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Protocol - Proposal Congruency

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The UMKC Office of Research Services is responsible for ensuring that all animal activity proposed in a funding proposal has been approved by the IACUC and is covered in an active, approved IACUC protocol (i.e. protocol to proposal congruency).

A Congruency Review must be completed for grants proposing animal studies before the award of funds either at JIT notice or Notice of Award for the following funding agencies:

  • National Institutes of Health (NIH)
  • All NIH subdivisions (e.g. NCI, NHLBI, NIAID, NIDDKD, NIAAA, etc.)
  • National Science Foundation (NSF)
  • American Heart Association (AHA)
  • American Cancer Society (ACS)
  • Veterans Affairs (VA)
  • March of Dimes (MOD)

The UMKC IACUC will conduct a congruency review between the proposal and the protocol to ensure the work described in the proposal comports with the protocol.  If there are discrepancies between the proposal and protocol, the IACUC will request a modification to the protocol to achieve congruence.  Note that investigators can submit a protocol modification prior to requesting a congruency review and this is highly recommended in instances where the animal work proposed is not yet covered in an approved protocol. 

Any award involving animal work requires a congruency review and IACUC congruency approval before UMKC Sponsored Programs will release funds associated with that award.  Some sponsors require proof of IACUC congruency approval at the time of submission.  When congruency is established, the UMKC IACUC will provide documentation to the investigator.   

The chart below shows the typical path of a congruency review.  If you have any questions about congruency requirements, please contact us at umkciacuc@umkc.edu.

A congruency review is a side by side comparison of a proposal (grant, award, contract, subaward, etc.) to a protocol to ensure that all animal activity outlined in that proposal has been approved by the UMKC IACUC and is contained in an approved animal protocol.  A congruency review is required for all funding that uses live vertebrate animals to ensure the work described in the proposal comports with an active, approved protocol. UMKC has a one-to-many/many-to-one system which means one funded proposal can be linked to one or many protocols, and one protocol can be linked to one or many proposals.

What are we looking for during our review?

The items we look at during our review include but are not limited to: 

  • General scope of work - disease area, target organs, and/or biological target being studied, etc.
  • Species – sex, age, numbers, strains, potential clinical issues, breeding, etc.
  • General procedures including administration of agents, blood/tissue collection, antibody generation, imaging, behavioral studies, etc.
  • Experimental and therapeutic agents.
  • Surgical procedures.
  • Euthanasia method.
  • Death as an endpoint – any procedures that suggest death as an endpoint (USDA pain category E) or survival curves generated (Note:  if a modification to the protocol is required to cover death as an endpoint studies, that modification must be reviewed by the full IACUC committee at a monthly IACUC meeting).
  • Personnel conducting animal work.

The principal funding source for live vertebrate animal research at UMKC is the U.S. Department of Health and Human Services (HHS), primarily through the Public Health Service (PHS) and the National Institutes of Health (NIH).  PHS and NIH Grants Policy requires the institution to verify, before award, that the institution’s IACUC has reviewed and approved the animal work outlined in the proposal.  Specifically, “It is an institutional responsibility to ensure that the research described in the application is congruent with any corresponding protocols approved by the IACUC.”  (NIH Policy Statement 10/12)

Therefore, a congruency review is required for all funding that uses live vertebrate animals to ensure the work described in the proposal comports with an active, approved protocol. At UMKC, the IACUC conducts a side by side direct comparison of the proposal and IACUC protocol.  Excerpts from both the PHS and NIH Grants Policy Statements can be found below.

NIH Grants Policy Statement (10/12)

4.1.1.2 Verification of IACUC Approval

NIH Grants Policy Statement

PHS Policy on Humane Care and Use of Laboratory Animals Frequency Asked Questions

NIH Frequently Asked Questions

PHS Policy on Humane Care and Use of Laboratory Animals

PHS Policy on Humane Care and Use of Laboratory Animals

To request a Congruency Review submit a Congruency Request Form (PDF) to umkciacuc@umkc.edu.  

As noted on the form you will need to supply the IACUC with the following grant application sections:
  • Vertebrate Animals Section
  • Grant Research Strategy Section
To expedite the review process your are encouraged to draw the IACUCs attention to the specific grant application sections that pertain to the particular IACUC application.  

The items we look at during our review include but are not limited to: 

  • General scope of work - disease area, target organs, and/or biological target being studied, etc.
  • Species – sex, age, numbers, strains, potential clinical issues, breeding, etc.
  • General procedures including administration of agents, blood/tissue collection, antibody generation, imaging, behavioral studies, etc.
  • Experimental and therapeutic agents.
  • Surgical procedures.
  • Euthanasia method.
  • Death as an endpoint – any procedures that suggest death as an endpoint (USDA pain category E) or survival curves generated (Note:  if a modification to the protocol is required to cover death as an endpoint studies, that modification must be reviewed by the full IACUC committee at a monthly IACUC meeting).
  • Personnel conducting animal work.