 5 business days?

15. Children, prisoners, psychiatric patients

16. Who are vulnerable populations?

17. PIs often receive multiple rounds of comments from this type of reviewer

18. Who is the nitpicker?

19. This facility official may NOT serve as a voting or non-voting member of research oversight committees, but may serve as a non-voting consultant to research oversight committees, and may attend meetings of these committees when requested by the committee or as described in local committee SOPs?

20. Who is the RCO?

21. This individual should be brought in if your IRB doesn’t have expertise in a particular area

22. Who is a consultant/ adhoc reviewer?

23. External agencies that require reporting of serious or continuing noncompliance for Investigational drug/device studies

24. Who are the FDA and OHRP?

25. Its IRB does not have to approve the research

26. What is an institution that is not engaged in human research?

27. An institution whose employees or agents obtain informed consent from subjects

28. What is an institution that is engaged in human research?

29. It holds an FWA, has a local PI, and its IRB of record has approved the project?

30. What is an institution that is engaged in human research?

31. Individuals who act on behalf of an institution, exercise institutional authority or responsibility, and/or perform institutionally designated activities

32. Who are an institution’s employees or agents?

33. Guidance followed by VA on whether or not a local VA facility is engaged in human research

34. What is OHRP guidance on engagement of institutions in human subjects research?

35. Documents that must be available within 3 weeks of convened IRB meetings

36. What are draft IRB minutes?

37. These can never be altered

38. What are final IRB minutes?

39. An IRB member must be _______ when she/he has a conflict of interest and cannot vote or be counted toward the quorum.

40. What is recused?

41. This is an issue that is highly debated among IRB members, resolved by the IRB, and documented in the minutes

42. What is a controverted issue?

43. These are included in the study when some or all of the subjects are likely to be vulnerable to coercion or undue influence

44. What are additional safeguards?

45. A project that is planned in advance and that uses data collection and analysis to answer a question

46. What is a systematic investigation?

47. A living individual about whom an investigator conducting research obtains identifiable private information

48. What is a human subject?

49. Expands the knowledge base of a scientific discipline or other scholarly field of study.

50. What is Generalizable Knowledge?

51. The probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological tests

52. What is minimal risk?

53. Is it research, is it human subjects research, is it exempt, can it be expedited

54. What is the proper sequence when determining the correct IRB review requirements?