Engagement in Human Research & Multi-Site Studies

K. Lynn Cates, M.D.Assistant Chief Research & Development OfficerDirector, PRIDE

May 30, 2012

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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?

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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

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Multi-Site Studies*

Studies with more than one site engaged in research involving human subjects

*VHA Handbook 1200.05, Paragraph 52

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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

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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

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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

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EngagementEmployees & AgentsIndividuals 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

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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

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Engaged in Human Research

How do you make a determination as to whether or not a facility is engaged in human research?

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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)

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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

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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

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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

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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 institution’s 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

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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

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EngagementDual 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)

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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

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Case Studies

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Cases – Potential Research StudiesCase 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

VA 1-6

VA 1

VA 1

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Case 1, Question 1- Which sites are engaged?

1 2 3

0% 0%0%

1. VA 12. VA 1-63. VA Central IRB

221 2 3

0% 0%0%

Case 1, Question 2 - Which sites need FWAs and IRBs?1. VA 12. VA 1-63. VA Central IRB

23

Case 1, Question 3 - Which IRB(s) Review?

231 2 3

0% 0%0%

1. VA 12. VA 1-63. VA Central IRB

24

Cases – Potential Research StudiesCase 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

VA 1-6

VA 1

VA 1

25

Case 2, Question 1 - Which sites are engaged?

251 2 3

0% 0%0%

1. VA 12. VA 1-63. VA Central IRB

26

Case 2, Question 2 - Which sites need FWAs and IRBs?

261 2 3

0% 0%0%

1. VA 12. VA 1-63. VA Central IRB

27

Case 2, Question 3 - Which IRB(s) Review?

271 2 3

0% 0%0%

1. VA 12. VA 1-63. VA Central IRB

28

Cases – Potential Research StudiesCase 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

VA 1-6

VA 1-6

VA 1-6

VA 1-6

VA 1-6

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Case 3, Question 1 - Which sites are engaged?

291 2 3

0% 0%0%

1. VA 12. VA 1-63. VA Central IRB

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Case 3, Question 2 - Which sites need FWAs and IRBs?

301 2 3

0% 0%0%

1. VA 12. VA 1-63. VA Central IRB

31

Case 3, Question 3 - Which IRB(s) Review?

311 2 3

0% 0%0%

1. VA 12. VA 1-63. VA Central IRB

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Cases – Potential Research StudiesCase 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

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Case 4, Question 1 - Which sites are engaged?

331 2 3

0% 0%0%

1. VA 12. VA 1-63. VA Central IRB

34

Case 4, Question 2 - Which sites need FWAs and IRBs?

341 2 3

0% 0%0%

1. VA 12. VA 1-63. VA Central IRB

35

Case 4, Question 3 - Which IRB(s) Review?

351 2 3

0% 0%0%

1. VA 12. VA 1-63. VA Central IRB

36

Cases – Potential Research StudiesCase 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 1’s Affiliate

VA 1 & VA 1’s Affiliate

VA 1 & VA 1’s Affiliate

VA 1 & VA 1’s AffiliateVA 1 & VA 1’s Affiliate

VA 1 & VA 1’s Affiliate

VA 1 & VA 1’s Affiliate

*VA 1 & VA 1’s affiliate each use their own IRB

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Case 5, Question 1 - Which sites are engaged?

371 2 3

0% 0%0%

1. VA 12. VA 1 Affiliate3. Both

38

Case 5, Question 2 - Which sites need FWAs and IRBs?

381 2 3

0% 0%0%

1. VA 12. VA 1 Affiliate3. Both

39

Case 5, Question 3 - Which IRB(s) Review?

391 2 3

0% 0%0%

1. VA 12. VA 1 Affiliate3. Both

40

Case 5, Question 4 – Which informed consent form should be used for subjects at VA 1’s Affiliate?

401 2 3

0% 0%0%

1. VA 1 (VA Form 10-1086)

2. VA 1 Affiliate3. Both

41

Case 5, Question 5 – Which informed consent form should be used for subjects at VA 1?

411 2 3

0% 0%0%

1. VA 1 (VA Form 10-1086)

2. VA 1 Affiliate3. Both

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Cases – Potential Research StudiesCase 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 & VA 2

VA 1-60

VA 1 & 2

VA 1 & 2

43

Case 6, Question 1 - Which sites are engaged?

431 2 3 4

0% 0%0%0%

1. VA 12. VA 23. VA 1 & 24. VA 1-60

44

Case 6, Question 2 - Which sites need FWAs and IRBs?

441 2 3 4

0% 0%0%0%

1. VA 12. VA 23. VA 1 & 24. VA 1-60

45

Case 6, Question 3 - Which IRB(s) Review?

451 2 3 4 5

0% 0% 0%0%0%

1. VA 12. VA 23. VA 1 & 24. VA 1-605. VA Central IRB

46

Cases – Potential Research StudiesCase 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

VA 1-60

VA 1-60

VA 1-60

VA 1-60

VA 1-60

47

Case 7, Question 1 –Which sites are engaged?

471 2 3 4

0% 0%0%0%

1. VA 12. VA 23. VA 1 & 24. VA 1-60

48

Case 7, Question 2 - Which sites need FWAs and IRBs?

481 2 3 4

0% 0%0%0%

1. VA 12. VA 23. VA 1 & 24. VA 1-60

49

Case 7, Question 3 - Which IRB(s) Review?

491 2 3 4 5

0% 0% 0%0%0%

1. VA 12. VA 23. VA 1 & 24. VA 1-605. VA Central IRB

50

Case 7, Question 4 - Does it make a difference if some sites are Contract Community Based Outpatient Clinics (CBOCs)?

501 2

0%0%

1. Yes2. No

51

Case 7, Question 5 - Does it make a difference if some sites are nursing homes?

511 2

0%0%

1. Yes2. No

52