Office of Research

Guidance and Resources

The Animal Use Protocol (AUP) is required by Federal Animal Welfare Regulations and the PHS Policy. The Clemson University AUP has been designed to provide all information required by the Animal Welfare Act, the PHS Policy and the ILAR Guide (e.g., the AUP must contain complete and accurate descriptions of the animal species and numbers that will be used, all animal procedures and activities that will be conducted and an accurate description of the training and qualification of all persons involved with proposed activities). The information requested in the “Clemson University Protocol for Use of Live Vertebrates” is based on:

Clemson assures all animal activities are conducted in accord with the PHS Policy on the Care and Use of Laboratory Animals and in accord with the CU PHS Assurance Number A3737-01 (Assurance was renewed on May 1, 2014 for four years. Assurance will expire on May 31, 2018).

Continued Full Accreditation through Association for Assessment and Accreditation of Laboratory Animal Care International (AAALAC) Issued June 24, 2015.

Exceptions to the recommendations in the ILAR Guide, the Agricultural Guide, and the AVMA Guidelines on Euthanasia, require written scientific justification and must be approved by the IACUC.

Study Personnel and Animal Contact

It is required that the “General Information, Qualifications of Personnel” be completed and the conditions met which are set forth under this requirement. The names of all individuals who will be working with the animals on this project must be provided. Include all investigators, student employees, graduate students and laboratory assistants.

If you have “significant animal contact” (defined as any contact with animals), you must enroll in the Clemson University Occupational Health Program (or sign a waiver of exclusion). You must also attend the Animal Care and Use Seminar. Enrollment and attendance at both seminars will be verified. For more information on these courses, contact the IACUC at 864-656-4538.

Review Procedure

  • Protocols are reviewed by the Office of Research Compliance, the attending veterinarian and the IACUC.
  • Protocols might be assigned either designated or full review status.

Designated: Designated review protocols will be assigned an IACUC reviewer. A five-business-day lapse period is assigned in which members have the opportunity to review the protocol and to respond to the reviewer if there are concerns. If no concerns are expressed by committee members or the reviewer, the protocol will be approved and the investigator and farm manager (if applicable) will be notified. If problems occur or concerns are noted, the protocol will be processed utilizing full committee review.

Full: Full committee reviews are reviewed and discussed at the monthly IACUC meetings. Prior to the meeting, two reviewers are assigned to review the protocol and to provide an overview to the committee at the meeting. The following actions may result:

  • Approve as submitted
  • Withhold approval pending clarifications or modifications
  • Disapprove

The investigator and farm manager (if applicable) will be notified of the review outcome.

Please note: Animal facility managers are not allowed to purchase, transfer or accept animals for projects until receipt of documented IACUC approval.

Qualifications of Personnel

Regulations in both the PHS Policy and The Animal Welfare Act require that Clemson University provide training for investigators, graduate students and technicians. The specific training areas mandated by The Animal Welfare Act and the institutional training program are described in the Animal Care and Use Handbook. Every investigator must attend a seminar on animal care and use conducted by the Office of Research Compliance (ORC) when offered. Currently, you must train online. If you have any questions, contact the IACUC Office at 864-656-4538.

The Animal Welfare Act places responsibility with the IACUC for determining qualifications of individuals involved in animal research, teaching and testing activities. Qualifications to perform specific procedures will be based on information provided in this section.

Graduate students who plan to perform surgery, administer anesthesia or perform euthanasia must document adequate training prior to conducting these procedures. Investigators and research technicians who are not experienced with animal procedures required by the protocol must schedule individual training through the Office of Research Services. Veterinary technicians and research technicians skilled in performing specific procedures will provide training and provide the IACUC with an assessment of the individuals’ qualifications.

All provided information will be verified and recorded. The IACUC is required by law to annually re-evaluate qualifications. This will be done by monitoring animal procedures and annually updating training and experience by request of an annual review. Investigators are responsible for ensuring that all their personnel are trained and that employees implement proper animal procedures.

Applying to NIH?

NIH Office of Extramural Research (OER) has produced a podcast explaining what must be included in your grant application if you use vertebrate animal in your research. The podcast or a transcript can be found at http://grants.nih.gov/grants/oer.htm.

The NIH proposal requires information about animal facilities where the work will be performed.  We have created a boilerplate statement to help you respond to this question.

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