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Multisite Human Subjects Research

Multisite Human Subjects Research. CUNY HRPP Coordinator Training October 19, 2012. Collaborative Research: When is CUNY IRB review & approval required?. When CUNY is ENGAGED in non-exempt RESEARCH involving HUMAN SUBJECTS

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Multisite Human Subjects Research

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  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 • CUNY’s role in the research • Each non-CUNY site’s 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

  5. Collaborative Research: CUNY PI’s Recordkeeping Requirements

  6. Collaborative Research: Do we collect IRB approvals?

  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 CUNY’s 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

  10. Collaborative Research: CUNY UI-IRB as the IRB of Record - Procedures • HRPP staff confirms requesting institution’s engagement in federally funded research • HRPP staff forwards request to UDRC • UDRC makes decision whether CUNY UI-IRB will serve as IRB of Record • If CUNY UI-IRB will serve as IRB of Record, the UDRC drafts an Agreement • CUNY VCR signs Agreement • Authorized individual for requesting institution signs Agreement • 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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