The federal regulations for the protection of human research subjects define “research” as a “systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.” 45 CFR 46.102(d)(Pre-2018 Requirements), 45 CFR 46.102(l)(2018 Requirements). In some courses students collect data from human subjects by using professional research methods, even though the student's work is not designed to develop or contribute to generalizable knowledge. For those student classroom activities that do not meet the federal definition of “research” because they are not designed to develop or contribute to generalizable knowledge, Institutional Review Board (IRB) review is not required. In these instances, the instructors are responsible for assuring that participants involved in the activity are protected. However, if such activities meet the definition of research involving human subjects, the activity must be reviewed and approved by the IRB or determined exempt prior to initiation of the activity.
Any activity that meets the definition of a “clinical investigation” involving “human subjects” must be reviewed and approved by the IRB prior to initiation of the activity. See the Human Research Protection Program (HRPP) Manual 4-3 “Determination of Human Subject Research” for definitions and requirements.
If at the conception of the student classroom activity the instructor or student is aware or expects that the data gathered by the student is designed to develop or contribute to generalizable knowledge (e.g., theses, dissertations), the activity must be reviewed and approved by an MSU IRB prior to initiation. Failure to obtain IRB approval is noncompliance. Such noncompliance will be reviewed pursuant to HRPP Manual 9-2 “Noncompliance.”
If a student collects data for non-research purposes and would subsequently like to use the data for research, IRB review may be required. The instructor or student should contact the IRB to determine if IRB review is required. When an IRB application is required, it should include an explanation of how the data were collected and why IRB approval was not sought prior to data collection. When appropriate, the consent process should be explained and a consent form attached.
When classroom activities not subject to IRB review are undertaken, instructors have primary responsibility for assuring that the rights and welfare of participants in the activity are protected. To fulfill this responsibility, it is recommended that instructors communicate to students the ethical principles for the protection of human subjects, review student classroom activities involving humans, and monitor classroom activities and reports of findings to assure that participants are protected.
Applicability of the Revised Common Rule (2018 Requirements)
See HRPP Manual Section 4-11 “Applicability of the Revised Common Rule (2018 Requirements),” for a description of whether the Revised Common Rule (2018 Requirements) or the Pre-2018 Common Rule Requirements apply.
Instructor Guidance
The following sections are provided as guidance for instructors in reviewing such activities that do not require IRB review. It is ultimately the instructors’ purview to allow the student classroom activities involving research methodologies to occur as part of the coursework.
Ethical Principles
Recommendations for Instructor Review
This policy and procedure supersedes those previously drafted.
Approved By: Vice President of Research and Graduate Studies, 3-3-2005. Revision 1 approved by VP Research & Graduate Studies on 7-22-2011. Revision 2 approved by Assistant VP Regulatory Affairs on 12-11-2015. Revision 3 approved by Senior VP for Research and Innovation on 1-18-2019.