Animal Subjects Research Policy
ºÚÁϳԹÏÍø±¬ÍøÕ¾ College has filed a written Assurance with the Office of Laboratory Animal Welfare, Office of the Director, National Institutes of Health. This document assures that the College will comply with the Public Health Service Policy on Humane Care and Use of Laboratory Animals.
The Assurance fully describes the College’s program for the care and use of animals in research activities on campus. The College’s Assurance is applicable to all research, research training, experimentation, biological testing, and related activities involving live, vertebrate animals. The regulations outlined in the Assurance are in accordance with the .
As outlined in the College’s Animal Welfare Assurance, there is a standing faculty committee, the Institutional Animal Care and Use Committee (IACUC). The IACUC has been established to approve all research, teaching and training activities under the auspices of ºÚÁϳԹÏÍø±¬ÍøÕ¾ College that involve the use of live, vertebrate animals or cephalopods – regardless of the funding source.
The IACUC is composed primarily of faculty members, appointed to the committee for a three-year term. The committee reports directly to the Dean for Academic Affairs, who serves as the Institutional Official for matters of animal research. A local veterinarian is a member of the IACUC and serves as a College consultant for animal care concerns. One outside member of the IACUC represents general community interests. This person’s role on the committee is to bring a non-College perspective to the overview of research.
Training Requirements
However, it is not just the IACUC that has responsibilities for animal research oversight. Any faculty member, staff member, student, or guest of the College who is planning to participate in a research, teaching or training project involving animals must undergo training in the care and use of research animals. Specifically, personnel should be trained in the recognition and alleviation of animal pain and distress as well as in the conduct of any specific animal procedures. Anyone handling live animals must first complete training. Documentation of training must be submitted to the IACUC before a research project will be reviewed. Online training is available at no cost through the .
Training must be completed prior to protocol submission for all researchers.
Protocol Review
All research, teaching, and training using live vertebrate animals conducted under the auspices of the College must be submitted to the IACUC for approval. Protocols are submitted via the Cayuse Animal Oversight module, an online protocol management software system, accessible through the College’s Okta Single-Sign On (SSO) portal. Time should be built into the research workplan for back-and-forth communication between the IACUC and the researcher in the event there are questions or requested revisions to be established before the protocol can be reviewed. With that consideration, a complete protocol must be submitted at least three weeks in advance of the scheduled IACUC meeting to be eligible for Full Committee Review. Protocols submitted in less time may not be reviewed until the next scheduled meeting.
There are two methods of protocol review:
- Full Committee Review – A convened meeting of a quorum of the IACUC can approve, request modifications of, or disapprove the proposed protocol by a simple majority vote.
- Designated Member Review – To utilize Designated Member Review, each IACUC member is provided with an abstract of the research proposal and has the opportunity to request Full Committee Review. If no member requests Full Committee Review within three days of receiving the application, the committee chair designates a member of the committee to review the proposal. The designated reviewer may approve or request modifications in the proposal, or may request Full Committee Review. A Designated Member may not disapprove a proposal.
Conflict of Interest
No committee member may participate in the review process of a project in which he/ she has a conflict of interest, except to provide information to the committee.
Committee Meetings
The IACUC has scheduled monthly meetings, dates and times can be found on the IACUC webpage. If a situation requiring a convened meeting arises, there is the possibility of the committee meeting during the summer.
Protocol Review Outcomes
There are three possible outcomes to the review of a research proposal:
- Approval – A protocol that has been approved by the IACUC requires no further action by the investigator before the research may commence.
- Request Modifications in Order to Secure Future Approval - The IACUC may request revisions to a proposal. The investigator will receive written details describing what additional information is required and the revised protocol will be reviewed at the next convened IACUC meeting.
- Withhold Approval – A protocol that has been disapproved by the IACUC may not be initiated. The investigator will receive written details describing the reasons for denial of approval, and will be given an opportunity to respond.
The researcher or instructor is required to wait for approval from the IACUC prior to initiation of the research or teaching activity.
Formal approval of the research protocol must also be obtained before ordering or housing any laboratory animals.
If a protocol is approved, the researcher will receive an approval letter via Cayuse from the IACUC. This letter will list the assigned IACUC number, as well as the date on which a continuing review progress report is due.
Per federal regulations, animal research protocols may be approved for a maximum of three years. At the end of the three-year approval, a de novo protocol application must be submitted to the IACUC for review. However, in order to assure compliance with all requirements and to inform the IACUC of the current status of the project, each protocol must also be reviewed annually. A continuing review form should be used for this purpose, and requires less time and effort from the investigator than submission of a de novo protocol application.
Other than the initial application, the annual continuing reviews, and the de novo protocol review after three years, there are a few other circumstances under which the investigator must submit further documentation to the IACUC. These include:
- an adverse event which is related to study procedures
- a change to the described study procedures
- a change in research or teaching staff, or
- termination of the study.
In addition to the scheduled IACUC meetings at which protocols and related documents will be reviewed, twice a year the committee conducts a thorough review of the College’s program for humane care and use of animals, including an inspection of all of the College’s animal facilities. The dates of these inspections are determined by the IACUC each year and are scheduled at six-month intervals. The results of the program and facility review are reported directly to the Dean for Academic Affairs (Institutional Official). The reports include information about the process of the evaluation and list in detail any program or facility deficiencies. Any deficiencies noted must be accompanied by a specific plan and schedule for correction.
Federal regulations require that all IACUC records be retained for at least three (3) years after the end of the duration of the animal activity. Proposals submitted to the IACUC must be kept for three years even if approval was not granted or animals were not used. All IACUC files will be retained in Cayuse and managed by the Research Compliance Manager.
For more information about the role of the IACUC, or for answers to questions about the submission process, please contact the iacuc@bowdoin.edu.