Research@UIC > OACIB > ACC > FAQs: Protocol Matches

Frequently Asked Questions: Protocol-Funding Matches

General Protocol Submission | Completing Protocols | Protocol-Funding Matches

In order for the University of Illinois at Chicago (UIC) to ensure full compliance with the PHS Policy for the Human Care and Use of Laboratory Animals, the NIH Grant Policies and Instructions, Terms and Condition of other granting agencies, and the UIC Animal Welfare Assurance on file with the NIH Office of Laboratory Animal Welfare (OLAW), a process for matching grant applications to approved ACC protocols has been developed. The potential consequences of noncompliance with this issue could result in loss of funding and suspension of research work related to the grant. To assist investigators in determining what is needed and when, the Office of Animal Care and Institutional Biosafety (OACIB) have developed the following FAQs and decision matrix diagrams.

What is needed to submit a funding proposal (grant or contract) to ORS if animal work is proposed in the application?
What do I need to do once my funding is submitted?
When should I submit a protocol or modification to ACC?
Do all funding applications proposing animal work need to be matched to an ACC protocol?
Can a single ACC protocol cover multiple grants/funding applications?
Can multiple UIC ACC protocols cover one grant?
What do I need to do if the grant proposes subcontracting work involving animals to another institution?
What do I need to do if the source of funding for my animal work is from a subcontract from another institution?
What do I need to do if I am submitting an institutional training grant, which may involve the use of animals on some trainee projects?
What do I need to do if I am submitting a travel or conference grant, which involves the use of animals at non-UIC sites?
What do I need for a noncompetitive renewal of an awarded grant?

1. What is needed to submit a funding proposal (grant or contract) to ORS if animal work is proposed in the application?

a. For agencies that require verification of IACUC (ACC) approval at the time of submission.

If the agency requires verification of IACUC approval at the time the funding application is submitted, then there must be an approved ACC protocol(s) that matches all of the proposed studies involving animals and the grant must be matched to the protocol by the OACIB prior to submission to ORS. The proposal approval form (PAF) submitted to ORS with the grant should indicate that the proposal involves the use of animals by checking the appropriate box under special clearances. An ACC number does not need to be provided on the PAF document. Failure to obtain a match will impact ability to submit grant. See Diagram 1.

b. For agencies that do not require verification of IACUC (ACC) approval at the time of submission.

For all new funding applications or all competitive renewals to any agency that does not require IACUC approval at the time of funding proposal submission, prior approval by the UIC ACC is notneeded at the time of submission to ORS. All funding applications must indicate that ACC approval is pending at the time of submission and no approval date should be listed. The proposal approval form (PAF) submitted to ORS with the grant should indicate that the proposal involves the use of animals by checking the appropriate box under special clearances. An ACC number does not need to be provided on the PAF document.

2. What do I need to do once my funding is submitted?

If approval from the funding agency was not required at the time of submission, then after processing of a funding proposal, the principal investigator of the funding application will receive an email from OVCR reminding them that one of the following actions needs to be taken (See Diagram 2 and 3). The email will outline the process listed below.

a. Principal Investigator or UIC Collaborator (listed on grant as collaborator for animal work) has a current approved protocol covering ALL (e.g., animal model, procedures, animal numbers, specific experiments) specific animal work proposed in funding application.

The investigator/collaborator will need to request that the funding proposal be matched to the ACC protocol via modification. The following information must be provided in the modification: 1) PI of the Funding Application, 2) Title of the Funding Application, 3) Funding Agency, 4) Proposal Approval Form (PAF) Number, 5) Funding Application Number (e.g. grant number) assigned by the Funding Agency, if known, and 6) Role of the ACC Protocol PI on the funding application, if they are not PI of the funding application.

Generally for grants in which animal work will be conducted by a UIC Collaborator, the PI of the grant needs to be listed as Co-PI on the ACC protocol and should be copied on all correspondence. This is especially important for fellowships and individual grants. The PI of the grant has ultimate responsibility for the animal work conducted using those funds and must have a say on what is being done in the protocol. For center grants and program project grants in which it is clear that there are multiple facets to the project, this may not necessary. See FAQ #6 for multiple ACC protocols.

b. Principal Investigator or UIC Collaborator (listed on grant as collaborator for animal work) has a current approved protocol, which could be modified to cover the specific work proposed with animals in the funding application. NOTE: If the scope/purpose and/or animal work deviate significantly from the approved protocol, a modification will not be accepted and a new protocol will be required.

The investigator/collaborator will need to submit a modification requesting the following:

The modification should request any additional animal models, animal numbers, procedures, etc. that are in the funding proposal and not currently approved in the protocol.
The modification should request a match of the ACC protocol to the new funding submission and provide the following information:

1) PI of the Funding Application,

if known

Generally the PI of the grant needs to be listed as Co-PI on the ACC protocol and should be copied on all correspondence. This is especially important for fellowships and individual grants. The PI of the grant has ultimate responsibility for the animal work conducted using those funds and must have a say on what is being done in the protocol. For center grants and program project grants in which it is clear that there are multiple facets to the project, this may not necessary.

c. Principal Investigator or UIC Collaborator does not have an approved protocol.

A complete Protocol for Animal Use with all necessary forms and appendices covering the animal work proposed in the funding application will need to be submitted for review and approval and to match the funding to the protocol.

3. When should I submit a protocol or modification to ACC?

As always, regardless of the funding source, an ACC protocol must be approved prior to the initiation of any work involving animals.

Please note that it is the investigator’s responsibility to submit complete protocol/modification forms for review and approval in a timely manner so as not to delay the awarding of funds. The review of protocols or modifications will follow the normal process, procedure and timeline for review and will not be expedited. The process of ACC review and approval for a new protocol or a modification for full committee review takes approximately 30-60 days to complete. In general, administrative modifications can be approved in approximately one week and modifications eligible for designated review within 15-30 days. A general rule of thumb is to submit a protocol and/or modification if the funding submission receives a favorable priority score. However, depending on the specific proposal, funding agency, etc., submission to the ACC should be done sooner, in order to ensure approval before requested by the funding agency. For most federally funded applications the approval process must be completed prior to UIC’s submission of just in time information and acceptance of the award.

4. Do all funding applications proposing animal work need to be matched to an ACC protocol?

Yes. All funding applications proposing the use of animals must be linked to a UIC ACC protocol. The actions outlined in FAQs 1-3 must be completed for each funding submission (PAF #) even if the same grant is submitted to more than one agency or if revisions to the grant are resubmitted to the same agency as a revised application. Each is processed as a separate submission by ORS. If the work has already been matched to a grant and the same animal work is being submitted in multiple grants then a modification is all that is needed for each new grant proposal.

5. Can a single ACC protocol cover multiple grants/funding applications?

Yes, it is possible to have a single ACC protocol linked/matched to several funding sources. This condition can exist for a couple of reasons. First, as outlined in FAQ 4, essentially the same grant is often submitted to several agencies and must be matched to a single protocol. In the second instance, different grants may all be covered by a single protocol. In order for the second example to exist, the grants must be clearly related in scope and overall purpose, and the animal work proposed on the different funding applications must be very similar if not identical. Complications with matching various aspects of protocols with multiple grants can delay approval of the protocol, so investigators are strongly advised to review all animal work proposed in the grants listed on a protocol to ensure that the protocol covers all aspects and that it is clear which studies relate to which grant. If the scope/purpose and/or animal work deviate significantly in the different funding applications, then separate protocols must be submitted. The OACIB should be contacted regarding questions as to whether to combine grants on single protocol. PIs are strongly advised to do this prior to submission of the protocol or modification. In addition, if multiple grants will be linked to a single protocol, the PI of the funding application must be the PI or a Co-PI on the ACC protocol.

Linking several protocols to a single ACC protocol is generally not recommended for funding applications submitted to Department of Defense Agencies, as a strict one-to-one match is often required by these funding sources. It is a strongly recommended that to have a single protocol for each DOD application.

It is also important to remember that all fellowship funding applications must follow the same rules as major grant applications. It is recommended that investigators review the grant agency requirements to determine if a single protocol, with the fellow as PI is required for acceptance of funding awards. At a minimum, the fellow must be listed as a Co-PI on the animal protocol and must be copied on all correspondence.

If a financial conflict of interest exists for one of the funding sources, then a separate protocol must be submitted for the animal work supported by this source. For questions related to conflict of interest contact the OACIB or the COI office.

6. Can multiple UIC ACC protocols cover one grant?

Yes, certain grants/funding applications may require approval on multiple protocols (e.g., program project grants, center grants, multiple collaborators, etc.). When multiple protocols are required to cover all aspects of a single grant, each protocol must list which portion of the grant it is covering (e.g., project 1 of a program project grant, specific aim 1 and 2 of an RO1 grant, etc.). In addition, a Form G Umbrella protocol must be submitted. The PI of the grant should be the PI of the Form G protocol. In order for UIC to transmit information related to ACC approvals to the funding agency, all aspects of a grant involving animals must be covered by a protocol. Form G protocols serve to link all ACC approvals together for the purposes of the grant and to provide a single date of ACC approval, which is the date that should be submitted to the granting agency. Failure to cover all aspects of a grant will result in a delay in transmitting the necessary approvals to a granting agency and could impact the award. See Form G and Example 1 for use of the Umbrella Protocol.

7. What do I need to do if the grant proposes subcontracting work involving animals to another institution?

If any portion of the work proposed in the funding application is being conducted at UIC, then the normal protocol submission process must be completed for the proportion of work that will be conducted with UIC as the performance site. The protocol(s) will need to list which portions of the grant are being conducted at UIC. In addition, a Form G Umbrella protocol must be submitted in order to cover those portions of the animal work that are being subcontracted to another institution. On Form G, the PI (this should be the grant PI) will need to list all UIC ACC approvals, as well as, the approvals from the institutions to which the animal work will be subcontracted. A copy of the approval letter(s) and the protocol(s) from the other institution(s) must be provided with the Form G protocol so that UIC can ensure that the work approved covers the scope of the subcontract. As the primary grantee, UIC is ultimately responsible for the animal work conducted and must ensure full compliance with all federal regulations. Form G protocols serve to link all ACC approvals together for the purposes of the grant and to provide a single date of ACC approval, which is the date that should be submitted to the granting agency. Failure to cover all aspects of a grant will result in a delay in transmitting the necessary approvals to a granting agency and could impact the award. See Form G and Example 1 for use of the Umbrella Protocol.
If all of the work proposed in the funding application is being subcontracted to outside institutions, then only Form G must be submitted. On Form G, the PI (grant PI) must list all ACC approvals from the institutions to which the animal work will be subcontracted. A copy of the approval letter(s) and protocol(s) from the other institution(s) must be provided with the Form G protocol. See Form G and Example 1.

8. What do I need to do if the source of funding for my animal work is from a subcontract from another institution?

The same rules apply to subcontracts as apply to funding applications submitted through UIC. Subcontract funding awards proposing the use of animals should not be accepted until all necessary ACC approvals and funding matches have been completed. PIs will need to request copies of grants from collaborators (portions to be done at UIC) or scope of work from subcontracts and provide appropriate grant information (grant PI, subcontracting institution, etc.) in order to provide funding matches.

PIs must request funding matches to protocols prior to submitting approval letters and dates of approval to collaborators at other institutions.

9. What do I need to do if I am submitting an institutional training grant, which may involve the use of animals on some trainee projects?

Institutional Training Grants have a central focus for training, but generally do not propose specific projects with details. However, many do propose training that could involve work with animals. As with all other funding proposals, these grants must be matched to an ACC protocol. In order to cover these grants, a Form G Umbrella protocol should be submitted. On Form G, all potential preceptors/mentors at the time of protocol submission, and their approved ACC numbers that apply to the focus of the grant should be provided. The PI of the training grant should be the PI of the Form G protocol.

If the agency requires approval at the time of submission, then the process outlined in FAQ 1a should be followed. For all other applications, the process outlined in FAQ 1b should be followed. See Form G and Example 2 for these grants.

10. What do I need to do if I am submitting a travel or conference grant, which involves the use of animals at non-UIC sites?

If a travel or conference grant is submitted that details specific studies involving animals, then an ACC protocol is required. If all the work will be done at a Non-UIC site, then Form G is required along with approval letters and protocols from the performance site. The PI of the grant should be the PI of the Form G protocol.

11. What do I need for a noncompetitive renewal of an awarded grant?

Once an award proposing the use of animals is made, the PI must maintain current ACC approval throughout the life of the award (including no cost extensions) unless the granting agency is informed that all animal work is completed and no additional animal work will be conducted. Approval cannot be pending at the time of noncompetitive renewal. Failure to maintain current approval can impact the processing of renewals by the granting agency. In addition, NIH does not allow grant funds to be used to maintain animals on expired protocols. Failure to submit renewal protocols in a timely manner so that they are approved prior to expiration of the old protocol will result in animals being transferred to the Institutional Holding Protocol, and transfer of animal expenditures to departmental accounts.

The maximum approval period for an ACC protocol is three years and in order to be continued, the protocol must be renewed annually. After the three-year maximum approval period, a new protocol must be submitted de novo review and approval. If requested by the granting agency, the approval date of the original protocol, replacement protocol, or the most recent renewal date should be reported on the progress report. The PAF submitted to ORS should indicate that the project involves animals by checking the appropriate box in the special clearance section of the form. An ACC number is not required on the form.