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IACUC Protocol and the Review Process
An animal use protocol is a written description of a planned research or teaching activity in
sufficient detail to allow for a review of the proposed research activities by the IACUC. Researchprotocols submitted for IACUC review should be submitted on the most recent version of theIACUC protocol form and are asked to follow a particular outline, detailing just the informationnecessary for a proper IACUC review in clear and plain language. Incomplete protocols,protocols containing confusing or highly technical language, or protocols involving excessiveand unnecessary detail are unacceptable.
Forms, along with instructions for completing them, are available on-line at: my.francis.edu. The most current forms are required to be submitted prior to review by the IACUC. Other forms of submission are not acceptable. The forms have been specifically designed to provide the information required by regulations and by the IACUC. The protocol form should be used for all research projects as required.
A protocol must be sufficiently detailed to permit the IACUC to evaluate the soundness of the procedures proposed and to determine appropriateness of the species, the proposed number of animals, and that alternatives to using animals have been completely searched. The protocol form and its associated appendices will guide the PI to provide the necessary information. PI's should, however, ensure that they give full and detailed answers and complete all relevant supplemental forms. Sketchy answers or missing appendices will lengthen the review process. As a general guide, the following special elements should be well justified in the protocol:
If all or a percentage of animals will experience either category B or C, the PI must complete appropriate appendix to document that alternatives to painful or distressful procedures in animals have been considered. The regulations of the Animal Welfare Act (AWA) require that the principal investigator consider alternatives to procedures that may cause more than momentary (more than a simple injection) or slight pain or distress to animals. PI's must provide a written narrative of the sources consulted to determine whether or not alternatives exist to procedures that cause pain or distress. The USDA, which is charged with enforcing the AWA, has promulgated two policies (Policy #11 and Policy #12) that assist investigators in understanding how to comply with these regulations. Policy #11 (http://www.aphis.usda.gov/animal_welfare/downloads/policy/Policy%2011%20Final.pdf) provides the definition of what is considered a painful or distressful procedure, and provides examples of both. In general, any procedure that would be expected to cause more than slight or momentary and/or distress in a human to whom the procedure is applied is considered to be painful and/or distressful in animals. Policy #12 (http://www.aphis.usda.gov/animal_welfare/downloads/policy/Policy%2012%20Final.pdf) provides guidance in what the minimal written narrative should include. In general, this requires a narrative describing a specific literature search for alternatives, including databases searched, time period covered, key words used, and the date of the search. If alternatives are described but will not be used, the principal investigator must describe why these are not adequate for the project described.
PI's should note that even after analgesic drugs have been administered, animals must bemonitored closely for the adequacy and persistence of analgesia. Protocols should describe the plan for monitoring animals and should indicate who on the research team will be responsible for monitoring animals. Contact information is essential; this should be kept up to date. As with anesthetics, it is critical to document the administration of analgesia.
The IACUC will meet monthly, if needed, to review submitted protocols and other business of the IACUC. In order for a protocol to be reviewed at a scheduled IACUC meeting, it must be received by the Chair of the IACUC at least two weeks prior to the meeting date. Particularly complex or controversial procedures with multiple follow-up questions may need additional review time by the IACUC. Every effort will be made to assist investigators with extenuating circumstances requiring special consideration.1. Process for the Initial Review of Research Involving the Care and Usea. Research Investigator Completes a Protocol Approval FormThe first step in obtaining IACUC approval for research involving animals is for the research investigator to complete the IACUC Protocol Approval Form and all applicable appendices. This form may be obtained from the IO or on the SFU web site in PDF format. Only university faculty or staff may serve as Principal Investigators for an IACUC animal use protocol. Student investigators must be named on the form as being a co-investigator, with the faculty or staffmember providing appropriate direction to the student researcher. The Principal Investigator then signs the submission form attesting to the submission materials'correctness and agreeing to follow the procedures established by the IACUC. The signed submission form should be sent directly to the Chair of the IACUC. Incomplete or illegible submissions will be returned to the Principal Investigator for resubmission. To avoid the perception of conflict of interest, committee members who are participants in the protocol being reviewed do not participate in the review, deliberations and decisions on those protocols.b. Routing by Chair of the IACUCThe Chair of the IACUC receives submitted protocols and reviews each protocol for completeness. Incomplete protocols are returned to the Principal Investigator with a short note indicating its deficiency. Complete protocols are given an IACUC tracking number and entered into a computer database. The Chair then routes the protocol to all IACUC members for review before the next IACUC meeting. For protocols submitted with an "A" pain classification, a designated review process may be used. The full IACUC committee would receive a copy of the protocol and are given the option of calling for a full review. If after a designated time period (3 working days), no committee member has requested full committee review, the IACUC Chair, or appointed designated member appointed by the chairperson, could approve or require modifications to the protocol. Regardless of pain classification, a full committee review is required to disapprove or deny an animal protocol.c. Full IACUC ReviewProtocols classified B or C must be reviewed at a meeting of the IACUC, defined as a quorum of the total membership. A majority of that quorum must vote in favor for it to be officially approved. All animal use protocols brought before the IACUC are: approved as submitted, withheld pending minor revisions, or denied with recommendations for major revisions.
1) ApproveThe IACUC has determined that, for a particular animal use and teaching protocol, appropriate justification for animal use has been made, a search for acceptable alternatives to animal use has been demonstrated, and methods described are within standard and acceptable guidelines. TheIACUC signifies its approval of a research protocol by issuing a letter to the Principal Investigator that the research protocol has been reviewed, approved, and may be conducted. Protocols involving little risk to the subjects may be approved even if the benefit to be gained is likewise small (e.g., class projects where the primary gain is for the student to experience a research process). Protocols having higher degrees of risk to the species must demonstrate both sound methodology and an importance to the information that would be gained.2) Withheld PendingProtocols with a review status of withheld pending are most typically in need of one (or more) minor corrections or clarifications. The Chair will write a letter to the Principal Investigator indicating that approval for the protocol is being withheld pending certain minor revisions that must be made to the protocol. The letter will detail the items or questions requiring attention and a time frame for submitting revisions. The Principal Investigator will be invited to submit these revisions directly to the Chair of the IACUC. In certain cases the Chair might also elect to contact the Principal Investigator directly, to insure that the needed revisions are understood or to discuss ways the Principal Investigator might meet the requirements of IACUC. If the Principal Investigator responds to these minor issues raised in the letter to the satisfaction of the Chair, the Chair, as designated reviewer, may approve the protocol as revised. If no revisions are made, or the revisions are not satisfactory to the Chair, the protocol will be maintained as withheld pending and will be scheduled for presentation and discussion at the next regular meeting of the IACUC committee. More substantive changes to a protocol with a status of withheld pending may result in a re-review by the IACUC. A protocol is most typically held in a withheld pending file for no more than 30 days, after which it is approved, sent out for additional review, or administratively denied due to insufficient information.3) DenialThe IACUC has determined that, for a particular research protocol, the risks outweigh the benefits to be gained by conducting that research. Research protocols might also be denied because:
A protocol may also be administratively denied when a Principal Investigator has not responded to a request for additional information and/or modifications from the IACUC in a timely fashion (30 days).
The Principal Investigator may enact research protocols approved under this procedure for a period not to exceed the approval period. The starting and ending dates of the approval period will be stated on the approval letter sent to the Principal Investigator. In certain cases the IACUC may require a shorter approval period and will require interim protocol status reports annually on the progress of the research and the status of the animals as a condition of approval. The exact period of approval, and any conditions, will be stated on the approval letter.d. Granting Agency Requirements and Protocol SubmissionMany agencies such as NIH, NSF, DOD and the American Heart Association will not review protocols involving animals unless formal notification of IACUC review and approval has been provided. Other agencies may review and score protocols, but they will withhold funding pending notification of IACUC review and approval. PI's are urged therefore to submit the IACUC protocol prior to the submission of a grant application. It is critical that the protocol must reflect all proposed animal use detailed in the corresponding grant application in regards to the use of animals. In the NIH application, for example, Section F of the Research Plan asks for specific information on the identification of the species and approximate number of animals to be used, rationale for the use of animals and appropriateness of the species and numbers as well as statements addressing steps to assure minimization of pain and distress, as well as euthanasia methods. Please refer to the grant application for a listing of all the points. The answers to these specific points should be fully reflected in the protocol.Proposals for funding that involve the use of animals are carefully reviewed prior to receiving institutional endorsement. The review ensures that if a protocol number is listed on the Protocol Approval Form that is the correct protocol, that it is active and the approval date listed is correct, and that the PI of the protocol is listed as either the PI of the protocol or as a member of the research team. If a protocol is submitted prior to receiving approval for the relevant protocol, the University will not process the award or provide a University account until the protocol is fully approved.e. Questions and AppealsAny PI may request an appointment with the IACUC Chair, or an opportunity to address the IACUC at a regular or special meeting, for any purpose related to the business of the IACUC. The two most common reasons for such an appointment or hearing are to answer questions concerning protocols in development or research in progress, or to resolve difficulties related to the approval of a protocol. Concerns should be brought to the IACUC Chair. If resolution cannot be reached with the Chair, the Principal Investigator may be scheduled to present his/her case before the IACUC at the next regular meeting or at a special meeting called by the Chair (if the situation warrants). The decision of the IACUC, however, is final.3. A Note About Revisions/Changes to Proposed ProtocolsInvestigators should note that it is not uncommon for protocols received by the IACUC torequire revisions. The goals of the process are to ensure humane care and use of animals,sufficient and accurate documentation in protocols, compliance with all applicable animal use regulations, and that the methods and practices proposed reflect the highest in current standards. To facilitate the protocol development and review process, it is highly recommended that investigators work closely with the consulting veterinarian and the IACUC Chair in advance of protocol submission. The protocol forms are also a useful guide to ensure that protocols are as complete as possible prior to submission. In addition, it is the IACUC's hope that the review process can facilitate research through education and through acting as a forum for discussion.