Oversight for classroom projects involving human subjects but designed exclusively for pedagogical purposes falls under the full purview of the course instructor, who has primary responsibility for assuring that the rights and welfare of human subjects are not violated. These instructors should consult the Course-based Project Guidelines located in the IRB's Standard Operating Procedures (SOP #8).
Many graduate level research courses and a few undergraduate courses, however, do require students to conduct research that meets the definition of human subjects research. These class projects require review and approval by SHSU's Institutional Review Board (IRB), also called the Protection of Human Subjects Committee (PHSC). The following information will help instructors to determine if IRB review and approval is needed for their respective courses.
What is the definition of human subjects research that would require PHSC review?
Per the federal regulations 45 CFR 46, under which the University operates, research is defined as the following:
a systematic investigation, including research development, testing, and evaluation designed to contribute to generalizable knowledge.
Investigations designed to develop or to contribute to generalizable knowledge are those that seek to draw general conclusions, inform policy or generalize findings beyond a single individual or an internal program. A human subject is defined as a living individual about whom an investigator conducting research obtains data through intervention with the individual or identifiable private information. Any research meeting this definition is subject to PHSC review.
Thesis or dissertation projects involving human subjects conducted to meet the requirement of a graduate degree are considered generalizable, and require IRB review and approval.
To what classroom projects do the Course-based Project Guidelines apply?
The guidelines apply to human subjects classroom-based projects conducted purely for pedagogical purposes that do not meet the definition of human subjects research that would require PHSC approval. The guidelines are intended to apply to those classroom activities that do not constitute generalizable knowledge, but instead serve as opportunities for students to gain practice in developing hypotheses, methods to test hypotheses. Practices in hypothesis testing do not require IRB review. The assignment must be clearly stated in the course syllabus, and the course-based project is to be performed by students enrolled in an undergraduate or a graduate course at SHSU as a requirement for completion of the course. Further, details on "best practices" for the conduct of course-based projects are provided in this policy.
Please click on the following link for assistance with determining when classroom research is purely for instructional purposes and when it is Human Subjects research requiring the review of SHSU's Institutional Review Board (IRB), also called the Protection of Human Subjects Committee (PHSC): Course-Based Projects Standard Operating Procedures.