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Multi-Site Studies

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Multi-Site Studies K. Lynn Cates, M.D. Assistant Chief Research & Development Officer Director, PRIDE HRPP 201 March 23, 2011 * * * * * * Cases Potential Research ... – PowerPoint PPT presentation

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Title: Multi-Site Studies


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 facilitys 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 institutions 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
    PIs 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 PIs
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 PIs
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 PIs 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 RD
  • 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 RD
  • 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 RD
  • 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 RD
  • 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 1s Affiliate
  • What sites will be participating? VA 1 VA 1s
    Affiliate
  • Which sites are engaged? ?????
  • Who interacts/intervenes? VA 1 VA 1s
    Affiliate
  • Who provides private identifiable information? VA
    1 VA 1s Affiliate
  • Who obtains private identifiable information? VA
    1 VA 1s Affiliate
  • Who obtains informed consent? VA 1 VA 1s
    Affiliate

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

34
Cases Potential Research StudiesCase 5
  • Which sites need FWAs IRBs? VA 1 VA 1s
    Affiliate
  • Which IRB(s)? VA 1 VA 1s Affiliate (unless VA
    1s IRB of record is VA 1s Affiliates 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 1s Affiliate? VAs Affiliates informed
    consent form
  • VA 1? VA 1s 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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