1. Engagement in Human Research & Multi-Site Studies K. Lynn Cates, M.D. Assistant Chief Research & Development Officer Director, PRIDE May 30, 2012

2. 2 Overview Why is it important to know whether or not a facility is engaged in the conduct of human research? How do you determine whether or not a site is engaged? How do you determine which IRB(s) should review a given study?

3. 3 Engagement VHA Handbook 1200.05, Paragraphs 50-51 VA follows guidance from the Office for Human Research Protections (OHRP), October 16, 2008 http://www.dhhs.gov/ohrp/policy/engage08.html http://www.dhhs.gov/ohrp/policy/engage08.html

4. 4 Multi-Site Studies* Studies with more than one site engaged in research involving human subjects *VHA Handbook 1200.05, Paragraph 52

5. 5 Engaged in Human Subjects Research If a VA facility is engaged in human subjects research it must Hold a Federalwide Assurance (FWA) Have a local VA PI or Local Site Investigator (LSI) for that study Have its IRB of record approve the study

6. 6 Not Engaged in Human Subjects Research* If a VA facility is not engaged in any human research then It does not need to have an FWA It does not need to have an IRB It does not need to have a local investigator It has no jurisdiction over any human research *VHA Handbook 1200.05, Paragraph 51

7. 7 Not Engaged in Human Subjects Research* A VA facility may have an FWA & an IRB of record, but not be engaged in a given study. If it is not engaged for the purposes of that study It has no jurisdiction over the study Except the facility Director may determine that the study cannot be conducted on its premises Its IRB of record does not need to approve the study *VHA Handbook 1200.05, Paragraph 51

8. 8 Engagement Employees & Agents Individuals who Act on behalf of the institution Exercise institutional authority or responsibility Perform institutionally designated activities (whether or not they receive compensation) May be Staff Students Contractors Volunteers

9. 9 Engaged in Human Subjects Research* In general, a VA facility is engaged when someone with a VA appointment obtains for the purposes of the research study Data about the subjects of the research through intervention or interaction with them Identifiable private information about the subjects of the research The informed consent of human subjects for the research *VHA Handbook 1200.05, Paragraph 50

10. 10 Engaged in Human Research How do you make a determination as to whether or not a facility is engaged in human research?

11. 11 Engaged in Human Subjects Research The facility is engaged if It receives an award through a grant, contract, or cooperative agreement for human subjects research even if all activities involving human subjects are carried out elsewhere (e.g., if the grant comes to the nonprofit)

12. 12 Engaged in Human Subjects Research The facility is engaged if Its employees or agents intervene for research purposes with any human subjects by performing invasive or noninvasive procedures such as Drawing blood Providing counseling Giving drugs or treatments

13. 13 Engaged in Human Subjects Research The facility is engaged if Its employees or agents intervene with any human subject by manipulating the environment for research purposes Controlling light, sound, temperature Orchestrating social interactions

14. 14 Engaged in Human Subjects Research The facility is engaged if Its employees or agents interact with any human subject for research purposes Protocol-dictated communication or interpersonal contact Asking someone to provide a specimen (e.g., urine) Conducting interviews Administering questionnaires

15. 15 Engaged in Human Subjects Research The facility is engaged if Its employees or agents obtain informed consent Its employees or agents obtain identifiable private information or identifiable biological specimens from any source for the research Even if the institutions employees or agents do not directly interact or intervene with the subjects, for example when they Observe or record private behavior Use, study, or analyze identifiable private information provided by another institution or already in possession of investigators

16. 16 Not Engaged in Human Subjects Research* If an employee or agent of a non-engaged facility provides identifiable private information or specimens, someone at the non-engaged facility should verify The subjects have provided informed consent & HIPAA authorization, or The responsible IRB (i.e., for the IRB for the engaged site) has approved a waiver of informed consent & a waiver of HIPAA authorization The facility Director may determine that a study cannot be conducted on its premises *VHA Handbook 1200.05, Paragraph 51

17. 17 Engagement Dual Appointment Investigators How can you determine if the VA is engaged? Is engaged if he/she uses VA resources (e.g., works on her VA time, uses VA space or equipment) Is not engaged if he/she does not use VA resources (e.g., works on her university time, in her university office & lab, using her university computer & university research team)

18. 18 Determining Who is Engaged & Which IRB(s) Review Studies Who is the sponsor? (e.g., ORD* or not) Where are PI(s) & other research staff appointments? What sites will be participating? Who obtains informed consent? Who interacts/intervenes? Who provides private identifiable information? Who obtains private identifiable information? Who uses, studies, or analyzes private identifiable information? *ORD sponsored multi-site studies go to VA Central IRB

19. 19 Case Studies

20. 20 Cases – Potential Research Studies Case 1 Who is the sponsor? Where is the PI(s) & other research staff? What sites will be participating? Who obtains informed consent? Who interacts/intervenes? Who provides private identifiable information? Who obtains private identifiable information? Who uses, studies, or analyzes private identifiable information? ORD Rehabilitation R&D VA 1 VA 1-6 VA 1 VA 1-6 VA 1

21. 21 Case 1, Question 1- Which sites are engaged? 1.VA 1 2.VA 1-6 3.VA Central IRB

22. 22 Case 1, Question 2 - Which sites need FWAs and IRBs? 1.VA 1 2.VA 1-6 3.VA Central IRB

23. 23 Case 1, Question 3 - Which IRB(s) Review? 23 1.VA 1 2.VA 1-6 3.VA Central IRB

24. 24 Cases – Potential Research Studies Case 2 Who is the sponsor? Where is the PI(s) & other research staff? What sites will be participating? Who obtains informed consent? Who interacts/intervenes? Who provides private identifiable information? Who obtains private identifiable information? Who uses, studies, or analyzes private identifiable information? NIH VA 1 VA 1-6 VA 1 VA 1-6 VA 1

25. 25 Case 2, Question 1 - Which sites are engaged? 25 1.VA 1 2.VA 1-6 3.VA Central IRB

26. 26 Case 2, Question 2 - Which sites need FWAs and IRBs? 26 1.VA 1 2.VA 1-6 3.VA Central IRB

27. 27 Case 2, Question 3 - Which IRB(s) Review? 27 1.VA 1 2.VA 1-6 3.VA Central IRB

28. 28 Cases – Potential Research Studies Case 3 Who is the sponsor? Where is the PI(s) & other research staff? What sites will be participating? Who obtains informed consent? Who interacts/intervenes? Who provides private identifiable information? Who obtains private identifiable information? Who uses, studies, or analyzes private identifiable information? NIH VA 1 VA 1-6

29. 29 Case 3, Question 1 - Which sites are engaged? 29 1.VA 1 2.VA 1-6 3.VA Central IRB

30. 30 Case 3, Question 2 - Which sites need FWAs and IRBs? 30 1.VA 1 2.VA 1-6 3.VA Central IRB

31. 31 Case 3, Question 3 - Which IRB(s) Review? 31 1.VA 1 2.VA 1-6 3.VA Central IRB

32. 32 Cases – Potential Research Studies Case 4 Who is the sponsor? ORD Health Services R&D Where is the PI(s) & other research staff? VA 1 What sites will be participating? VA 1-6 Who interacts/intervenes? VA 1-6 Who provides private identifiable information? VA 1-6 Who obtains private identifiable information? VA 1-6 Who obtains informed consent? VA 1-6 Who uses, studies, or analyzes private identifiable information? VA 1-6 32

33. 33 Case 4, Question 1 - Which sites are engaged? 33 1.VA 1 2.VA 1-6 3.VA Central IRB

34. 34 Case 4, Question 2 - Which sites need FWAs and IRBs? 34 1.VA 1 2.VA 1-6 3.VA Central IRB

35. 35 Case 4, Question 3 - Which IRB(s) Review? 35 1.VA 1 2.VA 1-6 3.VA Central IRB

36. 36 Cases – Potential Research Studies Case 5 Who is the sponsor? Where is the PI(s) & other research staff? What sites will be participating? Who obtains informed consent? Who interacts/intervenes? Who provides private identifiable information? Who obtains private identifiable information? Who uses, studies, or analyzes private identifiable information? Drug Company VA 1 & VA 1s Affiliate *VA 1 & VA 1s affiliate each use their own IRB

37. 37 Case 5, Question 1 - Which sites are engaged? 37 1.VA 1 2.VA 1 Affiliate 3.Both

38. 38 Case 5, Question 2 - Which sites need FWAs and IRBs? 38 1.VA 1 2.VA 1 Affiliate 3.Both

39. 39 Case 5, Question 3 - Which IRB(s) Review? 39 1.VA 1 2.VA 1 Affiliate 3.Both

40. 40 Case 5, Question 4 – Which informed consent form should be used for subjects at VA 1s Affiliate? 40 1.VA 1 (VA Form 10-1086) 2.VA 1 Affiliate 3.Both

41. 41 Case 5, Question 5 – Which informed consent form should be used for subjects at VA 1? 41 1.VA 1 (VA Form 10-1086) 2.VA 1 Affiliate 3.Both

42. 42 Cases – Potential Research Studies Case 6 Who is the sponsor? Where is the PI(s) & other research staff? What sites will be participating? Who obtains informed consent? Who interacts/intervenes? Who provides private identifiable information? Who obtains private identifiable information? Who uses, studies, or analyzes private identifiable information? VACO Nursing Office Research Project (employee survey) VA 1 & VA 2 VA 1-60 VA 1 & VA 2 VA 1-60 VA 1 & 2

43. 43 Case 6, Question 1 - Which sites are engaged? 43 1.VA 1 2.VA 2 3.VA 1 & 2 4.VA 1-60

44. 44 Case 6, Question 2 - Which sites need FWAs and IRBs? 44 1.VA 1 2.VA 2 3.VA 1 & 2 4.VA 1-60

45. 45 Case 6, Question 3 - Which IRB(s) Review? 45 1.VA 1 2.VA 2 3.VA 1 & 2 4.VA 1-60 5.VA Central IRB

46. 46 Cases – Potential Research Studies Case 7 Who is the sponsor? Where is the PI(s) & other research staff? What sites will be participating? Who obtains informed consent? Who interacts/intervenes? Who provides private identifiable information? Who obtains private identifiable information? Who uses, studies, or analyzes private identifiable information? VACO Mental Health Research Project (Patient Satisfaction Interviews) VA 1 & VA 2 VA 1-60

47. 47 Case 7, Question 1 – Which sites are engaged? 47 1.VA 1 2.VA 2 3.VA 1 & 2 4.VA 1-60

48. 48 Case 7, Question 2 - Which sites need FWAs and IRBs? 48 1.VA 1 2.VA 2 3.VA 1 & 2 4.VA 1-60

49. 49 Case 7, Question 3 - Which IRB(s) Review? 49 1.VA 1 2.VA 2 3.VA 1 & 2 4.VA 1-60 5.VA Central IRB

50. 50 Case 7, Question 4 - Does it make a difference if some sites are Contract Community Based Outpatient Clinics (CBOCs)? 50 1.Yes 2.No

51. 51 Case 7, Question 5 - Does it make a difference if some sites are nursing homes? 51 1.Yes 2.No

52. 52