A key question to ask in beginning the IRB process is whether the project is considered research. In general, research is defined by the Department of Health and Human Services as a "systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge" (45 CFR, Part 46).
A good rule of thumb for determining whether or not a particular project qualifies as research is to consider whether the results will be published or presented in some form or forum outside of the institution; if yes, then it is research. However publication is not the critical determinant. If the activity is one in which you conduct because of your professional position, then it may be research. If you intend to share the information with others beyond the purpose of the activity, then it may be research. In-house evaluations and assessment are not considered research that requires IRB review.
Data used for institutional purposes would not normally be considered research in this context.
What about research projects that are part of Grinnell coursework?
Current interpretation of guidelines suggest that research is held to a higher standard than instructional activities and requires research to be objectively reviewed whereas instructional activities of similar nature need not undergo review by the IRB. Because classroom-based projects will not usually be published nor contribute to the generalized knowledge, they need not go through the IRB process. Nonetheless, professors who use research projects or exercises as part of their teaching methods or those who teach research methods courses are expected to cover research ethics and to teach ethical research procedures before their students undertake such activities. Professors are also responsible for the ethical research behavior of the students in their courses even when students fulfill class projects off campus. In this context, students and faculty members are responsible for adhering to the IRB principles in their course projects. Feel free to contact the IRB for any questions that you may have.
The interpretation of the Code of Federal Regulations is that if a class project is designed with the potential to contribute to generalized knowledge, whether intended for publication or not, then the researcher should seek IRB approval prior to conducting the research. When a teacher elects not to have their class projects receive IRB review, the IRB recommends that the teacher act as an IRB Chair and require their students to submit materials for the teacher's review, that the teacher store and document the projects, so that should a participant find that the course activity harmed them in some way, the teacher has the necessary documentation of the student researchers' activity and materials.
Sometimes data from a classroom research project become part of a paper or poster submitted to a conference or a journal as a contribution to generalized knowledge even though that was not the original plan. At the time that this shift from classroom project to research occurs, the use of the data has changed, and the researcher is obligated to submit the research activity to IRB review.
Do studies that focus on quality improvement and quality assurance activities require IRB approval?
Quality Improvement and Quality Assurance activities conducted solely for the intent of maintaining or improving quality of services provided by an institution are not considered research activities. However, if the data collected are generalizable and are to be shared outside of the institution through discussion, presentation, or publication, the activity qualifies as research. In instances such as this, the research use of the data collected must be reviewed. Nevertheless, in all activities the principles of ethical practices should be observed.
Do evaluation projects require IRB approval?
Evaluations are systematic studies of programs (or of products or personnel) to determine impact and/or for improvement purposes. If the information generated from the evaluation is being used only for program administrators or staff, and is not intended for dissemination or publication, there is no need for IRB review. If there is a possibility that a publication or presentation may emerge from an evaluation study, IRB review is necessary. Please be aware that the agency for which the evaluation is being done, may require IRB approval.
