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Overcoming Challenges in Multi-Site Research: IRB Perspectives and Solutions

This article explores the various challenges faced by CTSA sites in multi-site and community-based research, as well as the education and preparation of new human subjects researchers. It discusses the impact of increased technology use and provides solutions to inconsistencies resulting from multiple IRB reviews.

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Overcoming Challenges in Multi-Site Research: IRB Perspectives and Solutions

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Presentation Transcript

  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. Thank you

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