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This updated guidance from the Office of Research Compliance outlines the definition and requirements of research according to federal regulations. It clarifies circumstances under which classroom projects may not require Institutional Review Board (IRB) review, particularly when the intent is to teach research techniques without contributing to generalizable knowledge. It also provides criteria for when classroom projects qualify as research and require IRB submission. Professors are responsible for ensuring students are adequately trained in human subjects' protection before project commencement.
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Special Update:Classroom Projects Human Subjects’ Protection Program Office of Research Compliance September 2006 (Updated December 2007)
What is Research? • Research is defined by federal regulation as systematic investigation designed to develop or contribute to generalizable knowledge. (45 CFR 46.102)
Classroom “Research” Projects • In some situations, there may not be IRB requirements for professors wishing to teach research techniques to their classes by having students develop and execute a “protocol” as a class project. • If learning a research technique is the objective of the process and there is no contribution to generalizable knowledge, this change applies.
Classroom Projects MAY be Research • If a classroom project is systematically designed as a research project and contributes to general knowledge, the protocol should be submitted for review. • Common indicators a project may be generalizable include the following: • Intent to publish project results outside class • Projects designed to contribute to future phases of work • Projects designed to offer further insight into existing knowledge • Students collecting data to be used by other research project
Classroom “Research” Projects • Professors are responsible for insuring students are trained in Human Subjects’ Protection prior to beginning their projects. • Training resources available to professors include: • CITI Training • Click training link – www.researchcompliance.tamu.edu/irb • First eleven modules recommended • Human Subjects’ Protection Program guest speaker • Call 458-4067 to schedule
Contact Information • Questions? • Call the Human Subjects’ Protection Program • Office of Research Compliance • 979-458-4067 • irb@tamu.edu