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Grant/Proposal Application and IACUC Protocol Congruency
The NIH Grants Policy Statement defines contractual or legal
obligations between the grantee institution and NIH. The Grant Policy Statement
requires the institution to verify, before award, that the institution’s IACUC
has reviewed and approved the animal work outlined in the proposal. In
particular, “It is an institutional responsibility to ensure that the
description of animal studies included in the application is congruent with any
corresponding protocol(s) approved by the IACUC.” (NIH Policy Statement
10/12). Consequently, a congruency
review is required for all funding that uses live vertebrate animals to ensure
that the work outlined in the proposal is supported by an active, approved
protocol.
Albert Einstein College of Medicine elects to proceed
according to Just-in-Time procedures for IACUC approval; and bears the
responsibility for supporting the decisions of the IACUC. Einstein’s IACUC should
not be pressured to approve a protocol or be overruled on its decision to
withhold approval.
In this case, the
IACUC approval date is not required at the time of grant submission. At time of
submission, the proposal can be submitted as “pending”. NIH grants management staff will request the
approval date as a Just-In-Time requirement in the pre-award stage.
When NIH requests
“Just in Time” information, it is the responsibility of the Principal
Investigator to contact the IACUC office to obtain the information.
The IACUC office conducts a side by side
direct comparison of the proposal and the IACUC protocol. Congruence will be evaluated for several important parts
of protocols and proposals. Initially, The Vertebrate Animal Section and
the Approach part of the Research Strategy Section are the areas of the grant
to be compared with the protocol.
However, other sections of the grant proposal may be reviewed. Information to be reviewed includes:
- General scope of work – disease
area, target organs, etc.
- Species of animals
- Number of animals and sex
- Agents administered (including
anesthetics, analgesics and experimental agents)
- Method to administer the agent
- Procedures to be conducted on
animals
- Method of euthanasia
- Personnel involved in the
animal studies
- Collaborative studies
It should be noted,
that congruency will be established by review of all the studies described in
the Grant Proposal, including: alternative studies and those proposed to be
carried out at later time (years four and five). NIH will accept Animal Use protocols that are
not more than three years old at the time of starting the Project. NIH considered that the ongoing work must
stop if
in fact an approved protocol expires.
IACUC
will work closely with investigators to clarify information or to help amend
the protocol in
a timely manner to ensure achieve congruency. In some cases, it might be necessary submit a
new protocol to establish congruency.
If
at the JIT congruence review the PI decides not to perform specific procedures
described in the grant a note should be filed, and the NIH should be informed
of the change with verification of IACUC approval, as part of the JIT process.
It is essential to recognize that compliance with the PHS
Policy is a term and condition of the Grants Policy Statement. More than just a
set of rules, the Grants Policy Statement defines contractual or legal
obligations between the grantee institution and NIH. If an institution accepts
PHS funds and fails to meet the terms and conditions, there can be fiscal,
civil, and/or criminal penalties.
For program consistency and to maintain the highest standards
for compliance, Einstein applies these rules to all funding proposals
regardless of source. Some sponsors
require proof of IACUC congruency approval at the time of submission. In those cases, IACUC will perform the congruence
review before the Grant submission.
NOTE: The Congruency Letter for IACUC Review is
different from the Protocol Approval letter. The Protocol Approval letter is
not acceptable documentation to ensure compliance with NIH Policy.
General information:
NIH Policy Statement 10/12 (4.1.1.2 Verification of
IACUC Approval)
http://grants.nih.gov/grants/policy/nihgps_2012/nihgps_ch4.htm#iacuc_approval_verification
Grant Policy and Congruence (Webinar)
Grants Policy and Congruence - June 7, 2012 | grants.nih.gov