Classroom Research
Projects Involving Human Subjects
Terms
- Research is defined as “a systematic investigation, including research
development, testing and evaluation, designed to develop or contribute
to generalizable knowledge….” 45
CFR 46.102(d)
- A human subject is defined as “a living individual about whom an
investigator (whether professional or student) conducting research obtains:
1) Data through intervention or interaction with the individual, or 2)
Identifiable private information” 45CFR46.102(f)
Review Procedures
- Classroom projects that involve systematic collection of data and
for which the objective or design is to develop or contribute
to generalizable knowledge are considered research.
In other words, if a student plans to use the data outside of the
classroom, then the project is considered research. Such projects
should be reviewed by the IRB.
- Classroom projects that are designed with the objective of
providing students with training about and experience with research
methods are
not considered research. In these cases, students will not use the data outside
of the classroom. Such projects do not require IRB review.
Responsibilities for Course Instructors
- Course instructors are responsible for overseeing the conduct of the
project. Instructors have the primary responsibility for ensuring
that human subjects are treated ethically.
- Instructors must communicate to
students about ethical principles for the protection of human subjects.
This includes providing students with training about human subjects
research through the NIH training course “Protecting Human Research Participants” or
other acceptable methods.
- Instructors are responsible for guiding their students, and for making
the determination regarding submitting materials to the IRB. For
example, instructors review projects involving human subjects to see if
the project is considered exempt in
accordance with 45CFR46.
- Students must submit a copy of any survey instruments or interview questions
to the course instructor for review.
- Instructors
should contact an IRB
Coordinator with any
questions regarding a project.
