Some course activities are sufficiently research-related to where they raise questions for faculty about whether or not they come under the province of the Institutional Review Board (IRB). In the spirit of providing guidance where hard-and-fast rules may not apply, two broad categories of course-related activities are suggested: Demonstrations and Students Learning to do Research in Class. They are based on the federal definition of research as "a systematic investigation (i.e. the gathering and analysis of information) designed to develop or contribute to generalizable knowledge."
In "demonstration" activities, data is collected from students enrolled in a course for the purpose of demonstrating principles of science and/or behavior firsthand. Such demonstrations are public within the context of the class, the risks are known to be minimal, and students can choose not to participate or they may choose other options. Data is not collected for publication in scholarly journals or for a report disseminated outside the course. There are no restrictions about how long the demonstration lasts (one or more class periods), where the data is initially collected (during or outside class time), or how "well-known" the principle being demonstrated is (as long as it is sufficiently like known phenomena to assure that the risks are minimal). These types of demonstration activities do not need IRB contact (although nothing precludes a professor from seeking advice from the IRB).
Students Learning To Do Research in Class
Class projects are generally conducted for educational purposes and not as research. While some may require submission of an IRB application or a determination that IRB approval is not required, some class projects require neither. For some courses, such as Research Methods, students may be required to become involved as participants in class projects (just as they may be required to write papers, do oral presentations, take tests, etc.). The catalog and course syllabus would alert students to this fact, and students "agree" to this participation by enrolling in the course. Although this does not eliminate the possibility of "risk" to them, it is a matter of professional teaching ethics that govern such class assignments, rather than human subject research ethics considerations.
If, on the other hand, such students are asked to serve as researchers with non-class participants serving as subjects, then the interests of these non-class members takes precedence. If the project would readily fit under the Exemption Categories of the IRB, then the professor may seek "blanket" IRB approval for exemption in advance, based on a generic description of topics and/or methods that the professor will subsequently allow students to pursue. Individual student research projects that fall outside of the exemption categories should be submitted for IRB review using the standard IRB Application for Non-Exempt Research (DOC).
Class research qualifies for "blanket" IRB approval if:
- It is an activity designed as part of a course requirement for purposes of learning research methods and;
- The results and data will not be presented, posted or published outside of the classroom.
NOTE: Students who intend to use research project data outside of the classroom (e.g., plans to use the data for a presentation, publication, thesis, etc.) must submit an IRB application. The application must be approved by the IRB before the student begins their research project.
Guidelines for Class Protocols
Projects are approved with the understanding that all students participating in the class exercise will conduct similar research projects. The IRB may grant approval for class protocols that repeat for subsequent semesters or are offered numerous times during the academic year. If a class protocol is approved as non-exempt, annual continuing review (renewal) is required to ensure that the approved guidelines are maintained.
- The instructor is assuming the responsibility for overseeing the conduct of the research.
- Research projects conducted under a "class protocol" will typically fall under the Exemption Categories of low-risk research. However, some projects may be classified as minimal-risk research that is eligible for non-exempt expedited review.
- Students will recruit research subjects from the general adult population and not involve vulnerable subjects (e.g., children under the age of 18, institutionalized persons, prisoners, persons who are "decisionally" impaired, etc.).
- Student projects will not involve any personal, sensitive or incriminating topics or questions which would place subjects at risk.
- Projects will not involve the manipulation of behavior of the participants beyond the range of "normal" classroom activity or daily life.
- Projects will not involve physically or psychologically invasive contact with the subjects.
The following scenarios might help you to determine whether or not a class project would require IRB review.
No IRB action required (neither approval nor determination of human research status).
- Class projects involving secondary data analyses that are assigned and conducted as educational exercises, using data that are either publicly available data, de-identified or otherwise impossible to be linked to personal identities.
- Class projects involving secondary data analyses that are assigned and conducted as educational exercises, and that use datasets that include private information and codes that link identifiers, but the students do not have access to the identifiers. Class instructor and department are responsible for providing the necessary training in respecting the confidentiality of the data.
- Class projects that involve direct interaction (e.g., in person, via mail or email, web surveys or telephone), but where the purpose is training, an educational exercise or professional development, and not research. The project is not "research" even if students ask people questions as part of learning how to conduct interviews or surveys, take histories or administer assessments, etc. Class instructor and department are responsible for providing the necessary training in respecting the privacy of the individuals and the confidentiality of any resulting information, along with training in the relevant ethics. Instructor should provide information about the assignment for the students to distribute to people who participate in these class projects, listing the instructor as an appropriate contact should questions arise. (Note: IRB approval may be requested by the "gatekeeper" (e.g., schools, businesses) for access to participants.)
Exception: If a student decides after completion of the class research activity to pursue additional activities with the same information to prepare a presentation, thesis, publication, etc., then an IRB application describing research use of secondary data should be submitted to the IRB for approval.
IRB approval required.
- Class projects that involve direct interaction or secondary analyses of private identifiable data and are undertaken as both an education experience and as research (e.g., results of these activities will be presented publicly or otherwise disseminated, or the data will be stored and used by the students or others as research data). When there are several students in a class doing similar projects, a single IRB application may be submitted by the course instructor as PI, listing all students who will be involved. If projects vary greatly, then it may be preferable to submit individual IRB applications with the student(s) as PI. Submission tip: Such projects may be very similar to one another. For example, each student may interview one or more persons for a group of oral histories, or conduct telephone surveys as part of a yearly poll, but all in the class follow the same general script or guidelines. If class projects follow different protocols, a table or chart can describe these more individualized activities under the umbrella of a single IRB application.
Please email the Human Subject Institutional Review Board at firstname.lastname@example.org.