Does my course activity constitute research?
Research is defined for IRB purposes as activities intended to contribute to "generalizeable knowledge". The criterion that triggers the need for IRB approval in the course setting is whether the project is designed as research (to contribute to "generalizable knowledge") or whether it is designed strictly as a learning exercise with results that are not used outside the course setting. Research with human study participants requires IRB approval, whereas course exercises do not.
Two very important points:
1. The intent to publish or otherwise publicly disseminate the results outside the course automatically establishes both the intent to contribute to generalizable knowledge and the need for IRB approval prior to beginning to collect data.
2. The IRB is not able under any circumstances to approve research retroactively.
I think I might want to incorporate my course activity into my future research/scholarship. What should I do?
Faculty often wish to incorporate the data or results from many types of course activities into their scholarship. They may want to present the data at conferences or apply for grant funding using the results as pilot data. Often, conference sponsors or funding agencies require evidence of IRB approval, which is why we advise faculty to seek IRB approval for any course activity that they may at some future time decide to consider to be research. Classifying a course activity as outside the definition of research and deciding not to seek IRB review/approval precludes any future use of the gathered data outside of the course.
What if my outside/community partner wants to use the data we collect in the course?
Working with an outside/community partner can add complexity, because the ways in which the outside/community partner intends to use the data collected can also factor into your decision about the need to seek IRB approval. Some outside/community partners have exceptions to IRB review for internal studies such as program reviews or needs assessments. However, your students gathering data for the partner may not be covered under that exception. It is wise to have a frank discussion with your outside/community partner about the various possible uses of the data collected before beginning your study, as IRB approval cannot be obtained retroactively.
What is the policy for research done by students in the context of a course?
Many research projects occurring in courses qualify for exemption. This means that the IRB will review the proposed projects to ensure that they meet the requirements for one of the categories for exemption. Please review the categories for exemption on the IRB site prior to submitting a proposal for a course exemption. If the projects within your course will not qualify for exemption, please do not submit a course exemption request. Often, it is easiest for us to work from sample materials submitted by the professor. These can be examples of important items like consent forms, survey instruments, interview protocols, etc that the students will use as models to create their own versions of these documents for their projects. IRB review of example materials (rather than materials created by the students in the course) also allows the professor to apply for a Course Notification of Review for Exemption at the beginning of the semester or even earlier in advance of when the course is taught. If you do apply in the midst of your course, please budget for the time required for us to review your application and for you to address any requested revisions. Unanticipated delays mid-semester can be very disruptive to your planned schedule for your course.
Next, we generally compile our feedback into a letter sent to the professor for the course. Along with the feedback letter, we usually send a Course Notification of Review for Exemption covering the exempt research occurring in the context of the course. The approval is contingent upon adequate responses to the feedback sent by the IRB. The professor teaching the course determines the adequacy of student responses to areas of concern and/or IRB feedback. Thus, the course professor effectively takes on many of the roles of the IRB during work with students in his or her course, i.e. reviewing proposed projects and evaluating student-generated forms or protocols. By accepting a Course Notification of Review for Exemption, the professor teaching the course agrees:
1. To be responsible for understanding the limitations of the applicable criteria for exemption.
2. To apply the exemption criteria properly to research projects proposed by students.
3. To refer any questions about specific projects to the IRB.
To re-submit the review for exemption every two years or more frequently if substantial changes occur in the research procedures or study materials.
What if students propose high-risk or otherwise non-exempt research project ideas during my course?
If there are any high-risk or potentially problematic projects among those proposed for the course by students, the professor should refer those projects to the IRB. Course exemptions cannot be granted for and do not apply to non-exempt research occurring in courses. The IRB will request a full application for IRB approval for the project, which must be approved before any data collection can occur in the course. This helps to protect the faculty member from issues arising from more complex questions of informed consent and other human participant-related research considerations. Please be aware that review of a full application can take from two to several weeks. An unplanned delay like this can be disruptive to a course schedule mid-semester. Faculty operating their course under a Course Notification of Review for Exemption must either mentor the students through the process of submitting a full IRB application for any non-exempt research occurring in their course or counsel students to select research projects that meet one of the exemption criteria.
What if I want to do research on the students in my course?
Your students are considered a potentially vulnerable population. Collecting data for the purposes of your own research or scholarship is subject to IRB review. Research with your own students as participants does not meet the criteria for exemption per SMC policy (see the section on exempt research). You will need to submit a full application for approval to do research on your own students. However, collecting data for the sole purpose of improving your own teaching or as part of a formal program review is not considered research (see the definition of research above). If you intend to use data for multiple purposes that include research/scholarship, seek IRB approval prior to collecting the data. Data collected as part of an activity not defined as research and without IRB review/approval cannot be used as research data in the future.
The IRB and the chair are available for any additional help or guidance you might need.