Policy on Protection of Human Subjects

II. Who Must Complete A Request for Approval of Human Subjects Research?

Anyone formally affiliated with Middlebury College (faculty, staff, students) who engages in scholarly research involving human subjects, either on- or off-campus, must apply for IRB approval.

Researchers not affiliated with the College but who wish to conduct research with human subjects on campus also must have their research approved by the IRB.

Finally, anyone utilizing unpublished data from human subjects which was collected at the College must submit their research protocol to the IRB for approval.

Students who conduct research as part of a regular course assignment 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.

Courses in which the curriculum consists substantially of independent student research (e.g., 500, 555, 600, 700 ) are subject to IRB approval, and each student engaged in research involving human subjects should submit a protocol to the committee.

“Human subject research” involves the systematic collection of personal or private data from living human beings. Please see the
definitions below for additional markers of research falling under the purview of this committee. Any discipline may involve human subject research. Sociological, anthropological, and psychological studies often involve human subjects; biological studies sometimes involve human subjects. Increasingly, research in the humanities involves human subjects.*

All faculty and students are urged to evaluate their research agendas in light of this policy in order to determine whether or not their research qualifies as “human subjects research,” even if human subjects or concerns regarding human subjects are traditionally not common in their disciplines.