Consistent with our liberal arts mission and commitment to engaged learning, many instructors at Macalester College support course-based activities and assignments that invite students to connect with the wider world. Some instructors design course activities and assignments that involve methods commonly used in human subjects research. For instance, these activities might include interactions with people using interviews, questionnaires, or behavioral interventions. In these cases, instructors must evaluate whether such activities should be reviewed by the Institutional Review Board (IRB).
Course-based activities and assignments that do not require IRB review
- Many course-based activities and assignments designed specifically for educational or teaching purposes do not require IRB review as long as all of the following conditions are met:
- Course-based activities or assignments that involve interaction with human subjects must exclude people from vulnerable populations.
- Course-based activities or assignments that involve interaction with human subjects must not ask individuals to participate in activities that entail more than minimal risk.
- Any data collected from human subjects as part of a class exercise or course requirement may only be shared with members of the class. These data may not be used outside of the classroom.
- Any data collected from human subjects as part of a class exercise or course requirement may not be disseminated through publications or public presentations nor used to inform policy decisions.
- If you have any questions concerning whether course-based activities and assignments require IRB review, contact the IRB chair ([email protected]) before you start the project.
- Even when a course-based assignment or activity does not require IRB review, instructors have an affirmative and ongoing obligation to ensure that students conduct their activities in accordance with ethical guidelines. Instructors should take special care to ensure that students realize the potential for harm in course-based activities and take all reasonable steps to eliminate the risks to students and individuals outside the class involved in the assignment or activities. These risks may include physical harm, psychological harm, legal harm, financial harm, and harms to reputation. In all cases, the IRB encourages instructors to work with their students to uphold the core values of ethical research as outlined in the Belmont Report: demonstrating respect for persons, protecting people from harm and securing their well-being, and ensuring an equitable distribution of risks and benefits for research participants.
Course-based activities and assignments that require IRB review
Course-based activities and assignments that are intended to collect information systematically about living individuals with the intent to develop or contribute to generalizable knowledge qualify as human subjects research under federal regulations. Instructors supervising students engaged in human subjects research must coordinate IRB review and approval of these activities before they begin. This may proceed in one of three ways.
- Instructors may encourage students to apply for IRB review. This option may be desirable where direct participation in the IRB review process has pedagogical value for student learning. This option may be most suited for students in methods-based courses or for students engaged in independent research projects, including capstone and honors projects. The instructor should expect to serve as the Research Advisor for students that apply.
- Instructors may generate an IRB application for the course-based activities and assignments and submit it for IRB review. This option may be desirable for activities that qualify for exempt or expedited review and/or will re-occur in subsequent course offerings. This is also the only appropriate option for activities that will be subject to a full review.
- Investigators may submit an IRB application to conduct human subjects research using data from course-based activities and assignments that were not originally collected through an IRB-approved protocol. This option is appropriate for instructors and students seeking to develop generalizable knowledge using a secondary data analysis study. There are, however, additional considerations that affect the feasibility of this option. For a study to be considered for review by the IRB as a secondary data analysis protocol, the investigator must not have had any involvement in the prior data collection and/or the data must have been originally collected for a purpose other than contributing to generalizable knowledge. For proposed research to be considered as a secondary data analysis protocol, the investigator must request to use data that is already available at the time the IRB protocol is being developed. A secondary data analysis review cannot be conducted for an ongoing research study. Because the IRB cannot retroactively approve studies, and because not all studies will meet the ethical requirements for approval as a secondary data analysis protocol, it is recommended that investigators seek IRB approval for a secondary data analysis protocol well in advance of the intended start of any research activities.