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Multi-Site Studies

Multi-Site Studies. K. Lynn Cates, M.D. Assistant Chief Research & Development Officer Director, PRIDE HRPP 201 March 23, 2011. Multi-Site Studies. Studies with more than one site engaged in research involving human subjects Questions Is it research? Is it human subjects research?

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Multi-Site Studies

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  1. Multi-Site Studies K. Lynn Cates, M.D. Assistant Chief Research & Development Officer Director, PRIDE HRPP 201 March 23, 2011

  2. Multi-Site Studies • Studies with more than one site engaged in research involving human subjects • Questions • Is it research? • Is it human subjects research? • Is more than one site engaged in research involving human subjects?

  3. Multi-Site StudiesEngagement • 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

  4. EngagementEmployees & Agents* • Individuals who • Act on behalf of the institution • Exercise institutional authority or responsibility • Perform institutionally designated activities • May be • Staff • Students • Contractors • Volunteers *Whether or not they receive compensation

  5. Engaged in Human Subjects Research* • In general, a VA facility is “engaged” when someone with a VA appointment at that facility 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 5

  6. 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 LSI for that study • Have the facility’s IRB of record approve the study

  7. 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 human research If a VA facility is not engaged in a given study • It has no jurisdiction over that 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 that study *VHA Handbook 1200.05, Paragraph 51

  8. Engaged in Human Subjects Research • Receives an award through a grant, contract, or cooperative agreement for non-exempt human subjects research (even if all activities involving human subjects are carried out elsewhere) • Employees or agents intervene for research purposes with any human subjects by performing invasive or noninvasive procedures such as • Drawing blood • Collecting cheek cells with a cotton swab • Counseling or psychotherapy • Giving drugs or treatments

  9. Engaged in Human Subjects Research • Employees or agents intervene with any human subject by manipulating the environment • Controlling light, sound, temperature • Presenting sensory stimuli • Orchestrating social interactions • Employees or agents interact with any human subject • Protocol-dictated communication or interpersonal contact • Asking someone to provide a specimen by voiding or spitting into a container • Conducting interviews or administering questionnaires

  10. Engaged in Human Subjects Research • Employees or agents obtain informed consent • Employees of agents obtain identifiable private information or identifiable biological specimens from any source for the research • Even if the institution’s employees or agents do not directly interact or intervene with the subjects • Examples • Observing or recording private behavior • Using, studying, or analyzing for research purposes identifiable private information or identifiable specimens • Provided by another institution • Already in possession of investigators

  11. Important Considerations for Determining Engagement in Human Research • Where are research staff appointments? • Will staff at local sites assist with recruitment? • What are the roles of staff from each site in terms of • Obtaining informed consent • Interacting or intervening with subjects • Obtaining private identifiable information or identifiable biological specimens • What types of data/specimens will the staff use at each institution for the research?

  12. Multi-Site StudiesPrincipal Investigator (PI) Responsibilities* • Having overall responsibility for the whole study • Submitting the protocol to the IRB of record for PI’s site • Ensuring all engaged sites have most current version of IRB-approved • Protocol • Informed consent form • HIPAA authorization • Ensuring all approvals obtained before study started or amendments implemented at a given site *VHA Handbook 1200.05, Paragraph 52a(1)

  13. Multi-Site StudiesPrincipal Investigator (PI) Responsibilities* • Notifying the Director of any facility not engaged in the research, but on whose premises research activities will take place • Ensuring all sites appropriately safeguard VA data • Communicating to engaged sites • Serious adverse events (SAEs) if they have the potential to affect implementation of the study • Study events • Interim results *VHA Handbook 1200.05, Paragraph 52a(1)

  14. Multi-Site StudiesPrincipal Investigator (PI) Responsibilities* • Ensuring all Local Site Investigators (LSIs) conduct the study appropriately • Ensuring all noncompliance is reported in accordance with VHA Handbook 1058.01 • Notifying local facility Directors and LSIs when the study no longer requires engagement of their site (i.e., all follow-up will be done by the PI and/or at other sites) *VHA Handbook 1200.05, Paragraph 52a(1)

  15. Multi-Site StudiesLocal Site Investigator (LSI) Responsibilities* • Overseeing all aspects of the study at the local site • Conducting the study according to • The most recent IRB-approved versions of the protocol, informed consent form, and HIPAA authorization • Local, VA, and other Federal requirements • Ensuring all amendments are approved by the local IRB of record before implementing • Reporting internal (local) serious adverse events (SAEs) in accordance with VHA Handbook 1058.01 *VHA Handbook 1200.05, Paragraph 52a(2)

  16. Multi-Site StudiesIRB Responsibilities – PI’s Facility • All usual IRB responsibilities in 38 CFR Part 16 (the Common Rule) & VHA Handbook 1200.05 plus • When a participating site is added to the study, determining • Will that site be engaged in research • If the site will be engaged, confirming it has • An active Federalwide Assurance (FWA) • Has provided documentation of all relevant approvals, including approval of its IRB of record • Approving the study-wide protocol & sample informed consent to be provided to each LSI *VHA Handbook 1200.05, Paragraph 52b

  17. Multi-Site StudiesIRB Responsibilities – PI’s Facility • Ensuring the study-wide protocol has provisions for ensuring any difference in protocol or informed consent at engaged sites are justified by the LSI & approved by the PI • Ensuring clear adverse event (AE) reporting requirements & a clearly defined feedback loop • Reviewing the PI’s plan for communicating critical information to participating sites • Ensuring privacy, confidentiality, and information security requirements are met • Reviewing reports from Data Monitoring Committees

  18. Multi-Site StudiesLocal Requirements When Using VA Central IRB* • The facility Director at each local site is responsible for • Overseeing the local HRPP & all research conducted locally • Entering into a Memorandum of Understanding (MOU) with VHA Central Office • Modifying the Federalwide Assurance (FWA) to list the VA Central IRB as an IRB of record • Maintaining standard operating procedures (SOPs) for using the VA Central IRB *VHA Handbook 1200.05, Paragraph 52c

  19. Multi-Site StudiesResearch & Development Committee Responsibilities* • Treating the study as conducted at the local site like any other study, no matter which of its IRBs of record approved it (e.g., the local IRB, the affiliate IRB, or the VA Central IRB) *VHA Handbook 1200.01

  20. Multi-Site StudiesResearch Compliance Officer Responsibilities • Treating the study as conducted at the local site like any other study (e.g., auditing & monitoring)

  21. Multi-Site StudiesORD-Funded Studies • All ORD-funded studies with more than one site engaged in research involving human subjects must be reviewed by the VA Central IRB • Pilot studies • Sites that do not use the VA Central IRB cannot participate in them • IRB shopping

  22. Cases – Potential Research Studies • Who is the sponsor? • Where is the PI? • What sites will be participating? • Which sites are engaged? • Who interacts/intervenes? • Who provides private identifiable information? • Who obtains private identifiable information? • Who obtains informed consent? • Which sites need FWAs & IRBs? • Whose resources are used? (e.g., staff time, space , equipment)

  23. Cases – Potential Research StudiesCase 1 • Who is the sponsor? ORD Rehabilitation R&D • Where is the PI(s)? VA 1 • What sites will be participating? VA 1-6 • Which sites are engaged? ????? • Who interacts/intervenes? VA 1 • Who provides private identifiable information? VA 1-6 • Who obtains private identifiable information? VA 1 • Who obtains informed consent? VA 1 • Which sites need FWAs & IRBs? ????? • Which IRB(s)? ?????

  24. Cases – Potential Research StudiesCase 1 • Who is the sponsor? ORD Rehabilitation R&D • Where is the PI(s)? VA 1 • What sites will be participating? VA 1-6 • Which sites are engaged? VA 1 • Who interacts/intervenes? VA 1 • Who provides private identifiable information? VA 1-6 • Who obtains private identifiable information? VA 1 • Who obtains informed consent? VA 1 • Which sites need FWAs & IRBs? VA 1 • Which IRB(s)? VA 1 (not VA Central IRB even though the study is funded by ORD)

  25. Cases – Potential Research StudiesCase 2 • Who is the sponsor? NIH • Where is the PI(s)? VA 1 • What sites will be participating? VA 1-6 • Which sites are engaged? ????? • Who interacts/intervenes? VA 1 • Who provides private identifiable information? VA 1-6 • Who obtains private identifiable information? VA 1 • Who obtains informed consent? VA 1 • Which sites need FWAs & IRBs? ????? • Which IRB(s)? ?????

  26. Cases – Potential Research StudiesCase 2 • Who is the sponsor? NIH • Where is the PI(s)? VA 1 • What sites will be participating? VA 1-6 • Which sites are engaged? VA 1 • Who interacts/intervenes? VA 1 • Who provides private identifiable information? VA 1-6 • Who obtains private identifiable information? VA 1 • Who obtains informed consent? VA 1 • Which sites need FWAs & IRBs? VA 1 • Which IRB(s)? VA 1 (only one site is engaged)

  27. Cases – Potential Research StudiesCase 3 • Who is the sponsor? NIH • Where is the PI(s)? VA 1 • What sites will be participating? VA 1-6 • Which sites are engaged? ????? • 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 • Which sites need FWAs & IRBs? ????? • Which IRB(s)? ?????

  28. Cases – Potential Research StudiesCase 3 • Who is the sponsor? NIH • Where is the PI(s)? VA 1 • What sites will be participating? VA 1-6 • Which sites are engaged? 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 • Which sites need FWAs & IRBs? VA 1-6 • Which IRB(s)? VA 1-6

  29. Cases – Potential Research StudiesCase 4 • Who is the sponsor? ORD Health Services R&D • Where is the PI(s)? VA 1 • What sites will be participating? VA 1-6 • Which sites are engaged? ????? • 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 • Which sites need FWAs & IRBs? ????? • Which IRB(s)? ?????

  30. Cases – Potential Research StudiesCase 4 • Who is the sponsor? ORD Health Services R&D • Where is the PI(s)? VA 1 • What sites will be participating? VA 1-6 • Which sites are engaged? 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 • Which sites need FWAs & IRBs? VA 1-6 • Which IRB(s)? VA Central IRB because the study is funded by ORD

  31. Cases – Potential Research StudiesCase 5 • Who is the sponsor? Drug Company • Where is the PI(s)? VA 1 & VA 1’s Affiliate • What sites will be participating? VA 1 & VA 1’s Affiliate • Which sites are engaged? ????? • Who interacts/intervenes? VA 1 & VA 1’s Affiliate • Who provides private identifiable information? VA 1 & VA 1’s Affiliate • Who obtains private identifiable information? VA 1 & VA 1’s Affiliate • Who obtains informed consent? VA 1 & VA 1’s Affiliate

  32. Cases – Potential Research StudiesCase 5 • Who is the sponsor? Drug Company • Where is the PI(s)? VA 1 & VA 1’s Affiliate • What sites will be participating? VA 1 & VA 1’s Affiliate • Which sites are engaged? VA 1 & VA 1’s Affiliate • Who interacts/intervenes? VA 1 & VA 1’s Affiliate • Who provides private identifiable information? VA 1 & VA 1’s Affiliate • Who obtains private identifiable information? VA 1 & VA 1’s Affiliate • Who obtains informed consent? VA 1 & VA 1’s Affiliate

  33. Cases – Potential Research StudiesCase 5 • Which sites need FWAs & IRBs? ????? • Which IRB(s)? ????? • Which informed consent form should be used for subjects at • VA 1’s Affiliate? • VA 1?

  34. Cases – Potential Research StudiesCase 5 • Which sites need FWAs & IRBs? VA 1 & VA 1’s Affiliate • Which IRB(s)? VA 1 & VA 1’s Affiliate (unless VA 1’s IRB of record is VA 1’s Affiliate’s IRB, then the part to be conducted at the VA needs to comply with VA requirements) • Which informed consent form should be used for subjects at • VA 1’s Affiliate? VA’s Affiliate’s informed consent form • VA 1? VA 1’s informed consent form (VA Form 10-1086)

  35. Cases – Potential Research StudiesCase 6 • Who is the sponsor? VACO Nursing Office (employee survey) • Where is the PI(s)? VA 1 & VA 2 • What sites will be participating? VA 1-60 • Which sites are engaged? ????? • Who interacts/intervenes? VA 1 & VA2 • Who provides private identifiable information? VA 1-60 • Who obtains private identifiable information? VA 1 & VA 2 • Who obtains informed consent? VA 1 & VA 2

  36. Cases – Potential Research StudiesCase 6 • Who is the sponsor? VACO Nursing Office (employee survey) • Where is the PI(s)? VA 1 & VA 2 • What sites will be participating? VA 1-60 • Which sites are engaged? VA 1 & VA 2 • Who interacts/intervenes? VA 1 & VA2 • Who provides private identifiable information? VA 1-60 • Who obtains private identifiable information? VA 1 & VA 2 • Who obtains informed consent? VA 1 & VA 2

  37. Cases – Potential Research StudiesCase 6 • Which sites need FWAs & IRBs? ????? • Which IRB(s)? ?????

  38. Cases – Potential Research StudiesCase 6 • Which sites need FWAs & IRBs? VA 1 & VA 2 • Which IRB(s)? VA 1 & VA 2

  39. Cases – Potential Research StudiesCase 7 • Who is the sponsor? VACO Mental Health (Patient Satisfaction Interviews) • Where is the PI(s)? VA 1 & VA 2 • What sites will be participating? VA 1-60 • Which sites are engaged? ????? • Who interacts/intervenes? VA 1-60 • Who provides private identifiable information? VA 1-60 • Who obtains private identifiable information? VA 1-60 • Who obtains informed consent? VA 1-60

  40. Cases – Potential Research StudiesCase 7 • Who is the sponsor? VACO Mental Health (Patient Satisfaction Interviews) • Where is the PI(s)? VA 1 & VA 2 • What sites will be participating? VA 1-60 • Which sites are engaged? VA 1-60 • Who interacts/intervenes? VA 1-60 • Who provides private identifiable information? VA 1-60 • Who obtains private identifiable information? VA 1-60 • Who obtains informed consent? VA 1-60

  41. Cases – Potential Research StudiesCase 7 • Which sites need FWAs & IRBs? ????? • Which IRB(s)? ?????

  42. Cases – Potential Research StudiesCase 7 • Which sites need FWAs & IRBs? VA 1-60 • Which IRB(s)? VA 1-60

  43. Cases – Potential Research StudiesCase 7 • Does it make a difference if some sites are • Contract Community Based Outpatient Clinics? • Nursing homes?

  44. Cases – Potential Research StudiesCase 7 • Does it make a difference if some sites are • Contract Community Based Outpatient Clinics (CBOCs)? • Nursing homes? Yes - They ordinarily do not have FWAs & IRBs of record so they cannot be engaged in research involving human subjects

  45. QUESTIONS 45

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