This clarifies the IRB’s role in reviewing class assignments and student research projects that involve human subjects.
It is common for instructors, especially those teaching courses in research methods, to design class assignments that utilize questionnaires, interviews, and other interactions with human subjects. Novel and imaginative classroom exercises help students learn and are, therefore, integral to high quality teaching. All teaching assignments, however, must respect the rights and welfare of all individuals involved. The IRB distinguishes between student research projects, which require IRB approval, and class assignments, which usually do not.
Student Research Projects
Independent research projects conducted by students, such as theses, dissertations, honors projects, and independent study projects that collect data through interactions with living people or access their private information fall under the jurisdiction of the IRB. Application to the IRB for student research projects must include endorsement by the faculty member. Per SHU policy, undergraduate and graduate students may not serve as principal investigators unless the project is a graduate student’s thesis or dissertation. In other instances students serve as co-investigators with their faculty mentors.
Faculty members may design assignments that engage students in interaction with individuals or data about individuals to teach research methods or to help students understand concepts covered in their courses. Such required class assignments often involve SHU students beyond those on the class roster as well as other participants. These assignments are not intended to create new generalizable knowledge or lead to scholarly publication. Therefore, class assignments, as a general rule, are not systematic data collection efforts intended to develop or contribute to generalizable knowledge and, thus, do not meet the federal regulatory definition of “research.” Such assignments do not fall under the jurisdiction of the IRB and do not require IRB application, approval, or oversight. Likewise, when students are conducting human subject research for class that is related to their responsibilities as employees in workplaces such as school districts, and the student secures permission from the workplace to share applicable data with instructor and fellow students, the class assignment does not require IRB approval. There are two exceptions in class assignments:
Exception 1: When class assignments are intended to contribute to generalizable knowledge (e.g., publish findings, presentations at research conferences inside or outside of SHU), the assignments are, indeed, “research” and fall under the jurisdiction of the IRB. Instructors and students wishing to use such assignments for presentation outside of class must apply to the IRB for review and approval of these assignments before they begin.
Exception 2: When class assignments extend to human subjects beyond queries of SHU students to minors or other vulnerable populations, or involve more than minimal risk to participants, such assignments fall under the jurisdiction of the IRB. Class assignments that involve more than minimal risk are assignments that ask students to survey, interview, or interact with the following populations:
- Minors (i.e., persons under the age of 18);
- Vulnerable individuals (e.g. those whose capacity to freely give consent may be compromised because of socio-economic, educational, or linguistic disadvantage; cognitive impairment; advanced age; or terminal illness);
- Individuals involved in potentially stigmatizing behaviors which, when anonymity cannot be sustained, place participants at more than minimal risk physically, socially, or economically or for civil or criminal liability;
- Other individuals who, by the nature of the class assignment, are placed at more than minimal risk.
In such cases, the class assignment requires IRB review and approval.
It is the instructor’s responsibility to ensure that her/his students understand the importance of protecting human subjects. Although most class assignments are designed as instructive measures and are not the type of activities typically reviewed by the IRB, there are instances when the nature of these projects is such that participants could be put at risk of harm, and IRB approval is required. For example, if a student proposes to ask peers about their safe-sex habits, names and responses could circulate, and the questions themselves could create emotional distress since they pertain to potentially stigmatizing behavior. In all cases, instructors are responsible for minimizing risks to participants in class assignments. The IRB strongly encourages instructors to contact the IRB for guidance and to ensure that their students are educated about risks and how to minimize them. If risks remain significant, the IRB will require a review.
Student research projects require review and approval by the IRB, whereas class assignments, in general, do not. There are two categories of class assignment that require IRB oversight—those that lead to dissemination of data or findings outside of class and those that involve more than minimal risk to human subjects.
See the Sacred Heart University Institutional Review Board website for guidelines and forms. Ask the IRB for guidance when you are unsure. The IRB secretary, Dr. Jim Carl, may be reached at 203-396-8454 or firstname.lastname@example.org.