multisite human subjects research cuny hrpp coordinator training october 19, 2012
TRANSCRIPT
Multisite Human Subjects Research
CUNY HRPP Coordinator TrainingOctober 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:o Data about the human subjects through intervention or interactiono Identifiable private information about the subjectso Informed consent of human subjects for the research
Collaborative Research: Requirements for ALL collaborative research
• PI must provide to IRB:o Names of all collaborating sites
o Name of PI of each collaborating site
o CUNY’s role in the research
o Each non-CUNY site’s role in the research
• PI must retain records of:o All communications with the CUNY UI-IRB
o 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 Required Not required
Each site’s designated IRB Required Required Not required
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 centerNot required
Designated IRB’s approval & approved IC documents
Documentation for each site engaged
Documentation for prime awardee or
coordinating center
Documentation for sites with
designated IRB
Collaborating site’s permission/authorization
Not required Not requiredDocumentation for
sites without designated IRB
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
No; only PI’s assurances
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:
o Procedures for CUNY’s oversight of the conduct of research at collaborating sites
o 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
1. HRPP staff confirms requesting institution’s engagement in federally funded research
2. HRPP staff forwards request to UDRC
3. UDRC makes decision whether CUNY UI-IRB will serve as IRB of Record
4. If CUNY UI-IRB will serve as IRB of Record, the UDRC drafts an Agreement
5. CUNY VCR signs Agreement
6. Authorized individual for requesting institution signs Agreement
7. 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