CMU IRB RELIANCE IRB Submission & Review Process

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Estimated Time
per Activity*
Day 0
CMU IRB RELIANCE
IRB Submission & Review Process
PPI submits IRB Application [or IRB
Amendment] and RI(s) IRB documentation
to the Reviewing IRB
PPI/RI(s) secure all Departmental,
School and Institutional approvals
(e.g., other regulatory committee
approvals) required at their
institution.
Reviewing IRB
HRP staff conduct initial pre-review/
assessment; works with the PPI to have
protocol “IRB Ready”
PPI working with Reviewing IRB
obtains approvals from the
Reviewing institution. RI(s) at
Relying site secures approvals
from Relying institution.
3–14 days
1-3 days
Reviewing IRB
sends the “IRB ready” protocol to Relying
IRB(s) to identify any substantive and/or
local issues
3-14 days
Relying IRB(s)
sends comments to Reviewing IRB
5-23 days
Reviewing IRB
reviews protocol, if approved
provides approved documents to Relying
IRB(s)
For New IRB
Applications
Only
PPI at Reviewing Site may
initiate research if all
institutional requirements are
met (e.g., contract finalized)
Relying IRB
reviews IRB-approved documents and
confirms that other applicable
institutional requirements are met.
Submits IRB Reliance Letter to the
Reviewing IRB. Releases institutionspecific IRB-approved documents to RI(s).
RI(s) at Relying Site may initiate research
if all institutional requirements are met
(e.g., sub-contract finalized)
3-14 days
*NOTE: Timeline estimates do
not include PPI/ RI(s) response
time, IRB determinations
requiring revisions and/or
resubmission, and review
timelines for other regulatory
committees.
The Project Principal Investigator or
‘PPI’ is the primary individual
responsible for submission of
required applications and reports to
the Reviewing IRB.
The Relying Investigator or ‘RI’ is the
Principal Investigator or Lead
Researcher (LR) at the Relying
institution.
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