Transcript Human Subjects Research & Engagement

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:
o Data about the human subjects through intervention or interaction
o Identifiable private information about the subjects
o 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
FWA for each site
engaged in research
Required
Required
Not required
Each site’s
designated IRB
Required
Required
Not required
CUNY PI = Lead PI
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
FWA
Documentation for
each site engaged
Documentation for
prime awardee or
coordinating center
Not 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
Not required
Documentation for
sites without
designated IRB
Collaborating site’s
permission/authori
zation
Not required
CUNY PI = Lead PI
Collaborative Research:
Do we collect IRB approvals?
Federally funded research
CUNY = prime
awardee or
coordinating center
CUNY ≠ prime
awardee or
coordinating center
No; only PI’s
assurances
For prime awardee
or coordinating
center only
Non-federally
funded research
CUNY PI = Lead PI
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