Congruence Training Powerpoint

Use and Care of Laboratory Animals
Grant Protocol Congruence
Slide 1
• RARC Office Contacts
– [email protected]
• Todd Forsythe: [email protected]
• RSP Contacts
– [email protected]
• David Ngo: [email protected]
• Kurt McMillen: [email protected]
Slide 2
• What are the PHS rules?
• Overview: Federal regulations
• What do the new PHS rules require us to do?
• New requirements in federal policy that intersect with
IACUC protocol approval and grants management
• How does all of this relate to research
• Revised Campus/RSP business processes
• JIT, Award Setup
Slide 3
PHS Agencies
Office of Global Affairs (OG)
Office of the Assistant Secretary for Health (OASH)
Office of the Assistant Secretary for Preparedness and Response (ASPR)
Agency for Health Care Research & Quality (AHRQ)
Agency for Toxic Substances and Disease Registry (ATSDR)
Centers for Disease Control and Prevention (CDC)
Food and Drug Administration (FDA)
Health Resources and Services Administration (HRSA)
Indian Health Service (IHS)
National Institutes of Health (NIH)
Substance Abuse and Mental Health Services Administration (SAMHSA)
Slide 4
Grant-Protocol Congruence
The 5 W’s (or is it 6 ?...)
• To meet unfunded Federal mandate:
• PHS Policy states:
“PHS awarding units may not make an award for an
activity involving animals unless…the awardee institution
has provided verification of approval by the IACUC of
those components of the application or proposal related
to the care and use of animals.” (IV.D.2)
• Animal Welfare Requirements has similar
language (Part II, A, 4.1.1)
Starting August 1, 2013
Check for congruence between IACUC
Protocols and PHS-Funded grants proposing
use of animals.
• “Congruence” = substantially similar,
not necessarily identical
• 1:1 ratio of Grant:Protocol is
NOT required
Exact Match
1 Grant: 1 Protocol,
but the Protocol has extra details
Protocol A
Extra in Protocol but NOT
Protocol B
Extra in Protocol but NOT
1 Grant: Multiple Protocols
which may/not have extra details
Grant 1
Extra in Protocol but NOT
Grant 2
Extra in Protocol but NOT
Multiple Grants: 1 Protocol
which may/not have extra details
Grant 1
Protocol A
Protocol B
Grant 2
Extra in Protocol but NOT
Protocol C
Grant 3
Protocol D
This section doesn’t appear in
any protocol = NOT congruent!
Extra in Protocol but NOT
Multiple Grants: Multiple Protocols
which may/not have extra details
Principal Investigators with
animal use protocols
• Congruence check will be conducted by
the RARC office.
• RSP will continue to coordinate all preaward activities, including confirmation of
congruence to PHS.
• PLuS will display documentation of
Example of PLuS View
IACUC Approval Letters
Slide 16
• Procedurally “When”
– Upon notification of potentially fundable score
• Implementation “When”
– Already have done alpha-testing
– February-June, 2013, beta-testing
– August 1, 2013, no grants will be allowed
through without congruence check.
• PI will submit a Congruence Review
Request Form to RARC (to Todd Forsythe)
– If PI forgets, or is not yet aware, RSP will
notify RARC at a later time, when RSP hears
from PHS. This could jeopardize timely
review of congruence and result in delayed
release of funds by RSP!
RARC, Grant-Protocol Congruence
RARC, Grant-Protocol Congruence
Key Points
• Grant is the Primary Document, & Protocol(s)
are the supporting document(s)
• Educating PIs to submit a Request as soon
as they learn of a fundable score will expedite
award setup, and prevent delays in funding
• INCENTIVE: RSP will no longer set up
awards until congruence has been
• Our goal is to minimize the burden to PI,
and be helpful in facilitating any needed
• RARC is providing a service to aid the PI
and Institution in meeting compliance.
Just In Time
Slide 24
JIT Overview – Pre 2010
A Just-in-Time request was a good indication of pending funding.
Just-in-Time information had to be submitted all at once. NIH eRA Commons did
not have the capability of appending information to previously submitted
NIH required that all JIT information had to be submitted within 2 weeks
of the date of the request.
IACUC approvals
PI notified RARC that he/she wanted a funding source added to an animal protocol.
RARC would then issue an approval letter with that funding source indicated.
Congruency reviews were typically not conducted.
Slide 25
JIT Overview - Currently
Slide 26
A request for Just-in-Time
information is NOT an indication of
NIH issues a “canned” JIT request
for ALL proposals that have
undergone scientific review and
received a score of 40 or less
(regardless of the IC’s payline).
Applicants are encouraged to submit
JIT information at least 60 days
before expected start date. NIH
understands that approvals may take
more than 2 weeks to obtain.
RSP JIT Process – Approved Protocols
1. RSP will review PLuS (an IACUC “approval letter” is NOT necessary)
2. If RARC has determined that the IACUC approval is congruent or a review is not
needed, RSP can submit a screenshot and enter the IACUC approval date in
ERA Commons.
Slide 27
RSP JIT Process – ERA Commons
It is the responsibility of the
Authorized Official to ensure that
information submitted to NIH is
correct and accurate.
When RSP presses the submit
button, we are assuring NIH that the
protocol is approved for this project.
Slide 28
Legal Attestation
JIT Process at RSP – In Some Cases…
1. RSP will review PLuS
2. If RARC has determined that the IACUC approval is under review by RARC, RSP
can submit a screenshot and will leave the IACUC approval date blank in ERA
Commons. This will not hold up or prevent a funding decision at NIH.
Slide 29
Award Acceptance
Slide 30
• When award is received RSP will review WISPER record
• Projects that have a “yes” answer on general tab question #3 will be
subject to the IACUC congruency screening
Slide 31
Award Setup
• In order to have an award setup RSP will require
the following 3 items:
– Approved protocol
• For the particular grant awaiting set-up
– Grant #
– Valid dates
• Must be current as of date of set-up
– RARC review: completed and congruent
• If protocol does not meet all items above, RSP will
send approval in WISPER
Slide 32
• Congruent protocol can be provided to RSP in one of two ways…
Valid Dates
Grant # - or- title match
Slide 33
Approved & Congruent
2) IACUC Approval Letter in WISPER Attachments
Grant # - or- title match
Approved & Valid Dates
Slide 34
• When Congruent protocol data is added to WISPER, RSP
can continue with set-up
Slide 35
Todd Forsythe, RARC
– 890-4829; [email protected][email protected]
Web Resources
Available to come to your individual Departments for presentations with PIs and
anyone else who would benefit.
Slide 36

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