Stipulations of Approved Protocols

Animal care and use at Duke is a privilege that is accompanied with unique responsibilities and obligations. The conditions under which animal use is granted for the Duke campus include:



Approval Period: The date of approval for a protocol is three (3) years, contingent upon annual reporting of protocol activity.



Approved Number of Animals: The species and numbers of animals approved for the full three-year period of this study are limited by the approved protocol. Researchers requiring more than the approved numbers may request an amendment to the approved protocol.



Annual Reporting: Continued approval during this three year period is contingent upon the timely submission of Annual Review reports. The report forms are available / downloadable from the animal program website. The web address for the necessary forms is:
http://vetmed.duhs.duke.edu/FormsReports.html

Annual Review reports must be received and approved by the anniversary date of the original approval for continued approval of your protocol. All personnel listed on the approved protocol must be current on employee health surveillance and training requirements; supervisors can assess the status of employees health and safety status on the OESO web site (see Management Reports). The Office of Animal Welfare Assurance will alert you to the approaching annual report date so that you may respond promptly with your report.



Protocol Access: Information contained in your animal use protocol is considered privileged. The policy that governs access to the file can be viewed here.



Renewal of the Protocol: Federal requirements dictate a complete new review of continuing studies at the end of the three-year approval period. If you desire continuation of the protocol beyond the current (3 year) approval, you will need to submit a renewal application for review and approval by the IACUC. This renewal application must be a de novo submission; the IACUC cannot consider the current document in its present form. The Office of Animal Welfare Assurance will alert you at approximately the 32nd month of your current approval period. At that time, please prepare a new application for animal use and submit it before the applicable deadline. Please use the most current protocol template, also available on the animal program web site.

Without renewed IACUC approval, ongoing research under the retiring protocol must be halted. Any remaining animals must be:

  • 1) turned over to DLAR for disposal;
  • 2) transferred to another approved protocol; or
  • 3) transferred to the DLAR holding protocol (you cannot use any animals in active research being held on the DLAR protocol).


  • With IACUC approval of a new protocol submission, a new protocol registry number will be assigned. Any cage cards for existing cages of animals should be transferred to the new protocol number. You will need to contact DLAR so that they can prepare cage cards for you, and your staff should replace the retiring cage cards with the cards that reflect the new registry information. Failure to promptly transfer the animals to the new protocol registry number may result in the placement of new cage cards by DLAR staff with assessment of a service charge.

    Principal Investigator Responsibilities: Use of animals for research, testing, teaching, production, or exhibition must be in accordance with the USDA Animal Welfare regulations, PHS Policy on Humane Care and Use of Laboratory Animals, the NIH/NRC Guide for the Care and Use of Laboratory Animals, AAALAC accreditation guidelines, and Duke University Institutional Animal Care and Use Committee (DUIACUC) care and use policies. These references materials are available for review on the animal program web site at: http://vetmed.duhs.duke.edu.

    Personnel Performing Work Under This Approval: All personnel working with animals must be enrolled in an appropriate occupational health and safety program. The Duke University Occupational Health Program is available to all Duke students, employees and staff. Enrollment forms are available from the animal program web site. If you determine that additional personnel should be associated with this approved activity, then you must notify the IACUC of these personnel changes to the protocol, including changes in roles for existing personnel, and the addition or deletion of animal care and use personnel. These changes must be approved by the IACUC before personnel can begin work with animals. Except for a change in the Principal Investigator, a Minor Amendment form should be used for this purpose, also available on the animal program web site at http://vetmed.duhs.duke.edu/FormsReports.html




  • Amendment of the protocol: Approval for any change to the protocol (whether Significant or Minor) must be obtained from the IACUC prior to implementation of the change. Forms for requesting either a Minor or Significant Change are available / downloadable from the animal program web site at
    http://vetmed.duhs.duke.edu/FormsReports.html



    Post-Approval Monitoring of Protocols: Duke University and Duke University Medical Center is fully committed to quality animal care and compassionate animal use in an atmosphere of progressive animal based research. To fulfill our legal, ethical, and moral obligations under federal regulations, funding commitment, and accreditation principles, the institution will perform post-approval monitoring of approved activities:

  • A. All animal use areas are inspected every 6 months by a subcommittee of the IACUC. When this activity is required, the Office of Animal Welfare Assurance may contact your staff and determine a convenient schedule to visit your laboratory. While these visits are usually announced, the IACUC has the obligation to perform unannounced visits on occasion.


  • B. A second method of meeting public expectation of animal research management is through the Office of Animal Welfare Assurance’s Compliance Liaison Program (CLP). These individuals assure research integrity for the institution while facilitating your research needs and goals.