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Protocol Review

A. Policies

In order to approve proposed activities or proposed significant changes in ongoing activities, the University Committee on Animal Care ( UCAC) will conduct a review of those components of the activities related to the care and use of animals and determine that the proposed activities are in accordance with the Animal Welfare Act , the NIH "Guide for the Care and Use of Laboratory Animals" ( Guide), and the Public Health Service Policy on Humane Care and Use of Laboratory Animals ( PHS Policy), unless acceptable justification for a departure is presented in writing. The UCAC will determine that the proposed activities or significant changes in ongoing activities meet the following requirements:

1. Procedures involving animals will avoid or minimize discomfort, distress, and pain to the animals.

2. The principal investigator has considered alternatives to procedures that may cause more than momentary or slight pain or distress to the animals, and has provided a written narrative description of the methods and sources, e. g. Medline, Agricola, or the Animal Welfare Information Center, used to determine that alternatives were not available.

3. The principal investigator has provided written assurance that the activities do not unnecessarily duplicate previous experiments.

4. Procedures that may cause more than momentary or slight pain or distress to the animals will:

a. Be performed with appropriate sedatives, analgesics or anesthetics, unless withholding such agents is justified for scientific reasons, in writing, by the principal investigator, and will continue for only the necessary period of time;

b. Involve, in their planning, consultation with the attending veterinarian or his or her designee;

c. Not include the use of paralytics without anesthesia.

5. Animals that would otherwise experience severe or chronic pain or distress that cannot be relieved will be painlessly euthanatized at the end of the procedure or, if appropriate, during the procedure.

6. The animals' living conditions will be appropriate for the species in accordance with the Animal Welfare Act and the Guide and contribute to their health and comfort. The housing, feeding, and nonmedical care of the animals will be directed by the attending veterinarian or other scientist trained and experienced in the proper care, handling, and use of the species being maintained or studied.

7. Medical care for animals will be available and provided as necessary by a qualified veterinarian.

8. Personnel conducting procedures on the species being maintained or studied will be appropriately qualified and trained in those procedures.

9. Activities that involve surgery include appropriate provision for pre-operative and post-operative care of the animals in accordance with established veterinary medical and nursing practices. All survival surgery will be performed using aseptic procedures, including surgical gloves, masks, sterile instruments, and aseptic techniques. Major operative procedures on non-rodents will be conducted only in facilities intended for that purpose which shall be operated and maintained under aseptic conditions. Non-major operative procedures and all surgery on rodents do not require a dedicated facility, but must be performed using aseptic procedures. Operative procedures conducted at field sites need not be performed in dedicated facilities, but must be performed using aseptic procedures.

10. No animal will be used in more than one major operative procedure from which it is allowed to recover, unless:

a. Justified for scientific reasons by the principal investigator, in writing.

b. Required as routine veterinary procedure or to protect the health or well-being of the animal as determined by the attending veterinarian.

c. In other special circumstances as determined by the Administrator of APHIS, USDA on an individual basis. Written requests and supporting data will be sent to the Administrator, APHIS, USDA, 4700 River Road, Riverdale MD 20737. Tel. 202-720-3668

11. Methods of euthanasia used will be in accordance with the definition of the term set forth in the USDA recommendations and the recommendations of the American Veterinary Medical Association (AVMA) Panel on Euthanasia, unless a deviation is justified for scientific reasons, in writing, by the investigator.

B. Procedures

1. The principal investigator will submit an Animal Study Protocol form . with all pertinent information to the office of the Division of Laboratory Animal Resources. One member of the UCAC, designated by the chairman, may conduct a preliminary review and may suggest modifications (to secure approval) for adherence to applicable guidelines. Prior to UCAC review, each member of the UCAC will be provided with a copy of the Animal Study Protocol and with a synopsis of proposed activities to be reviewed. Protocols may be approved by: a) approval at a convened meeting of the UCAC or b) by a designated reviewer. Approval at a convened meeting: Approval by the UCAC of the activities involving the use of animals may be granted after review, at a convened meeting of a quorum of the UCAC, and with the approval vote of a majority of the quorum present. Approval by a designated reviewer: In special circumstances the UCAC may use the designated reviewer procedure. All UCAC members will receive a copy of the proposed Animal Study Protocol by mail. Within one week of the mailing of the protocol any member of the UCAC may request that the protocol be reviewed by the full committee at the next UCAC meeting. If no UCAC member requests full committee review, then the UCAC Chair can refer the protocol in question to a designated reviewer. The Chair may select one or more UCAC members, qualified to review the specific protocol, who will act on behalf of the entire UCAC to approve the protocol, request additional information from the P.I., or refer it for full UCAC review.

No member may participate in the UCAC review or approval of an activity in which that member has a conflicting interest (e.g., is personally involved in the activity), except to provide information requested by the UCAC, nor may a member who has a conflicting interest contribute to the constitution of a quorum.

2. "Just in time" review by the UCAC: For ETSU R&D proposals and for competing PHS applications or proposals, verification of UCAC approval may be filed with the granting agency at any time prior to award unless specifically required earlier by the funding component. It is the responsibility of the Principal Investigator (PI) to secure UCAC approval in time to accept a PHS award. The UCAC will review animal study protocols at its regular monthly meetings only and will not call special meetings to review an impending award. Under no circumstances may the UCAC be pressured to approve an animal study protocol or be overruled on its decision to withhold approval.

3. The UCAC may invite consultants to assist in the review of complex issues arising out of its review of proposed activities. Consultants may not approve or withhold approval of an activity, and may not vote with the UCAC unless they are also members of the UCAC.

4. The UCAC will notify the principal investigator, the Vice President for Health Affairs, and the Vice President for Academic Affairs, in writing, of its decision to approve or withhold approval of those activities related to the care and use of animals, or of modifications required to secure UCAC approval. If the UCAC decides to withhold approval of an activity, it will include in its written notification a statement of the reasons for its decision and give the principal investigator an opportunity to respond in person or in writing. The UCAC may reconsider its decision, with documentation in UCAC minutes, in light of the information provided by the principal investigator.

5. The UCAC will conduct continuing reviews of each previously approved, ongoing activity involving the care and use of animals at appropriate intervals as determined by the UCAC but not less than annually. The UCAC will conduct a complete review of all activities related to the care and use of animals in accordance with the above described policies and procedures at least once every three years.

6. The UCAC may suspend an activity that it previously approved if it determines that the activity is not being conducted in accordance with the description of that activity provided by the principal investigator and approved by the UCAC. The UCAC may suspend an activity only after review of the matter at a convened meeting of a quorum of the UCAC and with the suspension vote of a majority of the quorum present.

7. If the UCAC suspends an activity involving animals, the Institutional Official at ETSU in consultation with the UCAC, will review the reasons for suspension, take appropriate corrective action, and report that action with a full explanation to APHIS and any Federal agency funding that activity.

8. Proposed activities and proposed significant changes in ongoing activities that have been approved by the UCAC may be subject to further appropriate review and approval by officials of ETSU. However, those officials may not approve an activity involving the care and use of animals if it has not been approved by the UCAC.

9. A proposal to conduct an activity involving animals, or to make a significant change in an ongoing activity involving animals, must contain the following:

a. Identification of the species and the approximate number of animals to be used.

b. A rationale for involving animals, and for the appropriateness of the species and numbers of animals to be used.

c. A complete description of the proposed use of the animals.

d. A description of procedures designed to assure that discomfort and pain to animals will be limited to that which is unavoidable for the conduct of scientifically valuable research, including provision for the use of analgesic, anesthetic, and tranquilizing drugs where indicated and appropriate to minimize discomfort and pain to animals.

e. A description of any euthanasia method to be used.

10. A copy of all approved protocols and changes to the protocols will be maintained in the office of the Division of Laboratory Animal Resources for the duration of the activity and an additional three years after completion of the activity. All records will be accessible for inspection and copying by authorized USDA or funding federal agency representatives at reasonable times and in a reasonable manner.

11. An animal study may involve a partnership between collaborating institutions. If the other institution has a current Public Health Service Assurance on file with the NIH Office of Laboratory Animal Welfare and is registered as a research animal facility with the US Department of Agriculture, ETSU and the other institution may exercise discretion in determining which institutional animal care and use committee (IACUC) reviews the research protocol(s) and under which institutional program the research will be performed. If the ETSU UCAC defers the protocol review to the other IACUC, documentation of the review will be maintained by the ETSU UCAC. It is imperative that the ETSU UCAC is informed about any significant questions or issues raised during a semiannual program inspection by the IACUC of the other institution housing a collaborative research activity for which that IACUC bears some responsibility. It will be the responsibility of the Principal Investigator to keep the ETSU UCAC informed.

12. Protocol Amendment: Any changes or modifications to an approved animal study protocol require prior approval by the UCAC. The principal investigator will submit a written amendment to the previously approved study protocol if it becomes necessary to modify the experimental procedures, the anesthesia, analgesia or euthanasia procedures, if additional animals are needed or if there will be a change in personnel handling the animals. A change of animal species used, or changes in the objectives of an approved study, or the addition of survival surgery procedures, or if the proposed change increases the potential for pain or distress in an animal, will require submission of a complete Animal Study Protocol. Using the forms provided on the UCAC website, the request for approval of an amendment to an approved protocol is submitted to the UCAC through the DLAR office.

Protocol Review Form

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