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Animal Care Committee Connection Between Grant Application and Animal Care and Use Protocol

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Public Health Service Policy on Humane Care and Use of Laboratory Animals is what dictates the relationship between your grant submissions and your animal care and use protocols.

PHS Policy IV (D)(1)(a-e) states the following:

"D.  Information Required in Applications and Proposals for Awards Submitted to PHS

    1.  All Institutions

    Applications and proposals (competing and non-competing) for awards submitted to PHS that involve the care and use of animals shall contain the following information:

        a.  identification of the species and approximate number of animals to be used;

        b.  rationale for involving animals, and for the appropriateness of the species and numbers used;

        c.  a complete description of the proposed use of the animals;

        d.  a description of procedures designed to assure that discomfort and injury to animals will be limited to that which is unavoidable in the conduct of scientifically valuable research, and that analgesic, anesthetic, and tranquilizing drugs will be used where indicated and appropriate to minimize discomfort and pain to the animals; and

        e.  a description of any euthanasia method to be used."

PHS Policy IV (D)(2) continues:

    "2.  Institutions That Have an Approved Assurance

    Applications or proposals (competing and non-competing) covered by this Policy from institutions which have an approved Assurance on file with OLAW shall include verification of approval (including the date of the most recent approval) by the IACUC of those components related to the care and use of animals.  For competing applications or proposals only, such verification may be filed any time prior to award unless specifically required earlier by the funding component.  If verification of IACUC approval is submitted subsequent to the submission of the application or proposal, the verification shall state the modifications, if any, required by the IACUC.  The verification shall be signed by an individual authorized by the institution, but need not be signed by the Institutional Official."

PHS Policy V (B) continues:

"PHS awarding units may not make an award for an activity involving animals unless the prospective awardee institution and all other participating institutions have approved Assurances on file with OLAW, and 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.  If any one of these institutions does not have an approved Assurance on file with OLAW, the awarding unit will ask OLAW to negotiate an Assurance with the institution(s) before an award is made.  No award shall be made until all required Assurances have been submitted by the institution(s), been approved by OLAW, and the institution(s) have provided verification of approval by the IACUC of those components of the application or proposal related to the care and use of animals."

So, what does this actually mean?

First, if you route your grant stating that you have approval for your proposal- and place an ACC number on the routing slip- the ACC will verify that claim. 

1.  The final, approved version of the protocol, with any approved modifications, will be reviewed and compared with the procedures written in the grant proposal. 

2.  The ACC will ensure that the latest approval date of the approved protocol is correct.  Often, PIs list the original approved date of the protocol, this is incorrect.  The approval date listed should be the date of the  latest approval granted by the ACC.

3.  If there is a discrepancy between  the grant and the approved animal care and use protocol in which the grant states a procedure or procedures will be performed to the animals, and that procedure is not approved in the animal care and use protocol, the grant routing sheet will be changed to "pending".  The grant submitter (and PI of the animal care and use protocol, if different than the grant PI) will be notified that there is a discrepancy, that the grant contains procedures not approved in the protocol, and outlines the PI's options.

4.  If there is a discrepancy between the grant and the approved animal care and use protocol in which the animal care and use protocol contains procedures that are not in the grant, no action is needed by the ACC.  This is an acceptable discrepancy as far as the ACC is concerned, as the requirement is for all the grant procedures to be approved by an IACUC.  However, you might need to check with your project officer in ORSP- there are many requirements of the NIH Grants Policy which may need to be addressed.

Second, the ACC will ensure that you have the correct PHS Assurance Number on the grant application.  Frequently, people give the animal care and use protocol number as this number.  This is incorrect.  At the University of Connecticut Health Center, the PHS Assurance Number is A3471-01 and it is this number that should be reflected on the grant application (including the dash).

Third, if your grant proposal is listed as pending for vertebrate animal approval, the grant will not be reviewed by the ACC office.  However, it will be reviewed at some point prior to award of money from PHS to the institution to ensure that the procedures in the grant are approved by the approved animal care and use application that will be submitted at a later date by the PI.  Please note:  ORSP will not prepare the fiscal package and Finance will not be able to set up the account without the ACC approval even if you receive the Notice of Grant Award.

What are the options of the grant and/or protocol PI if there is a discrepancy?

1.  The easiest thing to do is to leave the proposal as "pending" for the vertebrate animal section.  If the grant proposal is likely to be funded, then the issue can be addressed.  This is perfectly acceptable as of the 2002 revision of PHS policy which included what is commonly called the "Just In Time" rule and does not affect the review of your grant application.

2.  The PI on the grant can delete the procedures in the grant that are not approved by the Animal Care Committee.  This can be done easily and, after receiving the changes required, the grant can be processed as being approved by the ACC.

3.  The PI on the approved protocol has the option to modify the animal care and use protocol to include the procedures that are not approved.  This is an option if the procedures in the grant that need approval are appropriate to the original protocol, taking into account the original protocol's stated scope.

4.  The PI on the grant has the option to submit a new animal care and use protocol to the ACC.  This is usually the appropriate option if the PI on the grant is not the PI on the approved animal care and use protocol and the scope of the work does not match the scope of the original, approved protocol.

What exactly is the "Just In Time" Rule allowed by PHS?

The National Institutes of Health changed the Public Health Service Policy on Humane Care and Use of Laboratory Animals (PHS Policy) to permit institutions with PHS Animal Welfare Assurances to submit verification of IACUC approval for competing applications after peer review, but prior to award. This change in PHS Policy is effective as of September 1, 2002 [Federal Register 67, 51289-51290 (7August 2002)].  Therefore, an application for funding from NIH agencies may choose to utilize the "just in time" (JIT) rule when processing proposals through Research Administration, by checking "Pending" in the approval date block. The NSF subsequently adopted this policy, and as of 2005, OCAST permits application of the JIT rule.  When notification of funding or likelihood of funding, the protocol application must be processed and approval obtained before the award.  If discrepancies are identified in the animal care and use protocol by the IACUC review, these must be corrected and then the funding agency is notified.  You typically get 60 days notice to get your letter of IACUC approval to the funding agency.

However;  there is a chance that, if you wait for your notification from the granting agency to submit your animal care and use protocol application to the ACC, you won't have an approval in 60 days.  Much depends on how the application is written and how complete it is.  It is generally recommended that, as soon as the PI hears that the proposal is likely to get funded, s/he should submit the animal care and use application to the ACC for review.

What if you have to modify your new protocol as a result of ACC review?

Your 398 grant application form certifies, among other things, that the ACC has (or will have within 60 days of the application) reviewed and approved all animal-related activities associated with that grant application.  The signature of an authorized institutional official indicates the Health Center's intent to comply with the laws, regulations, and policies we abide by.  The IO is also stating that the information contained in the grant application is true and complete and conforms with federal, state, and institutional policies and procedures.   The signatures for both the PI and the IO make it clear that there are potential civil and criminal penalties for submitting false statements or claims, however inadvertent those statements might be. 

If the ACC requires modifications to secure approval for the protocol and these changes the procedures contained in your grant application those changes must be communicated to the Public Health Service and it is the responsibility of the PI to do this.