Full Review

• A full committee review is required for all protocols with pain levels of D or higher (USDA Pain Levels:  B, C, D, E).
• The IACUC uses a primary/secondary reviewer method for full Committee reviews.
• The primary reviewer is always a scientific representative of the Committee and is responsible for presenting a summary of the protocol at a fully convened meeting along with any concerns or points requiring clarification and/or stipulations.
• A secondary reviewer is usually assigned by the IACUC Chair.  The secondary reviewer adds any additional concerns.
• The University Veterinarian then outlines any additional issues and then the review is opened for discussion by the Committee. 
• All Committee members are provided relevant materials and have access to all other documentation related to the study.
• The IACUC is required to ensure that all research described in a grant application or proposal is entirely consistent with any corresponding protocol(s) reviewed and approved by the IACUC.  Any discrepancies must be resolved prior to the start of the project.
• The IACUC works with Sponsored Project Administration to establish that an appropriate connection is made between the application and the protocol being reviewed.

Designated Review

• Protocols that meet the criteria for designated review are posted to allow all IACUC members an opportunity to review. 
• If no member calls for a Full Committee review, the IACUC Chair will assign one Committee member and the University Veterinarian to complete the review. 
• The reviewers’ comments and clarifications and/or stipulations are resolved with the investigator. 
• The Designated IACUC reviewer or the IACUC Chair may at any point call for a Full Committee Review.
• The IACUC is required to ensure that all research described in a grant application or proposal is entirely consistent with any corresponding protocol(s) reviewed and approved by the IACUC. 
• Any discrepancies must be resolved prior to the start of the project. 
• The IACUC works with Sponsored Project Administration to establish that an appropriate connection is made between the application and the protocol being reviewed.

Administrative Review- Protocol Identical to Previously Approved Protocol

• To be considered identical or substantially similar, the project must have the same hypothesis, specific aims and animal model.
• The chair alone (or his/her designee from the Committee) reviews and approves actions in this category.
• This category captures review of actions that do not require an actual Committee review, e.g., minor amendments, some continuing reviews, previously approved protocols that have been resubmitted or identical protocols submitted to different funding agencies, protocols with no direct animal use, or when funds will be used for salary support only on a previously approved protocol.
• The IACUC is required to ensure that all research described in a grant application or proposal is entirely consistent with any corresponding protocol(s) reviewed and approved by the IACUC. 
• Any discrepancies must be resolved prior to the start of the project. 
• The IACUC works with Sponsored Project Administration to establish that an appropriate connection is made between the application and the protocol being reviewed.

Animal Products

• Animal products are defined as material obtained from a USDA slaughterhouse, animal byproducts, or shared animal products from other investigators. 
• These projects do not require IACUC review.

Commercial Farms

• When a UVM faculty member contracts or arranges to utilize animals on a commercial farm for purposes of research or teaching, the IACUC must determine that the specific farm is committed to providing a high standard of animal welfare.
• Commercial farm operators are encouraged to follow best management practices.
• Prior to the submission of the Animal Use protocol to the IACUC, the farm owner or manager must complete the assessment checklist (PDF) such as the National Milk Producers’ Federation (NMPF) FARM program or other and provide a copy of the assessment checklist to the Principal Investigator.
• The completed farm assessment must accompany the IACUC protocol submission.
• Based on the level of invasiveness of the planned research and the completed farm assessment, the IACUC will evaluate the suitability of the collaborator farm, determine whether a farm inspection is warranted and, if so, whether that inspection will be carried out by IACUC members or by Committee designees.

• Any projects proposing to utilize recombinant DNA or infectious agents, requires review and approval from the Institutional Biosafety Committee (IBC).
• The IBC is charged with reviewing all research projects and activities involving recombinant DNA (as outlined in the “Guidelines for Research Involving Recombinant DNA Molecules”) to assure that specific practices for constructing and handling (i) recombinant DNA molecules and (ii) organisms and viruses containing recombinant DNA molecules are followed.
• A representative of the Office of Environmental Safety serves on the IBC, as does the Director of the Department of Risk Management, the University Veterinarian, the Radiation Safety Director, and faculty in the College of Medicine with particular expertise in infectious agents.
• For more information visit the Institutional Biosafety Committee and the UVM Radiation Safety Office.

If your project utilizes biohazardous materials, you must have approval from both committees (IACUC and IBC) prior to beginning the project.

Continuing Review

There are requirements for continuing review in both the Public Health Service (PHS) Policy on Humane Care and Use of Laboratory Animals and the United States Department of Agriculture (USDA) Regulations on Animal Welfare. 

Animal welfare regulations require a continuing review at least annually for USDA-covered species and according to PHS Policy Section IV.C.5, “The IACUC shall conduct continuing review of each previously approved, ongoing activity covered by this Policy at appropriate intervals as determined by the IACUC, including a complete review in accordance with IV.C.1.-4. at least once every three years.”

The IACUC developed the following processes to meet the requirements of both of the above. 

Ptotocols covered by the Animal Welfare Act (USDA covered species) or that are spnsored by certain funding agencies, require an annual continuing review. 

Each protocol, regardless of funding source, require a triennial review.

The purpose of continuing review is to monitor:

1. the status of the protocol;
2. verify that completed activities were conducted in accordance with the approved protocols;
3. solicit information about activities projected for the coming year; and
4. changes in key personnel and whether mandatory training is complete.

Amendments

• Review of any changes to previously approved research is required by regulation and is an essential element of the ongoing review of research involving vertebrate animals.
• Regulations mandate that changes cannot occur until after review and approval.
• The IACUC recognizes that research is a continuous process and that changes in the conduct of the research are necessary.
• However, no changes to an approved protocol should be implemented until the IACUC has reviewed and approved the changes. 
• The determination of whether a proposed amendment is “significant” vs. “minor” falls to the IACUC chair, in consultation with the University Veterinarian, as necessary.

PI or Key Personnel Changes

• Changes to protocol personnel or PI require an amendment to the protocol. 
• The IACUC has a specific form, Request for Change in Personnel, to make these changes. 
• Note:  Make sure any new personnel have completed the required training.

Addition of Commercial Farms

• When a UVM faculty member contracts or arranges to utilize animals on a commercial farm for purposes of research or teaching, the IACUC must determine that the specific farm is committed to providing a high standard of animal welfare.
• Commercial farm operators are encouraged to follow best management practices.
• Prior to the submission of the Animal Use protocol to the IACUC, the farm owner or manager must complete the assessment checklist (PDF) such as the National Milk Producers’ Federation (NMPF) FARM program or other and provide a copy of the assessment checklist to the Principal Investigator.
• The completed farm assessment must accompany the IACUC protocol submission.
• Based on the level of invasiveness of the planned research and the completed farm assessment, the IACUC will evaluate the suitability of the collaborator farm, determine whether a farm inspection is warranted and, if so, whether that inspection will be carried out by IACUC members or by Committee designees.
• Responsibilities of each party are further described in the Policy and Procedures for Use of Agricultural Animals in Research and Teaching (PDF).

Protocol Closure

• It is the responsibility of the investigator to notify the IACUC when a project is completed. 
• Projects that have been completed, withdrawn or terminated are closed immediately upon notification.
• The Office of Animal Care Management is notified by the IACUC of all closures.
• All animal use on a specified protocol is stopped and no further purchase of animals can be made under the specified protocol number.
• Notification can be done by submitting a continuing review submission ini UVMClick-IACUC.