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 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

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

Collaborative Research: Assurance & Designated IRB Requirements 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 Not required Each site’s designated IRB

Collaborative Research: CUNY PI’s Recordkeeping Requirements 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 IRB’s approval & approved IC documents Documentation for sites with designated IRB Collaborating site’s permission/authorization Documentation for sites without designated IRB WHY?

Collaborative Research: Do we collect IRB approvals? 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 PI’s assurances For prime awardee or coordinating center only WHY?

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

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

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)

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

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