Protocol Review

Small black mice investigate their animal housing enclosureA critical component of the Institutional Animal Care & Use Committee (IACUC)’s charge includes compliance with the U.S. Government Principles for the Utilization and Care of Vertebrate Animals Used in Testing, Research, and Training Principle II which states that “procedures involving animals should be designed and performed with due consideration of their relevance to human or animal health, the advancement of knowledge, or the good of society.”

To that end, the IACUC, along with veterinary staff specializing in laboratory animal medicine, carefully review the goals, objectives, and scientific benefits of all proposed projects to verify that:

multi color lines iconThe project has appropriate merit

The proposed research complies with all federal, state, and University laws, regulations, and guidelines

Humane use guidelines are followed and all animals involved are provided with the best possible treatment and professional veterinary care

A sufficient, but not excessive, number of animals being used is justified

Those who will be working with the animals have received the proper training, and

Proper practices and procedures are in place to reduce as much pain and/or distress to the animals as possible.

As part of its review and approval process, the IACUC specifically looks to the following to ensure that the protocol is compliant and upholds the highest animal welfare standards:

The U-M uses a web-based system called eResearch Animal Management (eRAM) for managing the submission, review, and approval of all applications involving the use of vertebrate animals. Learn more about the eRAM system, including how to request access, by visiting our eRAM page.

Protocol Review Timeline

Each member of the IACUC is provided access to all applications up for review. Members review the applications during a designated review period and indicate their approvals or issues of concern before the end of that period. Reviewer concerns will be communicated to the applicant, and his/her response returned to the designated reviewer for further consideration. Once all outstanding issues are resolved to the satisfaction of the reviewers, the application can be approved.

At any time during this process, any member may call for review of an application at a convened meeting of the IACUC. Applications reviewed at a convened IACUC meeting may be approved, denied approval, or require modification by majority vote of a quorum of members.

Failure to obtain proper approval and/or exemption from the IACUC is a violation of federal law.

Applications and proposals that have been approved by the IACUC may be subject to further appropriate review and approval by University officials. However, those officials may not approve an application if it has not been approved by the IACUC.

Occasionally, you may be required to submit additional documentation before your protocol can be reviewed and approved. Several of the most common scenarios requiring additional documentation are outlined below, along with links to more information and the required submission forms.

  • Requests for Special Treatments or Procedures:
    If your project includes special treatments and/or procedures that are exceptions to the Animal Welfare Act, PHS Policy, the Guide, or U-M policies and guidelines, you will need to submit a Request for Special Treatment or Procedure form.

  • Projects Not Subject to External Peer Review:
    As part of its review and approval process, and in compliance with federal law, the IACUC must assure scientific or instructional merit in the projects it approves. The IACUC considers a funding decision by external peer review to be adequate evidence of scientific merit. However, proposed projects that are NOT subjected to external peer review (including internally-funded projects, industry contracts or gifts, and instructional use of animals) must provide alternative evidence of scientific or instructional merit.

To that end, the IACUC requires that the Chair/Director of the home department/unit assure the scientific or instructional merit of ANY project to be undertaken prior to its review and approval. If your proposed project is not subject to external peer review, your Chair/Director must review the project and assure its scientific merit through the electronic submission of an eRAM application. Additional details can be found in the IACUC’s Guidelines for Unit Heads in Assuring Scientific or Instructional Merit: Proposals for Animal Use in Research or Teaching.

  • Projects Involving the Use of Non Pharmaceutical-Grade Drugs:
    Any animal-based research involving the use of non pharmaceutical-grade drugs, defined as those substances or drugs NOT approved by the FDA for use in humans or animals, MUST be approved by the IACUC and be based on either:
     
    1. The unavailability of an acceptable veterinary or human pharmaceutical-based compound, or
    2. Scientific necessity

Please note that cost savings alone is not considered an adequate justification for the use of non pharmaceutical-grade substances in laboratory animals. For more information, please review the U-M Policy on the Use of Non Pharmaceutical-Grade Drugs and its accompanying document, Information for Investigators on the Use of Non Pharmaceutical-Grade Drugs.

  • “Fee-for-Service” Protocols and Centers:
    Investigators who plan to utilize University of Michigan-based centers or cores offering research services on a “fee-for-service” basis in their protocol can reduce administrative burden by referencing the use of the service (and protocol number, if applicable) in their own IACUC-approved protocols. Please review the U-M Policy on the Use of “Fee-for-Service” Protocols and Centers for more information. Details on how to add a fee-for-service provider to your protocol in eRAM are available here.

Questions?

If you have additional questions about protocol review, please contact the Animal Care & Use Office at (734) 763-8028 or acuoffice@umich.edu.