use and care of laboratory animals grant protocol congruence slide 1
TRANSCRIPT
Use and Care of Laboratory Animals
Grant Protocol Congruence
Slide 1
Intro
• RARC Office Contacts– [email protected]
• Todd Forsythe: [email protected]
• RSP Contacts– [email protected]
• David Ngo: [email protected]• Kurt McMillen: [email protected]
Slide 2
Agenda
• 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 administration?• 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 ?...)
• Why• What• Who• Where• When• How
Why
• 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)
What
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
Grant Protocol
Exact Match
Grant Protocol
1 Grant: 1 Protocol,but the Protocol has extra details
Grant Protocol A
Protocol B
Extra in Protocol but NOT Grant
Extra in Protocol but NOT Grant
1 Grant: Multiple Protocolswhich may/not have extra details
Grant 2
Grant 1 Protocol
Extra in Protocol but NOT Grant
Extra in Protocol but NOT Grant
Multiple Grants: 1 Protocolwhich may/not have extra details
Grant 1 Protocol A
Grant 2
Grant 3
Protocol B
Protocol C
Protocol D
Extra in Protocol but NOT Grant
Extra in Protocol but NOT Grant
This section doesn’t appear in any protocol = NOT congruent!
Multiple Grants: Multiple Protocolswhich may/not have extra details
Who
Principal Investigators with
PHS-funded
animal use protocols
Where
• Congruence check will be conducted by the RARC office.
• RSP will continue to coordinate all pre-award activities, including confirmation of congruence to PHS.
• PLuS will display documentation of congruence.
Example of PLuS View
IACUC Approval Letters
Slide 16
OLDNEW
When
• 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.
How
• 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
Congruence Review
Request Form
Notification of
Non-Congruence
RARC, Grant-Protocol Congruence
Pre-Review Cover
Sheet
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 established!
Summary
• Our goal is to minimize the burden to PI, and be helpful in facilitating any needed changes.
• 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 information.
• 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
• A request for Just-in-Time information is NOT an indication of funding.
• 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.
Slide 26
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.– Legal Attestation
Slide 28
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…
1) PLUS
Slide 33
Valid Dates
Approved & CongruentGrant # - or- title match
2) IACUC Approval Letter in WISPER Attachments
Slide 34
Congruent
Approved & Valid Dates
Grant # - or- title match
• When Congruent protocol data is added to WISPER, RSP can continue with set-up
Slide 35
Questions?
• Todd Forsythe, RARC– 890-4829; [email protected]– [email protected]
• Web Resources– www.rarc.wisc.edu/faq/protocol_help_sheets.html#relate– https://www.rsp.wisc.edu/awardsetup/rarc/
• Available to come to your individual Departments for presentations with PIs and anyone else who would benefit.
Slide 36