Guidelines for Classroom Activities Involving Research Methods

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.

The purpose of the Teaching Research Methods Forms is to delegate to the faculty member the IRB’s responsibility for the protection of human subjects involved in these classes.

The IRB needs to understand the nature of the course (Part I) and have a summary report of the research to be carried out (Part II). Each faculty member teaching a research methods course should complete the Part I form and submit it to the IRB for approval. This will cover all the instructional research activities in the course as long as certain conditions outlined below on the Part II form are met. Faculty members need to obtain initial approval only once for research-designated courses that will be repeated without modifications – one application per course per instructor. If there are any modifications, this application must be resubmitted (modifications include, but are not limited to, changes affecting course numbers, titles, and descriptions).

Once a course has been approved by the IRB, the faculty member teaching it needs to complete the Teaching Research Methods Part II form each semester the course is taught. This form outlines the student projects and allows the IRB to be sure that each student research project involves minimal risk, adheres to ethical standards, maintains the confidentiality and informed consent of the subjects, and generally is to be used only for classroom purposes.

NOTE: This application is not to be used for instances where students are conducting true research activities. ThesIs and capstone projects are clearly understood as research and fall within the IRB purview when human subjects are involved, making courses with such an outcome objective not eligible for this application.

The IRB holds the instructor responsible for reviewing all student proposals to ensure that they meet the guidelines. Students in approved research courses covered by the Teaching Research Methods Application and Part II form do NOT submit an individual application to the IRB. Any proposals that involve more than minimal risk are not covered by the Teaching Research Methods approval process and, therefore, must be submitted by the student as a separate IRB Application for Human Subjects Research Approval.

If faculty members would like students to have the experience of completing the Application for Human Subjects Research Approval, it is available in Word format on the IRB website for draft versions to be submitted for review as a class assignment.

Teaching Research Methods Part I
Teaching Research Methods Part II

Definitions

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:

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.

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.

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.

Class Activities that Require IRB Approval

• Graduate thesis 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 Utica University'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.