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ÁÔÆæÖØ¿Ú Congruency Review

Requirements

The Congruency Review at the ÁÔÆæÖØ¿Ú is a critical process designed to ensure that research involving live vertebrate animals complies with both institutional and federal regulations. It confirms alignment between externally funded research proposals and Institutional Animal Care and Use Committee (IACUC)-approved protocols. This review safeguards the ethical treatment of animals and ensures research compliance with funding agency requirements.

What Is the Congruency Review?

The Congruency Review is a formal process conducted by the Office of Research Compliance in collaboration with the IACUC. Its purpose is to verify that the procedures and goals outlined in an investigator's grant proposal match the approved IACUC protocol. Any discrepancies must be identified and resolved before funds can be released. This ensures transparency, ethical standards, and adherence to the Guide for the Care and Use of Laboratory Animals.

Who Must Undergo a Congruency Review?

Any Principal Investigator (PI) conducting research with live vertebrate animals that is funded by external sources must undergo a Congruency Review. This applies to grants, contracts, and cooperative agreements from agencies such as the National Institutes of Health (NIH), National Science Foundation (NSF), and other public or private funding organizations.

Congruency review is required in the following situations:

1. Before the Release of PHS Funds:
   As per NOT-OD-10-049, institutions must verify that the animal activities described in a funded grant are consistent with the corresponding IACUC-approved protocol. This ensures compliance with the Animal Welfare Act and PHS Policy.
2. For New and Competing Grants:
   A congruency review is required whenever a new or competing grant involving animal research is submitted to a PHS agency, ensuring that all described procedures, animal numbers, species, and objectives align with the approved IACUC protocol.
3. For Amendments to the Scope of Work:
   If the grant is modified to include additional animal work or significantly change existing protocols, a new congruency review must be performed to ensure continued compliance.
4. In Response to Funding Agency Requests:
   Agencies like NIH may request documentation verifying congruency as part of their oversight responsibilities.

Key Congruency Review Requirements

1. Alignment with the IACUC Protocol
   • The research objectives, procedures, and animal use described in the funding proposal must align precisely with the corresponding IACUC-approved protocol. This includes species, number of animals, experimental design, and any procedures that involve animals.
   • Any changes to the research plan must be submitted as an amendment to the IACUC protocol and approved prior to initiating the modified work.
2. Submission Timeline
   • To avoid delays, PIs are encouraged to submit their funding proposal and IACUC protocol for Congruency Review as soon as the grant application is submitted. Early submission allows sufficient time for review and resolution of any discrepancies.
   • The review must be completed before the Office of Sponsored Programs can authorize funding release.
3. Detailed Animal Use Justification
   • Funding proposals must include detailed descriptions of animal use, including:
     • Justification for the species selected and the number of animals required.
     • A description of all experimental procedures, including surgery, behavioral testing, or sampling.
     • Plans to minimize animal pain, distress, or discomfort, and a description of appropriate anesthetics, analgesics, or humane endpoints.
4. Regulatory Compliance
   • The Congruency Review ensures compliance with all relevant policies, including:
     • The Guide for the Care and Use of Laboratory Animals.
     • Public Health Service (PHS) Policy on Humane Care and Use of Laboratory Animals.
     • U.S. Department of Agriculture (USDA) Animal Welfare Regulations (where applicable).
5. Resolution of Discrepancies
   • If discrepancies are identified between the funding proposal and the approved protocol, the PI will be notified and required to address them. The resolution may involve amending the protocol, revising the grant proposal, or both.
   • No research activities involving animals may begin until the Congruency Review is complete and the discrepancies have been resolved.

Why Is the Congruency Review Important?

The Congruency Review is essential for ensuring that all animal research conducted at the ÁÔÆæÖØ¿Ú is ethically sound, compliant with regulations, and consistent with the institution's commitment to humane animal care. The process protects the university, its researchers, and the animals involved by:

• Ensuring that research adheres to high ethical standards.
• Preventing non-compliance issues that could jeopardize funding or research timelines.
• Demonstrating transparency and accountability to funding agencies.
• Supporting the institution’s mission to conduct responsible and impactful research.

Congruency review protects animal welfare and upholds scientific integrity by ensuring:

• Research adheres to the Guide for the Care and Use of Laboratory Animals (8th Edition).
• Compliance with 9 CFR, Part 2, Subpart C, the regulations enforcing the Animal Welfare Act.
• Institutional accountability under the Office of Laboratory Animal Welfare (OLAW) assurance agreements.

Failure to maintain congruency can result in delays in funding, non-compliance findings, or potential loss of funding. Institutions and researchers alike benefit from this process by fostering a culture of ethical research and regulatory compliance.

ÁÔÆæÖØ¿Ú Congruency Review Form

How Does the Congruency Review Work?

1. Initial Submission:
   • The PI submits the funding proposal and the associated IACUC protocol to the IACUC Office.
2. Review Process:
   • Staff from the IACUC Office review the funding proposal and compare it to the IACUC-approved protocol.
   • Specific elements reviewed include: species, number of animals, experimental procedures, and objectives.
3. Feedback:
   • If discrepancies are found, the PI is notified and provided with clear guidance on how to address them.
4. Approval and Funding Release:
   • Once the proposal and protocol are aligned, the Congruency Review is approved, and a Congruency Review Certification is sent to the Office of Research and Creative Scholarship (ORCS) to communicate that compliance requirements have been met.

Resources and Support

The ÁÔÆæÖØ¿Ú provides extensive support to ensure that researchers can successfully navigate the Congruency Review process. Resources include:

• Guidance documents and templates for preparing grant proposals (ORCS) and IACUC protocols.
• Training on the ethical use of animals in research and compliance requirements.
• Direct support from the Office of Research Compliance and the IACUC office to address questions or concerns.

For additional information, visit the contact the IACUC office directly.