Institutional Review Board

The Institutional Review Board Committee (IRB) at Keystone College is responsible for protecting the rights of human subjects who participate in research conducted by faculty, students, professional and administrative staff.

The Committee is charged with assuring that people engaging in research as representatives of Keystone College and people who wish to use members of the campus community as human subjects honor the ethical principles set forth by the Belmont Report (1978).

The IRB carries out its duties by reviewing research activities that intend to use human subjects.

IRB Responsibilities

Activities within the scope of the IRB’s responsibilities include research, development, and related activities, which would normally be construed as biomedical and behavioral investigations involving human participants. Included are studies involving not only adults and children, but also investigations of prenatal life and the deceased. Studies or procedures utilizing organs, tissues, bodily fluids of a human being are also included, as are the use of graphic, written, or recorded information about individuals even when other institutions or investigators have collected this information.

Definition of Research

Any systematic investigation, including research development, testing and evaluation, designed to develop or contribute to the well-being of participants and to general knowledge. Activities that meet this definition constitute “research” for the IRB, whether or not they are considered research in other contexts. Excluded from this definition are activities whose sole purpose is instructional; also excluded are activities whose purpose is related to routine course or program development. However, when such research involves students outside of the course, the investigator should file an IRB application sheet and consent form. Research activity would normally include the following:

• Persons or programs requesting extramural (federal, state, or private) funds for research or training.
• Individual faculty members (as well as members of the staff and administration) engaged in research as part of their professional role within the College or as part of their job assignment.
• Students performing human subjects research as part of a course, an independent study or the honors program.
• Individuals (including students or persons from outside the College other than faculty, staff, or administration) conducting research at Keystone College.

Minimal Risk

The probability of 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. (Investigators have the obligation to request a clarification by the IRB regarding activities or procedures that are seen by the investigator as questionable in terms of their inclusion in this description).

IRB Approval

Means that the IRB has reviewed the research and that the research will be conducted within the policies and procedures outlined in this booklet and within the constraints of other institutional and federal requirements. IRB approval does not necessarily include approbation of the research itself.

Applications

Student IRB applications are due to the chair of the IRB committee no later than the Friday of mid-term week each semester. Applications must be reviewed and approved by the course instructor and the School IRB representative prior to submission to the IRB chair.