Common Problems and Omissions in Preparing Protocol A
All new protocols submitted for IACUC review, or those that are three years old and will continue, must be documented on the latest IACUC protocol forms. To obtain the most updated version of all IACUC forms see our web site.
It is the aim of the IACUC and the administrative staff to review protocols and proposals in a timely manner. Many of the protocols must be returned because of housekeeping errors or over-sights which have to do with the procedural aspects of the protocol and not necessarily the scientific content of the research. Listed below are common reasons for preliminary approval instead of full approval by the Committee. Attention to details and the elimination of simple housekeeping errors would expedite the process and reduce the investigators', the Committee's, and the ORA staff's time required for approval.
1. Omission Of Emergency Telephone Numbers. These are important if the animal handlers and veterinary staff find animals that are ill and a decision must be made by the principal investigator or designee in managing these animals. Hospital and University numbers are not considered emergency numbers.
2. Appropriate Signatures. Department Chairperson signatures are necessary for faculty and Dean signatures are necessary if the principal investigator is the Department Chairperson. Non-faculty members must have the appropriate faculty sponsor signature. Also, the principal investigator must sign the last page of the original copy of the protocol.
3. Lay Abstract. Goals of the research must be clearly written to explain the purpose, scope, and significance of the research being proposed. It should be written in language that can be understood by a college graduate with no medical background. Scientific jargon should be held at a minimum. Abstracts that are submitted to scientific meetings and abstracts which are parts of a grant proposal generally have too much scientific jargon and assume considerable knowledge of the subject being discussed. Not all scientific disciplines are represented on the Committee and the non-faculty members of the Committee should be able to clearly understand the intent and significance of the study.
4. Justification of Animal Numbers. A common error is that the number of animals requested does not match up with the number of experiments that have been outlined. Simply asking for a specific number of animals without justifying the numbers and indicating how they are going to be used is not sufficient for the Committee. If there are a large number of animals with multiple experiments, a brief table outlining the experiments and the number of animals is extremely helpful.
5. The Administration of Drugs. When drugs are administered to awake animals, the principal investigator should indicate overt actions of the drug, whether side effects are anticipated, and the consequences of the drug actions on the animal. If the effects of the drug will alter the behavior or well being of the animal to a considerable degree, describe what changes are expected and for how long. The principal investigator should describe possible adverse reactions and outline corrective actions.
6. Clarification of Terminal Surgery as a Painful/Non-Painful Procedure. It is the USDA position that terminal surgery has the potential for pain. Thus, the USDA requires that the investigator consider alternatives to the procedure and that the IACUC review and approve the procedure. Accordingly, protocols involving terminal surgery procedures will be classified as Category B under USDA classification system and require full IACUC review.
7. Anesthesia and Analgesia
If a research, testing or teaching procedure is likely to cause pain and discomfort that would be reduced by the administration of anesthesia, the animal shall first be rendered incapable of perceiving pain and be maintained in that condition until the procedure is completed. The only exception to this policy should be those cases where the general anesthesia would defeat the purpose of the experiment and data cannot be obtained. A scientific justification must be recorded in the protocol in these instances and approved by the IACUC.
The person responsible for direct supervision or implementation of anesthesia shall be qualified by training and experience to assess the animal as an anesthetic risk, and shall monitor the phases and depth (plane) of anesthesia and determine the recovery status for discharge.
All personnel who are performing anesthesia must be technically qualified in procedures for induction, maintenance and postoperative care of the species that is being used. The agent used must be appropriate for both the species being utilized and the requirements of the experimental procedure.
Adequate grounding in the above areas will enhance the well-being of the subject and promote the success of the procedure. Such procedures must be specifically approved by the IACUC and shall be closely supervised by the investigator in charge of the research project or teaching activity, or a qualified designee.
Post-procedural care of animals shall include the use of anesthesia or analgesics as required to minimize discomfort and the consequences of any disability resulting from the experiment or teaching procedure, in accordance with acceptable practices in veterinary medicine. Post-operative or post-procedure care and the duration of such care must be outlined by the investigator. For procedures deviating from normal practice, appropriate consultation and IACUC approval must be obtained.
The surgical procedure should be carefully explained, all sections of the protocol related to surgical procedures and post-operative care should be completed. Investigators or instructors performing any surgical procedure on an animal shall conform to the requirements stated in the Guide for the Care and Use of Laboratory Animals and the Law. A facility intended for aseptic surgery shall be directed and staffed by trained personnel and used only for that purpose. All animals except rodents must have survival surgery accomplished in an aseptic surgery as defined in this paragraph. Aseptic techniques shall be used on all animals undergoing survival surgery. Survival surgery on rodents does not require a special facility but should be performed using sterile instruments, surgical gloves, and aseptic procedures. Surgery shall only be performed and/or directly supervised by persons qualified by training and experience.
Post-surgical care shall be provided as necessary by qualified personnel.
Minor surgical procedures, such as wound suturing and peripheral vessel cannulation, can be performed under less stringent conditions if they are performed in accordance with standard veterinary practice.
9. IACUC Guidelines and Policies. There are presently numerous annexes contained within the University Guidelines to assist principal investigators when documenting a protocol. These are universally accepted procedures, which have been outlined and adopted by the IACUC at this University. These procedures (Guides) can be used by the principal investigator, simply stating that you will follow the IACUC guidelines is sufficient for the Committee. If you must deviate from any of the adopted procedures, you must outline your method and indicate why you have to deviate from a specific guide. These Guides and Annexes are on the Office of Regulatory Affairs web site .
10. Euthanizing Animals. If it is necessary to euthanize an experimental animal, the investigator in charge of the research, testing or teaching procedure, or a qualified designee, shall use only methods that are approved by the American Veterinary Medical Association Panel on Euthanasia or approved by the IACUC. The ULAR clinical staff has the ethical and legal obligation to euthanize animals that are in pain and/or distress exceeding that described in the IACUC approved protocol. Normal procedure is to attempt to contact the research staff prior to euthanizing the animal. However, if that attempt is unsuccessful, humane considerations prevail. The PI must describe in the protocol the method and indicate the signs that indicate that the animal has been successfully euthanized.