Classroom assignments, exercises, and projects involving human participants may or may not require IRB/ERC review depending on whether they meet the federal definition of “research” which is defined as “a systematic investigation designed to develop or contribute to generalizable knowledge” (45CFE46).
According to the federal definition, all students completing theses (undergraduate honors or graduate), independent studies, or doctoral dissertations, must apply through the IRB or ERC.
Research activities that are designed as part of a course requirement and involve human participants may not require IRB/ERC review and approval. Eligible assignments, exercises, or projects are those that do not involve a systematic investigation designed to contribute to generalizable knowledge. Such activities may engage students in interaction with individuals in order to teach research methods or to help students comprehend topics covered by the course. In most instances, such activities are not intended to create new knowledge or to lead to scholarly publication or presentation.
Classroom projects may not require IRB/ERC review if all of the following conditions are true:
The course instructor is responsible for informing students of the ethical considerations of human subjects research. Procedures for course assignments should include proper instruction regarding: informed consent, appropriate recruitment of subjects, minimizing risk to subjects, and protecting confidentiality.
IRB/ERC approval cannot be provided retroactively. If a classroom project produces interesting results, the data MAY NOT be used nor may the results be disseminated if IRB/ERC approval was not obtained prior to the implementation of the project. If an instructor believes that data collected may be useful for research purposes, then IRB/ERC approval must be sought before any research activity begins
Office of Research and Sponsored Programs | Keith J. O'Neill Center for Healthy Families, Room 214 | (570) 340-6088 | email@example.com