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Multisite Human Subjects Research

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Title: Human Subjects Research & Engagement Author: Farida Lada Last modified by: Derek Steele Created Date: 4/20/2012 1:16:39 PM Document presentation format – PowerPoint PPT presentation

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Title: Multisite Human Subjects Research


1
Multisite Human Subjects Research
  • CUNY HRPP Coordinator Training
  • October 19, 2012

2
Collaborative Research When is CUNY IRB review
approval required?
  • When CUNY is ENGAGED in non-exempt RESEARCH
    involving HUMAN SUBJECTS
  • In general, this means that CUNY affiliated
    individuals obtain
  • Data about the human subjects through
    intervention or interaction
  • Identifiable private information about the
    subjects
  • Informed consent of human subjects for the
    research

3
Collaborative Research Requirements for ALL
collaborative research
  • PI must provide to IRB
  • Names of all collaborating sites
  • Name of PI of each collaborating site
  • CUNYs role in the research
  • Each non-CUNY sites role in the research
  • PI must retain records of
  • All communications with the CUNY UI-IRB
  • All communications with the collaborators and
    funding agency, when applicable

4
Collaborative Research Assurance Designated
IRB Requirements
Federally funded research Federally funded research Non-federally funded research
CUNY prime awardee or coordinating center CUNY ? prime awardee or coordinating center CUNY PI Lead PI
FWA for each site engaged in research Required Required Not required
Each sites designated IRB Required Required Not required
5
Collaborative Research CUNY PIs Recordkeeping
Requirements
Federally funded research Federally funded research Non-federally funded research
CUNY prime awardee or coordinating center CUNY ? prime awardee or coordinating center CUNY PI Lead PI
FWA Documentation for each site engaged Documentation for prime awardee or coordinating center Not required
Designated IRBs approval approved IC documents Documentation for each site engaged Documentation for prime awardee or coordinating center Documentation for sites with designated IRB
Collaborating sites permission/authorization Not required Not required Documentation for sites without designated IRB
6
Collaborative Research Do we collect IRB
approvals?
Federally funded research Federally funded research Non-federally funded research
CUNY prime awardee or coordinating center CUNY ? prime awardee or coordinating center CUNY PI Lead PI
No only PIs assurances For prime awardee or coordinating center only No only PIs assurances
7
Collaborative Research Oversight by prime
awardee / coordinating center / lead PI
  • When CUNY is the prime awardee or coordinating
    center or CUNY PI is the lead PI, the CUNY PI
    must provide the following information with their
    IRB submission
  • Procedures for CUNYs oversight of the conduct of
    research at collaborating sites
  • Procedures for ensuring timely communications
    amongst the collaborating sites regarding
  • Modifications to the protocol related documents
  • Unanticipated problems involving risks to
    subjects or others

8
Collaborative Research HRPP Staff
Responsibilities
  • Confirm engagement determination
  • Verify that the PI has submitted required
    documents assurances in accordance with CUNY
    Policy
  • For federally funded research where CUNY is not
    the prime awardee, verify and document the
    current FWA number of the prime awardee
    institution

9
Collaborative Research CUNY UI-IRB as the IRB
of Record
When? On a case by case basis For federally funded research ONLY
Who decides? University Director for Research Compliance (UDRC)
Request format In writing Describe role of requesting institution in research Indicate whether requesting institution has a designated IRB (if yes, why the request for CUNY to serve as IRB of Record)
10
Collaborative Research CUNY UI-IRB as the IRB
of Record - Procedures
  1. HRPP staff confirms requesting institutions
    engagement in federally funded research
  2. HRPP staff forwards request to UDRC
  3. UDRC makes decision whether CUNY UI-IRB will
    serve as IRB of Record
  4. If CUNY UI-IRB will serve as IRB of Record, the
    UDRC drafts an Agreement
  5. CUNY VCR signs Agreement
  6. Authorized individual for requesting institution
    signs Agreement
  7. Agreement goes into effect

11
Collaborative Research CUNY UI-IRB as the IRB
of Record
  • IMPORTANT NOTES
  • ONLY the Vice Chancellor for Research is
    authorized to sign these Agreements on behalf of
    CUNY
  • Requesting institution must have their own FWA
  • Requesting institution may be required to
    designate CUNY UI-IRBs 1-5 (IRB00008625) on their
    FWA
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