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Guidelines for Classroom Activities Involving Research Methods




Certain courses are designed to teach students how to conduct research. The question often arises as to whether or not IRB approval for human subjects research is needed for such a course or the students taking the course.

Is it Research?
Activities designed to educate/train students in research methods, under the normal classroom setting, usually do not fall within the federal definition of research as described in 45 CFR 46.102(d):
Research means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.

A "systematic investigation" is an activity that involves a prospective plan that incorporates data collection, either quantitative or qualitative, and data analysis to answer a question.  Examples of systematic investigations include:
- surveys and questionnaires
- interviews and focus groups
- analysis of existing data
- evaluations of social or educational programs
- cognitive and perceptual experiments

Investigations designed to "develop or contribute to generalizable knowledge" are those designed to draw general conclusions, inform policy, or add to the scientific or academic record (e.g., publications or presentations outside of campus). The intent to contribute to "generalizable (scholarly) knowledge," however, makes an experiment or data collection research, regardless of publication.

Class Activities
Class activities or assignments include those conducted during or outside of class with students enrolled in an official course as well as activities in fulfillment of class assignments involving interactions with individuals other than the members of the class. These assignments are typically initiated and completed within a single term. Faculty members may design assignments that engage students in interaction with individuals or data about individuals to teach research methods or to help students understand concepts covered by the course. For the most part, they are not intended to create new knowledge or to lead to scholarly publication.

Minimal Risk
Although most student class assignments pose little or no risk to students or others, some may warrant enhanced attention because of risks to students or to the individuals outside the class. These risks may include physical harm or potential psychological, social, economic, or legal harm, especially when data is collected about sexual activity, use of alcohol or illegal drugs, or involvement in illegal activities. Class activities posing greater than minimal risk must be submitted to the IRB for review.

Required Forms
Faculty teaching a research methods course or other related courses should submit an Application for Teaching Research Methods to the IRB, which can provide blanket approval to students in the course as long as certain conditions are met as outlined in the Teaching Research Methods paperwork. The Teaching Research Methods Part II form must be submitted by the instructor each semester an approved course is taught. Only students whose research does not meet those conditions are required to apply individually for IRB approval. These documents are available via the Forms and Guides link to the left.

When Classroom Activities Require IRB Approval
There are several situations when educational activities designed to teach research methods require submitting an IRB Application for Human Subjects Research Approval:
  • Graduate theses and capstone projects are clearly understood as research and fall within the IRB purview when human participants are involved.
  • If a student's proposed research project involving human subjects may result in a formal publication or presentation (beyond UC's Student Research Day), involves more than minimal risk to the subjects, or in any other way meets the federal definition of "research" according to 45 CFR 46, the student must receive IRB approval before beginning the study.
  • There may be instances when a student or instructor wishes to use data for research that was previously collected for educational purposes. An application should be submitted to the IRB when a student or instructor wishes to analyze the data with the intent of contributing to generalizable knowledge.
Examples:
- An instructor is surprised at some of the unique findings that appeared when students completed surveys as part of a classroom activity. The instructor would like to do additional analysis on the data and submit it for presentation or publication when the course ends. The instructor's intent has changed and the IRB application is necessary because the instructor will now be analyzing existing data that was collected for a non-research purpose.

- Similarly, an undergraduate student in PSY 412 or SOC 312 has unique findings from their class research project and now wishes to publish or present the data with the intent of contributing to generalizable knowledge.  IRB review and approval is necessary because the intent has changed and the activity is now defined as "research."

- An undergraduate junior psychology major wishes to conduct research in the hopes of having a publication to list on her application to graduate school. She plans to devise an experiment, enroll subjects, analyze the results, and write a manuscript. This is human subjects research, and therefore requires prior IRB review and approval.