Animal Research and Care

B.  The qualifications, authority and percent of time contributed by veterinarian(s) who will participate in the program are as follows:

Dr. Stephanie Carle, D.V.M. is the veterinarian who participates in the IACUC, contributing time as needed to the functions of the IACUC.  Her qualifications are as follows:

Dr. Carle is the full-time veterinarian for the Abilene Zoo, demonstrating experience with a variety of animals of captivity and wildlife. She has past experience serving in an IACUC role.

We have established a relationship with Dr. Carle that permits us to avail ourselves of her services on an “as needed” basis rather than in terms of some fixed percentage of her time. Dr. Carle has delegated program authority and responsibility for the institution’s animal care and use program and has access to all animals and protocols.

C. This institution has established an Institutional Animal Care and Use Committee (IACUC), is properly appointed in accordance with the AWA/AWR and is qualified through the experience and expertise of its members to oversee the institution’s animal care and use program and facilities. The IACUC consists of at least three members, and its membership meets the compositional requirements set forth in the AWA/AWR.

D. The IACUC will:

a. Review at least once every six months the institution’s program for humane care and use of animals, using the documents outlined in II as a basis for evaluation. The IACUC procedures for conducting semiannual program reviews are as follows:

The chair calls a meeting at least every six months. At least two members must be in attendance for review to take place. Prior to the meeting, the chair reviews the evaluation checklist to ensure it is complete and accurately reflects the current animal program, and distributes the checklist and any other supporting materials to the committee. At the review meetings, guests from relevant departments and the Office of Risk Management may be invited to report on all activities involving animals, training and/or occupational health and safety. All elements of the checklist are reviewed and discussed. Records are provided to IACUC members as needed to determine the status of the program. Deficiencies are noted, timelines for correction discussed and recommendations for the IO noted. The chair follows up on any matters of concern with relevant campus personnel.

b. While no laboratory animals will be housed by this institution, agricultural facilities housing animals for agricultural purposes will be reviewed at the time of semi-annual review. At this time, the ACU Farm will provide assurance that no agricultural animals will be used for purposes other than agricultural uses and/or agricultural research, as defined by the AWA/AWRs.

c. Prepare reports of the IACUC evaluations according to AWA/AWR and submit the reports to the Institutional Official (IO). The IACUC procedures for developing reports and submitting them to the Institutional Official are as follows:

Detailed minutes of review meetings and evaluations are taken by the chair and transcribed for the report. As appropriate, the report is circulated electronically to members of the IACUC for majority signature prior to submission to the Institutional Official and includes any applicable minority views. Any departures from the AWA and the documents outlined in IIE, as appropriate, are included in the report submitted to the Institutional Official. Departures are identified as significant or minor, and a plan for correction is included.

Such departures are discussed with the researcher involved and corrections requested. The IACUC chair follows up on the corrections that are made. The chair reports any deficiencies in the program or facilities to the IO. The chair also meets in person with the IO to review progress toward remediation of deficiencies. When significant deficiencies are not addressed according to the plan, this will be reported to USDA, when required, within 15 business days of the deadline.

d. Review concerns involving the care and use of animals at the institution. The IACUC procedures for reviewing concerns are as follows:

Any matters arising regarding specific concerns are discussed by the IACUC. In general, responses to concerns by students or others not involved in any animal research (such as students interested in animal rights issues) are addressed by one-on-one meetings with the department chair or departmental representatives. A written report is submitted to the institutional official about the IACUC findings and recommendations.

Any persons with concerns regarding animal welfare may bring these concerns in writing or in person to the IACUC chair. Matters that cannot be resolved by a simple conversation are brought to the full committee for discussion and resolution. Concerns may be reported anonymously, and there will be no repercussions for personnel reporting policy violations.

This policy is posted on the Sponsored Research Office website at www.acu.edu/academics/orsp/non-human-research/animal-research.html. In addition, instructions for reporting concerns regarding animal welfare are also available on that site.

e. Make written recommendations to the Institutional Official regarding any aspect of the institution’s animal program or personnel training. The procedures for making recommendations to the Institutional Official are as follows:

Recommendations are developed by the committee and are drafted by the chair. All proposals are reviewed and approved by members of the committee, who are free to propose alternative suggestions until consensus is reached. These proposals are sent to the Institutional Official. The chair also provides liaison with relevant campus offices to assure that recommendations are carried out.

f. In accordance with the AWA/AWR, the IACUC shall review and approve, require modifications in (to secure approval), or withhold approval of covered activities related to the care and use of animals. The IACUC procedures for protocol review, are as follows:

Protocols are submitted on a standardized form, consistent with policy guidelines, for all non-agricultural research and teaching activities involving the use of live vertebrate animals. Protocols are circulated electronically to all committee members and given at least one week to call for a full board meeting. If no call is made, the protocol will be sent to a single voting IACUC member for designated review. This member will be selected by the IACUC Chair. If called to full board, the protocol will be discussed at a meeting of a quorum of voting members. All voting members may ask questions and propose changes as appropriate. The committee conducts voice votes at meetings, with decisions made by simple majority of voting members in attendance. Possible outcomes include “Approval,” “Approval with Clarifications or Modifications” or “Approval Withheld.” The chair communicates to the investigator in writing either approval, request for clarification prior to approval, request for specific changes or denial of approval. In the case of requested revisions, the committee will determine at the full board meeting whether revisions can be confirmed by a designated voting member or whether the protocol needs to return to full board meeting. The decision to allow designated review of revisions must be unanimous. The designated reviewer will be assigned by the IACUC chair.

Full board reviews may, on occasion, take place electronically, according to guidelines in NIH Notice #NOT-OD-06-052. A meeting may be conducted by real-time conference call or by videoconference with a quorum of IACUC members to confirm the vote. Members must be given all necessary materials in advance and be able to interact and vote in real time.

If a designated review is assigned, the IACUC member is generally given a two-week period to review and make a decision. Decisions may include “Approval” or “Approval with Clarifications or Modifications.” However, a designated reviewer may not withhold approval. In such a case, the protocol must be discussed at a full board meeting.

Guidelines for determining designated review vs. full board:

It is recommended that full board meetings be called for studies involving a high degree or potential for pain, distress or harm. Such studies may be those involving, but not limited to, survival surgery, radiation sickness, tumor inducement, toxicology or infectious disease. Designated review may be appropriate for studies involving, but not limited to, non-survival surgery, tissue collection, antibody production, telemetry or behavioral observation, when appropriate steps are taken to minimize pain and distress.

Committee members with conflicts of interest (for example, those submitting research protocols for review) must recuse themselves from all deliberations on the protocol, other than to answer questions. They may not vote to approve any research activities for which there is a conflict of interest. Consultants may attend meetings and contribute to discussion; however, these individuals do not count toward quorum and may not vote.

No activities covered under this policy may begin until IACUC approval is granted.

g. Procedures to review and approve, require modifications in (to secure approval) or withhold approval of proposed changes regarding the use of animals in ongoing activities as set forth in the AWA. The IACUC procedures for reviewing proposed significant changes in ongoing research projects are similar to those outlined in Section D-6.

Significant changes that require IACUC review include those involving new procedures, changes in pain/distress categories, change in primary personnel (e.g., PI) or changes in species.

Minor administrative changes, such as changes in non-essential personnel or contact information, may be submitted for administrative approval by the IACUC Office.

Minor increases in animal numbers may be administratively approved when the request is no more than 10% of the initial request and a satisfactory justification for the increase is provided. The IACUC chair may make this determination. At any time, the chair may determine that the request requires IACUC review.

Certain changes may be approved by Veterinary Verification and Consultation (VVC). Such requests must not involve new procedures, but may involve minor changes to already approved procedures, such as the frequency, duration or number of procedures performed; the type or dose of medication used; or the method of euthanasia. To request a VVC, the researchers should complete a consultation form and submit it to orsp@acu.edu. The request will be sent to the veterinarian who will determine if the requested change is permissible under VVC, conduct the consult, and either approve the request, recommend revisions or defer the decision to the IACUC.

h. Notify investigators and the institution 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 IACUC approval as set forth in the AWA/AWR policy. The IACUC procedures to notify investigators and the institution of its decisions regarding protocol review are as follows:

The chair communicates in writing the approval, request for clarification prior to approval, or request for specific changes to the investigator, who then submits a revised protocol, if necessary. The investigator must provide requested material in a timely matter before approval of the research protocol. The chair provides a letter indicating IACUC approval.

The Institutional Official is informed of IACUC actions through semi-annual reports, and as appropriate, written reports submitted by the IACUC chair at other times during the year.

i. Conduct continuing review of each previously approved, ongoing activity at appropriate intervals as determined by the IACUC, but not less than annually. The IACUC procedures for conducting continuing reviews are as follows:

Investigators are notified by the IACUC Chair approximately 6-8 weeks prior to continuing review deadline. Submitted applications are distributed to the IACUC members in the same manner as new applications. Review procedures are conducted in the same manner as described in III.D.6 above.

j. Be authorized to suspend an activity involving animals. The IACUC procedures for suspending an ongoing activity are as follows:

In the event of a serious breach of guidelines, a special meeting of the IACUC is called to review the incident and determine appropriate responses. The committee shall vote whether or not to suspend research activity; a quorum must be present for this vote to take place and suspension must be by majority vote of those in attendance. Should it be deemed necessary to suspend a research activity, the chair communicates in writing to the Institutional Official and the investigator, outlining the details of the breach of guidelines and recommending suspension of research activities until appropriate remediation is completed. The Institutional Official has responsibility to assure that the investigator abides by the IACUC decision. In addition, the IACUC may determine that a report must be sent to appropriate oversight officials. In such a case, the chair will draft a report to be sent by the Institutional Official to appropriate authorities.

k. Authorized to determine when a study is exempt from AWA/AWR based on definition provided in Part 1 of the regulations, including studies involving non-covered species or the use of agricultural animals for agricultural purposes. Generally, the IACUC chair will make this determination. Individual researchers should not make this determination without IACUC consultation and confirmation of exemption. Researchers are still expected to follow standard ethical guidelines for the care and use of animals, even when studies are exempt from AWA/AWR.

E. The risk-based occupational health and safety program (OHSP), for personnel working around or having frequent contact with animals, is developed in consultation with the university’s risk management officer. This individual is invited to meet with the IACUC annually to update the committee about new regulations or when changes in current facilities or training are under consideration. The OHSP is based on identification of known hazards and development of procedures to avoid them. Principal investigators have primary responsibility for overseeing the individuals working with and around animals. The attending veterinarian is responsible for determining whether the procedures undertaken for animal care are appropriate according to current practice. Finally, the IACUC has responsibility, through regular reviews/inspections, to assure that all components of the OHSP program are consistent with policy.

Known hazards for species frequently encountered by ACU personnel include:

1) bites or scratches from rodents and birds;
2) possible allergic reactions from exposure to animals;
3) exposure to zoonotic diseases;
4) injuries from handling equipment.

Workers must be instructed in issues of personal health and safety, including:

1) the use of personal protective equipment to reduce exposure to allergens;
2) proper handling of animals to prevent bites or other personal injuries;
3) appropriate vaccinations or other preventative measures for protecting against zoonotic disease;
4) and safe handling of equipment.

Personnel are provided with lab coats, gloves and face-masks as appropriate. Workers are instructed not to eat or drink around animals, apply cosmetics or other such activities. They are also required to wash their hands upon completion of work with animals.

Workers are also instructed that in the event of any injury, however minor, they must report the injury to their supervisor for follow-up. Because most workers are students, any injuries would be handled through the campus health center and related services. Faculty and other staff would be eligible for workman’s compensation coverage should an injury be work-related.

Workers who have concerns because of pregnancy, illnesses or immunocompromised status will be encouraged to consult with their personal physicians regarding any special actions that must be taken. Where appropriate, workers may be assigned other tasks without penalty.

F. The training or instruction available to IACUC members, scientists and other personnel involved in animal research or teaching is as follows: Researchers are required to complete Animal Research/Working with the IACUC modules through AALAS. IACUC members complete these modules, as well as the IACUC member modules. These modules meet the federal requirements for basic training in the humane care and use of animals in research and teaching, in research or testing methods that minimize the number of animals needed to obtain valid results and that minimize pain and distress.

IV. Institutional Program Evaluation

All of this institution’s programs for activities involving animals have been evaluated by the IACUC within the last six months and will be reevaluated by the IACUC at least once every six months, in accordance with AWA. Reports have been and will continue to be prepared in accordance with AWA policy. All IACUC semiannual reports will include a description of the nature and extent of this institution’s adherence to the regulations and documents outlined in IID. Any departures are identified specifically and reasons for each departure will be stated. Where program or facility deficiencies are noted, the report will contain a reasonable and specific plan and schedule for correcting each deficiency. Semiannual reports of the IACUC evaluation will be submitted to the Institutional Official. Semiannual reports of the IACUC evaluation will be maintained by this institution and made available to outside officials, as required and upon request.

V. Record-keeping

A. This Institution will maintain for at least three years:

a. A copy of this policy and any modifications made to it.

b. Minutes of IACUC meetings, including records of attendance, activities of the committee and committee deliberations.

c. Records of applications, proposals and proposed significant changes in the care and use of animals and whether IACUC approval was given or withheld.

d. Records of semiannual IACUC reports and recommendations (including minority views) as forwarded to the Institutional Official (vice-provost).

e. Documentation of any IACUC-approved exception to the regulations.

B. This institution will maintain records that relate directly to applications, proposals and proposed changes in ongoing activities reviewed and approved by the IACUC for the duration of the activity and for an additional three years after completion of the activity.

C. All records shall be accessible for inspection and copying by authorized representatives/officials, as required, at reasonable times and in a reasonable manner.