IACUC SOP 302

AUP Review Criteria

  1. PURPOSE
    1. All research protocols that use vertebrate animal subjects must meet certain criteria before study related procedures can be initiated. The criteria are based on the principals of scientific conduct and guidelines established by the PHS, USDA, the Guide and the AWA and AWAR. In addition, certain other criteria that are unique to Texas A&M University’s system may apply and must be met as well.
  2. APPLICABLE REGULATIONS AND GUIDELINES
    1. AWAR 9CFR Ch. 1 §2.31(d)
    2. PHS Policy IV
    3. AVMA Guideline on Euthanasia (June 2007)
  3. PROCESS OVERVIEW

Minimal Criteria for Approval of Research

    1. In order for proposed animal activities to be approved, the IACUC must find that:
      1. Procedures with animals will avoid or minimize discomfort, distress and pain to the animals, consistent with sound research design;
      2. Procedures that may cause more than momentary pain and distress to the animals will be performed with appropriate sedation, analgesia or anesthesia, unless withholding of such is justified for scientific reasons in writing by the Pl;
      3. Animals that would otherwise experience severe or chronic pain that cannot be relieved will be euthanized at the end of the procedure before anesthetic recovery or during the procedure if appropriate;
      4. The living conditions of the animals will be appropriate for the species and contribute to their health and comfort;
      5. Medical care for animals will be available and provided as necessary by a qualified veterinarian;
      6. Personnel conducting procedures on the species being maintained or studied will be appropriately qualified and trained in those procedures;
      7. Methods of euthanasia used will be consistent with the recommendations of the AVMA Guidelines on Euthanasia, unless a deviation is justified for scientific reasons and detailed in writing by the investigator and approved by the IACUC;
      8. The Pl has provided written assurance that the activities do not unnecessarily duplicate previous experiments;
      9. Activities involving surgery include pre and post-operative care of the animals in accordance with established veterinary medical practices;
      10. No animal will be used in more than one major operative procedure from which it is allowed to recover unless justification is provided in writing by the Pl and approved by the IACUC.

4. RESPONSIBILITIES

    1. Pl – Investigators must submit an Animal Use Protocol (AUP) that provides accurate information regarding the proposed activities, including sources of external funding, conduct of certain activities and use of hazardous agents in or on animals.
    2. Research Compliance Staff Reviewers – Appropriately trained Research Compliance staff will conduct an unbiased evaluation of the submitted AUP
      1. Research Compliance staff will notify Pl upon receipt of a new submission acknowledging receipt, and verify that all required information is present at the time of submission or notify the Pl that additional information is needed.
      2. Research Compliance staff will send the protocol to all members of the IACUC for review.
      3. Research Compliance staff is responsible for ensuring grant proposals or funding contracts for studies receiving external funds are submitted and reviewed prior to IACUC approval of the AUP.
      4. Research Compliance staff verifies that all signatures of participants are obtained and that all participants have active CITI training on file.
    3. IACUC Reviewers – IACUC reviewers conduct an unbiased evaluation of the animal activities using criteria established by institutional and federal regulations, policies and recommendations, and maintain confidentiality regarding information provided in the AUP and grants.
      1. The Chair will assign members as the designated member reviewers (DMR) of each protocol.
      2. The committee members have five days to review a protocol and submit comments or call it to a full committee review.
      3. The DMRs have five additional days to review the protocol and evaluate the comments from other members.

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