Congruency Review of Federal Awards and IACUC Protocols

• Regulation
• Requirement
• Definitions
• Roles and Responsibilities
• Conducting Congruency Reviews
• Special Circumstances
• Contacts
• References

Regulation

The Public Health Service (PHS) Policy and the Department of Defense (DoD) Instruction 3216.01

states that the awardee must verify that the IACUC reviewed and approved those components of the grant/contract proposal related to the care and use of animals [PHS Policy IV.D.2]; DoD Instruction 3216.01 states, “The performing institution’s IACUC must approve DoD-supported RDT&E and training involving animals in accordance with Title 7, U.S.C., before the activity begins.  In addition, the National Institutes of Health’s (NIH) Grants Policy Statement states that it is an institutional responsibility to ensure that the research described in the application is congruent with any corresponding protocols approved by the IACUC.  No costs for activities with live vertebrate animals may be charged to PHS and PHS like grants, unless the IACUC approves the activity. [NIH GPS 4.1.1.2]

Requirement

Federal sponsors require congruency as part of the terms and conditions of the award.  Congruency between the federal award and an IACUC protocol shall be established prior to using the awarded funds on animal research activities. 

Definitions

Congruence is agreement between the animal activities described in a federal grant application and the protocol reviewed and approved by the IACUC. The review of the protocol and application is herein called a congruency review. Yale has the authority to determine the extent of the agreement between grants and protocols and what they deem congruent [OLAW Webinar 06/07/12, OLAW Webinar 03/10/2016].

Grant application, herein referred to as “Application”, is a request for financial support of a project or activity submitted to PHS, DoD, and other federal sponsors. Resulting awards may be in the form of a grant, cooperative agreement, or contract.

Congruency date is the date that the IACUC determined congruency between the Federal grant application and the protocol.  This date is entered into the IRES Proposal Tracking record’s “Approvals” tab under “Additional Approval information/Animal Protocol Congruency”.  An approval letter is uploaded into the IRES general tab for the parent record of the award.

Roles and Responsibilities

Principal Investigator (PI) and/or their Business Office

• Requests a congruency review as soon as possible when a Just-in-Time notification is received from a federal sponsor. 
• Seeks prior approval from the sponsor regarding a proposed change in scope of an award.
• Communicates with OSP who is responsible to submit all change in scope requests.
• Notifies OARS if a change in scope affects an animal protocol (in case a protocol modification is required) and submits all appropriate documentation for review. [NIH GPS 8.1.2.5.]
• The IACUC must review and approve all modifications to an IACUC-approved protocol before modification implementation

Office of Animal Research Support (OARS)

• Delegated by the Institutional Official to assure congruency between federal applications and approved Yale protocol(s).
• Receives and conducts congruency requests from investigators, department’s business office, or the Office of Sponsored Projects.

• If incongruent, the protocol liaison works with the PI to achieve a resolution.

Office of Sponsored Projects (OSP)

• Communicates the congruency date to the sponsor so that the award can be issued or any special terms and conditions in an award is/are satisfied.
• Ensures a congruency date exists prior to setting up an award and if not, places a restriction on animal-related expenses charged to the award.
• Creates the sponsored award in Workday in order to incur award-related expenses.
• Communicates with the grantee institution regarding subawards.

Conducting Congruency Reviews

Congruency reviews are typically conducted when a federal funding source is linked to an IACUC protocol(s).  Congruency reviews (and eventual approval) of the application and protocol are completed as follows:

1. The PI or department business office requests OARS to conduct a congruency review.  To avoid delays in issuing an award, the request should be made as soon as the Just-in-Time, or other notification of a high score/award, is received.  Such requests are made to OARS (iacuc@yale.edu; 203-785-5992).

2. A congruency review by the Research Liaisons (OARS) focuses on three sections of the grant application:

• Research Strategy Section: Verification that overarching research themes that are described are in one or more IACUC protocol(s).
• Vertebrate Animal Section (VAS):  Verification that details describe/“match” one or more IACUC protocol(s)
• Performance Sites: Verify with OSP all sites where animal work is proposed.

3. A congruency review of a DoD grant by the Research Liaisons (OARS) focuses on the sections of the grant application proposing animal research including but not limited to:

• Research Strategy Section:  Verification that overarching research themes that are described are in one or more IACUC protocol(s).
• Specific Aims: Verification that details describe/“match” one or more IACUC protocol(s)
• Performance Sites: Verify with OSP all sites where animal work is proposed. 

4. If congruency cannot be established, the PI is notified to clarify the perceived incongruence and/or modify the protocol to be consistent with the grant application.  In rare cases, authorization from the sponsor’s grant specialist or program official may be requested in order to proceed with the grant-protocol linkage, understanding that the protocol may exclude significant portions of the grant.

5. When congruency has been established, OARS will document the grant-protocol linkage in IRES Approval tab and/or MAPS as the “Congruent Date” field.  OARS wills send an email stating congruency has been established to the PI of the grant, the PI of the protocol as well as the OSP contact.  OSP will then notify the sponsor of the congruency approval date, if required, so that funds may be released.

6. When the Notice of Award or Fully Executed agreement is received, OSP creates a sponsored award in Workday in order to begin the research and incurring related expenses.  Congruency cannot be established until an IRES number is created by OSP.

Congruency review is required for:

Public Health Service (PHS) agencies and other federal sponsors.  Congruency review is required for PHS agencies and other federal sponsors, such as, the National Science Foundation, Department of Veterans’ Affairs, and Department of Defense

Department of Defense requires a side-by-side match of its awards, Yale protocols, and DoD ACUROs.  In order to assist the investigators with the DoD’s side-by-side review, the OARS congruency confirmation of DoD awards will be less flexible than for other awards. Please note: DoD agencies require that their ACURO approve Yale’s protocol before the work can begin. ACURO approval is the final requirement prior to DOD funding activities taking place. 

Subawards to Yale from an Applicant or Grantee Institution (a.k.a. Recipient or Prime Awardee).  If the grantee institution plans to issue a subaward to Yale which includes the performance of live vertebrate animal work funded by a federal sponsor, a congruency review will be performed between the scope of work included in Yale’s subaward application to the grantee institution and the Yale protocol(s).

• In order to perform a congruency review, a copy of the Research Aims and Vertebrate Animals Section from the grantee institution’s grant application may be necessary. OSP will work with the Yale PI and the grantee institution to obtain this information
• The grantee Institution may request Yale’s assurance of congruency for Yale’s scope of work.  The OSP Proposal Manager would submit this at just-in-time.
• The grantee Institution may request the Yale IACUC protocol covering the proposed animal work, the date of IACUC protocol approval, the protocol approval letter, or additional documentation, which would be submitted to the grantee institution by the OSP Proposal or Award Manager.

Congruency review is NOT required for:

Fellowships/Training Grants. Congruency reviews are not required for fellowships or training grant applications that have budgets containing only stipend support (funds for animal research are not included). All related vertebrate animal work must be approved by the IACUC. These awards will be setup following OSP’s normal process.

Other Sponsors.  Non-federal awards do not require Yale to follow federal guidelines regarding congruency. In these cases, in order to support associated business processes, the IRES “Approved” date indicates the date when it was determined that the award does not require a congruency review.  OSP will follow its usual process for award setup. 

Internal (University) funds used to support animal research are not subjected to a congruency review.  Internal funds include unrestricted departmental accounts, a PI’s start-up package, gifts, etc.

Subawards issued by Yale to a Subrecipient Institution (a.k.a. Consortium or Collaborating Institution).  Yale relies on the subrecipient institution to conduct a congruency review using its own protocol(s) and the scope of work submitted to Yale as part of the subrecipient’s subaward application to Yale.  If the subrecipient is not a participant in the FDP Pilot (FDP Expanded Clearinghouse website), they will complete a Subrecipient Information and Compliance (SIC) form, which OSP and OARS will review. 

• Active NIH Animal Welfare Assurance (domestic) or an active Animal Welfare Assurance for Foreign Institutions (international)

• AAALAC Accreditation – if the institution is not accredited and animal ownership is not clear in the subaward, then a memorandum of understanding regarding animal ownership will be written (by OARS)
• Active USDA Registration, if applicable
• IACUC approval date(s) of the associated protocol(s)

Performance Sites. For federal sponsors requiring congruency review, off-site institutions where Yale-supported research is performed should be listed as a “performance site”, if applicable. 

Special Circumstances

Time-Sensitive Awards that are NOT Congruent. If the grant application is awarded or ready to be awarded, but congruency cannot be immediately determined in a short period time, the PI may work with OSP to create either an account in Workday or At-Risk Account (depending on the circumstances) in order to conduct in vitro studies or other activities but restricting the PI from incurring any animal-related expenses. The PI must write to OSP attesting no animal work will be conducted until the grant application and protocol is determined to be congruent.  In such cases, OSP will set up the award through the expected congruent date.  If the at-risk award is not funded by the sponsor, the PI’s department will be responsible for any incurred costs that would have been funded by the award. 

Variations to the procedures described in this process document will be reviewed on a case-by-case basis by the OARS Director and other interested parties (IO, OSP, etc.).

Contacts

References

• PHS Policy (2015)
• OLAW Webinar (2012)
• OLAW Webinar (2016)
• NIH Grants Policy Statement (2016). Section 8.1 Changes in Project and Budget
• Policy 1307 Subrecipient Monitoring
• Procedure 1307 PR.03 Monitoring Subrecipient Activity Associated with Sponsored Programs