Committee business

Member requirements

The Institutional Animal Care and Use Committee (IACUC) must include at least five members, according to NIH Office of Laboratory Animal Welfare (OLAW) regulations.

• One veterinarian with training or experience in laboratory animal science and medicine, who has direct or delegated authority and responsibility for activities involving animals at the institution;
• one practicing scientist experienced in research with animals;
• one member whose primary concerns are in a nonscientific area (e.g., ethicist, lawyer, member of the clergy); and
• one member who is not affiliated with the institution other than as a member of the IACUC.

Current number of members: 10

Meeting information

IACUC meetings are held the third Wednesday of the month. Protocols must be submitted by the last Friday of the month prior to the upcoming IACUC meeting in order to be considered for review at the following month’s meeting. Protocols received after this deadline will be evaluated at the next scheduled IACUC meeting. Administrative amendments can be submitted at any time.

While IACUC meetings are open meetings, they are currently being held using teleconferencing technology. Anyone who would like to attend an IACUC meeting or request meeting minutes can email the IACUC office to receive the necessary information.

The date or time of an IACUC meeting may change slightly if the need arises or if the scheduled meeting time falls on a holiday.

IACUC review workflows

Process for IACUC review

Protocol submittals/amendments are due the last Friday of each month for review at the following month’s IACUC meeting. When a submittal deadline falls on a holiday, then the protocol must be submitted the last business day prior to the holiday; these instances are noted in the IACUC meeting/submittal deadline table in the previous section.

The IACUC uses eProtocol software by Key Solutions to process IACUC submittals and to manage protocol/amendment reviews. Once a submittal is received, then the protocol is sent out to the IACUC for review the Monday following the submittal deadline. The IACUC reviewers are given approximately five business days to review the protocol and enter their comments into eProtocol. If there are any comments to address, the comments are returned and the PI has approximately five business days to address the committee’s comments and resubmit the protocol. The goal of the preliminary review is to address any potential IACUC comments prior to the meeting so protocols/amendments can be reviewed and approved in an efficient manner.

Generally, the preliminary review allows for most submittals to either be approved outright or to be approved with the need for very minor clarifications/corrections. While it is rare for the IACUC to “table” a protocol/amendment for the next meeting, sometimes this occurs when a submittal lacks the necessary level of detail needed for the committee to adequately evaluate the proposal. Every attempt is made to bring each protocol/amendment to a “meeting ready” status so that this does not happen.

Designated member review verses full committee review

Protocol submittals/amendments are generally reviewed utilizing full committee review (FCR), but in some circumstances a PI may request that a designated member review (DMR) be initiated. DMR review is reserved for only the most urgent of situations as the IACUC does not possess the resources to conduct the majority of business in this manner; however, a PI may request a DMR by contacting IACUC when the need arises.

The request is promptly brought to the committee chair and if the request is granted, then a designated reviewer is assigned and a 72 business-hour review period begins in which any member of the IACUC can call for a full committee review if they are not satisfied with any detail of the proposed submittal. Once the 72-hour period has passed, without a request for FCR, then the DMR reviewer will review the protocol and if there are comments, they will promptly be sent to the PI to address. Once all of the comments have been addressed to the DMR reviewer’s satisfaction and the submittal has been recommended for approval, then the protocol/amendment submittal is approved and the PI is notified of the approval.

For example, a researcher has realized that they will need to place an order in the next week for a specific type of transgenic mouse that will no longer be readily available. The approved IACUC protocol lists USDA Pain Categories C&D. The PI submitted their amendment asking to order additional animals but cannot wait another 6 weeks for the next IACUC meeting, even though they missed the deadline for the upcoming IACUC meeting that is only a few weeks away. At this point, the researcher would initiate the DMR review request with IACUC and the request would be brought to the IACUC chair. If approved, then the workflow outlined above is followed.

Protocols that include USDA Pain Category E are ineligible for DMR review.

Questions regarding the DMR verses FCR review processes or the DMR review request can be directed to IACUC.

Administrative Reviews

IACUC policy UNR-2015-03 dictates that IACUC approval of proposed changes to animal activities or significant changes to previously approved animal activities is granted after full committee review (FCR) or alternatively after designated member review (DMR). For a summary of the approval methods for different types of proposed changes to protocols, please reference policy UNR-2015-03: Guidance on Significant Changes to Animal Activities (email iacuc@unr.edu for access to the policy).

Changes where IACUC action is required

Significant changes include those that have the potential for a negative impact on animal welfare. In addition, some activities that may not have a direct impact on animal welfare are also considered to be significant per NIH Office of Laboratory Animal Welfare (OLAW) Guidance on Significant Changes to Animal Activities: NOT-OD-14-126.

Thus, changes of the types in the following list must be approved by the University’s IACUC full committee review (FCR) or designed member review (DMR) method of approval.

• Change from non-survival to survival surgery
• Changes resulting in greater pain, distress or degree of invasiveness
• Change in housing or use of animals to a location that is not part of the animal program overseen by the IACUC
• Change in species or the addition of new species
• Change in study objectives that are not extensions of existing aims
• Changes in timing of study endpoints resulting in increases in level or duration of discomfort
• Changes in route of administration of approved test article or agent that is more invasive or may cause more discomfort
• Change in Principal Investigator (PI)
• Changes that impact personnel safety
• Increases greater than 10% of the approved total of the number of animals used for non-USDA regulated species (no allowances are provided for USDA regulated animals)
• Addition of new procedures
• Changes in sedation, anesthesia or analgesia in a manner not according to Animal Resource guidelines
• Changes to a method that is not approved or is conditionally approved in the American Veterinary Medical Association guidelines for the euthanasia of animals
• Changes in hazardous agents or test articles or agents that are substantively different from already approved test articles or agents
• Delays in date of weaning in breeding protocols if requirements of Animal Resources animal housing density standards are exceeded

Veterinary verification and consultation (VVC) method of approval

Some significant changes to protocols of the type described below may be handled administratively in consultation with the University’s attending veterinarian in such cases where IACUC has developed a policy pertaining to a specific change being requested. In these instances, the attending veterinarian is not conducting a designated member review (DMR) for IACUC, but is instead serving as a subject matter expert to verify that investigators are complying with IACUC policies relative to the proposed changes in animal use. Consultation with the attending veterinarian is documented via emails or memos which are then included as part of the corresponding IACUC file. The attending veterinarian may instead refer such requests from PIs to IACUC for their review (for any reason), and in fact, must refer any requests that do not meet the parameters of IACUC policies. Significant changes allowed to proceed using the VVC method include:

• VVC #1: Changes in anesthesia, analgesia, sedation, or experimental substances
• VVC #2: Changes in euthanasia to any method approved in the American Veterinary Medical Association guidelines for the euthanasia of animals (2020 Edition)
• VVC #3: Changes in duration, frequency, type, or number of procedures performed on an animal

Examples of VVC-eligible changes include (if there is an accompanying IACUC policy):

• Addition of strain that is more susceptible to pain or discomfort
• Changes made to an approved surgical procedure from survival to non-survival
• Decrease in timing of study endpoint or shorter discomfort
• Change in level of discomfort resulting in the same or less pain, distress, or degree of invasiveness
• Change in route of administration of approved test article or agent that is less invasive or causes the same or less discomfort
• Change to nonhazardous agents and/or to test articles or agents substantively similar to those already approved
• Delays in date of weaning in breeding protocols if survival or health of pups is enhanced and requirements of Animal Resources animal housing density standards are not exceeded

Requests for VVC approval should be made to the attending veterinarian, who will then communicate the request to the IACUC chair prior to taking action. Unless objections are raised by the IACUC chair (or vice-chair, in cases of conflicting interests), the attending veterinarian will summarize the request to verify why they believe such changes are, or are not, compatible with the intent of IACUC policies. All VVC approvals will be reported to IACUC by appearing on the agenda under administrative business for the next convened meeting and will also be noted in the corresponding meeting minutes.

Administrative methods of approval

IACUC allows for a limited increase in the number of animals used on a protocol to be processed administratively if the proposed value does not increase animal numbers by more than 10% or 100 animals (whichever is the smaller number) over the approved numbers for non-USDA regulated species. Please contact IACUC if you need clarification.

Other protocol changes that may be handled administratively without committee action or the VVC method include:

• Correction of typographical errors
• Correction of grammar
• Contact information updates
• Funding agency updates
• Additions of new study objectives which are not extensions of existing aims (with agreement of the IACUC chair)
• Addition or change in strain of approved species that is equivalent in susceptibility to pain or discomfort
• Decreases in duration, frequency, or number of procedures performed on an animal
• Changes in personnel, other than the PI

In the case of non-PI personnel changes, there must be a review by the IACUC administrator to ensure that all personnel are appropriately identified, adequately trained and qualified, enrolled in occupational health and safety programs, and meet other criteria as required by IACUC.