These guidelines are intended to assist instructors in determining when class projects meet the definition of research with human subjects and require review by the Boise State University’s Institutional Review Board (IRB) for the Protection of Human Subjects.
For clarification, the following are NOT class projects; they are considered research and must be reviewed and approved by the IRB:
- Senior theses
- Honor’s theses
- Master’s theses
- Doctoral dissertations
Instructors’ Responsibilities
- Instructors should meet with students as soon as possible and go over these guidelines to determine if the proposed class project could be considered research.
- If there is even a remote possibility that a class project may fall under the definition of research, instructors are advised to submit a human subjects review application with the student to the IRB.
Training
Instructors should complete the required CITI training before deciding whether to assign research as part of classroom requirements. The IRB strongly encourages students to also complete this training before they design their projects, even if the projects do not need IRB review.
Criteria
Research qualifies for the designation of student class project (and thus does not require IRB review) 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 university (e.g., presenting the results in class or at the Boise State Undergraduate Research and Scholarship Conference is fine; presenting the results at another conference or publishing the work is not allowed under this exception).
A student class project does not meet the definition of human subject research because the project is intended only for educational and classroom purposes. The student cannot use the project for any presentation, conference, publication, thesis, dissertation, or report outside of the course for which it is assigned unless they submit a protocol application through the IRB for approval. This application must be approved before the student starts the project. Instructors must make this clear to their students.
Class Project Is “Research”
If the project meets IRB definition of research:
- The instructor should meet with the student(s) to prepare the human subjects review application.
- The instructor will need to be listed on the application as the Principal Investigator. Students are not permitted to serve as PIs unless they are conducting research for graduate thesis or dissertation.
- If the project goes before the Full Board at its monthly meeting, the instructor may be asked to attend the IRB meeting with the student (s).
Class Project Is Not “Research”
If the project does not meet IRB definition of research:
- It is the responsibility of the instructor to ensure that any changes to the project over the course of the semester would not change the project in such a way that would require IRB approval (e.g., student decides to publish their findings).
- It is the responsibility of the instructor to ensure that the class project is conducted according to the ethical standards of the relevant discipline.
- Remember that from the participant’s viewpoint, giving out personal information does not differ for a class assignment or a research project. Personal information is personal information. Instructors should advise students to identify the project to participants as a class assignment and be sensitive to the personal nature of the obtained information. Labeling the class project as “research” is inaccurate and misleading to participants.
- Students should inform participants that data will be destroyed after their assignment or class project is completed.
- Instructors are advised to tell students that data from human subjects should not contain any personal, identifying information whenever possible.
- All class projects should include informed consent language that closely follows the guidelines. Information on what to include in a consent form/script is described below. For an on-line survey, this would be the first page of the survey or in the email post.
- The IRB is available to give feedback on any proposed class project not meeting the definition of research, even though the IRB would not officially act on the project.
Consent
Obtaining consent is important to the ethical conduct of research. It is strongly recommended students obtain either verbal or signed consent from participants in their projects. In most cases it is better to provide an information sheet to project participants. However, students may use a verbal script to inform project participants instead. If students choose to use scripts instead of consent forms, instructors should make sure that their scripts accurately reflect the plans of the project (see samples on the Forms and Templates page).
Red Flags
- If the student expresses intent to use the project for a presentation, conference, publication, thesis, or dissertation, they must submit an IRB application.
- The project’s activities expose participants to more than “minimal risk” (minimal risk means no more risk than everyday life). The IRB strongly discourages class projects using more than minimal risk.
- The project involves sensitive/private information such as sexual attitudes or behaviors, illegal behaviors, and/or the use of alcohol or drugs. The IRB strongly discourages class projects asking about such behaviors.
- The project uses vulnerable populations (e.g., children under the age of 18, institutionalized persons, prisoners, persons who are “decisionally” impaired, etc.). The IRB strongly discourages class projects using vulnerable populations as subjects.
- Results of the project activities or data collected are recorded in such a way that the subjects are identifiable (images in videotapes or photographs and voices on audiotape are identifiable). The IRB strongly discourages class projects using identifiable data.
- There is no informed consent process in place.
- Subjects are under the direction or supervision of students collecting data (e.g., TAs collecting data from their own students or supervisors collecting data from employees). This could be considered coercion and is rarely acceptable under IRB guidelines.
- Students do not plan to maintain confidentiality of the data (e.g., using subjects’ real names, inability to store consent forms in locked office/cabinet, etc.). Again, the IRB strongly discourages class projects using identifiable data.
- Subjects are forced to participate or are ostracized if they do not participate. Again, this is coercion and is not allowed under IRB guidelines