1. IRB Review Mechanics: Looking under the hood IRB Administrators 2012 PRIDE Lucindia Shouse, MS, CIP May 31, 2012

2. 2 Road Map Question-and-Answer Session Traveling to and fro (basic, beyond and in between) Exploring the IRB Meeting Agenda Quorum Approval Criteria Minutes Communication

3. 3 IRB meetings are to occur at intervals appropriate for which of the following: 1.Quantity, complexity, and frequency of required actions 2.Adequate IRB oversight of the progress of approved research 3.Both of the above

4. 4 Scheduling Scheduled meetings of the IRB are to occur At intervals appropriate for the quantity, complexity, and frequency of required actions To permit adequate IRB oversight of the progress of research it has approved Other meetings may be scheduled as needed in accordance with facility SOPs VHA Handbook 1200.05, Paragraph 13.b

5. 5 Members attending in person must have received all relevant materials prior to the meeting and must be able to participate actively and equally in all discussions 1.True 2.False

6. 6 Agenda Materials All members including those participating by conference call or videoconference must have received all relevant materials VHA Handbook 1200.05, Paragraph 13.c.

7. 7 Discussion What about last minute agenda items? Best effort SharePoint Sufficient discussion by members attending Other Ideas?

8. 8 Quorum Majority of all voting members Not majority of voting members present Not majority of voting members present after members are recused Maintained throughout the meeting VHA Handbook 1200.05, Paragraph 13.jjj.

9. 9 A member has declared a conflict of interest. This member cannot: 1.Contribute to the quorum 2.Be present for the discussion 3.Be present for the vote 4.All of the above

10. 10 Conflict of Interest A member with a COI cannot Contribute to a quorum Be present for the discussion except to answer questions Be present for the vote This member must be recused VHA Handbook 1200.05, Paragraph 3.jjj.

11. 11 For the purposes of quorum, a VA representative must be present if an affiliate IRB or another VA facility’s IRB is an IRB of record 1.Yes 2.No

12. 12 VA Representative One of the officially-designated VA representatives must be present to constitute a quorum for the review of VA research VHA Handbook 1200.05, Paragraph 13.(2)

13. 13 VA IRBs must include a Veteran or Veteran representative 1.True 2.False

14. 14 Veteran Representative VA IRBs should make every effort to include a Veteran or Veteran representative as part of the fulfillment of the requirement of relevant diversity of experience and expertise Strongly encouraged, but not required VHA Handbook 1200.05, Paragraph 12.a.

15. 15 In a convened IRB meeting, consultants or ad hoc advisors may vote with the IRB 1.True 2.False

16. 16 Consultants A consultant or ad hoc advisor with expertise in special areas May be invited to assist in the review of issues which require expertise beyond, or in addition to, that available on the IRB May not vote with the IRB VHA Handbook 1200.05, Paragraph 12.i.

17. 17 The quorum is 11 and 11 voting members are present. A voting member leaves the meeting room. Issues requiring a vote may be discussed but no vote may be taken. 1.True 2.False

18. 18 Voting Member Quorum must be restored before any discussion of, or action on, issues requiring a vote may occur VHA Handbook 1200.05, Paragraph 13a.(1)

19. 19 The quorum is 11 and 12 voting members are attending. The non-scientist leaves the room. Is the quorum still maintained? 1.Yes 2.No

20. 20 Non-scientific Member For the quorum to be maintained at least one voting member, whose primary concerns are in non-scientific areas, must be present VHA Handbook 1200.05, Paragraph 13.a.

21. 21 Quorum Question The quorum is 8 and 11 voting members attend the meeting. For one vote: 3 are recused 8 are present The vote is 5 in favor, 3 opposed

22. 22 Does the motion carry? 1.Yes 2.No

23. 23 Quorum Question Quorum was maintained A majority of the voting members attending voted in favor

24. 24 Approval Criteria Must be met before IRB can grant approval (expedited review, convened initial review or continuing review) Must be met, when relevant, before IRB can grant approval of an amendment VHA Handbook 1200.05, Paragraph 17

25. 25 Approval Criteria Minimization of Risks Risks and Benefits Equitable Selection of Subjects Informed Consent Safety Monitoring VHA Handbook 1200.05, Paragraph 17

26. 26 Approval Criteria Privacy and Confidentiality Information Security Vulnerable Subjects Conflict of Interest Investigator Qualifications VHA Handbook 1200.05, Paragraph 17

27. 27 Approval Criteria HIPAA Authorization The IRB must determine the following are consistent with each other Protocol Informed consent HIPAA authorization VHA Handbook 1200.05, Paragraph 17

28. 28 Approval Criteria IRB Members and Staff need to know them Mechanisms Checklists Handouts Posters Other ideas?

29. 29 Final Meeting minutes must be available within three weeks of convened IRB meetings 1.True 2.False

30. 30 Minutes Draft minutes of IRB meetings must be written and available for review within 3 weeks of the meeting date VHA Handbook 1200.05, Paragraph 28

31. 31 Final IRB minutes cannot be altered 1.True 2.False

32. 32 Minutes Final minutes cannot be altered by anyone, including other authorities or committees However, corrections can be made and documented in subsequent meeting minutes VHA Handbook 1200.05, Paragraph 28

33. 33 Minutes must provide a summary of the discussion of controverted issues and their resolution 1.True 2.False

34. 34 Minutes Controverted issue Highly debated between IRB members Resolved by the IRB Must be documented in the minutes including Rationale or resolution VHA Handbook 1200.05, Paragraph 28.n.

35. 35 The IRB must determine that risks to human subjects are minimized. Which of the following are risks to subjects or others? 1.Physical 2.Legal 3.Social 4.Economic 5.Psychological 6.All of the above

36. 36 Risk Minutes must document Level of risk Rationale for determination of level of risk VHA Handbook 1200.05, Paragraph 28.j.

37. 37 Social Security Numbers Minutes must provide a summary of discussion when real SSNs, scrambled SSNs, or the last four digits of SSNs will be used Include security measures VHA Handbook 1200.05, Paragraph 28.q.

38. 38 Waiver of Informed Consent Minutes must document protocol-specific findings justifying determinations: Waiver or alteration of informed consent The minutes must specifically document that the IRB determined that all criteria for waiver or alteration of the informed consent process were met VHA Handbook 1200.05, Paragraph 28.g.

39. 39 Vulnerable Subjects The IRB must document Why individuals or populations are vulnerable That adequate safeguards are in place for those likely to be vulnerable including those who Are susceptible to coercion or undue influence Lack comprehension Have increased susceptibility to harm At risk for economic, social or legal consequences VHA Handbook 1200.05, Paragraph 45.b.

40. 40 A CRADO Waiver is required for research involving which of the following: 1.Children 2.Prisoners 3.Category D or X Drugs in Pregnant Women 4.All of above

41. 41 Vulnerable Subjects In addition to a CRADO waiver, the IRB minutes must document and justify protocol-specific findings for Children Prisoners Pregnant Women VHA Handbook 1200.05, Paragraphs 28.g.(2) and 46-48

42. 42 Vulnerable Subjects Persons who lack decision-making capacity Are not to be subjects in research simply because they are readily available VHA Handbook 1200.05, Paragraph 49

43. 43 Who has the responsibility to make sure the protocol and informed consent form address usual care? 1.IRB 2.Investigator 3.Neither of the above 4.Both of the above

44. 44 Usual Care The investigator is responsible for differentiating usual care from research The IRB must ensure usual care is clearly differentiated VHA Handbook 1200.05, Paragraphs 10.g. and 17.b.(1)

45. 45 The IRB is required to perform a scientific review 1.True 2.False

46. 46 Scientific Review The IRB is not required to perform a comprehensive scientific review The IRB is responsible for being sufficiently familiar with the science to perform its review Weighing potential risks and benefits VHA Handbook 1200.05, Paragraph 15.b.

47. 47 The investigator can start a study as soon as he receives IRB approval 1.True 2.False

48. 48 IRB Approval The research must not be initiated until the investigator has been notified in writing by the ACOS for R&D that all applicable approvals have been obtained and the study may be initiated VHA Handbook 1200.05, Paragraph 25.a.(2)

49. 49 The investigator may continue the study after receiving written approval from the IRB 1.True 2.False

50. 50 Continuing IRB Approval The IRB must notify the investigator, the R&D Committee, and the local research office of its determination to approve, disapprove or require changes The notification must be signed by the IRB Chair, another voting member of the IRB, or a member of the IRB staff VHA Handbook 1200.05, Paragraph 25.d

51. 51 There is a requirement for the IRB staff to send the investigator a copy of the IRB-approved informed consent form 1.True 2.False

52. 52 Informed Consent Form IRB correspondence must clearly indicate which version of the consent form has been approved IRB approval date must be documented on each page Use of a stamp Preprinted box VHA Handbook 1200.05, Paragraphs 25.b. and 33.b.

53. 53 IRB Approval Date Convened IRB Review The convened IRB approves a study contingent on minor modifications. The IRB Chair uses expedited review procedures to verify the minor conditions were met.

54. 54 The date of approval is the date the Chair verifies the minor conditions were met 1.True 2.False

55. 55 IRB Approval Date Convened Board Review The date of approval for purpose of determining the date of continuing review is the date the study was approved by the convened IRB contingent on minor conditions being addressed VHA Handbook 1200.05, Paragraph 24.a.(2)

56. 56 The date of continuing review is based on the date the IRB Chair, or experienced IRB member gives IRB approval 1.True 2.False

57. 57 IRB Approval Date Expedited Review The date of continuing review of the research study is based on the date the IRB Chair, or experienced IRB voting member(s), gives IRB approval to the research study VHA Handbook 1200.05, Paragraph 24.b.

58. 58 The IRB may only use expedited review for continuing review for research which was previously approved under the expedited review procedure? 1.True 2.False

59. 59 Expedited Continuing Review The IRB may use expedited review for continuing review in the following circumstances: Permanently closed to enrollment, all subjects have completed all research interventions, and all research remains active only for long term follow-up; or No subjects enrolled and no additional risks identified or Remaining research activities limited to data analysis VHA Handbook 1200.05, Paragraph 20

60. 60 A project has been reviewed and approved by another VA facility’s IRB. Your local IRB can perform expedited review since the project has already been approved by a VA IRB. 1.True 2.False

61. 61 Review by another IRB Whether a project can be reviewed using the expedited review procedures is dependent on the following: Research fits into a category eligible for expedited review and Research is found by the IRB reviewer(s) to involve no more than minimal risk VHA Handbook 1200.05, Paragraph 18.a.(1)

62. 62 The investigator can determine if a project qualifies for exemption 1.True 2.False

63. 63 Exemption The investigator must submit the proposed research study and request for exemption to the IRB The IRB chair, or an experienced IRB voting member designated by the Chair, must make the determination of whether or not to grant the Exemption VHA Handbook 1200.05, Paragraph 16.a.

64. 64 A facility’s IRB can require more frequent audits by the RCO 1.True 2.False

65. 65 RCO Audits The IRB may require More frequent audits More focused audits on one or more aspects Vulnerable populations Level of risk Issues of noncompliance VHA Handbook 1200.05, Paragraph 29

66. 66 All IRB records including protocol files and meeting minutes must be maintained for: 1.For 1 year 2.For 3 years 3.Per current FDA regulations 4.For the foreseeable future

67. 67 Records Retention Required records, including investigator research records must be retained until disposition instructions are Approved by the National Archives and Records Administration Published in VHA’s Records Control Schedule VHA Handbook 1200.05, Paragraph 26.h.

68. 68 Questions and Discussion

69. 69 References VHA Handbook 1200.05 “Requirements for the Protection of Human Subjects in Research” Published May 2, 2012 Common Rule 38 CFR 16

70. 70 Contact Information Lucindia Shouse, MS, CIP Program Analyst Dept of Veterans Administration Office of Research & Development/PRIDE Email: Lucindia.Shouse@va.gov