Vertebrate Animals in Research

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The Institutional Animal Care and Use Committee (IACUC) ensures that the use of animals in research is in accordance with institutional and federal guidelines and to assist the faculty whose research and teaching activities involve animals.

IACUC applications are required to be submitted electronically through IRBNet. Please click here for more information.


Protocol Application Form - Use for filing a new protocol approval form or for a 4th-year renewal of an active approved protocol.
Protocol Modification or Renewal Form - Use for filing of annual protocol renewals or for modifications on active approved protocols.
*Note: Every three years, investigators are required to submit a new application. PHS Policy states that the IACUC must perform a de novo review every three years (we call this a 4th year renewal). Under the Animal Welfare Act, the IACUC must review ongoing protocols every year. In order to satisfy both agencies, the IACUC performs annual reviews of all ongoing protocols, as well as reviews new protocols.
Protocol Application Form for Contracted or Subcontracted Vertebrate Animal Activities - for use only when following LU IACUC SOP: Collaborative Work with Outside Institutions (see IACUC Standard Operating Procedures section below)
Lehigh University Assurance of Compliance: Lehigh University assures all animal activities are conducted in accord with the PHS Policy on Human Care and Use of Laboratory Animals and in accord with PHS Assurance Number A3877-01. The Assurance serves as the institution's policy on the conduct of teaching and research activities involving animals.

CITI Training for Investigators


IACUC Guidance


IACUC Standard Operating Procedures

Assurances and Registrations

PHS OLAW Animal Welfare Assurance

Assurance number D16-00505 (A3877-01) Effective 01-Aug-2017 to 31-Aug-2021
USDA Registration Registration number 23-R-0064 Expires 26-Feb-2020


IACUC Protocol Review Process (click here for a flow chart)

1The Principal Investigator (PI) must submit the required complete, original, hard-copy forms, including all signatures, to the Research Integrity office. Qualification Forms for all personnel listed on the protocol must be included with new applications or modifications involving adding new personnel. Incomplete and/or unsigned forms will be returned to the PI without review.

2. An acknowledgement of receipt is sent via email to the PI reaffirming that no animals may be purchased or any protocol activity can move forward until the PI receives the IACUC Approval Notice.

3. The IACUC Chair completes a pre-review that includes resolution of any open questions with the PI and assignment of Designated Member Reviewers.

4. Unless the IACUC Chair has called for Full Committee Review (FCR) during the pre-review process, the protocol forms are distributed to all IACUC members for review. Any IACUC member may call for FCR. Responses are due within five business days. If no member calls for FCR by the response date, the protocol is reviewed by Designated Member Review (DMR) by the reviewers assigned by the Chair. All comments and questions raised during the initial review are incorporated into the materials provided for DMR.

5. The DMR process may result in approval or request for modifications in order to secure approval. All designated reviewers must be unanimous in their response. If they cannot agree, then the protocol is returned for FCR.

6. When FCR is implemented, protocols are reviewed only at a convened meeting of the IACUC with a quorum present.  The available outcomes of FCR are (1) approval, (2) modifications required to secure approval, or (3) disapproval.  If modifications are necessary to secure approval, the PI must re-submit and the review process begins again.

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