Research Oversight Committee

Animal Subjects Research at Bowdoin College

Bowdoin 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 Guide for the Care and Use of Laboratory Animals.

As outlined in the College’s Animal Welfare Assurance, there is a standing faculty committee, the Research Oversight Committee (ROC), which serves as the Institutional Animal Care and Use Committee (IACUC) for Bowdoin College. The ROC has been established to approve all research projects under the auspices of Bowdoin College that involve the use of live, vertebrate animals or cephalopods – regardless of the funding source for the research.

The ROC 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. There is also a local veterinarian who is a member of the ROC and who serves as a College consultant for animal care concerns.  One outside member of the ROC represents general community interests. This person’s role on the committee is to bring a non-College perspective to the overview of research.

However, it is not just the ROC that has responsibilities for animal research oversight. Any faculty member, staff member, or student who is planning to participate in a research 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. All members of the research team must complete training before being allowed to participate in animal research. Documentation of training must be submitted to the ROC before a research project will be reviewed. There are a number of websites that offer training in general animal research topics, such as the NIH Office of Animal Care and Use and the AALAS Learning Library.

All research using live vertebrate animals conducted under the auspices of the College must be submitted to the ROC for approval. A protocol application form has been created for this use. There are two methods of protocol review:

  • Full Committee Review – A convened meeting of a quorum of the ROC can approve, request modifications of, or disapprove the proposed protocol by a simple majority vote.
  • Designated Member Review – To utilize Designated Member Review, each ROC 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, 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.

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.

The ROC will convene for meetings a minimum of six times a year. There shall be at least three convened meetings in the fall semester and at least three convened meetings in the spring semester. If a situation requiring a convened meeting arises, there is the possibility of the committee meeting during the summer. 

Animal research protocols must be submitted to the ROC at least two weeks in advance of a scheduled meeting to be guaranteed a place on the agenda.

There are three possible outcomes to the review of a research proposal:

  • Approval – A protocol that has been approved by the ROC requires no further action by the investigator before the research may commence.
  • Conditional Approval - The ROC 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 ROC meeting.
  • Negative Decision – A protocol that has been disapproved by the ROC 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 investigator is required to wait for approval from the ROC prior to initiation of the research study. 

 
No research may begin before it is approved.

If a protocol is approved, the investigator will receive an approval letter from the ROC. This letter will list the assigned ROC 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 ROC for review. However, in order to assure compliance with all requirements and to inform the ROC 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 ROC. These include

  • an adverse event which is related to study procedures
  • a change to the described study procedures
  • a change in research staff, or
  • termination of the study.

 
In addition to the convened ROC 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 ROC 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 ROC records be retained for at least three (3) years after the end of the duration of the animal activity. Proposals submitted to the ROC must be kept for three years even if approval was not granted or animals were not used. All ROC files will be retained in the office of the Dean for Academic Affairs.

For more information about the role of the Research Oversight Committee, or for answers to questions about the submission process, please contact the ROC Chair, Patsy Dickinson.