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CAREB May 2015 Michael D. Coughlin, Ph.D. Chair, Tri-Hospital Research Ethics Board

A Collaborative Research Ethics Review Process between Three Community Hospitals and a University. CAREB May 2015 Michael D. Coughlin, Ph.D. Chair, Tri-Hospital Research Ethics Board

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CAREB May 2015 Michael D. Coughlin, Ph.D. Chair, Tri-Hospital Research Ethics Board

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  1. A Collaborative Research Ethics Review Process between Three Community Hospitals and a University CAREB May 2015 Michael D. Coughlin, Ph.D. Chair, Tri-Hospital Research Ethics Board Note: Julie Joza, Senior Manager, Research Ethics at U Waterloo was primary collaborator in working out this process.

  2. Context for Collaborative Review • Three community hospitals in Kitchener/Cambridge area (CMH, GRH, SMGH) with joint REB (Tri-Hospital Research Ethics Board – THREB) • Universities in same area – UW, WLU, Guelph • Not all hospitals in academic centres • Not all academic centres have their own hospitals • Collaboration often needed for academic health related research • How simplify research review through a process other than “reciprocity” agreements?

  3. Reasons for a Simplified Process • Projects involving both hospital and university students and faculty • Burden on researchers and on REBs of back and forth reviews; need to get approval at one REB for changes requested by other REB • Model of UW – WLU collaboration • Encourage and facilitate more collaboration

  4. Examples of Projects Needing Review at Both Institutions • Use of hospital facilities (e.g. fMRI) • Kinesiology studies with various groups of patients • Psychology studies with patient groups • Obtaining tissue samples for biochemical studies at UW • Various other collaborations

  5. Goals of a Simplified Process • Not a single review (both hospital and university REBs review project) • Advantages (simplification): • Single application form • Single contact person for researchers • Single response to required revisions or modifications • Single approval letter • Reduce work of REBs in dealing with multiple reviews

  6. Developing the Process • Get agreement in principle from REBs and administrations to develop process • Work out agreement using UW-WLU model • Different from UW-WLU model in that research may involve more than minimal risk • Decide on which forms to use for application, etc. • Coordination of reviews to occur at level of REB administrators • Single contact person depending on PI’s institution • Joint approval letter from both REBs

  7. Additional Issues • Process has not yet been implemented • Coordinating different processes: paper-based for THREB vs online for UW • Expectation is that it will work as well as the UW-WLU process • Items still handled separately: • Administrative resource impact review • Contracts • Privacy issues (e.g. RDA or DSA)

  8. Questions? ?

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