I. Purpose of the Policy

This policy's purpose is to protect human subjects of original research conducted either at Kalamazoo College or by an employee or student of Kalamazoo College. It is intended to assure that subjects of research are aware of their rights and protections. Moreover, the College is required to assure the federal government that such safeguards are being provided and enforced. These safeguards are derived from ethical principles articulated in the Belmont Report issued by the
national Commission for the Protection of Human Subjects of Biomedical and Behavioral Research in 1979. Kalamazoo College follows the ethical principles articulated by the Belmont Report which are respect for persons, beneficence, and justice. Human subjects should enter into research voluntarily: and with adequate information. Possible risks to human subjects should be weighted against possible benefits and possible improvement of knowledge. Selection of human subjects should ensure that no group of participants is either consistently selected or deprived of the opportunity to participate. The IRB also recognizes that research with human subjects is a privilege - not a right, and that researchers must respect the dignity and integrity of study participants. The Institutional Review Board (IRB) is the body charged with reviewing, prior to its commencement, all research involving human subjects conducted under the auspices of Kalamazoo College. The procedures for review described below adhere to the regulations of the Department of Health and Human services (45 CFR 46, as amended and published in the Federal Register on June 18, 1991). The College has adopted sections from the policies of The College of Wooster, Middlebury College, and Bryn Mawr College.

II. Who must complete an application for IRB review of research with human subjects?

Anyone who engages in scholarly research involving human subjects, either on- or off- campus.

This includes:

  • Kalamazoo College faculty and staff;
  • Kalamazoo College students who conduct independent research and Senior Individualized Projects;
  • *Researchers not affiliated with Kalamazoo College conducting primary research with subjects on-campus; and
  • *Anyone analyzing unpublished data collected at Kalamazoo College.

Please note: Visitors to the campus and off-campus scholars may engage in research involving human subjects on campus only with the permission of the Dean of Students Office. Once the Dean of Students Office has agreed to support the project, please file an application with the Kalamazoo College IRB. If you already have IRB approval from another institution for the project, in most cases,
documentation of that approval will be sufficient to get Kalamazoo College IRB approval.

Instructors assigning student research as part of a course need not submit a proposal, unless the instructor chooses to invite committee review. Nonetheless, each faculty member engaging in such an instructional activity is expected to maintain professional standards to protect any human subject in accordance with his or her field, and to ensure compliance with this policy. For Independent Study research, see Section VII.

Human subject research is research involving data from or about living human beings. Any discipline may involve human subject research.

III. Definitions

area reviewer: member of IRB that reviews Applications for IRB Review of Research with Human Subjects forms for their Department or close academic area. The area reviewer will determine whether the application is “exempt” from review or requires IRB review. If the application requires IRB review, the application will be forwarded to the chair of IRB who will then assign a member of IRB to review the application.

data: facts, figures, and information. For the purpose of this policy, the term "data" is considered to be material from primary sources analyzed as part of scholarly efforts.

deception: intentionally misleading or providing untruthful information, any concealment, withholding information from participant, trickery, or deceit.

IRB: Institutional Review Board.

human subject: any specific living person, or information about a living person, who is the subject (participant) or object of study for the purpose of expanding our knowledge or understanding.

minimal risk: Federal guidelines state, "minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests."

original research: any activity conducted for the purpose of expanding knowledge or understanding, including the collection and analysis of data from questionnaires, observation, manipulation, sampling, experimentation, interview procedures, etc. Research using human subjects, even if it is simply verifying existing hypotheses, theses, theories, or ideas, is considered original research. This includes pilot projects and feasibility studies. Works dealing entirely with
properly attributed secondary sources are not considered original research for the purposes of this policy. Activities where human subjects perform exclusively for instructional purposes* are not original research (i.e., are not subject to these reviews). Data gathering for the purposes of fundraising by the external affairs offices; market research for the purposes of admissions recruiting; recruiting efforts for faculty or staff; statistical data collected for the management of
institutional affairs; and research with alumni, students, or parents regarding college activities and policies are excluded from the category of original research under the purview of this committee.

principal investigator: the primary person conducting the research. The principal investigator (P.I.) can be a professional or a student.

review: a process of oversight resulting in an acknowledgment of the status ("approved," "pending required amendments," or "denied") of a project under the guidelines of this policy.

risk: potential for physical, psychological, social, or financial harm.

unreasonable harm: any physical, psychological, social, or financial damage or injury, which might have been avoided without sacrificing the goals of the activity, as well as any damage or injury whatsoever whose extent can not be justified by the contribution of the research to the expansion of human understanding.

IV. Who are the members of the IRB at Kalamazoo College?

The IRB consists of at least five faculty members appointed by the Provost; at least one member of the community unaffiliated with the College, also appointed by the Provost; and, serving ex officio, the Director of Faculty Grants and Institutional Research. Information about the current members of IRB can be found on the Kalamazoo College IRB website.