Class Protocols for Research Methods Courses

Courses in research methods or class assignments that meet the definition of research with human subjects must be reviewed and approved by the Institutional Review Board (IRB) prior to initiation of the research tasks.

While the class exercise may not fit the standard definition of research in the sense that the results are not intended for generalization to other situations, the potential for risk to subjects who participate in research class exercises requires that the protocol and consent information be reviewed by the IRB.

In the interests of fostering solid education and ethical conduct of research, modeling good peer review practices is essential to research pedagogy.

How to request approval for a Class Protocol

When the overall objective of a class assignment is to learn about how research projects are designed and conducted and data analysis will occur for learning purposes only, the instructor may make a request for approval of a "Research Methods Class Protocol" . This request typically includes:

• Exempt Screening Application form (category 1, 2, 3, 4, or 6)
• Appendix P
• Appendix J

The objective of the IRB review is to ensure that the class assignment includes appropriate precautions for protecting the human subjects. Given the scope and nature of the assignments, the IRB may require minor modifications in subject population or topic areas for the research to ensure protection of human subjects.

Very ambitious projects or projects involving sensitive topics and vulnerable/protected populations are not suited to Class Protocols.

Guidelines for Class Protocols

Projects are approved with the understanding that all students participating in the class exercise will conduct similar research projects. The IRB may grant approval for Class Protocols that repeat for subsequent semesters or are offered numerous times during the academic year.

Annual continuing review updates are required to ensure that the approved guidelines are maintained.

Guidelines:

1. The instructor is assuming the responsibility for overseeing the conduct of the research.
2. Research projects conducted under "Class Protocol" will typically fall under the Exemption categories of low risk research. In special advanced research courses, some may be minimal risk research that is eligible for expedited review. In this case, use the Health & Medical/Biological Application Form or the Social & Behavioral Sciences Application Form, depending on the type of research.
3. Students will draw research subjects from the general adult population and involve non-vulnerable subjects.
4. Student projects will not involve any personal, sensitive or incriminating topics or questions which could place subjects at risk;
5. Projects will not manipulate behavior of participants beyond the range of "normal" classroom activity or daily life;
6. Projects will not involve physically or psychologically invasive contact with the subjects.

Recommended Materials for Students in Class Protocols

• Protecting Human Subjects Guide
• CITI Online Training

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