Institutional Animal Care and Use Committee Policies and Procedures


Consult the college veterinarian (ext. 2177) or the IACUC chair (ext. 2692) to determine which form is appropriate for your study or research project  

Introduction
Berry College is committed to the humane care and use of animals in all activities related to research and teaching. Thus, Berry College has adopted, on an institution-wide basis, the principles regarding animal care as stated in the Animal Welfare Act (PL 89-544 and amendments), the Guide for the Care and Use of Laboratory Animals (published by the National Research Council), and the Guide for the Care and Use of Agricultural Animals in Agricultural Research and Teaching (published by the Federation of Animal Science Societies). In order to accomplish the objectives inherent in these regulations and principles, Berry College established the Institutional Animal Care and Use Committee (IACUC).

All research, classroom, or other activities (with or without internal or external funding) that involve the use of vertebrate animals must undergo IACUC review and receive written approval prior to initiation. Investigators are required to consult with the Berry College veterinarian about the project and submit a completed Application for Protocol Review to the IACUC for review. The IACUC is authorized to request modifications, approve, withhold approval, or suspend previously approved animal research and teaching projects. In addition to reviewing specific research projects, the IACUC also carries out other federally-mandated functions such as reviewing and reporting on the overall animal program; inspecting and evaluating all of the animal facilities, at least once every six months; reviewing and investigating concerns involving the care and use of animals at the institution; and making recommendations to the provost regarding any aspect of the research, animal program, facilities, or personnel training.

Membership
The IACUC shall consist of at least seven members. Membership shall include one faculty member from the departments of animal and horticultural science, biology, psychology, and religion and philosophy; the College veterinarian; a member of the community who has no connections to Berry College; the Dean of Mathematical and Natural Sciences; the Director of Research and Sponsored Programs (ex-officio member); and the Provost (ex-officio member). Members are appointed by the provost for a three-year term and may be reappointed at the discretion of the provost.

Meetings
The IACUC will meet monthly, usually on the first Friday of the month. Special meetings may be called as deemed necessary for the performance of IACUC responsibilities. A simple majority of the membership shall constitute a quorum.

Review Procedures
All Berry College faculty, staff, and students are required to have research and teaching activities involving vertebrate animals reviewed by the IACUC prior to the beginning of the activity. The Application for Protocol Review (see Appendix E) should be submitted to the IACUC via the Office of Research and Sponsored Programs. If the activity is being submitted to an outside agency for funding, the application form and proposal must be approved by the IACUC before the proposal is mailed to the sponsoring agency.

The following steps are involved in the review process:

Step 1: Submission of the Protocol. Investigators submit two completed and signed application forms to the director of Research and Sponsored Programs in typed, hard copy.

Step 2: Initial Review. Following the receipt of an application form by the FRASP director, the form will be checked for completeness and compared to the final proposal. Complete application forms are then forwarded to the committee for review and discussion.

Step 3: Review. At their monthly meetings, the IACUC considers new protocols. Possible outcomes of the IACUC’s review include unqualified approval, approval pending modification(s) and/or clarification(s), table (deferral), or disapproval.

Step 4: Investigator Notification. If a protocol receives unqualified approval, the investigator is provided with a signed copy of the approved Application for Protocol Review. In cases where the IACUC requires clarification(s) or modification(s), the investigator is notified by the FRASP director. In such cases, the approval is issued following receipt of an acceptable response from the investigator. In cases of a tabled or disapproved protocol, the investigator is notified by the FRASP director and advised as to available options.

Criteria for Review
All proposed activities are reviewed to ensure that the following federal requirements for granting IACUC approval are met:

Activities 

- All activities involving animals must be in accord with USDA Regulations/PHS Policy

Pain/Distress 

- Projects must avoid/minimize discomfort/distress/pain. If pain/distress is caused, appropriate sedation, analgesia, or anesthesia will be used.
- Attending veterinarian must be involved in planning.
- Use of paralytics is prohibited.
- Animals with chronic/severe unrelievable pain will be painlessly killed.

Alternatives 

- The Principal Investigator has considered alternatives to procedures that may cause more than momentary or slight pain or distress to the animal and has provided a written narrative description of the methodsand sources, e.g., the Animal Welfare Information Center, used to determine that alternatives were not available.

Rationale/Methods
     All proposals must include:

- Identification of the species and the approximate number of animals to be used;
- A rationale for involving animals and for the appropriateness of the species and numbers of animals to be used;
- A complete description of the proposed use of the animals;
- A description of procedures designed to assure that discomfort and pain to animals will be limited to that which is unavoidable.
- A description of any euthanasia method to be used.

Surgery 

- Must meet requirements for sterile surgery and pre/post operative care.
- Cannot use one animal for several major operative procedures from which it will recover, without meeting specified conditions.

Housing/Health 

Animal living conditions must be consistent with standards of housing, feeding, and care directed by veterinarian or scientist with appropriate expertise. Medical care must be provided by qualified veterinarian.

Qualifications

Personnel must be appropriately trained and qualified.

The Committee’s review process always includes a check for compliance with all applicable IACUC or institutional policies and procedures.

Continuing Review, Amendments and Termination of Protocols

Continuing Review and Three-Year Renewal of Ongoing Projects

Animal research protocols are approved for a three-year term, subject to continuing review at least annually.

Continuing Review Process

A letter is sent two months prior to the anniversary date of the last review to the principal investigator indicating that the continuing review is due. The investigator must complete and return a Continuing Review Summary, which is then reviewed by at least two IACUC members. Upon recommendation of the reviewers, the protocol is either approved outright for a period of time up to an additional year, or a protocol modification is requested and the normal review process resumes.

Three-Year Renewal

At the end of the third year of a protocol, the investigator must resubmit the protocol for IACUC review in order to continue research or teaching activities. A new Application for Protocol Review must be submitted; this form undergoes the same review process as any new protocol. The renewal should include all previous modifications or amendments made to the protocol since its original approval.

Modifications or Amendments to Approved Protocols

Modifications to approved protocols must be documented appropriately, reviewed, and approved. The method for obtaining approval for a modification or amendment is similar to that for a complete protocol. A letter requesting the modification including an explanation of the rationale for the change, and any amended Application for Protocol Review pages resulting from this change should be submitted to the IACUC. The chairperson or administrator, in consultation with the college veterinarian, determines if the modification is "minor" or "significant." Minor modifications may entail such things as small numbers of additional animal subjects, the addition of new personnel, or perhaps changing the route of administration of drug. Minor modifications may be approved administratively by the IACUC chairperson and the college veterinarian without full review. A major modification may entail a large change in numbers of animals being used or requested, an increase in invasiveness, a change in species, an increase in pain or discomfort, or a change in the method of euthanasia. Major modifications require review by the full committee. A written description of the significant change in the protocol should be provided to the IACUC. The veterinarian will notify the IACUC of any changes in choice of anesthetics or analgesics and any changes in their dosage.

Termination of IACUC Protocols

It is the responsibility of the investigator to notify the IACUC when a project is completed. Completed, withdrawn, or terminated projects are closed immediately upon notification. All animal use on a specified protocol is stopped. No further purchase of animals can be made under the specified protocol number. All closed projects are filed in the FRASP office for a three-year period from date of closure.