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Do I Need IRB Review?

Do I Need IRB Review?

The information below will assist you in determining if your research requires IRB Review.

IRB Decision Tree

Guidance for Faculty Conducting Research as Part of a Course or Class Project

Faculty Teaching/Research and Related Activities

This section is intended to provide guidance to faculty regarding course activities that are research-related and present issues regarding whether or not the course activities fall under the jurisdiction of the Institutional Review Board (IRB). What follows is guidance only.

Review by the IRB should be sought if a project uses methods designed to develop or contribute to generalizable knowledge, involves human participants, and any of the following apply:

      1. The student intends to disseminate the results beyond the classroom (e.g., presentations at local, regional, and national conferences; publications; blogs and websites). Dissemination at Senior Conference or Honors Day, on campus, does not necessitate IRB review unless one or more of the conditions described in points 2 through 5 below apply.

      2. The project involves greater than minimal risk, meaning the probability and magnitude of physical or psychological harm is greater than what is normally encountered in the daily lives of the participants.

      3. The project collects sensitive information that is recorded in such a way that the respondent can be linked with their responses (either through collected identifiers or demographic data). Sensitive information may include information about drug use, sexual preferences, family violence, and similar topics.

      4. The project collects data from people unable to provide informed consent due to their age, incarceration, or limited mental capacity.

      5. The research involves deception.

Class and Course Research Exceptions to Review Requirements and Research Requiring Review

Faculty are encouraged to consult with the IRB Chair or committee members if they have questions. 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" is the key concept defining IRB jurisdiction. The following three categories illustrate how applying the concept to activities combining teaching and research may or may not require IRB review.

      1. Demonstrations

        Classroom projects that are for the primary purpose of teaching a student about research, to illustrate scientific principles, or to conduct statistical analysis, and are not for dissemination beyond the instructor and other students in the class, do not constitute human subjects research because they are not designed to develop or contribute to generalizable knowledge. The following sections provide additional guidance regarding circumstances where classroom projects do or do not require review by the IRB.

        Data are collected from students enrolled in a course for the purpose of demonstrating principles of science and/or behavior firsthand or to provide data for learning statistical analysis. Such demonstrations are public only within the context of the class, the risks are known to be minimal, and students are able to choose not to participate and are provided alternate means of earning participation credit. The data are not collected for publication in scholarly journals or disseminated outside the course. There are no restrictions about how long the demonstration lasts (one or more class periods), where the data are initially collected (during or outside class time), or how "well-known" the principle being demonstrated is. The primary components of these types of class activities are that the risk of harm to students is minimal and gathering and dissemination of the data is confined within the class setting. If the activities in a class conducted by faculty are as described in this section, IRB review is not required.

      2. Students Learning About Research or How to Do Research in a Class

        This category differs from the first in that students may be asked to be participants in research projects as a credit earning class activity, but the research is not confined to one just one class. An example is joining a participant pool of students enrolled in introductory social science classes or students conducting human participant research as a component of a research methods class.

        If students are enrolled in a course where, as a component of the course, they are offered the opportunity to participate in research as subjects, this should be clearly stated in the course syllabus. Faculty teaching courses where credit is offered for participating in research should seek a single, global informed consent for participation from the students (or students' parents or legal guardians if they are under 19 years of age) for all participation opportunities throughout the term. Researchers should then obtain assent from the subject pool participants for each project in which an opportunity to participate is offered.

        In other cases students may be enrolled in classes designed to develop research capacity and skill. Students in these classes may individually or jointly conduct several research projects in one term. Faculty instructing these classes should request IRB approval for all projects to be conducted in the class at the beginning of the term. The faculty member must stipulate that none of the projects will be disseminated beyond the classroom or BSC campus setting, involve greater than minimal risk, collect sensitive information that is recorded in such a way that the respondent can be linked with their responses, or collect data from people unable to provide informed consent.

        When 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 in advance, based on a generic description of topics and/or methods that the professor will subsequently allow students to pursue. Otherwise, the project should be submitted under standard IRB procedures.

      3. Students Doing Research under Faculty Guidance

        Students doing individual or group research under faculty guidance (e.g., senior project, independent study, Honors projects, etc.) are not conducting classroom projects and may or may not require IRB review. Consultation with the IRB is recommended.

Change in Status of Research Approved for Instructional Purposes

If the original project is primarily for instructional purposes but researchers wish to disseminate the results publicly at a later time, the researchers or course instructor may file for IRB review of the archival data analysis at that time. Similarly, if the investigator finds that demonstration or instructional research conducted and/or approved under the principle of minimal risk of harm to participants poses a greater than minimal risk of harm the research must stop. Full IRB review and approval is required before the research may continue.