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U-MIC

2. Use of a Single IRB in multisite research
NIH Policy
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U-MIC
University of Michigan IRB Collaborative

3. NIH sIRB Policy National Institutes of Health (NIH)
Policy on the Use of a Single Institutional Review Board (sIRB) for Multisite Research
single IRB of record
ethical review of
nonexempt
NIH-funded human subjects research
more than one US site
issued June 21, 2016
effective May 25, 2017
Objectives
enhance/streamline IRB review process in multisite research
eliminate duplicative IRB review
reduce administrative burdens/inefficiencies
maintain human subjects protections
allow IRBs to concentrate on single-site protocols
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4. NIH sIRB Policy Scope US sites of NIH-funded multisite studies
all sites following one protocol
nonexempt human subjects research
supported through
grants
cooperative agreements
contracts
NIH Intramural Research Program
Policy does not apply to
career development
research training
fellowship awards
foreign sites participating in NIH-funded multisite studies
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5. NIH sIRB Policy Definitions
authorization agreement (or reliance agreement)
documents respective
authorities
roles
responsibilities
communication between sIRB and participating site
multisite study
single protocol
nonexempt human subjects research
more than one site
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U-MIC

6. NIH sIRB Policy Responsibilities applicant/offeror
submits plan in funding application/proposal
use of sIRB as IRB of record for all sites
all participating sites will adhere to NIH policy
how sites and sIRB will communicate
delayed-onset research (sIRB not yet identified)
awardees will follow NIH policy
inform funding IC before initiating multisite study
plan to use registered IRB of record
may request direct-cost funding
costs of establishment/review of multisite study by sIRB
requires appropriate justification
Costs must be reasonable and consistent with cost principles.
NIH Grants Policy Statement
Federal Acquisition Regulation
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7. NIH sIRB Policy Responsibilities awardee
ensures authorization agreements are in place
maintains copies of authorization agreements and other documentation
to document compliance with policy
ensures mechanism for communication between sIRB and participating sites
may delegate tasks
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8. NIH sIRB Policy Responsibilities Funding NIH Institute/Center (IC)
manages/oversees award
communication with awardee regarding plan for complying with policy
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U-MIC

9. NIH sIRB Policy Responsibilities sIRB
conducts ethical review of NIH-funded multisite studies for all participating sites
must meet Common Rule requirements (45 CFR 46 Subpart A)
may also serve as Privacy Board
HIPAA Privacy Rule
use/disclosure of PHI for research
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U-MIC

10. NIH sIRB Policy Responsibilities participating sites
rely on sIRB to carry out review functions
meet other regulatory obligations, such as
informed consent
overseeing the implementation of approved protocol
reporting to sIRB
unanticipated problems
study progress
information regarding
local context issues
state or local regulatory requirements
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U-MIC

11. NIH sIRB Policy Exceptions
permitted where sIRB review would be prohibited by a federal, tribal, or state
law
regulation
policy
NIH will consider other requests for exceptions
requires justification
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12. NIH sIRB Policy Effective date all competing grant applications new
renewal
revision
resubmission
received on or after May 25, 2017
Ongoing, noncompeting awards
not subject to policy
until grantee submits competing renewal application
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13. NIH sIRB Policy
Note
Although NIH does not require use of an sIRB for NIH-sponsored collaborative research when the site’s involvement does not include subject interaction or intervention under a single protocol, an sIRB may still be utilized.
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U-MIC

14. NIH Policy on the Use of a Single IRB for Multisite Research
NIH sIRB Policy
NIH Policy on the Use of a Single IRB for Multisite Research
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U-MIC

15. Thank you.
Brian Seabolt
IRBMED
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U-MIC