V. Frequently Asked Questions
1. Guidance for the proper care and humane use of animals within University programs.
Live vertebrate animals should be used in teaching, research, and extension programs only as required to demonstrate principles, obtain new information, and achieve results which will ultimately benefit society. Whenever feasible, mathematical models, in vitro biological systems, demonstrations, and computer and audiovisual aids should augment, complement, or possibly replace live vertebrate animal use entirely, thereby reducing the number of animals needed. The procurement, care, and use of animals shall be in accordance with the regulations and terms of the federal Animal Welfare Act and the Health Research Extension Act of 1985 and subsequent revisions.
All research projects and educational or extension activities using live vertebrate animals under the jurisdiction or control of TAMIU shall be reviewed and approved by the Institutional Animal Care and Use Committee (IACUC). In its reviews, the Committee will apply standards and guidelines set forth in the Animal Welfare Act, the Health Research Extension Act of 1985, and subsequent revisions.
The housing, care, feeding, and observation of all live vertebrate animals must be supervised by individuals trained in such matters. PIs of animal care facilities are expected to meet the guidelines set forth in the Guide for the Care and Use of Laboratory Animals (for biomedical research projects) or other guides as adopted by the Institutional Animal Care and Use Committee. These guides are available from the TAMIU IACUC website.
Live vertebrate animal use shall be planned and conducted so as to avoid or minimize pain and distress to the animals. Procedures involving live vertebrate animals must be performed by, or be closely supervised by, a faculty or staff member who is skilled in the procedure. Students taking part in such procedures must be appropriately instructed and supervised. If any experimental or demonstrative procedure or its consequences have the potential to induce significant and/or lasting pain, distress, or suffering, appropriate methods of tranquilization, anesthesia, and analgesia must be used. Any painful or distressful procedure, regardless of whether it can or cannot be obviated, must be reviewed and approved in advance by the Institutional Animal Care and Use Committee.
Procedures for euthanasia must be performed in a manner consistent with the latest recommendations of the American Veterinary Medical Association Panel on Euthanasia, and all proposed methods must be approved in advance by the Institutional Animal Care and Use Committee.
Any faculty member, staff member, or student of the University who has reason to know or believe that this policy is being violated may submit a written request to the Chair of the IACUC for review of the procedure or situation in question. The Committee will examine all pertinent facts regarding the alleged policy violation. If the allegation is substantiated, the Committee will report the violation to the appropriate administrative officials. The University will take all steps possible to prevent retaliation against the person requesting the review.
2. What animal use activities require IACUC approval?
All research projects and educational or extension activities using live vertebrate animals under the jurisdiction or control of TAMIU shall be reviewed and approved by the Institutional Animal Care and Use Committee (IACUC). The following provides additional clarification of this policy:
3. What animal use activities that do NOT require IACUC approval?
Although IACUC review and approval are not required for these activities, the IACUC is willing to conduct standard review as requested. The IACUC recommends that these activities receive some type of administrative review for potential legal, liability, and public relations concerns.
4. What is the application procedure for animal use?
All use of live vertebrate animals at TAMIU requires prior IACUC approval.
The TAMIU IACUC meets twice yearly in June and December. Therefore, it is prudent to submit the forms to the IACUC as soon as the need is anticipated. All protocols must be submitted to the IACUC no later than 10 days before the meeting (contact IACUC chair to find out the biannual meeting dates).
- Complete the Animal Use Protocol Application (AUP) or Field Research Application (FRA) form
- Complete the TAMIU Medical Health Questionnaire and have current tetanus vaccine
- Submit both the signed AUP or FRA application form and page 5 of the TAMIU Medical Health Questionnaire to the Office of Research and Sponsored Projects (KL 326)
- All personnel listed on the application form who will either enter animal facility or directly handle animals must complete CITI IACUC Training, submit the TAMIU Medical Health Questionnaire and have a current tetanus vaccine prior to the initiation of any animal research.
5. What are the training requirements and who has to do them?
Online CITI IACUC training (www.citiprogram.org) will be provided to all scientists, research technicians, animal technicians, and other personnel involved in live vertebrate animal care, treatment, and use conforming to those requirements outlined in 9CFR2.32. The committee and each investigator will assure that personnel are qualified to perform their specific duties. The training and instruction will be made available, and the qualifications of personnel reviewed, with sufficient frequency to fulfill TAMIU’s responsibility as specified in 9CFR Subpart A and as specified in the TAMIU IACUC Policy and Procedures manual.
Currently Responsible Conduct of Research (RCR) is not mandatory unless working on a federally funded project. RCR training is required every four years or once per level (ie. once as an undergraduate, once as a master's student etc.). All trainings may be completed over multiple sessions.
Initial IACUC training takes about 3 hours and a refresher course is required every 3 years.
If you have any difficulties getting signed up for CITI, contact Celeste Kidd for assistance, email@example.com, 326-3028.
6. What is the Medical Health Questionnaire and why is it required?
The Medical Health Questionnaire is used to enroll all personnel exposed to live vertebrate animals in the occupational health and safety program. Enrollment in this program is required for all personnel directly handling live vertebrate animals, working in the animal facilities (including cage cleaning) or conducting field research requiring direct contact with animals.
7. Must new personnel be added to an approved protocol?
Yes. Names of all personnel who are actively handling, manipulating, or performing procedures on live vertebrate animals must be provided to the IACUC either in the original AUP or FRA submission or in an amendment to the AUP or FRA. New personnel must be added to the protocol, complete CITI IACUC Training, submit the TAMIU Medical Health Questionnaire and have a current tetanus vaccine prior to the beginning any animal research.
8. How to amend a protocol?
Any changes in the protocol procedures, number of animals, or personnel require the submission of the Animal Use Protocol Amendment form, which must be submitted to the Office of Research and Sponsored Projects (KL326), who will then:
a. Notify the IACUC Chair an amendment has been received, who will then notify all members of the IACUC in writing that an amendment has been submitted. This written notification shall contain, at a minimum the title of the study and the number of the amendment.
b. The IACUC chair will forward a copy of the amendment and parent protocol to any member of the IACUC who requests such information.
Members of the IACUC may request:
a. A copy of the written amendment and supporting documentation.
b. Submission of the amendment to the full committee at the next scheduled meeting.
If full committee review is not requested by any member of the IACUC after distribution of the amendment within 10 business days, the review may be carried out using the designated-member review method.
Designated-member review method: the Chair, or one or more experienced reviewers designated by the Chair from among the members of the IACUC, shall carry out the review. Any IACUC member who has a conflicting interest shall not participate in the review of that amendment except to provide information requested by the IACUC. The IACUC Expedited Reviewer(s) or Subcommittee shall have the same responsibilities and authority as that of the full IACUC except disapproval.
9. How to request additional or replacement live vertebrate animals?
There is the possibility of unforeseen technical difficulties and additional or replacement animals may be necessary for completion of an approved research protocol.
1. The Chair is authorized by the IACUC to increase the number of animals up to 50% of the number requested for a previously approved research protocol during the period for which the approval is authorized.
a. The Veterinarian will assure that the information sought by the use of the additional/replacement animals is sufficiently important to warrant their use.
b. The Veterinarian and/or Chair may not disapprove a request of additional/replacement animals. A request for additional/replacement animals may be disapproved only after review by the full committee.
c. The Chair will notify the IACUC at the next scheduled meeting of any request for additional/replacement animals approved using this authorization. This action will be documented in the written minutes of the meeting.
2. The IACUC may restrict, suspend or terminate this authorization.
3. Administrative Procedures:
a. Procedures of Approved Requests: When a request for additional/replacement animals is approved by the Chair of the IACUC:
• The principal investigator shall be notified of the IACUC’s decisions, conditions and requirements.
• The approved request should be filed in the protocol and committee files.
b. Procedures for requests resulting in either "modifications required for approval" or "disapproval": When a request for additional/replacement animals is made that requires modifications for approval or is disapproved:
- The principal investigator shall be notified of the IACUC’s decisions, conditions and requirements.
- The reasons for the IACUC’s decision shall be provided to the principal investigator in writing and he/she shall be given the opportunity to respond.
- The results of this request should be filed in the protocol and committee files.
10. Grant Submission
For all funded grants, the IACUC requires that a copy of the grant's vertebrate animal section be submitted with the protocol application. Before the protocol is approved the grant section will be reviewed by the IACUC to verify that the animal work described in the proposal is essentially the same as described in the listed approved animal use protocol. The investigator will be notified in writing of any major inconsistencies found. It is the responsibility of the investigator to correct the grant application and resubmit it to the funding agency.
11. Application for Multiple Projects, Co-submission and Re-review
Under certain circumstances, it may be possible to cover live vertebrate animal use for more than one project under a single AUP or FRA. For example, resubmission of a grant within one year of approval to the same or another funding agency which may involve changes in title, size of project, or contain other changes, but for which the scope of animal use (procedures, numbers, duration) does not significantly change, does not require another AUP/FRA. Co-submission of the same proposal to two or more granting agencies requires only one AUP/FRA application and a copy of each proposal. Resubmission of an unfunded proposal will not require re-review as long the nature of animal use is not significantly changed over the previous submission and the previous submission was within the last three years. A renewal of a previously funded project does not require animal use re-review as long as it has not been significantly revised and it has been reviewed by the Committee within the last three years.
12. Overseas and Field Research and IACUCs from Other Institutions
While the IACUC does not conduct inspections of field and overseas research sites, the use of live vertebrate animals at those sites by PIs is expected to be in accordance with University policy. That portion of live vertebrate animal use conducted at TAMIU in collaboration with outside researchers must be reviewed by the TAMIU IACUC, even if it has already been reviewed by an IACUC or similar committee at the collaborating institution.
TAMIU investigators participating in live vertebrate animal research conducted at other sites which has been reviewed and approved by IACUCs at other institutions may not be required to submit an application to the TAMIU IACUC. However, the TAMIU IACUC requires investigators to submit a copy of the IACUC approval from the other reviewing institution. The TAMIU IACUC will assess, whether or not a TAMIU IACUC application is also required under these circumstances.
With regard to collection of tissue samples (i.e. biopsies, blood, etc.), if samples are collected expressly for the purposes of a TAMIU investigator's research or teaching projects, that investigator must file an application for vertebrate animal use with the TAMIU IACUC. For example, clinically necessary biopsies and blood samples may be split for research purposes without IACUC review, but no clinically unnecessary sample may be taken without IACUC review and approval. This policy also applies to field studies in which samples are collected expressly for the purposes of an investigator's research or teaching projects and to studies covered by government permits. The IACUC must review these projects.
13. Preparation and Review of Blanket Protocols
Principal Investigators may wish to seek “blanket” approval for live vertebrate animal use where procedures can be described, but specific treatments and/or animal numbers are not yet determined. The potential advantage of this approach is that only an amendment would need to be filed, once the additional details are known. However, the process for approving amendments that involve significant changes requires essentially the same steps as a new submission; therefore, there may not be significant time savings in review. On the other hand, if amendments include only non-significant changes, then those changes would generally be approved quickly. If a PI has special need for rapid turnaround time on review of an AUP or FRA, s/he should contact the IACUC Chair to discuss the issue.
The AUP/FRA is approved for three years. The PI is required to submit an annual report form updating any changes that may have occurred during the year. After three years, the AUP/FRA must be re-written and undergo the entire review process again.
If changes to the procedure, number of animals or addition of new personnel is anticipated in an on-going project, a AUP Amendment Form or FRA Amendment form must be submitted to the IACUC prior to initiation of these changes. However, total approval time for a single AUP/FRA may not exceed three years.
14. What regulations and guidelines address the proper handling of vertebrates?
15. Reporting an accident, injury or medical problem related to exposure to animals
Any accidents within the animal facilities, including animal bites are to be reported to the PI and the IACUC. Anyone involved in an accident is required to submit the TAMIU Incident Report Form to the IACUC Chair (or Office of Research and Sponsored Projects, who will notify Chair of its receipt) and provide a copy to the PI. The PI is responsible for following up with IACUC regarding the outcome.
Individuals are required to notify their PI if they are experiencing medical problems thought to be related to exposure to animals and to complete the Incident Report Form. All personnel are trained in the use of PPE and appropriate respiratory safeguards when working with animals.
16. Facility Inspections
The IACUC shall inspect, at least once every six months, all of the research and live vertebrate animal facilities, including animal study areas, using title 9, chapter 1, subchapter A-Animal Welfare, as a basis for evaluation, provided, however, that animal areas containing free-living wild animals in their natural habitat need not be included in such inspections (9CFR2.31(c)(2)).
The IACUC can inspect the facility at any time. If the procedures in use prohibit inspections (for example mating rituals that cannot be disturbed by human presence) the IACUC should be informed in advance as part of the IACUC protocol application or any restrictions on the time of entry should be clearly posted on the door of the live vertebrate animal facility.
17. Annual Reviews
Annual reviews must be completed each year for all approved protocols. The reviews must be approved no less than 365 days after the original approval date or the last annual review. Annual reviews are a shortened version of the protocol application and include a description of progress made over the previous year. Annual reviews are sent to the Office of Research and Sponsored Projects and will be submitted for designated review unless any of the IACUC members request a full committee review.
Prior to the IACUC review each member shall (per 9CFR2.31 (d) (2)):
1. Be provided a list of proposed activities to be reviewed.
2. Have available access to written descriptions of all proposed activities that involve the care and use of live vertebrate animals.
3. Have the option to request a full committee review of those activities.
4. If full committee review is not requested within 10 business days, at least one member of the IACUC, designated by the chairman and qualified to conduct the review, shall review those activities and shall have the authority to approve, require modifications in (to secure approval), or request full committee review of any of those activities.
5. If full committee review is requested for a proposed activity, approval of that activity may be granted only after review, at a convened meeting of a quorum (majority) of the IACUC and with approval vote of a majority of the quorum present.
6. No member may participate in the IACUC review or approval of an activity in which that member has a conflicting interest (e.g. is personally involved in the activity) except to provide information requested by the IACUC, nor may a member who has a conflicting interest contribute to the constitution of a quorum.
18. Authorization to Suspend and to Reinstate Activities
The IACUC shall:
1. Be authorized to suspend any activity involving live vertebrate animals in accordance with the specifications set forth in paragraph (d) (6) of 9CFR2.31 as follows.
The IACUC may suspend an activity that it previously approved if it determines that the activity is not being conducted in accordance with the description of that activity provided by the principal investigator and approved by the committee. The IACUC may suspend an activity only after review of the matter at a convened meeting of a quorum of the IACUC and with the suspension vote of a majority of the quorum present;
2. If the IACUC suspends an activity involving live vertebrate animals, the Institutional Official, in consultation with the IACUC, shall review the reasons for suspension, take appropriate corrective action, and report that action with a full explanation to APHIS (if an APHIS regulated species) and any Federal agency funding (if externally funded).
3. After all the issue(s) requiring suspension of a protocol have been corrected and after review of the matter by a quorum of the IACUC, the suspended protocol can be reinstated with a majority vote of the quorum.
4. Proposed activities and proposed significant changes in ongoing activities that have been approved by the IACUC may be subject to further appropriate review and approval by officials of the research facility. However, those officials may not approve an activity involving the care and use of live vertebrate animals if it has not been approved by the IACUC.
19. How to report any suspected misconduct of research or mistreatment of animals?
You can report suspected misconduct of research or mistreatment of animals to any IACUC member, the TAMIU IACUC Chair at 326-2637, to the TAMIU Institutional Official (Provost and Vice President for Academic Affairs) at 326-2240, to TAMU system Ethics Hotline via phone 888-501-3850 or at https://secure.ethicspoint.com/domain/en/ report_custom.asp?clientid=19681
Your identity will NOT be disclosed - student and employee “whistle-blowers” are protected under Federal Law and University Policy
III. Training - Required
IV. IACUC Members
IX. TAMIU IACUC Policy and Procedures Manual (available from IACUC Chair)
If you have questions, please contact the IACUC Chair, Dr. Roberto Heredia, (firstname.lastname@example.org, CH 205B, 956-326-2637