1.2 Human Subjects Research Defined and Who Must Submit Protocols

Virtually all federally funded research with human subjects is governed by federal regulations patterned on those of DHHS (Department of Health and Human Services,) described at 45 CFR 46.115, and known as "the Common Rule." This federal code defines research as: "a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge."

Human subjects, sometimes called human participants, are defined as "living individual(s) about whom an investigator conducting research obtains data through intervention or interaction with the individual, or identifiable private information." Systematic investigations are studies that are intended and designed to collect data about human subjects with the purpose of drawing conclusions and reporting research findings.

"Intervention" includes both physical procedures by which data are gathered and manipulations of the subject or the subject's environment that are performed for research purposes. "Interaction," on the other hand, includes communication or interpersonal contact between the investigator and a subject such as by way of interviews or survey questionnaires.

"Private information" includes data about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, as well as information that has been provided for specific purposes by an individual in circumstances or conditions where the individual reasonably expects the information will not be made public. Private information must be individually identifiable (i.e., the identity of the subject is or may readily be ascertained by the investigator or associated with the information) in order to constitute research involving human subjects.

At Kenyon College, all faculty and staff research that conforms to these definitions in the Common Rule must be submitted for review by the IRB regardless of funding source: federal, state, local, private or unsponsored. The Kenyon College IRB reviews protocol applications from all disciplines. In accordance with the Federal-Wide Assurance ( FWA No. 00015567) issued to Kenyon College by the Office for Human Research Protections (OHRP), DHHS, all human subjects research funded by the federal government must be performed in accordance with 45 CFR 46. In addition, the actions of Kenyon College officials, researchers, and staff must conform to all applicable federal, state and local laws and regulations.

Student research intended to result in generalizable knowledge must also be submitted for review, for example, all honors theses proposals or undergraduate research intended for publication or wide dissemination such as a web page or presentation outside of the classroom i.e., at a conference or poster session. Student research involving human subjects must be supervised by a Kenyon College faculty advisor who will assume the responsibility for ensuring that all research procedures comply with federal, state and college policies designed to protect human participants. Classroom projects, problems courses, and independent studies that are exclusively for instructional or mentorship purposes need not undergo review by the IRB if the risks are NOT GREATER than minimal.

However, faculty advisors and students are encouraged to follow the IRB Policies & Procedures Manual when designing and conducting class exercises, projects or other assignments that involve the use of human volunteers or respondents, even if not submitted for review. All research, including student research, that poses GREATER than minimal risk must be submitted for IRB review.