The USU IRB recognizes that cutting-edge pedagogical strategies to maximize student engagement and learning require hands-on activities. We celebrate our faculty’s commitment to providing optimal learning environments for USU students. USU IRB also recognizes the need to protect persons who support our students’ learning by lending their time and participation in research-related activities whose sole purpose is to teach new material or reinforce previously learned material.
Most classroom-based activities do not constitute research. Federal regulations define research as “a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge” (45 CFR 46). Classroom-based activities that mimic research (e.g., purpose, method) are not designed to develop or contribute to generalizable knowledge. As such, the USU IRB can assign oversight of methodological and human subjects protections to a Ph.D.-level, CITI certified instructor (i.e., Principal Investigator or PI). USU IRB will assign this oversight in the form of an approval to the PI after a formal request for oversight.If students have a priori intention to collect data that may be used for publication or to contribute to generalizable knowledge, they will need to submit a separate application for IRB review to cover their conduct of research activities while participating in the class.
Instructors may wonder why oversight approval is needed for classroom research (CR) activities. First and foremost, the USU IRB is responsible for determining whether academic activities constitute research. For activities considered research, IRB must determine the nature of the research (e.g., minimal risk) and the level of approval needed (i.e., exempt, expedited, full review). While other levels of institutional approval may be needed to carry out research, no human subjects research can be carried out without IRB approval (45 CFR 46.112). In addition, instructors are asked to consider the importance of clarity and transparency in communicating with community members about the nature of their participation in research-related activities (i.e., whether solely for educational purposes or to develop and or contribute to generalizable knowledge). Clear communication will help maintain and strengthen bonds with our broader community (i.e., Logan, Cache Valley) so that USU and its faculty/staff are perceived as trustworthy members of this community.
In order to achieve maximum balance between cutting-edge, rigorous pedagogical practices and optimal protection of human participants in research activities, PIs must:
- Notify the IRB of the course name and number
- Provide a description of the specific assignment that requires research-related activities. If at all possible describe the potential participants and methods to be used in the research. If such information is not available at the time of the application, please provide the scope of possible work. Typically this is already in the syllabus in the form of a detailed description of the course requirement.
- Verify that students enrolled in the course will: (a) become CITI certifiedprior to engaging in any research-related activities; (b) prepare a letter of information (LOI) for any human participants, which will be reviewed and approved by the PI before it is used; (c) limit research activities to adults; any research activities involving children have to be reviewed and approved by the IRB in advance.
- PIs are responsible for reviewing all research-related materials (e.g., procedures, survey questionnaires, interview questions) to ensure exempt status. The scope and definition of “exempt status” can be found in the USU Investigator Handbook for Human Participant Research (see p. 7). Specifically, PIs must be careful to ascertain:
- Research-related activities are of minimal risk. For example, participants may not be queried regarding sensitive material (e.g., any disclosure of the human subjects’ responses outside the research could reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects’ financial standing, employability, or reputation)
- Adequacy of reading comprehension level of all materials (6th grade level)
- Adequacy of all translated materials
- Videotaping is not permitted. Audio recordings may be permitted, if they are necessary to the teaching method being utilized in the course. Please note that if audio recordings are taken, they must be destroyed prior to the end of the course. If you would like your students to audio or video record an interaction with a participant, please consider an exempt application rather than the Classroom Research application.
- No use of deception
- No Interactions with children under 18, pregnant women, fetuses, prisoners, or persons with limited ability to give consent
- PIs are responsible for reporting deviations from protocol and unanticipated problems or events to the IRB (see p. 39 in the Investigator Handbook).
The IRB will close CR protocols at the end of the semester. A new semester will require a new protocol to be submitted.
Students enrolled in a course and who wish to engage their classroom research-related activity as possibly “to develop or contribute to generalizable knowledge” must fill a general IRB application. Any classroom-based research activities that are designed a priori to develop or contribute to generalizable knowledge must be approved by the USU IRB under standard protocol review procedures prior to the activities taking place . Students who engage in course research activities that were not intended to produce generalizable knowledge but that nonetheless do, can submit a USU IRB protocol under exemption #4 for review and approval. These students must document CITI certification at the time of data collection and appropriate consent procedures in order to obtain approval.
If you are completing an application for COURSE RESEARCH, please use this LOI template:
Research-Related Activities in USU Classrooms / Checklist
YES Students will be required to take the CITI certification course. Students must pass with an overall average of 80%.
YES Students will be required to draft a Letter of Information when needed. The LOI will be reviewed and approved by the instructor. Instructor must be a Ph.D.-level, CITI certified, professional.
YES Research projects fall under one of the exempt categories
YES Research is minimal risk
YES Research does not take place with any vulnerable populations (children, pregnant women, prisoners, persons incapable of giving consent).
YES PI is responsible for closing classroom demonstration projects, including safe disposal of data collected and careful review of final student reports.
YES Course research application is approved prior to any data collection for classroom research activities.
In the case that other instructors are teaching the course, a Ph.D.-level instructor will need to be identified to oversee the set-up, delivery, and evaluation of the research-related activities. The Ph.D. instructor will serve as the “Principal Investigator” on the IRB application.
A LOI is needed when research is being conducted with “human subjects,” that is, “a living individual about whom an investigator (whether professional or student) conducting research obtains (1) data through intervention or interaction with the individual or (2) identifiable private information.” (45 CFR 46).