IRB Challenges for CTSA Sites - PowerPoint PPT Presentation

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IRB Challenges for CTSA Sites

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IRB Challenges for CTSA Sites Challenge Areas Multi-site Research Community Based Research Education and Preparation of New Human Subjects Researchers Increased ... – PowerPoint PPT presentation

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Title: IRB Challenges for CTSA Sites


1
IRB Challenges for CTSA Sites
2
Challenge Areas
  • Multi-site Research
  • Community Based Research
  • Education and Preparation of New Human Subjects
    Researchers
  • Increased Use of Technology

3
Multi-site Research Challenges
  • Inconsistencies Resulting from Multiple IRB
    Reviews
  • Changes in consent
  • Changes in design
  • CTSA structure emphasizes inter-institutional
    collaboration and data sharing

4
Multi-site Research Challenges
  • Some Alternative Models not Recognized by VA
    HRPPs
  • NCI Central IRBs
  • Reviews under IRB authorization agreements
  • Particularly impacts sites with research centers
    in VA facilities (former GCRC sites)

5
Multi-site Research Challenges
  • Reciprocity Agreement UC Case Study
  • Agreement signed by all UC campuses and national
    labs
  • All FWAs amended
  • Applies to expedited review and exempt
    determination only

6
Multi-site Research Challenges
  • UC Reciprocity Agreement Case Study
  • Coordination challenges among campuses
  • Who takes lead?
  • Requires central record repository
  • Challenge educating research community on new
    requirements
  • Issues with local non-IRB policies and committees
  • Conflict of Interest, radiation use, etc.

7
Community Based Research
  • Community institutions have little or no human
    subjects research experience
  • Need FWA and policies
  • Need commitment to Belmont
  • Community researchers have few resources to
    conduct research
  • Clinical Research Coordinators
  • Time

8
New Human Subjects Researchers
  • Translational research involves new players not
    familiar with human subjects research
    requirements
  • Basic scientists
  • Clinical practitioners
  • Additional training and resources needed

9
Technology Challenges
  • Increased use of technology to conduct research
  • Issues regarding data use and exchange
  • Research tasks performed automatically

10
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